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Life Sciences

Our life sciences training courses cover Pharmaceuticals, Medical Devices, IVDs, Biotech/Biopharma and Animal Health and have been designed to focus on regulatory affairs, clinical trials, pharmacovigilance, medical writing, latest developments, and best practices (GxP).  Our portfolio of events is extensive and provides training from basic to advanced levels in a variety of formats.  

The pandemic created numerous challenges across all areas of business worldwide and companies had to respond and adapt very quickly. Now, as the healthcare sector emerges stronger and with renewed strategy, life science companies continue to focus on key areas for development, explore the use of emerging technologies, and seek opportunities to harness collaborations and build resilience. 

Please note: full product details will be shown on our training portal IPI Academy where you can find out more and book

Risk Management for Clinical Research Training Course

Risk Management for Clinical Research

6 Jun 2025 - Online webinar
Also on: 7 Oct 2025

This essential course will explain the importance of using risk management techniques in clinical trials to comply with the latest focus on inspection in this area.

Presented by Laura Brown (bio)

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A Practical Approach to Developing the CMC Package for Veterinary Pharmaceutical Products Training Course

A Practical Approach to Developing the CMC Package for Veterinary Pharmaceutical Products

1 May 2025 - Online webinar
Also on: 4 Nov 2025

Understanding the chemistry, manufacturing and controls (CMC) requirements for veterinary pharmaceuticals is essential to support successful registration in the EU.

Presented by Craig Evans (bio)
Dave Parry (bio)

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A Practical Approach to Veterinary Vaccine Development and Registration in the EU (European Union) Training Course

A Practical Approach to Veterinary Vaccine Development and Registration in the EU

13-14 May 2025 - Online webinar
Also on: 6 Nov 2025

This event has been designed to give practical advice and guidance on how to successfully develop market approval in the EU. The programme will take participants through a step-by-step approach to the process and will also provide key guidance on how to maintain MA once achieved.

Presented by Mel Munro (bio)

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A Practical Guide to Producing and Maintaining the PSMF Training Course

A Practical Guide to Producing and Maintaining the PSMF

14 Feb 2025 - Online webinar
Also on: 23 Jun 2025

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

Presented by Graeme Ladds (bio)

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A Practical Guide to Writing Risk Management Plans (RMPs) Training Course

A Practical Guide to Writing Risk Management Plans (RMPs)

21 Mar 2025 - Online webinar
Also on: 11 Jul 2025

Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.

Presented by Graeme Ladds (bio)

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A Practical Introduction to Good Clinical Practice (GCP) Training Course

A Practical Introduction to Good Clinical Practice (GCP)

24-25 Jun 2025 - Online webinar
Also on: 7 Oct 2025

This highly interactive and practical course will introduce you to both the principles of GCP and give you an understanding of how to apply it in different settings.

Presented by Sarah Gregory (bio)
Joe Milne (bio)

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A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU (European Union) and UK Training Course

A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU and UK

30 Apr 2025 - Online webinar
Also on: 21 Oct 2025

This course will provide an excellent opportunity to hear the latest developments from regulatory experts, and enable participants to discuss the implications of the regulations on working practices and the potential impact on future regulatory strategies.

Presented by Theresa Jeary (bio)
and 3 more leading experts

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Additional Risk Minimization Measures (aRMMs) and Their Effectiveness Training Course

Additional Risk Minimization Measures (aRMMs) and Their Effectiveness

9 Apr 2025 - Online webinar
Also on: 10 Sep 2025

Delve into the world of additional Risk Minimization Measures (aRMMs) and explore everything from the regulatory framework surrounding aRMMs to their impact on patient safety and healthcare outcomes.

Presented by Alina Panourgia (bio)

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Advanced Pharmacovigilance Training Course

Advanced Pharmacovigilance

24-26 Mar 2025 - Online webinar
Also on: 2 Jul 2025

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

Presented by Graeme Ladds (bio)

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Advanced Project Management in Clinical Research Training Course

Advanced Project Management in Clinical Research

9 Jun 2025 - Online webinar
Also on: 3 Oct 2025

This Clinical Research Project Management Training course will provide you with key techniques to apply during your clinical research project to aid successful project delivery. This course will be key for those involved in clinical research projects and will cover system thinking, agile approaches and risk analysis.

Presented by Roger Joby (bio)

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Advanced Regulatory Affairs for Medical Devices Training Course

Advanced Regulatory Affairs for Medical Devices

3-4 Jun 2025 - Online webinar
Also on: 2 Oct 2025

Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)

Presented by Janette Benaddi (bio)
Theresa Jeary (bio)

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Advanced Veterinary Pharmacovigilance Training Course

Advanced Veterinary Pharmacovigilance

24-25 Jun 2025 - Online webinar
Also on: 15 Oct 2025

Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit.

Presented by Declan O'Rourke (bio)

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AI in Pharmacovigilance Training Course

AI in Pharmacovigilance

12 Mar 2025 - Online webinar
Also on: 7 Jul 2025

In this exciting new course, gain an introduction into the transformative impact of artificial intelligence on drug safety and monitoring.

Presented by Alina Panourgia (bio)

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An Essential Overview of Medical Information Training Course

An Essential Overview of Medical Information

14 Mar 2025 - Online webinar
Also on: 18 Jul 2025

In this one-day course, understand everything from the role of medical information to the guidelines for medical information and advertising.

Presented by Graeme Ladds (bio)

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An Essential Overview of Pharmacovigilance Training Course

An Essential Overview of Pharmacovigilance

15 May 2025 - Online webinar
Also on: 8 Sep 2025

A practical guide to understanding the role of pharmacovigilance.

Presented by Graeme Ladds (bio)

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An Essential Overview of the Medical Device Industry Training Course

An Essential Overview of the Medical Device Industry

14 Mar 2025 - Online webinar
Also on: 3 Jul 2025

This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.

Presented by Theresa Jeary (bio)
David Jefferys (bio)

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An Essential Overview of the Pharmaceutical and Biotech Industries Training Course

An Essential Overview of the Pharmaceutical and Biotech Industries

12 May 2025 - Online webinar
Also on: 22 Sep 2025

This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.

Presented by Laura Brown (bio)

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An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices Training Course

An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices

1 May 2025 - Online webinar
Also on: 10 Nov 2025

Sterile devices are free of viable microorganisms and EO sterilization is one of the key processes in the production of sterile medical devices. This course provides an introduction to the regulatory requirements as they relate to EO sterilisation and how manufacturers may demonstrate compliance.

Presented by Annette Callaghan (bio)

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An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals Training Course

An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals

17 Mar 2025 - Online webinar
Also on: 9 Jul 2025

This course will cover the key regulations used globally in human factors and usability engineering: the specific standards and guidances, methods, and the tools commonly used in medical device development.

Presented by Greg Thay (bio)

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An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices Training Course

An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices

22 May 2025 - Online webinar
Also on: 17 Nov 2025

Sterile devices are free of viable microorganisms and the sterile barrier system is the key to maintaining this sterility until the medical device is ready to be used on a patient. This course provides an introduction to the regulatory requirements as they relate to typical sterile barrier systems used for single-use and reusable medical devices, and how manufacturers may demonstrate compliance.

Presented by Annette Callaghan (bio)

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An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course

An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices

13 Mar 2025 - Online webinar
Also on: 3 Jul 2025

This course has been specifically designed to provide an essential introduction to ISO 13485 and the QMS and provides a comprehensive and valuable overview of the requirements and responsibilities involved.
Where ever you and your company sit within the medical device arena this is an excellent opportunity to become appraised of the requirements.

Presented by Linda Garrod (bio)

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An Introduction to Pharmaceutical Packaging Training Course

An Introduction to Pharmaceutical Packaging

2-4 Jun 2025 - Online webinar
Also on: 24 Sep 2025

This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.

Presented by Chris Penfold (bio)

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An Introduction to Pharmacology in Drug Development Training Course

An Introduction to Pharmacology in Drug Development

18 Mar 2025 - Online webinar
Also on: 8 Jul 2025

The concise course covers the fundamental principles of drug action, including small molecules, monoclonal antibodies, oligonucleotides and other advanced therapies.

Presented by Simon Hutchings (bio)

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An introduction to Risk Management ISO 14971:2019 Training Course

An introduction to Risk Management ISO 14971:2019

11 Mar 2025 - Online webinar
Also on: 11 Jul 2025

Dive into the core principles of risk management using ISO14971:2019. Learn to assess, analyse, and mitigate risks effectively, ensuring compliance with international standards and enhancing decision-making in various industries.

Presented by Linda Garrod (bio)

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An Introduction to the Design and Development of Medical Devices Training Course

An Introduction to the Design and Development of Medical Devices

8-9 Apr 2025 - Online webinar
Also on: 23 Jul 2025

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

Presented by David Howlett (bio)

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An Introduction to the Medical Device Regulation Training Course

An Introduction to the Medical Device Regulation

16-18 Jul 2025 - Online webinar
Also on: 3 Nov 2025

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

Presented by Janette Benaddi (bio)
Will Burton (bio)
Theresa Jeary (bio)

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An Introduction to the ‘Soft Side’ of Technology Transfers Training Course

An Introduction to the ‘Soft Side’ of Technology Transfers

16 Jun 2025 - Online webinar
Also on: 3 Nov 2025

The ability to create a working relationship with your partners in a technology transfer is normally overlooked. In the current pharmaceutical landscape, gaining trust should never be an after thought.

Presented by Laura Buttafoco (bio)

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An Introduction to Upstream and Downstream Manufacturing in the Biopharmaceutical Industry Training Course

An Introduction to Upstream and Downstream Manufacturing in the Biopharmaceutical Industry

4 Apr 2025 - Online webinar
Also on: 12 Sep 2025

In this talk, explore the fundamental concepts, techniques, and processes that make up the backbone of biomanufacturing, pharmaceutical production, and biotechnology.

Presented by Mustafa Edik (bio)

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Animal Feed and Feed Additive Registration in China and Thailand Training Course

Animal Feed and Feed Additive Registration in China and Thailand

27 Feb 2025 - Online webinar
Also on: 26 Jun 2025

Learn how to navigate the regulatory system for animal feed and feed additives in two emerging markets.

Presented by Bi Jun (bio)
Anongrut (Mai) Surarutrungsri (bio)

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Antimicrobial Resistance (AMR) and 'One Health': Current Challenges, Regulatory Frontiers and Future Solutions Training Course

Antimicrobial Resistance (AMR) and 'One Health': Current Challenges, Regulatory Frontiers and Future Solutions

9 Apr 2025 - Online webinar
Also on: 17 Sep 2025

This course will allow participants to explore the regulatory landscapes governing AMR, discover innovative solutions and understand the challenges AMR poses across different sectors.

Presented by Linda Oyama (bio)

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Application of Artificial Intelligence (AI) and Machine Learning in Clinical Trial Data Management Training Course

Application of Artificial Intelligence (AI) and Machine Learning in Clinical Trial Data Management

10 Mar 2025 - Online webinar
Also on: 30 Jun 2025

AI and Machine Learning are revolutionising clinical trial data management by enhancing efficiency, streamlining processes, and minimising human error. This course will be of use in both the pharmaceutical and medical device industry.

Presented by Zuzanna Kwade (bio)

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Be In the Know With Pharma 4.0: Building The Business Case For Pharma 4.0

Be In the Know With Pharma 4.0: Building The Business Case For Pharma 4.0

12 Mar 2025 - Online webinar
Also on: 16 Sep 2025

This course will equip you with the tools and insights needed to articulate your vision, secure funding, and pave the way for Pharma 4.0 success.

Presented by Lewis Shipp (bio)

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Be In the Know With Pharma 4.0: Digital CMC

Be In the Know With Pharma 4.0: Digital CMC

19 Mar 2025 - Online webinar
Also on: 23 Sep 2025

Through this interactive session, participants will explore the forces driving the shift toward digital transformation, understand the challenges Digital CMC addresses, and learn about its operational and regulatory advantages.

Presented by Lewis Shipp (bio)

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Be In the Know With Pharma 4.0: Digital Technology Transfer

Be In the Know With Pharma 4.0: Digital Technology Transfer

5 Mar 2025 - Online webinar
Also on: 9 Sep 2025

This course explores how leveraging digital solutions, companies can not only accelerate the transfer of critical knowledge but also foster innovation and gain an edge in increasingly competitive markets.

Presented by Lewis Shipp (bio)

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Best Practice for Writing Effective SOPs (Standard Operating Procedures) Training Course

Best Practice for Writing Effective SOPs

27 Mar 2025 - Online webinar
Also on: 17 Jul 2025

An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.

Presented by Laura Brown (bio)

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Best Practices for Supplier Qualification in Life Science Training Course

Best Practices for Supplier Qualification in Life Science

27-28 Mar 2025 - Online webinar
Also on: 16 Jul 2025

Explore the intricacies of Life Science Supplier Qualification through our comprehensive course. Gain expert insights into regulatory compliance, supply chain optimization, and strategic sourcing. Elevate your proficiency in maintaining product integrity with proven industry best practices.

Presented by Mustafa Edik (bio)

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Biological Evaluation of Medical Devices Training Course

Biological Evaluation of Medical Devices

15-16 May 2025 - Online webinar
Also on: 15 Sep 2025

Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices.

*Includes:* Interactive workshops and discussion sessions

Presented by Annette Callaghan (bio)

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Biosimilars Training Course

Biosimilars

21-22 May 2025 - Online webinar
Also on: 30 Sep 2025

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

Presented by Andrew Willis (bio)

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Biotechnology for the Non-Biotechnologist Training Course

Biotechnology for the Non-Biotechnologist

24-28 Mar 2025 - Online webinar
Also on: 9 Jul 2025

An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.

Presented by Robert Alvarez (bio)
and 6 more leading experts

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Building Better Health via Digitalised and Personalised Patient Support Programmes Training Course

Building Better Health via Digitalised and Personalised Patient Support Programmes

12 Mar 2025 - Online webinar
Also on: 2 Jul 2025

Learn how to build digital technology that is specifically aligned to match with the patient, the study, the disease and the treatment program.

Presented by Graham Howieson (bio)

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CAPA (Corrective and Preventative Action) Training Course

CAPA (Corrective and Preventative Action)

28 Mar 2025 - Online webinar
Also on: 18 Jul 2025

This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement, and planning and implementation in process improvements and CAPA.

Presented by Laura Brown (bio)

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Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products Training Course

Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products

27-28 Feb 2025 - Online webinar
Also on: 26 Jun 2025

The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance.
This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.

Presented by Andrew Willis (bio)

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Classification of Software as a Medical Device (SaMD) and Medical Device Software (MDSW) Training Course

Classification of Software as a Medical Device (SaMD) and Medical Device Software (MDSW)

28 Feb 2025 - Online webinar
Also on: 9 Jul 2025

Master the complexities of software classification under the Medical Device Regulations (MDR), ensuring compliance and clarity with expert insights into MDCG guidelines, practical case studies, and regulatory frameworks.

Presented by Koen Cobbaert (bio)

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Cleaning Validation - Best Practice in Pharmaceuticals Training Course

Cleaning Validation - Best Practice in Pharmaceuticals

8-9 Apr 2025 - Online webinar
Also on: 8 Jul 2025

Master the principles of cleaning validation to ensure pharmaceutical manufacturing equipment meets stringent regulatory standards, preventing contamination and safeguarding public health.

Presented by Mustafa Edik (bio)

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Clinical Evaluation of Medical Device Software and Software as a Medical Device Training Course

Clinical Evaluation of Medical Device Software and Software as a Medical Device

22 Jan 2025 - Online webinar
Also on: 13 May 2025

This one-day course will provide a clear understanding of the clinical evaluation requirements and their practical application for software products, including AI/ML-based devices.

Presented by Zuzanna Kwade (bio)

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Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

21-22 Jul 2025 - Online webinar
Also on: 25 Nov 2025

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

Presented by Janette Benaddi (bio)

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Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application Training Course

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

5-6 Feb 2025 - Online webinar
Also on: 18 Jun 2025

This seminar looks at the latest guidance on how to prepare a clinical overview and summary in accordance with regulatory expectations and to comply with the requirements of the Common Technical Document (CTD).

Presented by John Price (bio)

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Clinical Quality Management Systems Training Course

Clinical Quality Management Systems

22-23 May 2025 - Online webinar
Also on: 18 Sep 2025

A two-day course that will ensure you comply with new regulatory requirements.

Presented by Laura Brown (bio)

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Clinical Research Project Management Training Course

Clinical Research Project Management

11-13 Jun 2025 - Online webinar
Also on: 22 Oct 2025

The leading clinical research project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health

Presented by Laura Brown (bio)

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Clinical Trial Monitoring Training Course

Clinical Trial Monitoring

28-29 Apr 2025 - Online webinar
Also on: 21 Jul 2025

This course will assure monitors understand the importance of compliance with latest ICH GCP R3 requirements, and how these apply to monitoring clinical trials in the future.

Presented by Laura Brown (bio)

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Clinical Trial Regulatory Requirements Training Course

Clinical Trial Regulatory Requirements

20-21 Jan 2025 - Online webinar
Also on: 8 May 2025

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and a brief review of key FDA requirements.

Presented by Laura Brown (bio)

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Cognitive Testing in Clinical Drug Trials: Successful Test Selection and Integration Training Course

Cognitive Testing in Clinical Drug Trials: Successful Test Selection and Integration

19 Mar 2025 - Online webinar
Also on: 17 Sep 2025

An excellent opportunity to hear from two renowned cognition experts and gain a better understanding on the selection and successful integration of cognitive testing into therapeutic development programmes, as well as the emerging science of blood-based biomarkers.

Presented by John E. Harrison (bio)
Alison Green (bio)

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Cosmetovigilance Training Course

Cosmetovigilance

19-20 Jun 2025 - Online webinar
Also on: 13 Oct 2025

This course will provide a comprehensive overview of cosmetogivilance in Europe, the USA and the Rest of the World (ROW).
It will provide key guidance for manufacturers and distributors on how to comply with the regulatory requirements, and will be valuable for pharmaceutical and medical device companies looking to access the cosmetic market.

Presented by Graeme Ladds (bio)

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Cyber Security for Medical Devices Training Course

Cyber Security for Medical Devices

8-9 May 2025 - Online webinar
Also on: 11 Sep 2025

This seminar will provide you with an understanding of cybersecurity and its increasing regulatory focus, and how to embed and apply state-of-the-art security in your existing processes to deliver safe and secure products and solutions.

Presented by Ben Kokx (bio)

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Data Innovation for AI-enabled Medical Devices Training Course

Data Innovation for AI-enabled Medical Devices

28 Feb 2025 - Online webinar
Also on: 9 Jul 2025

This course provides an in-depth understanding of data governance for AI-enabled medical devices, focusing on European regulations like the AI Act and GDPR, ensuring compliance while fostering innovation in high-risk AI systems.

Presented by Koen Cobbaert (bio)

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Data Integrity and Document Management Training Course

Data Integrity and Document Management

7 Apr 2025 - Online webinar
Also on: 14 Jul 2025

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

Presented by Laura Brown (bio)

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Data Integrity Auditor Masterclass Training Course

Data Integrity Auditor Masterclass

4-5 Feb 2025 - Online webinar
Also on: 12 Jun 2025

During this course, data integrity will be discussed from the perspective of GxP audits, with practical advice for successful data integrity audits given.

Presented by Mustafa Edik (bio)

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Deep Dive into the IVDR (In-Vitro Diagnostic Regulation) Annex XIII Training Course

Deep Dive into the IVDR Annex XIII

5 Mar 2025 - Online webinar
Also on: 10 Jul 2025

Explore IVDR Annex XIII in-depth, covering Performance Evaluation, Performance Studies, and Post-market Performance. Learn what information is required, where to put it, and when, with a detailed review of nine essential documents.

Presented by Jane Leadsham (bio)

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Developing and Managing Software as a Medical Device (SaMD) and Medical Device Software (MDSW) Training Course

Developing and Managing Software as a Medical Device (SaMD) and Medical Device Software (MDSW)

3 Mar 2025 - Online webinar
Also on: 10 Jul 2025

Gain essential knowledge in developing and managing Software as a Medical Device (SaMD) and Medical Device Software (MDSW), focusing on regulatory compliance, risk management, and lifecycle management to ensure safety and effectiveness.

Presented by Koen Cobbaert (bio)

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Development of Combination Products: Critical Interactions Training Course

Development of Combination Products: Critical Interactions

24-25 Jun 2025 - Online webinar
Also on: 2 Oct 2025

Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.

Presented by Andrew Willis (bio)

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Effective Technical Writing & Editing Training Course

Effective Technical Writing & Editing

5 Jun 2025 - Online webinar
Also on: 1 Oct 2025

Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.

Presented by Barbara Grossman (bio)

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Effective Technology Transfer Training Course

Effective Technology Transfer

3-4 Feb 2025 - Online webinar
Also on: 2 Jun 2025

The ‘how to’ of technology transfer across the product lifecycle.

Presented by Bruce Davis (bio)

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EU (European Union) Clinical Trial Regulation 536/2014: Overview and Implementation Experience Training Course

EU Clinical Trial Regulation 536/2014: Overview and Implementation Experience

13-14 Feb 2025 - Online webinar
Also on: 2 Jun 2025

This course will provide an update on the experience of working to the regulation since Go-live, to help your implementation and compliance including transferring clinical trials from the directive to the regulation.

Presented by Laura Brown (bio)

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EU (European Union) Pharmaceutical Regulations & Strategy Training Course

EU Pharmaceutical Regulations & Strategy

10-11 Feb 2025 - Online webinar
Also on: 9 Jun 2025

The course will provide an up-to-date overview of the current European pharmaceutical regulatory environment including procedures for obtaining marketing authorisation and post-approval obligations. The proposed changes to the EU pharmaceuticals legislation will be discussed in the relevant sections and impact on strategic considerations for obtaining and maintaining marketing authorisations Procedures for obtaining marketing authorisations in in the UK will be discussed.

Presented by Norah Lightowler (bio)

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EU (European Union) Proposed Pharmaceutical Legislation Changes Training Course

EU Proposed Pharmaceutical Legislation Changes

20 Jan 2025 - Online webinar
Also on: 19 May 2025

This course will provide an up-to-date overview of current European pharmaceutical legislation and the regulatory impact of the proposed changes.

Presented by Norah Lightowler (bio)

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European Post Marketing Pharmacovigilance - Including the EMA/PRAC Deliberations and Brexit Implications Training Course

European Post Marketing Pharmacovigilance - Including the EMA/PRAC Deliberations and Brexit Implications

3-7 Mar 2025 - Online webinar
Also on: 14 Jul 2025

This course provides a comprehensive overview of key post-market pharmacovigilance activities required as the foundation for further understanding of new EU legislation that was introduced in 2012 and has undergone over 20 updates in the last ten years.

Presented by Graeme Ladds (bio)

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FDA (Food and Drug Administration) Approval Process for Medical Devices Training Course

FDA Approval Process for Medical Devices

31 Mar-1 Apr 2025 - Online webinar
Also on: 22 Jul 2025

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

Presented by Jonathan Hughes (bio)

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GCP (Good Clinical Practice) and Clinical Research Update - Hot Inspection Topics Training Course

GCP and Clinical Research Update - Hot Inspection Topics

14 Mar 2025 - Online webinar
Also on: 1 Jul 2025

This course provides recent updates on the New ICH GCP R3 guideline, EU Clinical Trial Regulation update, other EU and FDA requirements, consideration for managing studies in the future and AI and other technology developments.

Presented by Laura Brown (bio)

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Global Market Access for Medical Device Software Training Course

Global Market Access for Medical Device Software

31 Mar-1 Apr 2025 - Online webinar
Also on: 8 Sep 2025

Navigate global market access for medical device software with insights on international regulations, reimbursement strategies, and Health Technology Assessment (HTA) to improve your product’s chances of commercial success

Presented by Catarina Carrao (bio)

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GMP (Good Manufacturing Practice) Principles in Vaccine Manufacturing Training Course

GMP Principles in Vaccine Manufacturing

16-17 Apr 2025 - Online webinar
Also on: 10 Sep 2025

Vaccinology continues to advance and mature impressively, both in developing new and improved vaccines and in administering vaccines to prevent disease. On this course, explore GMP principles in vaccine manufacturing.

Presented by Mustafa Edik (bio)

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Good Distribution Practices of Pharmaceuticals and APIs Training Course

Good Distribution Practices of Pharmaceuticals and APIs

17-18 Mar 2025 - Online webinar
Also on: 9 Jul 2025

Gain a comprehensive understanding of industry-leading practices, ensuring precision in distribution from manufacturer to end user. Navigate complex supply chains, focus on compliance, and elevate your commitment to quality assurance throughout the entire distribution process.

Presented by Mustafa Edik (bio)

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Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course

Human Factors and Usability Engineering in the Development of Drug Delivery Products

13-14 May 2025 - Online webinar
Also on: 16 Sep 2025

This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

Presented by Richard Featherstone (bio)

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ICH Q9(R1) Quality Risk Management (QRM) Training Course

ICH Q9(R1) Quality Risk Management (QRM)

12 May 2025 - Online webinar
Also on: 9 Sep 2025

ICH Q9(R1) Quality Risk Management has recently been updated by the regulators. This training course will bring participants right up-to-date with the latest Q9(R1) requirements. It will explain the changes and give context as to how these impact pharmaceutical products and processes. It will cover a range of product types and situations.

Presented by Bruce Davis (bio)

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Innovate: The MedTech Series – Digital Health Training Course

Innovate: The MedTech Series – Digital Health

27 Mar 2025 - Online webinar
Also on: 7 Nov 2025

This session will guide participants through the key phases of digital health’s evolution, showcasing real-world cases that illuminate the challenges of  digital adoption.

Presented by David Chadima (bio)
Núria Vázquez (bio)

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Innovate: The MedTech Series – The EU (European Union) AI Act Training Course

Innovate: The MedTech Series – The EU AI Act

3 Apr 2025 - Online webinar
Also on: 2 Oct 2025

This session will summarise the EU AI Act and its implications on the healthcare sector, including how to be compliant with the new regulatory framework.

Presented by Cheryl Barton (bio)

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Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

5-6 Feb 2025 - Online webinar
Also on: 16 Jul 2025

This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.

Presented by Stuart Angell (bio)

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Introduction to the New Performance Evaluation Requirements Mandated Under the IVDR (2017/746) Training Course

Introduction to the New Performance Evaluation Requirements Mandated Under the IVDR (2017/746)

4 Mar 2025 - Online webinar
Also on: 9 Jul 2025

Understand the essentials of performance evaluation under the In Vitro Diagnostic Regulation (2017/746) in this comprehensive seminar. Essential for regulatory compliance and business success.

Presented by Jane Leadsham (bio)

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Introduction to Veterinary Pharmacovigilance Training Course

Introduction to Veterinary Pharmacovigilance

10-11 Mar 2025 - Online webinar
Also on: 3 Jul 2025

A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance.

Presented by Declan O'Rourke (bio)

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Managing Service Providers including CRO (Contract Research Organisation) and CMOs oversight to comply with ICH GCP (Good Clinical Practice) R3 Training Course

Managing Service Providers including CRO and CMOs oversight to comply with ICH GCP R3

6-7 Feb 2025 - Online webinar
Also on: 23 Jun 2025

Optimising oversight for inspection compliance.

Presented by Laura Brown (bio)

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Market Authorisation of Software as a Medical Device (SaMD) and Medical Device Software (MDSW) Training Course

Market Authorisation of Software as a Medical Device (SaMD) and Medical Device Software (MDSW)

26-27 Feb 2025 - Online webinar
Also on: 7 Jul 2025

Learn the critical regulatory requirments and best practices for obtaining market authorisation or Software as a Medical Device (SaMD) and Medical Device Software (MDSW) in global markets.

Presented by Koen Cobbaert (bio)

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Masterclass: Market Authorisation of AI-enabled Medical Devices Training Course

Masterclass: Market Authorisation of AI-enabled Medical Devices

4 Apr 2025 - Online webinar
Also on: 11 Jul 2025

This course provides essential guidance on navigating regulatory requirements and securing market authorization for AI-based medical devices, covering key regulations, compliance strategies, and best practices for global market access.

Presented by Koen Cobbaert (bio)

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Medical Device Regulation in the Eurasian Union, Russia and the CIS Training Course

Medical Device Regulation in the Eurasian Union, Russia and the CIS

3-4 Apr 2025 - Online webinar
Also on: 23 Jul 2025

A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.

Presented by Anna Harrington-Morozova (bio)

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Medical Device Regulations in the Middle East and North Africa Training Course

Medical Device Regulations in the Middle East and North Africa

10-11 Mar 2025 - Online webinar
Also on: 23 Jul 2025

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa. Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen.

Presented by Heba Hashem (bio)
Ilona Putz (bio)

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Medical Device Single Audit Programme (MDSAP) Training Course

Medical Device Single Audit Programme (MDSAP)

24-25 Mar 2025 - Online webinar
Also on: 10 Jul 2025

The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices.
This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.

Presented by Stuart Angell (bio)

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Medical Device Studies: Clinical Evidence Training Course

Medical Device Studies: Clinical Evidence

7-8 Apr 2025 - Online webinar
Also on: 15 Oct 2025

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR.

Presented by Janette Benaddi (bio)

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Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

7-8 May 2025 - Online webinar
Also on: 15 Sep 2025

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

Presented by Janette Benaddi (bio)

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Medical Editing for Peer-Reviewed Journals

Medical Editing for Peer-Reviewed Journals

8 Apr 2025 - Online webinar
Also on: 8 Oct 2025

Presented by Alex Evans (bio)

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Medical Writing for Consumers

Medical Writing for Consumers

1 Apr 2025 - Online webinar
Also on: 1 Oct 2025

On this course, learn the basics of writing health and medical articles for the layperson.

Presented by Alex Evans (bio)

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Medical Writing for Medical Devices Training Course

Medical Writing for Medical Devices

1-2 Jul 2025 - Online webinar
Also on: 20 Nov 2025

How to produce quality regulatory documents including the clinical evaluation report (CER).

Presented by Janette Benaddi (bio)
Barbara Grossman (bio)

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Medical Writing with Artificial Intelligence (AI)

Medical Writing with Artificial Intelligence (AI)

29 Apr 2025 - Online webinar
Also on: 15 Oct 2025

Explore the intersection between AI and medical communications in this medical writing power hour.

Presented by Alex Evans (bio)

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Metered Dose Inhaler (MDI) Technology Training Course

Metered Dose Inhaler (MDI) Technology

24-27 Feb 2025 - Online webinar
Also on: 19 Jun 2025

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

Presented by David Howlett (bio)

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Metrics and Earned Value in Clinical Research Projects Training Course

Metrics and Earned Value in Clinical Research Projects

5 Mar 2025 - Online webinar
Also on: 22 Jul 2025

This workshop will focus on the effective use of metrics to monitor the real progress of your clinical research project. A valuable master class for anyone involved in clinical research.

Presented by Roger Joby (bio)

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Microbiomics in Clinical Trials Training Course

Microbiomics in Clinical Trials

27 Feb 2025 - Online webinar
Also on: 4 Jun 2025

Explore the microbiome and its high clinical relevance, as well as learning about the different methodology used in microbiomic clinical trials.

Presented by Nikolaj Sørensen (bio)

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Molecular Biology for the Non-molecular Biologist Training Course

Molecular Biology for the Non-molecular Biologist

25-26 Mar 2025 - Online webinar
Also on: 3 Jun 2025

Explore the applications and significance of molecular biology in the pharmaceutical industry, covering DNA, RNA, proteins, gene expression, biotechnology, drug discovery, personalised medicine, and the latest breakthroughs like CRISPR-Cas9 and mRNA vaccines.

Presented by Sayed Goda (bio)

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Navigating China’s API Regulations: An Essential Guide to DMF Registration Training Course

Navigating China’s API Regulations: An Essential Guide to DMF Registration

12 Feb 2025 - Online webinar
Also on: 23 Jun 2025

Enhance your knowledge of the regulatory requirements for Active Pharmaceutical Ingredients and the Drug Master File in China. An opportunity to learn the quickest pathway options for DMF registration and to hear from industry leaders in this important region.

Presented by April Wang (bio)
Helen Ye (bio)

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Navigating Regulatory Compliance Whilst Developing and Distributing PCR-Based IVD Tests Training Course

Navigating Regulatory Compliance Whilst Developing and Distributing PCR-Based IVD Tests

6 Mar 2025 - Online webinar
Also on: 26 Jun 2025

In this three-hour course, learn from an expert about developing and distributing PCR-based IVD tests, as well as exploring the latest regulatory requirements.

Presented by Dmitriy Kosarikov (bio)

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New EU (European Union) GMP (Good Manufacturing Practice) Annex 1: Compliant Aseptic Operations Training Course

New EU GMP Annex 1: Compliant Aseptic Operations

11-13 Mar 2025 - Online webinar
Also on: 1 Jul 2025

Maintaining a sterile production environment on an ongoing basis is critical in the production of sterile pharmaceuticals, and strict adherence to guidelines and relevant standards is required to minimize contamination risks and ensure product quality and safety.

During this training, all changes in Annex 1 will be evaluated, and the minimum requirements that aseptic operations must meet will be discussed and presented to the participants through examples.

Presented by Mustafa Edik (bio)

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Non-Conformance and Corrective Action for Medical Device Manufacturers Training Course

Non-Conformance and Corrective Action for Medical Device Manufacturers

10 Apr 2025 - Online webinar
Also on: 18 Jul 2025

The identification of non-conformances and ensuring that they are dealt with in a timely and appropriate manner is a key part of any medical device Quality Management System (QMS). This course provides an introduction to the regulatory requirements as they relate to the identification and handling of non-conformances and how manufacturers may demonstrate compliance.

Presented by Annette Callaghan (bio)

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Pharmaceutical Development of ATMPs Training Course

Pharmaceutical Development of ATMPs

17-18 Jun 2025 - Online webinar
Also on: 13 Oct 2025

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

Presented by Andrew Willis (bio)

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Pharmaceutical Regulatory Affairs in Africa Training Course

Pharmaceutical Regulatory Affairs in Africa

24-25 Feb 2025 - Online webinar
Also on: 8 Jul 2025

Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia

Presented by Salma Ismail (bio)
Makram Nehme (bio)

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Pharmaceutical Regulatory Affairs in Asia Training Course

Pharmaceutical Regulatory Affairs in Asia

25-27 Feb 2025 - Online webinar
Also on: 11 Jun 2025

This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia including, China, Hong Kong SAR, Brunei, the Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Cambodia, Laos, Vietnam, Taiwan, Korea, Japan

Presented by Alan Chalmers (bio)
Monica Dressler-Meyer (bio)

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Pharmaceutical Regulatory Affairs in China Training Course

Pharmaceutical Regulatory Affairs in China

8-9 Apr 2025 - Online webinar
Also on: 25 Jun 2025

A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.

Presented by Alan Chalmers (bio)
Monica Dressler-Meyer (bio)

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Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union Training Course

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

6-7 Feb 2025 - Online webinar
Also on: 19 Jun 2025

This interactive course will discuss the regulatory requirements for human pharmaceuticals within these regions, and discuss the implications of the new joint Eurasian Union regulation.

Presented by Anna Harrington-Morozova (bio)

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Pharmaceutical Regulatory Affairs in the Middle East Training Course

Pharmaceutical Regulatory Affairs in the Middle East

25-26 Feb 2025 - Online webinar
Also on: 23 Jun 2025

Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen

Presented by Heba Hashem (bio)
Ilona Putz (bio)

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Pharmacovigilance Aspects of Licensing Agreements Training Course

Pharmacovigilance Aspects of Licensing Agreements

10 Mar 2025 - Online webinar
Also on: 1 Jul 2025

This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance

Presented by Joanne Flitcroft (bio)
Graeme Ladds (bio)

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Pharmacovigilance QMS & Inspection Preparation Training Course

Pharmacovigilance QMS & Inspection Preparation

20-21 Jan 2025 - Online webinar
Also on: 19 May 2025

This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.

Presented by Graeme Ladds (bio)

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Post-Market Surveillance - Practical Application for Medical Devices and IVDs Training Course

Post-Market Surveillance - Practical Application for Medical Devices and IVDs

12 Feb 2025 - Online webinar
Also on: 5 Jun 2025

In this practical, one-day course, learn the regulatory requirements needed for successful post-market surveillance of medical devices and IVDs.

Presented by Anne Jury (bio)
Karen Pearson (bio)

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Post-market Surveillance and Vigilance of Software as a Medical Device (SaMD) and Medical Device Software (MDSW) Training Course

Post-market Surveillance and Vigilance of Software as a Medical Device (SaMD) and Medical Device Software (MDSW)

2-3 Apr 2025 - Online webinar
Also on: 10 Sep 2025

Learn the essential regulatory requirements for post-market surveillance (PMS), post-market clinical follow-up (PMCF), and vigilance of digital health technologies, ensuring product safety, compliance, and continued value creation throughout the product lifecycle

Presented by Catarina Carrao (bio)

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Practical Implementation of a Human Factors Study Training Course

Practical Implementation of a Human Factors Study

4-5 Mar 2025 - Online webinar
Also on: 1 Jul 2025

This training focuses on the practical and logistical aspects of planning, preparing and performing human factors studies for medical devices and combination products.

Presented by Richard Featherstone (bio)

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Practical Implementation of GCP (Good Clinical Practice) in Veterinary Field Studies Training Course

Practical Implementation of GCP in Veterinary Field Studies

14-15 May 2025 - Online webinar
Also on: 25 Nov 2025

This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.

Presented by Rachel Anderson (bio)
Donna Taylor (bio)
Jenny Webster (bio)

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Practical Requirements of the Arab Pharmacovigilance Guidelines Training Course

Practical Requirements of the Arab Pharmacovigilance Guidelines

12-13 Jun 2025 - Online webinar
Also on: 16 Oct 2025

Practical guidance on how to comply with the pharmacovigilance requirements in the Middle East

Presented by Graeme Ladds (bio)

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Pre-Filled Syringes: End-to-End Processing Training Course

Pre-Filled Syringes: End-to-End Processing

20-21 Mar 2025 - Online webinar
Also on: 21 Jul 2025

Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.

Presented by Dale Charlton (bio)
Susanne Hall (bio)
Andreas Rothmund (bio)

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Process Validation for Medical Devices Training Course

Process Validation for Medical Devices

25-26 Feb 2025 - Online webinar
Also on: 5 Jun 2025

This course focuses on the Regulatory and Quality Management System links to Process Validation for medical devices, and reviews the Installation Qualification, Operation Qualification and Performance Qualification Processes and how these fit with regulatory needs and technical documentation.

Presented by Mustafa Edik (bio)

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Process Validation with Qualification Training Course

Process Validation with Qualification

20-21 May 2025 - Online webinar
Also on: 22 Sep 2025

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

Presented by Bruce Davis (bio)

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Protein Engineering for Pharmaceutical Biotechnology Training Course

Protein Engineering for Pharmaceutical Biotechnology

8-9 May 2025 - Online webinar
Also on: 10 Sep 2025

Advance your expertise in protein engineering with this comprehensive course. Learn cutting-edge techniques in therapeutic development, biotechnology applications, and regulatory compliance, ideal for professionals in pharmaceutical and industrial sectors.

Presented by Sayed Goda (bio)

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Real World Evidence (RWE), Real World Data (RWD) and the Application of Artificial Intelligence (AI) in The Pharmaceutical Market Training Course

Real World Evidence (RWE), Real World Data (RWD) and the Application of Artificial Intelligence (AI) in The Pharmaceutical Market

26 Mar 2025 - Online webinar
Also on: 16 Jul 2025

A deep dive into the importance of real world evidence (RWE), real world data (RWD) and artificial intelligence (AI) in pharmaceuticals.

Presented by Graham Howieson (bio)

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Registration of Veterinary Pharmaceuticals in China Training Course

Registration of Veterinary Pharmaceuticals in China

27 Feb 2025 - Online webinar
Also on: 26 Jun 2025

Learn how to navigate the regulatory system of veterinary pharmaceuticals in China.

Presented by Bi Jun (bio)

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Regulatory Affairs for Support Staff Training Course

Regulatory Affairs for Support Staff

27-28 Jan 2025 - Online webinar
Also on: 12 May 2025

This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.

Presented by Norah Lightowler (bio)

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Regulatory Strategies for Orphan Drugs Training Course

Regulatory Strategies for Orphan Drugs

23 Jun 2025 - Online webinar
Also on: 7 Oct 2025

This must-attend event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

Presented by Shaun Stapleton (bio)

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Risk Evaluation and Mitigation Strategies (REMS) vs Risk Management Plans (RMP) Training Course

Risk Evaluation and Mitigation Strategies (REMS) vs Risk Management Plans (RMP)

21 May 2025 - Online webinar
Also on: 24 Sep 2025

A comprehensive comparison between Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMP).

Presented by Alina Panourgia (bio)

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Signal Detection and Regulatory Expectations Training Course

Signal Detection and Regulatory Expectations

17-18 Mar 2025 - Online webinar
Also on: 7 Jul 2025

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement

Presented by Graeme Ladds (bio)

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Smart Packaging and Electronic Patient Information Training Course

Smart Packaging and Electronic Patient Information

13 Mar 2025 - Online webinar
Also on: 3 Jul 2025

This course will provide an overview of the current technologies, the patient and societal benefits and some building blocks for the establishment and delivery of e-PIL and SMART strategic initiatives.

Presented by Graham Howieson (bio)

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Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course

Stability Testing of Pharmaceuticals and Biopharmaceuticals

24-27 Feb 2025 - Online webinar
Also on: 21 Jul 2025

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

Presented by Paul Palmer (bio)

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Sterilization of Medical Devices Training Course

Sterilization of Medical Devices

3-4 Feb 2025 - Online webinar
Also on: 5 Jun 2025

Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations. This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.

Presented by Annette Callaghan (bio)

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Successful Medical Writing – from Protocol to CTD Training Course

Successful Medical Writing – from Protocol to CTD

16-17 Jan 2025 - Online webinar
Also on: 5 Jun 2025

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.

Presented by Cheryl Roberts (bio)

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Sustainable Design and Manufacture for Medical Devices Training Course

Sustainable Design and Manufacture for Medical Devices

24 Mar 2025 - Online webinar
Also on: 3 Jul 2025

This seminar will give you an in-depth understanding of what sustainability options exist, what the benefits are, what drives them, and how to choose which will work for your company.

Presented by Cormac O'Prey (bio)

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The Advancement of Research and Development (R&D) Clinical Trials using Software Automation Training Course

The Advancement of Research and Development (R&D) Clinical Trials using Software Automation

4 Jun 2025 - Online webinar
Also on: 1 Oct 2025

This course will help delegates gain a better understanding of the automation technology driving change within the clinical trials landscape.

Presented by Graham Howieson (bio)

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The Animal Health Summer School: Working Through Veterinary Drug Development in the EU (European Union) and USA Training Course

The Animal Health Summer School: Working Through Veterinary Drug Development in the EU and USA

16-19 Jun 2025 - London

This practical four-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.

Presented by Andrew Hewitt (bio)
David Petrick (bio)

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The Common Technical Document Training Course

The Common Technical Document

11-12 Mar 2025 - Online webinar
Also on: 7 Jul 2025

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

Presented by Andrew Willis (bio)

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The Common Technical Document (CTD) Submission in the MENA Region Training Course

The Common Technical Document (CTD) Submission in the MENA Region

13 Mar 2025 - Online webinar
Also on: 1 Jul 2025

This one-day course will provide you with an in depth understanding of the technical and regulatory requirements of CTD submissions in different countries in the MENA region.

Presented by Mohammad Fat'hy Elnadi (bio)

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The FDA (Food and Drug Administration) Drug Approval Process Training Course

The FDA Drug Approval Process

24-25 Feb 2025 - Online webinar
Also on: 11 Jun 2025

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

Presented by Andrew Willis (bio)

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The Importance of Patient Adherence Data and How Digital Tools Can Improve Patient Outcomes Training Course

The Importance of Patient Adherence Data and How Digital Tools Can Improve Patient Outcomes

26 Feb 2025 - Online webinar
Also on: 18 Jun 2025

In this course, you will determine the value of remote patient adherence monitoring and learn how to stay ahead of the curve by creating your own digital solutions. 

Presented by Graham Howieson (bio)

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The Medical Device School - From Concept to CE Marking Training Course

The Medical Device School - From Concept to CE Marking

9-13 Jun 2025 - London

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

Presented by Stuart Angell (bio)
and 7 more leading experts

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The Regulatory Requirements on Nitrosamines in the Pharmaceutical Industry Training Course

The Regulatory Requirements on Nitrosamines in the Pharmaceutical Industry

12-13 May 2025 - Online webinar
Also on: 13 Oct 2025

In this webinar, we will discuss the major requirements and strategies on Nitrosamines, a hot topic that is on the forefront of many company's minds.

Presented by Jason Brown (bio)

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The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course

The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR

23 Jan 2025 - Online webinar
Also on: 22 May 2025

This one day course will cover the role of the Person Responsible for Regulatory Compliance (PRRC) introduced by the implementation of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Device Regulation 2017/746. The course will review Article 15 from the regulation in detail to enable understanding of the intent of each requirement. It will also present the UK Medical Device Regulation requirements and discuss the proposed Qualified Person role with current information.

Presented by Nancy Consterdine (bio)
Tsz Wai Woo (bio)

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Thinking Outside of the GMP (Good Manufacturing Practice) Box Training Course

Thinking Outside of the GMP Box

13-14 May 2025 - Online webinar
Also on: 17 Sep 2025

In this two-day course, you will be able to gain a whole new perspective on GMP requirements, including how to implement them.

Presented by Mustafa Edik (bio)

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UK Conformity Assessed (UKCA) Marking for Medical Devices Training Course

UK Conformity Assessed (UKCA) Marking for Medical Devices

26 Jun 2025 - Online webinar
Also on: 21 Oct 2025

This course provides UK and global companies practical guidance on what you need to do to continue market access or gain market access with your medical device in the UK.

Presented by Janette Benaddi (bio)

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Understanding Active Pharmaceutical Ingredients (APIs) Training Course

Understanding Active Pharmaceutical Ingredients (APIs)

25-26 Mar 2025 - Online webinar
Also on: 16 Jul 2025

This course will cover key terminology, the EU and USA regulatory framework, Good Manufacturing Practice (GMP) requirements including controls and validation, and consider Good Distribution Practice (GDP) and how to manage your supply chain.

Presented by Paul Palmer (bio)

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Understanding Computer System Validation (CSV) Training Course

Understanding Computer System Validation (CSV)

18-19 Mar 2025 - Online webinar
Also on: 9 Jul 2025

This course covers the key concepts of computer systems validation and provides practical guidance on how to comply with the regulations applicable to the pharmaceutical industry.

Presented by Paul Palmer (bio)

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Understanding Pharmacovigilance Regulations in APAC Training Course

Understanding Pharmacovigilance Regulations in APAC

13-14 Feb 2025 - Online webinar
Also on: 16 Jun 2025

Pharmacovigilance regulations in Asia are dynamic and fast-changing. As the Asia-Pacific region becomes increasingly important for pharmaceutical companies, it's vital to ensure compliance and safety by staying informed of the latest regulatory developments.

Presented by Param Dayal (bio)
and 4 more leading experts

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Unique Device Identification (UDI) and Labelling for Medical Device Manufacturers Training Course

Unique Device Identification (UDI) and Labelling for Medical Device Manufacturers

24 Mar 2025 - Online webinar
Also on: 8 Jul 2025

The information supplied with medical devices, both on their labels and in any accompanying Instructions for Use form part of the device itself, and are critical to the safety and performance of the device and to compliance with regulatory requirements. This course provides an introduction to the regulatory requirements as they relate to the labelling of medical devices and how manufacturers may demonstrate compliance.

Presented by Annette Callaghan (bio)

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US FDA (Food and Drug Administration) - Understanding Key Factors When Working with the FDA (Food and Drug Administration) Training Course

US FDA - Understanding Key Factors When Working with the FDA

13 Mar 2025 - Online webinar
Also on: 11 Jul 2025

This course has been designed to provide an essential overview of the critical factors when working with the FDA (Food and Drug Administration).  For those short on time this course is for you, as you will receive a focused and comprehensive overview of the key strategic considerations when making applications to the FDA.  

Presented by Andrew Willis (bio)

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Variations to Marketing Authorisations Training Course

Variations to Marketing Authorisations

3-4 Jun 2025 - Online webinar
Also on: 15 Oct 2025

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

Presented by Andrew Willis (bio)

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Veterinary Pharmaceutical Submissions in the EU (European Union) Training Course

Veterinary Pharmaceutical Submissions in the EU

19-20 May 2025 - Online webinar
Also on: 25 Nov 2025

Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, critical expert reports and regulatory submissions.

Presented by Andrew Hewitt (bio)
Dave Parry (bio)

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