Training courses & Webinars:
Regulatory Affairs

Our regulatory affairs training courses have been designed to update delegates on a wide range of regulatory topics, from updates on the latest regulations to registration procedures and strategies. We provide information on regulatory approval in key regions globally, with practical advice from our expert speaker panel.

 

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

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

Animal Feed and Feed Additive Registration in China and Thailand

26 Jun 2025 - Online webinar
Also on: 23 Oct 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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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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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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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

26-27 Jun 2025 - Online webinar
Also on: 20 Oct 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)

9 Jul 2025 - Online webinar
Also on: 12 Nov 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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Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application Training Course

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

18-19 Jun 2025 - Online webinar
Also on: 1 Oct 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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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

9 Jul 2025 - Online webinar
Also on: 12 Nov 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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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)

10 Jul 2025 - Online webinar
Also on: 13 Nov 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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EU (European Union) Pharmaceutical Regulations & Strategy Training Course

EU Pharmaceutical Regulations & Strategy

9-10 Jun 2025 - Online webinar
Also on: 6 Oct 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

19 May 2025 - Online webinar
Also on: 16 Sep 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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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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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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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: 17 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 – 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)

16-17 Jul 2025 - Online webinar
Also on: 4 Nov 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)

9 Jul 2025 - Online webinar
Also on: 4 Nov 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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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)

7-8 Jul 2025 - Online webinar
Also on: 10 Nov 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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Navigating China’s API Regulations: An Essential Guide to DMF Registration Training Course

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

23 Jun 2025 - Online webinar
Also on: 23 Oct 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 Polymerase Chain Reaction (PCR)-Based IVD Tests Training Course

Navigating Regulatory Compliance Whilst Developing and Distributing Polymerase Chain Reaction (PCR)-Based IVD Tests

26 Jun 2025 - Online webinar
Also on: 6 Nov 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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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 Regulatory Affairs in Africa Training Course

Pharmaceutical Regulatory Affairs in Africa

22-23 Jul 2025 - Online webinar
Also on: 4 Nov 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

19-20 Jun 2025 - Online webinar
Also on: 2 Oct 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

23-24 Jun 2025 - Online webinar
Also on: 21 Oct 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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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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Practical Implementation of a Human Factors Study Training Course

Practical Implementation of a Human Factors Study

1-2 Jul 2025 - Online webinar
Also on: 18 Nov 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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Registration of Veterinary Pharmaceuticals in China Training Course

Registration of Veterinary Pharmaceuticals in China

26 Jun 2025 - Online webinar
Also on: 23 Oct 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

12-13 May 2025 - London
Also on: 22 Sep 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 Compliance and Safety Standards for Aesthetic Devices Training Course

Regulatory Compliance and Safety Standards for Aesthetic Devices

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

Navigate regulatory complexities and device classifications in the aesthetic medical device industry.

Presented by Catarina Carrao (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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Sterilization of Medical Devices Training Course

Sterilization of Medical Devices

5-6 Jun 2025 - Online webinar
Also on: 16 Oct 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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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 (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

11-12 Jun 2025 - Online webinar
Also on: 7 Oct 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 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

22 May 2025 - London
Also on: 22 Sep 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 Stuart Angell (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 Farah Nadeem (bio)
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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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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The presentation was outstanding. The presenters were welcoming. The session was interactive and insightful.

Vivian Ilonzeh, Director Reg Operations, Bristol Myer Squibb

This was an excellent webinar. Very useful and [speaker] has a lot of knowledge and experience, giving us examples from real life, making the concepts easier to understand and the course more enjoyable, was fantastic - kept me engaged the entire time. Very well organized.

Maria Jesus Lopez Villanueva, QA Administrator Eng, Endomag

The training successfully addressed Learning more about the role and responsibility of the PRRC. Content and presentation all good. Not too formal, not too informal. Just right. Speakers [have] Great knowledge about the subject.

Wessel Nomen, PRRC/Engineer, Enraf-Nonius

The content was structured logically and could be followed easily. The atmosphere was friendly and inviting to participate/ask questions. [Speakers were] competent, very helpful, friendly and patient with us.

Elena Louisa Lange, Quality Management Officer, Farstar medical

The course was informative and helpful. The content was exhaustive and touched all the aspects of Biocompatibility. Really loved the presenter [who] made the course fun and easy to understand. Speed was perfect for me to follow along, and [it] certainly gave me the confidence to be able to provide support to my product development team.

Shraddha Paliwal, Lead RA Specialist, Imperative Care (Vascular)

Content, speaker and presentation were all of a high standard and I came away with a much better understanding of biocompatibility / biological evaluation. The content on chemical characterization was particularly helpful. I was overall very happy with this training course.

Sarah Tait, Regulatory Affairs Manager, Kimal PLC

Excellent content, presentation and speaker.

Sandra Frenkel, RA Device, Nueroderm

Good Content. Presentation/Speakers - 5* Very good.

Mariusz Dabrowski, Quality, Regulatory & Logistics Officer, Eurobio Scientific UK

Good content [particularly liked] MDR requirements.

Ziva Mesika, VP RA, NeuroDerm

The course provided valuable insights and practical examples that clarified complex concepts. I particularly appreciated the detailed explanations of the ISO 10993, and the practical cases-workshops. Clear, well-structured with a very experienced and professional speaker. Thank you!

Daria Manoli, Quality & Regulatory Affairs Specialist, NOVAX PHARMA