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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, pharmacovivilance, 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
A Practical Approach to Developing the CMC Package for Veterinary Pharmaceutical Products
5 Nov 2024 - Online webinar
Understanding the chemistry, manufacturing and controls (CMC) requirements for veterinary pharmaceuticals is essential to support successful registration in the EU. Regulations for CMC of veterinary pharmaceuticals are complex and are regularly updated, making pharmaceutical product development challenging. This course is designed to guide you through the essential steps in development of the formulation and manufacturing process, in a manner that will ensure regulatory compliance for clinical trial applications and marketing authorisation applications.
A Practical Approach to Veterinary Vaccine Development and Registration in the EU
11-12 Nov 2024 - London
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)
A Practical Guide to Producing and Maintaining the PSMF
5 Aug 2024 - Online webinar
Also on: 10 Oct 2024
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)
A Practical Guide to Writing Risk Management Plans (RMPs)
1 Aug 2024 - Online webinar
Also on: 9 Oct 2024
Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.
Presented by Graeme Ladds (bio)
A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU and UK
22 Oct 2024 - Online webinar
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 4 more leading experts
Advanced Pharmacovigilance
18-20 Sep 2024 - Online webinar
Also on: 9 Dec 2024
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)
Advanced Project Management in Clinical Research
4 Oct 2024 - Online webinar
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)
Advanced Regulatory Affairs for Medical Devices
7-8 Oct 2024 - Online webinar
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
Advanced Veterinary Pharmacovigilance
2-3 Jul 2024 - Online webinar
Also on: 9 Oct 2024
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)
An Essential Overview of Medical Information
29 Nov 2024 - Online webinar
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)
An Essential Overview of Pharmacovigilance
9-10 Sep 2024 - Online webinar
A practical guide to understanding the role of pharmacovigilance.
Presented by Graeme Ladds (bio)
An Essential Overview of the Medical Device Industry
8 Nov 2024 - Online webinar
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.
An Essential Overview of the Pharmaceutical and Biotech Industries
13 Sep 2024 - Online webinar
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)
An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices
11 Nov 2024 - Online webinar
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)
An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals
23 Oct 2024 - Online webinar
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)
An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices
18 Nov 2024 - Online webinar
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)
An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices
20 Nov 2024 - Online webinar
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 Stuart Angell (bio)
An Introduction to Pharmaceutical Packaging
25-27 Sep 2024 - London
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)
An Introduction to the Design and Development of Medical Devices
24-25 Jul 2024 - Online webinar
Also on: 10 Dec 2024
A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products
Presented by David Howlett (bio)
An Introduction to the Medical Device Regulation
31 Jul-2 Aug 2024 - Online webinar
Also on: 4 Nov 2024
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.
Animal Feed and Feed Additive Registration in China and Thailand
16 Oct 2024 - Online webinar
Also on: 27 Feb 2025
Learn how to navigate the regulatory system for animal feed and feed additives in two emerging markets
Best Practice for Writing Effective SOPs
18 Jul 2024 - Online webinar
Also on: 12 Dec 2024
An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.
Presented by Laura Brown (bio)
Best Practices for Supplier Qualification in Life Science
7-8 Nov 2024 - Online webinar
Also on: 27 Mar 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)
Biological Evaluation of Medical Devices
16-17 Sep 2024 - Online webinar
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)
Biosimilars
10-11 Jul 2024 - Online webinar
Also on: 1 Oct 2024
A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.
Presented by Andrew Willis (bio)
Biotechnology for the Non-Biotechnologist
25-27 Sep 2024 - London
Also on: 2 Dec 2024
An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.
Presented by
Suzanne Aldington (bio)
and 6 more leading experts
CAPA (Corrective and Preventative Action)
19 Jul 2024 - Online webinar
Also on: 13 Dec 2024
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)
Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products
17-18 Oct 2024 - Online webinar
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)
Clinical Evaluation of Medical Device Software
18 Sep 2024 - Online webinar
Also on: 22 Jan 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)
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report
5-6 Aug 2024 - Online webinar
Also on: 27 Nov 2024
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
Presented by Janette Benaddi (bio)
Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application
23-24 Oct 2024 - Online webinar
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)
Clinical Quality Management Systems
19-20 Sep 2024 - Online webinar
A two-day course that will ensure you comply with new regulatory requirements.
Presented by Laura Brown (bio)
Clinical Research Project Management
23-25 Oct 2024 - Online webinar
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)
Clinical Trial Monitoring
29-30 Jul 2024 - Online webinar
Also on: 2 Dec 2024
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)
Clinical Trial Regulatory Requirements
16-17 Sep 2024 - Online webinar
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)
Cognitive Testing in Clinical Drug Trials: Successful Test Selection and Integration
12 Sep 2024 - Online webinar
Also on: 19 Mar 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.
Cosmetovigilance
14-15 Oct 2024 - Online webinar
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)
Cyber Security for Medical Devices
15-16 Oct 2024 - Online webinar
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)
Data Integrity and Document Management
22 Jul 2024 - Online webinar
Also on: 6 Dec 2024
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)
Data Integrity Auditor Masterclass
17-18 Oct 2024 - Online webinar
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)
Deep Dive into the IVDR Annex XIII
5 Nov 2024 - Online webinar
Also on: 5 Mar 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)
Delivery of Biologics to the Nasal Cavity
8 Oct 2024 - Online webinar
The nasal cavity is an established pathway to treat local diseases as well as systemic conditions using small molecules. As the pharmaceutical industry shifts towards targeted biologics, the nasal cavity is also an attractive target for delivery of peptides, monoclonal antibodies, nucleic acids and stem cells. This is an ideal opportunity to hear from experts in the field of nasal drug delivery who will address topics such as: challenges associated with formulation, barriers to cell penetration and absorption, the pros and cons for liquid versus powder formulations, and strategies for maintaining stability and prolonging retention in the nasal cavity.
Presented by
Gemma Budd (bio)
and 3 more leading experts
Development of Combination Products: Critical Interactions
3-4 Oct 2024 - Online webinar
Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.
Presented by Andrew Willis (bio)
Drug Discovery: A Step-by-Step Introduction
23-24 Sep 2024 - Online webinar
This drug discovery training course takes you on a science-based drug discovery journey. You will travel from inception of a new project to the point of hand-over of the newly discovered molecule to the Drug Development Team for pre-clinical and clinical studies. The course breaks down the long, multi-faceted drug discovery process into individual steps which build towards this key goal. The focus is on how essential science, technology and infrastructure elements are constituted, deployed and integrated to maximise the likelihood of a successful drug discovery project.
Presented by Peter A. Lowe (bio)
Effective Technical Writing & Editing
1 Oct 2024 - Online webinar
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)
Effective Technology Transfer
16-17 Jul 2024 - Online webinar
Also on: 7 Oct 2024
The ‘how to’ of technology transfer across the product lifecycle
Presented by Bruce Davis (bio)
EU Clinical Trial Regulation 536/2014: Overview and Implementation Experience
25-26 Jul 2024 - Online webinar
Also on: 11 Nov 2024
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)
EU Pharmaceutical Regulations & Strategy
14-15 Oct 2024 - Online webinar
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 and post-Brexit changes in the UK will be discussed in the context of regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations.
Presented by Norah Lightowler (bio)
EU Proposed Pharmaceutical Legislation Changes
18 Sep 2024 - Online webinar
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)
European Post Marketing Pharmacovigilance - Including the EMA/PRAC Deliberations and Brexit Implications
15-17 Jul 2024 - Online webinar
Also on: 4 Nov 2024
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 10 years.
Presented by Graeme Ladds (bio)
FDA Approval Process for Medical Devices
10-11 Sep 2024 - London
Also on: 2 Dec 2024
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)
GCP and Clinical Research Update - Hot Inspection Topics
22 Nov 2024 - Online webinar
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)
GMP Principles in Vaccine Manufacturing
14-15 Nov 2024 - Online webinar
Also on: 16 Apr 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)
Good Distribution Practices of Pharmaceuticals and APIs
21-22 Nov 2024 - Online webinar
Also on: 17 Mar 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)
Human Factors and Usability Engineering in the Development of Drug Delivery Products
17-20 Sep 2024 - Online webinar
Also on: 5 Dec 2024
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)
ICH Q9(R1) Quality Risk Management (QRM)
25 Sep 2024 - Online webinar
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)
Introduction to the In-Vitro Diagnostic Regulation (IVDR)
5-8 Nov 2024 - Online webinar
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)
Introduction to the New Performance Evaluation Requirements Mandated Under the IVDR (2017/746)
4 Nov 2024 - Online webinar
Also on: 4 Mar 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)
Introduction to Veterinary Pharmacovigilance
2-3 Oct 2024 - Online webinar
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.
*INCLUDES: Interactive workshop and discussion sessions*
Presented by Declan O'Rourke (bio)
Managing Competence within the Medical Device Industry
5 Nov 2024 - Online webinar
This webinar has been designed to help you understand the ‘big picture’ of competence management, from selection of the right competencies for success to the maintenance of collective organisational knowledge.
Presented by Anne Jury (bio)
Managing Service Providers including CRO and CMOs oversight to comply with ICH GCP R3
17-18 Oct 2024 - Online webinar
Optimising oversight for inspection compliance
Presented by Laura Brown (bio)
Masterclass: Artificial Intelligence-based Medical Devices
26 Jul 2024 - Online webinar
Also on: 7 Nov 2024
Many companies take part in the global ‘race to AI’ by continuously broadening the role of AI in their product portfolio. However, the rules of the game appear to be changing. The increased visibility of the technology’s risks has led to calls for regulators to look beyond the benefits, and also secure appropriate legislation to ensure AI that is ‘trustworthy’– legal, ethical, and robust and to ensure data is portable and qualitative. During this session, we will discuss the main players, trends, and challenges in the ‘race’ to AI regulation and how companies can move forward with an advantage.
Presented by Koen Cobbaert (bio)
Medical Device Regulation in the Eurasian Union, Russia and the CIS
2-3 Jul 2024 - Online webinar
Also on: 9 Dec 2024
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)
Medical Device Regulations in the Middle East and North Africa
7-8 Oct 2024 - Online webinar
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
Medical Device Single Audit Programme (MDSAP)
28-29 Nov 2024 - Online webinar
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)
Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations
22-25 Jul 2024 - Online webinar
Also on: 18 Nov 2024
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
Medical Device Studies: Clinical Evidence
11-12 Nov 2024 - Online webinar
Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR
Presented by Janette Benaddi (bio)
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting
16-19 Sep 2024 - Online webinar
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)
Medical Writing for Medical Devices
21-22 Nov 2024 - Online webinar
How to produce quality regulatory documents including the clinical evaluation report (CER).
Metered Dose Inhaler (MDI) Technology
9-10 Oct 2024 - Online webinar
A comprehensive overview of MDIs including development, manufacture, regulation and market potential
Presented by David Howlett (bio)
Metrics and Earned Value in Clinical Research Projects
11 Jul 2024 - Online webinar
Also on: 25 Nov 2024
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)
Navigating EU and FDA Regulations for Drug/Device and Device/Drug Combination Products
17-18 Sep 2024 - Online webinar
Also on: 21 Jan 2025
Gain practical guidance on the complex regulatory landscapes of EU and FDA for drug/device & device/drug combination products in this comprehensive course.
Presented by
Tina Amini (bio)
and 3 more leading experts
New EU GMP Annex 1: Compliant Aseptic Operations
2-4 Jul 2024 - Online webinar
Also on: 26 Nov 2024
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)
Non-Conformance and Corrective Action for Medical Device Manufacturers
12 Dec 2024 - Online webinar
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)
Pharmaceutical Development of ATMPs
14-15 Oct 2024 - Online webinar
This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.
Presented by Andrew Willis (bio)
Pharmaceutical Regulatory Affairs in Africa
19-20 Nov 2024 - Online webinar
Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia
Pharmaceutical Regulatory Affairs in Asia
9-11 Oct 2024 - Online webinar
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
Pharmaceutical Regulatory Affairs in China
10-11 Dec 2024 - Online webinar
A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.
Pharmaceutical Regulatory Affairs in Latin America
22 Oct 2024 - Online webinar
Also on: 25 Feb 2025
This programme offers a detailed examination of the regulatory landscape, emphasizing both challenges and opportunities for the pharmaceutical industry across key Latin American markets, including Argentina, Brazil, Chile, Colombia, Mexico, and Peru.
Presented by Belkys Ruiz (bio)
Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union
3-4 Oct 2024 - Online webinar
This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.
Presented by Anna Harrington-Morozova (bio)
Pharmaceutical Regulatory Affairs in the Middle East
9-10 Dec 2024 - Online webinar
Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen
Pharmacovigilance Aspects of Licensing Agreements
10 Jul 2024 - Online webinar
Also on: 27 Nov 2024
This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance
Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors - Broadening your Knowledge
30 Sep-2 Oct 2024 - Online webinar
This course has been designed for those wishing to expand their knowledge in pharmacovigilance and explore what they would like to understand next in this complex area.
Presented by Graeme Ladds (bio)
Pharmacovigilance QMS & Inspection Preparation
26-27 Sep 2024 - Online webinar
This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.
Presented by Graeme Ladds (bio)
Post-Market Surveillance - Practical Application for Medical Devices and IVDs
10 Oct 2024 - Online webinar
In this practical, one-day course, learn the regulatory requirements needed for successful post-market surveillance of medical devices and IVDs.
Practical Implementation of GCP in Veterinary Field Studies
26-27 Nov 2024 - London
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.
Pre-Filled Syringes: End-to-End Processing
6-7 Nov 2024 - Online webinar
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.
Process Validation for Medical Devices
15-16 Oct 2024 - Online webinar
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)
Process Validation with Qualification
23-24 Sep 2024 - London
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)
Registration of Veterinary Pharmaceuticals in China
16 Oct 2024 - Online webinar
Also on: 27 Feb 2025
Learn how to navigate the regulatory system of veterinary pharmaceuticals in China
Presented by Bi Jun (bio)
Regulatory Affairs for Support Staff
24-25 Sep 2024 - Online webinar
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)
Regulatory Strategies for Orphan Drugs
8 Oct 2024 - Online webinar
This must-attend event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.
Presented by Shaun Stapleton (bio)
Risk Management for Pharma and Biopharma Professionals
8 Oct 2024 - Online webinar
This essential course will explain the importance of using risk management techniques in drug and device development to comply with the latest focus on inspection in this area.
Presented by Laura Brown (bio)
Signal Detection and Regulatory Expectations
12-15 Nov 2024 - Online webinar
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)
Smart Packaging and Electronic Patient Information
10 Jul 2024 - Online webinar
Also on: 4 Nov 2024
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)
Stability Testing of Pharmaceuticals and Biopharmaceuticals
11-12 Jul 2024 - Online webinar
Also on: 11 Nov 2024
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.
Sterilization of Medical Devices
17-18 Oct 2024 - Online webinar
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)
Successful Medical Writing – from Protocol to CTD
27-29 Nov 2024 - Online webinar
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.
Sustainable Design and Manufacture for Medical Devices
4 Oct 2024 - London
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)
The Common Technical Document
25-26 Nov 2024 - Online webinar
A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.
Presented by Andrew Willis (bio)
The Common Technical Document (CTD) Submission in the MENA Region
28 Nov 2024 - Online webinar
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)
The FDA Drug Approval Process
2-3 Dec 2024 - Online webinar
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)
The Latest Updates in Global GMP
9 Jul 2024 - Online webinar
In this free 90-minute webinar, you will gain an insight into the latest updates in GMP, as well as consolidating your existing knowledge on the subject.
Presented by Mustafa Edik (bio)
The Medical Device School - From Concept to CE Marking
2-6 Dec 2024 - Online webinar
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
The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR
24 Sep 2024 - Online webinar
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)
Thinking Outside of the GMP Box
10-11 Sep 2024 - Online webinar
Also on: 14 Jan 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)
UK Conformity Assessed (UKCA) Marking for Medical Devices
19 Nov 2024 - Online webinar
The requirements for the new UKCA mark will impact technical documentation, labelling, logistics and regulatory compliance.
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)
Understanding Active Pharmaceutical Ingredients (APIs)
18-19 Nov 2024 - Online webinar
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.
Understanding Computer System Validation (CSV)
24-25 Jul 2024 - Online webinar
Also on: 25 Nov 2024
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.
Understanding Pharmacovigilance Regulations in APAC
8-9 Jul 2024 - Online webinar
Also on: 8 Oct 2024
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
Unique Device Identification (UDI) and Labelling for Medical Device Manufacturers
5 Dec 2024 - Online webinar
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)
US FDA - Understanding Key Factors When Working with the FDA
27 Nov 2024 - Online webinar
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)
Variations to Marketing Authorisations
28-29 Nov 2024 - Online webinar
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)
Veterinary Pharmaceutical Submissions in the EU
26-27 Nov 2024 - London
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.