Regulatory affairs courses & webinars

We offer a comprehensive programme of training courses and webinars on a wide range of regulatory affairs topics. Our courses and webinars are delivered by highly regarded experts from industry and government agencies and are suitable for professionals at all stages of their regulatory career.

Read more about the different regulatory affairs course categories and how these relate to your own career.

Our commitment to quality

TOPRA is proud to have provided gold standard training for regulatory affairs professionals for more than 40 years. Our commitment to the profession, to everyone who attends our training and to employers who entrust their staff development to us, is given in our Quality Statement.

Start dateTitleDescriptionCityCountry
14/10/2020Webinar: Genesis of Medical Device Regulatory IntelligenceThis webinar is designed to support those new to the Regulatory Intelligence concept in the medical device sector and to provide a foundational plan to anyone looking to take their first steps in assuming primary responsibility for regulatory intelligence in their organisation. OnlineWEBRIMD
15/10/2020Webinar: Medical Device Reg Intelligence for Decision-MakersRegulations for a pharmaceutical or medical device product not only differ across the globe but are constantly evolving too. Proactively acting in a very challenging regulatory scenario is crucial for medical device and in vitro diagnostic companies and decisions need to be supported by accurate and timely information. Join our webinar to understand why regulatory intelligence matters for global regulatory activities and how it can impact business decisions! OnlineWEBMDRIA
21/10/2020CRED Understanding Digital Health and Electronic ProductsA two half-days course on regulation of electrical, electronic and software medical devices. OnlineEE20
03/11/2020Understanding the Needs of HTA as a Market Access ToolThis webinar will cover key HTA considerations in the UK and EU for regulatory professionals planning their regulatory strategy for non-drug technologies. OnlineWEBHTA
04/11/2020Regulatory and Related Activities Through the LifecycleThis Masterclass is also Module 17 of the MSc Regulatory Affairs and will provide regulatory affairs professionals with insight into the strategic issues affecting the commercial and regulatory maintenance of a medical device throughout its lifecycle, with focus on post-launch activities and future pressures. OnlineMC172020
12/11/2020Essentials of European Medical Device Regulatory AffairsThis course will provide a basic, comprehensive overview of regulatory requirements and considerations for medical devices in a relaxed and interactive environment. OnlineMDBASIRE20
17/11/2020The Autumn Introductory Course (Pharmaceuticals)An Introduction to Pharmaceutical Regulatory Affairs (Module 0 of the MSc Regulatory Affairs). This course covers all aspects of the product development process, and provides a sound overview of EU legislation and regulatory procedures, including the central role regulatory affairs plays in modern healthcare companies. OnlineIC22020
24/11/2020Essentials of European Pharmaceutical Regulatory AffairsThis course will provide a basic, comprehensive grounding in regulatory affairs in a relaxed and interactive environment. OnlineBAS1120
25/11/2020Regulatory Control of Clinical OperationsThis Masterclass is also Module 5 of the MSc and  will provide you with an understanding of the practical and regulatory aspects of global clinical research, in order to offer effective advice on the regulatory issues likely to arise during clinical programmes. OnlineMSCM52020
01/12/2020CRED+ Optimising Interactions With RegulatorsA practical workshop covering interactions with EU and US health authorities and how to manage them effectively. OnlineADVICE20
20/01/2021Data for Abridged Applications and Specialised ProductsModule 8 of the MSc: Learn to consider and evaluate the practical regulatory aspects of regulatory strategy and data requirements for abridged applications (generics), specialised products (herbals, drug-device combination, radiopharmaceuticals, cosmetics, inhalation and blood products) and strategic issues of abridged US options.LondonUnited KingdomMSCM821
20/01/2021Data for Abridged Applications and Specialised ProductsModule 8 of the MSc: Learn to consider and evaluate the practical regulatory aspects of regulatory strategy and data requirements for abridged applications (generics), specialised products (herbals, drug-device combination, radiopharmaceuticals, cosmetics, inhalation and blood products) and strategic issues of abridged US options.Online MSCM821O
08/02/2021Drug Device Combinations and Other TechnologiesModule 18 of the MSc (Medical Devices) and Masterclass: This module will enable you to consider and evaluate the practical regulatory aspects including the design, development and lifecycle of a medical device product.LondonUnited KingdomMC182021
08/02/2021Drug Device Combinations and Other TechnologiesModule 18 of the MSc (Medical Devices) and Masterclass: This module will enable you to consider and evaluate the practical regulatory aspects including the design, development and lifecycle of a medical device product.Online MC1820210
03/03/2021US Regulation of Medical DevicesThis Masterclass will provide you with a comprehensive understanding of the US regulatory procedures for medical devices, to enable you to make recommendations about regulatory strategy for the US market. Additionally it will provide you with an understanding of a globally important market in addition to the knowledge of the EU that the rest of the course provides.This is also Module 21 of the MSc Regulatory Affairs.LondonUnited KingdomMC212021
03/03/2021US Regulation of Medical DevicesThis Masterclass will provide you with a comprehensive understanding of the US regulatory procedures for medical devices, to enable you to make recommendations about regulatory strategy for the US market. Additionally it will provide you with an understanding of a globally important market in addition to the knowledge of the EU that the rest of the course provides.This is also Module 21 of the MSc Regulatory Affairs.Online MC212021O
22/03/2021Registering Biological Biotech and Advanced Therapy ProductsThis Masterclass is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation and scientific principles underpinning development of biological, biotechnology and advanced therapy products, which provide challenges with their inherent complexities. The module includes consideration of the data requirements for clinical trial applications and marketing applications. This is also Module 9 of the TOPRA MSc Regulatory Affairs: The lecturers are highly experienced professionals in their field of work.LondonUnited KingdomMSCM921
22/03/2021Registering Biological Biotech and Advanced Therapy ProductsThis Masterclass is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation and scientific principles underpinning development of biological, biotechnology and advanced therapy products, which provide challenges with their inherent complexities. The module includes consideration of the data requirements for clinical trial applications and marketing applications. This is also Module 9 of the TOPRA MSc Regulatory Affairs: The lecturers are highly experienced professionals in their field of work.Online MSCM921O
21/04/2021Leadership and Strategic Management in Regulatory AffairsThis Masterclass is designed for regulatory affairs professionals to develop their understanding of the management and leadership skills needed to run a successful regulatory affairs department/organisation.  The course is designed to be applicable to both drugs and device regulatory affairs by applying the principles taught to your own particular environment. This is also Module 10 of the TOPRA MSc Regulatory Affairs. BelgiumMSCM1021
01/06/2021Regulation of In Vitro Diagnostics Medical DevicesThis Masterclass is also Module 19 of the MSc and is primarily focused on the In Vitro Diagnostic Regulation, this course will present the latest information covering the new regulation and how this differs from the In Vitro Diagnostic Directive in the EU and other jurisdictions. This class is also module 19 of the TOPRA MSc Regulatory Affairs.LondonUnited KingdomMC192021
30/06/2021Strategic Planning in Regulatory AffairsThis Masterclass will help you understand the practical and strategic aspects of global regulatory affairs, and enable you to develop your knowledge and skills to provide advice to your company to help develop a regulatory strategy. This is also Module 1 of the TOPRA MSc Regulatory affairs. NetherlandsMSCM12021
06/09/2021Regulatory Requirements for Cell Tissue and Gene TherapiesThis module is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation of advanced therapy medicinal products, which has grown in significance over the past five years. It fills a gap in the educational needs for contemporary regulatory affairs specialists. It will allow students to examine the regulatory requirements for advanced therapy medicinal products in the EU and compare this with other territories. It will consider the scientific principles underpinning the development and regulation of advanced therapy medicinal products and the complexities involved. This is also module 22 of the TOPRA MSc Regulatory Affairs.LondonUnited KingdomMSCM222021
29/09/2021Regulation of Electrical, Electronic and Software DevicesThis Masterclass will enable you to understand the practical and strategic regulatory issues relating to the development, maintenance and marketing of active devices. It will enable you to critically debate the commercial implications and the impact of the regulations on product stakeholders. (This course is also Module 20 of the TOPRA MSc Regulatory Affairs.)LondonUnited KingdomMC202021
20/10/2021Regulatory Strategy for a New Active Substance: NonclinicalThis Masterclass will give delegates an understanding of the practical and legislative requirements for the nonclinical phase of global drug development. It will explore the regulatory issues that are likely to arise and provide advice and discussion around solutions to such situations. This is also Module 2 of the TOPRA MSc Regulatory Affairs.LondonUnited KingdomMC22021
01/12/2021Data Management and Digitalisation in Regulatory AffairsThis Masterclass will provide you with  the theoretical background to data management, document management, electronic submissions, eCompliance regulatory information management and the new identification of Medicinal Products (IDMP) requirements, and find solutions to practical problems in this area. Deal with large volumes of data and deal with different data (from nonclinical to post-market pharmacovigilance).  This is also Module 12 of the TOPRA MSc Regulatory Affairs.LondonUnited KingdomMSCM1221NE