Regulatory affairs courses, conferences and events

We offer a comprehensive programme of training courses and conferences on a wide range of regulatory affairs topics. Our courses 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.

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20/11/2018TOPRA/RAPS Inter-regulatory and Stakeholder WorkshopAddressing the impact of the EU Medical Device Regulation (MDR) on device-drug and drug-device ‘combination’ productsRAPS2018
22/11/2018Essentials of European Pharmaceutical Regulatory AffairsRegulatory Affairs can be confusing and complex, particularly if you have no formal industry background. This course provides an awareness of the regulatory environment.BAS1118
26/11/2018TOPRA In Sweden Meeting - Clinical TrialsThis evening is an ideal opportunity to hear the latest regulatory news about the new EU Regulation for clinical trials, the requirements for publishing of clinical data, and how you find information about ongoing and completed studies. A perfect opportunity to network with regulatory colleagues in a relaxed and sociable setting.TISNOV2018
28/11/2018Data 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.MSCM82018
03/12/2018MDR & Digital Health Technologies - Views From EU/USA TOPRA In North America Member event hosted by the USC Department of Regulatory and Quality Sciences focused on the EU's Medical Device Regulation and other digital health technologies issues.NADEC201
31/12/2018Webinar: Global Development Series OfferTHREE FOR TWO OFFER: Explore the world of regulatory affairs with TOPRA's Global Development webinar series.WEBOFFER
11/01/2019Webinar: The Registration of Medical DevicesThis webinar will provide an introduction to the registration of medical devices for regulatory affairs professionals.WEBMDINTRO
22/01/2019Webinar: The Regulation of Biotechnology ProductsThis webinar will provide an introduction to biotechnology products for regulatory affairs professionals.WEBBIOIC2
30/01/2019Leadership 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. This is also Module 10 of the TOPRA MSc Regulatory Affairs.MSCM1018
05/02/2019Essentials of European Veterinary Regulatory AffairsThe world of Veterinary Regulatory Affairs can be a confusing and complex place, particularly if you have no formal Veterinary background. The purpose of this course is to provide you with a clear and concise understanding of the role played by Regulatory Affairs in obtaining and maintaining Marketing Authorisation for veterinary products.VETBAS19
13/02/2019Generics: Understanding the Regulatory ConsiderationsGeneric medicines are becoming increasingly important in the current healthcare environment and delivering these medicines to market as quickly as possible is critical.GEN19
20/02/2019Regulation of In Vitro Diagnostic Medical DevicesThis Masterclass 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 such as the US, Japan, China and Brazil. This is also module 19 of the TOPRA MSc Regulatory Affairs.MSCM19
05/03/2019Project Management for Regulatory Affairs ProfessionalsA two-day course providing an essential overview of project management relating specifically to regulatory affairs professionals.PM19
07/03/2019Essentials 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.MEDBAS19
14/03/2019Optimising Interactions With RegulatorsA practical workshop covering interactions with EU and US health authorities and how to manage them effectively.ADVICE19
20/03/2019Regulatory Document Writing and ManagementSkills based course on the theory and practice of writing regulatory documents and communications for optimal impact and effectiveness.DOC19
28/03/2019Essentials of European Pharmaceutical Regulatory AffairsThis course will provide a basic, comprehensive grounding in regulatory affairs in a relaxed and interactive environment.BAS0319
03/04/2019Registration of Biological, Biotech and Adv 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, 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.MSC92019
09/04/2019Optimising Regulatory Strategies for Orphan DrugsThere are regulatory processes and procedures to expedite approval and access, and help support the development of medicines for the therapy of rare diseases. This course will provide key information about those regulatory processes and first-hand insights on how to get the best out of them.ORPHAN19
11/04/2019Optimising Regulatory Development From Cradle To GraveOptimising regulatory development from cradle to grave - Ensuring the needs of special populations are met.SPECPOP18
17/04/2019Webinar: ATMPs, Human Tissues and the MDRThis webinar will give you sufficient understanding to classify new products and technologies containing human tissues or cells and to understand the impact of such products in a portfolio.ATMP2019
08/05/2019Strategic Planning in Regulatory AffairsThis Masterclass will help you understand the practical and strategic aspects of global regulatory affairs and will help to develop your knowledge and skills to provide advice to their companies and help develop a regulatory strategy. This is also Module 1 of the TOPRA MSc Regulatory affairs.MSC12019
09/05/2019Drug-device Combination Products: Major Changes Ahead!Are you developing new pharmaceutical products? Do they include (or are they provided with) any type of administration device?  If yes, are you fully aware of the impact of the new Medical Device Regulations on MAAs from May 2020?  - This course will explain the current stage of developments as MAHs prepare for the new requirements.DRUG19
20/05/2019The Spring Introductory Course (Pharmaceuticals)An Introduction to Pharmaceutical Regulatory Affairs (Module 0 of the MSc Regulatory Affairs)IC12019
29/05/2019Regulation 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 is also Module 20 of the TOPRA MSc Regulatory Affairs.MSCM2019
06/06/2019Essentials of European Pharmaceutical Regulatory AffairsThis course will provide a basic, comprehensive grounding in regulatory affairs in a relaxed and interactive environment.BAS0619
12/06/2019Managing Lifecycle and Variations EffectivelyRegulatory professionals in industry and agency spend a significant amount of time  on variations, so getting them right is critical.VAR19
19/06/2019Compiling Successful Clinical Trial ApplicationsThis course will equip you with the key knowledge on Clinical Trials applications you need as a regulatory professional.CT19
03/07/2019Regulatory 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.MSC22019
10/07/2019The Medical Device Introductory Course(Module 13 of the MSc Medical Devices) Providing those new to Medical Device Regulatory Affairs with an understanding of the regulatory requirements for medical devices in the EU.INTROMD19