Regulatory affairs courses, webinars, 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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28/03/2019Webinar: EU Labelling RequirementsThis webinar will look at the steps involved in the EMA’s Linguistic Review procedure of product information following MA or post-authorisation procedures for centrally authorised products and how to efficiently manage the process.OnlineWEBLABEL19
28/03/2019Essentials of European Pharmaceutical Regulatory AffairsThis course will provide a basic, comprehensive grounding in regulatory affairs in a relaxed and interactive environment.United KingdomBAS0319
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.United KingdomORPHAN19
11/04/2019Brexit Roundtable: What Happens Next?Following the series of discussions held last year, it is now time to reflect on the implications of the UK’s withdrawal from the EU and to explore how to achieve the best outcomes for the future of pharmaceutical medicines.United KingdomRTAPR2019
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.OnlineATMP2019
26/04/2019Brexit Roundtable: Implications of Brexit on Medical DevicesThe second of a series of three Roundtable meetings to help our members manage Brexit will take place on 26 April and will cover medical devices and IVDsUnited KingdomRTAPR219
08/05/2019Strategic 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.NetherlandsMSC12019
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.United KingdomDRUG19
20/05/2019The Spring 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.United KingdomIC12019
21/05/2019Regulatory Careers Live 2019 for ProfessionalsRegulatory Careers Live is your opportunity to meet with potential future employers and get essential advice from some of the most respected and influential leaders in the field of regulatory affairs.United KingdomCAREERS19
21/05/2019Regulatory Careers Live 2019 for StudentsRegulatory Careers Live is your opportunity to meet with potential future employers and get essential advice from some of the most respected and influential leaders in the field of regulatory affairs.United KingdomCAREERST19
22/05/2019TOPRA In Sweden Meeting - Networking and Regulatory UpdateThis evening is an ideal opportunity to hear the latest regulatory news on Pharmaceuticals and how the new Regulations influence Clinical Evaluation of Medical Devices. We will also talk about implementation of Serialisation, e-VIS, and TOPRA news.SwedenTSMAY2019
23/05/2019TOPRA Summit 2019How the regulatory process works and how decisions are made is evolving. Two of the most significant factors influencing this are the drive for patient-centred regulation and the expansion in innovative sources of regulatory data.United KingdomSUMMIT19
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 course is also Module 20 of the TOPRA MSc Regulatory Affairs.)United KingdomMSCM2019
30/05/2019Webinar: Introduction To Data VisualisationThis webinar will provide an introduction to the latest data visualisation techniques being used to get the most insight from scientific and clinical data. How you visualise scientific and clinical data can powerfully influence the insights gained, conclusions drawn and the decisions that are made. This webinar can help you make the most of your data and ensure you aren’t missing important insights that could be used to support your internal decision making processes or your regulatory approvals.OnlineWEBDATA19
05/06/2019Webinar: GMDN Primer for Regulatory Affairs ProfessionalsGet an understanding of Global Medicinal Device Nomenclature (GMDN) and how this can be best managed.OnlineWEBGMDN19
06/06/2019Essentials of European Pharmaceutical Regulatory AffairsThis course will provide a basic, comprehensive grounding in regulatory affairs in a relaxed and interactive environment.BelgiumBAS0619
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.United KingdomVAR19
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.United KingdomCT19
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.United KingdomMSC22019
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.United KingdomINTROMD19
05/08/2019Essentials of European Pharmaceutical Regulatory AffairsThis course will provide a basic, comprehensive grounding in regulatory affairs in a relaxed and interactive environment.United KingdomBAS0819
11/09/2019Getting the CMC Dossier RightThis course workshop led by agency and industry experts will provide an insight into the preparation and management of the pharmaceutical (CMC) information in Module 3 of the regulatory dossier.United KingdomCMC19
19/09/2019Critically Evaluating DossiersThis course will help you critically analyse dossiers by understanding the importance of helping the assessor find pivotal information, as well as the importance of having consistent messages across Module 2, and between the summaries and the documents of Module 3-5.United KingdomDOSS19
25/09/2019US 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.United KingdomMSCM212019
30/09/2019Human Medicines Symposium 2019Speakers from agencies across Europe will provide a broad range of insight and facilitate discussion into the world of regulatory affairs on matters affecting industry professionals today and in the future.IrelandSYM2019
30/09/2019TOPRA Annual Symposium Exhibitor Package 2019A truly unique and valuable event in regulatory affairs – the only conference entirely focused on healthcare regulatory affairs allowing you to meet a closely defined group of professionalsIrelandSYMEXHIB19
30/09/2019Veterinary Medicines Symposium 2019The Veterinary Medicines Symposium will concentrate on how we can improve animal health with veterinary medicines by looking at how we collaborate now and in the future, what strategies could be put in place and how we can work together towards new solutions.IrelandVETSYM2019
01/10/2019Medical Devices/IVDs Symposium 2019The regulation of medical devices is continually changing as more innovative technologies and drug-device combinations are being developed. Anyone involved in medical devices and in vitro diagnostics needs to keep up to date with both the new EU regulations and the clinical requirements.IrelandMDSYM2019
02/10/2019Regulatory Updates for SMEsDesigned for small to medium-sized enterprises (SMEs), our 2019 regulatory update is a one-day event which will take place on 2 October in parallel with TOPRA's 2019 Annual Symposium.IrelandSME2019