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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25/02/2019Webinar: Get the Recognition You Deserve with CSciHave you been working in regulatory affairs for 4-6 years? Do you have a high level of competence? If so, then get the recognition you deserve with Chartered Scientist! Find out how from this webinar.OnlineWEBCSCI19
05/03/2019Project Management for Regulatory Affairs ProfessionalsA two-day course providing an essential overview of project management relating specifically to regulatory affairs professionals.United KingdomPM19
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.IrelandMEDBAS19
07/03/2019TOPRA In Ireland MeetingTOPRA Members are invited to join this evening meeting to listen to  guest speakers cover topics such as the role and responsibilities of the MAH and on how to grow a global regulatory team. You will also have a chance to meet the Irish member network steering group and find out what other activities are planned in Ireland throughout 2019. Non-members are welcome to join at a small fee too, so why not invite a colleague along with you?IrelandIREMARCH19
14/03/2019Optimising Interactions with RegulatorsA practical workshop covering interactions with EU and US health authorities and how to manage them effectively.NetherlandsADVICE19
18/03/2019Essentials of European Regulatory Affairs, United StatesThis course will provide you with the opportunity to learn about European Regulatory Affairs direct from the source.United StatesESS118
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.United KingdomDOC19
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
03/04/2019Registering Biological, Biotech & 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.United KingdomMSC92019
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
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
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.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
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 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