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.

 
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.

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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.LondonUnited KingdomMSCM212019
26/09/2019Webinar: Quality/CMC Considerations for ATMPsThis webinar will provide an overview of the quality/CMC considerations with respect to clinical trial applications and marketing applications for advanced therapy medicinal products (gene and cell therapy products). This will include an outline of the current guidance for these product types for the EU and the USA and specific challenges for cell-based therapies, gene therapies and combined ATMPs. OnlineWEBATMPCMC
30/09/2019Webinar: Global Development Series Offer 2019THREE FOR TWO OFFER: Explore the world of regulatory affairs with TOPRA's Global Development webinar series.  WEBGD19
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.DublinIrelandVETSYM2019
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.DublinIrelandSYM2019
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 professionalsDublinIrelandSYMEXHIB19
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.DublinIrelandMDSYM2019
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.DublinIrelandSME2019
03/10/2019TOPRA In Scotland - EMA’s centralised authorised ProcedureThe next TOPRA in Scotland meeting will be held from 14:00 to 17:00 on Thursday, 3 October 2019, at the historic Linlithgow Burgh Halls.LinlithgowUnited KingdomSCOT5OCT19
10/10/2019Webinar: Effects of EU-Mercosur Trade Agreement (Pharma)This webinar will provide an overview of the Mercosur regulatory affairs system for pharmaceutical companies that want to benefit of the free-trade agreement signed between European Union and the South America trade bloc. OnlineWEBMERPHAR
16/10/2019Essentials 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.LondonUnited KingdomMEDBAS219
16/10/2019TOPRA in Sweden Meeting on Health Technology AssessmentTOPRA invites you to a Networking meeting on Health Economics (HTA) from a regulatory perspective. This evening is a great opportunity to hear the latest in this area. You also get the opportunity to meet colleagues in a relaxed and pleasant environment.UppsalaSwedenTSOCT2019
17/10/2019Regulatory Update: Veterinary Variations in the EUThis is a comprehensive overview of how to prepare and submit variations to VMP marketing authorisations. It provides an update on the latest changes and advice on best practice for experienced regulatory professionals.LondonUnited KingdomVETVAR19
04/11/2019EMA Article 58 Pathway for Global Health MedicinesThis webinar discussion given by Dr Agnes Saint-Raymond, Head of International Affairs Division, Head of Portfolio Board, European Medicines Agency will give a comprehensive understanding of the added value and opportunities offered by EU-Medicines4All/Article 58 right through the medicine development lifecycle. OnlineRTNOV2019
05/11/2019The Autumn Introductory CourseOur annual Autumn Introductory course is a comprehensive 4-day introduction to EU Pharmaceutical Regulatory Affairs (also Module 0 of the MSc Regulatory Affairs programme).BerlinGermanyIC219
19/11/2019CRED Successful and Skilful CommunicationSkilful communication and negotiation skills are essential for effective regulatory professionals. Learn to recognise and use different negotiation strategies whilst maintaining trust and respect with complex groups of stakeholders. Develop and deliver impactful presentations and documents that deliver the results you need.LondonUnited KingdomCOMM19
20/11/2019Data 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 KingdomMSCM122019
20/11/2019Webinar: Effects of EU-Mercosur Trade Agreement (Devices)This webinar will provide an overview of the Mercosur regulatory affairs system for medical device companies that want to benefit of the free-trade agreement  signed between European Union and the South America trade bloc. OnlineWEBMERMD
21/11/2019The Awards for Regulatory ExcellenceJoin us at The Merchant Taylors' Hall on 21 November for the 10th annual Awards for Regulatory Excellence to celebrate the achievements of individuals, teams and organisations in the regulatory affairs community.London AWARDS19
28/11/2019Essentials of European Pharmaceutical Regulatory AffairsThis course will provide a basic, comprehensive grounding in regulatory affairs in a relaxed and interactive environment.LondonUnited KingdomBAS1119
04/12/2019Regulatory Requirements for a New Active Substance: QualityThis Masterclass will help you understand and provide advice on quality data requirements in the pharmaceutical regulatory environment as well as addressing practical regulatory questions in this area.  This is also Module 3 of the TOPRA MSc Regulatory Affairs.CheshamUnited KingdomMSC32019
22/01/2020Regulatory Strategy for a New Active Substance: GCDRegulatory Strategy for a New Active Substance: Global Clinical Development (Module 4 of the MSc) This module will help you to understand and develop regulatory strategies for all aspects of global clinical research, as well as addressing practical regulatory issues in this area.CheshamUnited KingdomMSCM420
12/02/2020Regulation of In Vitro Diagnostic 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 is also module 19 of the TOPRA MSc Regulatory Affairs.LondonUnited KingdomMSCM1920
19/02/2020CRED Practical Document Writing and ManagementA two-day, skills based, course on the theory and practice of writing optimal regulatory documents and communications for those working in the pharmaceutical industry.LondonUnited KingdomDOC2020
27/02/2020Essentials of European Pharmaceutical Regulatory AffairsThis course will provide a basic, comprehensive grounding in regulatory affairs in a relaxed and interactive environment.LondonUnited KingdomBAS0220
04/03/2020Design Development and Certification of Medical DevicesThis Masterclass is also module 14 of the MSc Regulatory Affairs and will help you to gain an understanding of the design, manufacturing and quality management requirements for product development, the importance and concepts of risk management and the ways in which risk is managed from the design stage onwards, so that you can provide appropriate advice on the key regulatory issues affecting design, certification and manufacturing of medical devices.LondonUnited KingdomMC142020
11/03/2020CRED An Overview of Regulatory Product InformationThis one day workshop from regulators and industry experts will provide an insight on European SmPC, package leaflet (PL) and label preparation and implementation, from a strategic and practical point of view.LondonUnited KingdomSMPC20
12/03/2020CRED European Regulatory ProceduresA course designed for individuals involved in developing European regulatory strategies for projects or wishing to gain the knowledge and skills to contribute to regulatory strategies.LondonUnited KingdomERP20
26/03/2020Essentials of European Veterinary Regulatory AffairsThe world of veterinary regulatory affairs can be a confusing and complex place, particularly if you have no formal veterinary or regulatory affairs 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.LondonUnited KingdomVETBAS20
31/03/2020The 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.Cheshunt, HertsUnited KingdomIC12020