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.

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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
20/11/2019Webinar: 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
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
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
03/12/2019CRED Sucessfully Navigating European GMO RegulationsLearn how to navigate the EU GMO legislative framework and implementation for successful clinical trial submissions. The course will primarily focus on the EU requirements but will also discuss the Canadian requirements. This blended online course will be presented through a series of presentations that can be accessed at a time that is convenient for you with a live question and answer panel session with the speakers and a case study on 3 December 2019.LondonUnited KingdomBIOTECH19
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.CheshuntUnited KingdomIC12020
29/04/2020Essentials of In-Vitro Diagnostics Regulatory AffairsThis course will provide a basic, comprehensive grounding in regulatory affairs for IVDs in a relaxed and interactive environment.LondonUnited KingdomIVDBAS20
14/05/2020CRED Managing Lifecycle and Variations EffectivelyRegulatory professionals in industry and agencies spend a significant amount of time on variations, so getting them right is critical.LondonUnited KingdomVAR20
19/05/2020CRED+ Optimising Interactions With RegulatorsA practical workshop covering interactions with EU and US health authorities and how to manage them effectively.LondonUnited KingdomADVICE20
03/06/2020Clinical Evaluation of Medical DevicesThis Masterclass is also Module 15 of the MSc Regulatory Affairs and will help you to understand the broad scope of clinical investigation and the regulatory processes required with the alternative routes to demonstrate compliance.LondonUnited KingdomMC152020
10/06/2020CRED Understanding Clinical DevelopmentThis two-day workshop will provide an overview with practical advice from regulators and industry on the process of designing and conducting clinical trials from phase I through phases II, III and even clinical trials considerations beyond drug marketing approval.LondonUnited KingdomCD20
25/06/2020CRED Optimising Regulatory Strategies for Orphan DrugsThere are regulatory processes and procedures to expedite approval and access, and to help support the development of medicines for the treatment 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.LondonUnited KingdomORPHAN20
01/07/2020Regulatory Strategy From Development To the Market PlaceThis Masterclass is also Module 6 of the MSc regulatory Affairs, and will enable you to consider and evaluate the practical regulatory aspects of regulatory strategy for commercialising products and maintaining the brand from the development stages to registration and throughout the product lifecycle. You will explore and critically debate the regulatory issues likely to arise prior to and during commercialising of products in order to be able to provide effective advice on such situations.CheshamUnited KingdomMSCM620
02/09/2020Post Market Surveillance and Vigilance for Medical DevicesThis Masterclass is also Module 16  of the MSc Regulatory Affairs and will help to define the terminology and explain the concepts of vigilance and post-market surveillance, their practical applications and integration into the lifecycle of a medical device. This course will focus on meeting European requirements.LondonUnited KingdomMC162020
08/09/2020CRED Project Management for Regulatory Affairs ProfessionalsA two-day course providing an essential overview of project management relating specifically to regulatory affairs professionals.LondonUnited KingdomPM20
22/09/2020CRED Getting 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. This course will focus on synthetic molecules and provide a brief introduction to biologics.LondonUnited KingdomCMC20
23/09/2020Regulatory Strategy for Established Active SubstancesThis Masterclass is also Module 7 of the MSc and is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation of the strategic issues to be considered in relation to medicines containing established active substances, including; line extensions, generics and the relevant aspects for OTC products. It will allow them to examine the regulatory requirements imposed on these substances.DublinIrelandMSCM72020
22/10/2020CRED Understanding Digital Health and Electronic ProductsRegulation of electrical, electronic and software medical devices.LondonUnited KingdomEE20
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.LondonUnited KingdomMC172020