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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30/05/2018Regulatory Strategy for Established Active SubstancesModule 7 of the MSc (Medicines) and Masterclass: This module 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.MSCM72018
07/06/2018CRED Managing Variations EffectivelyVariations are core to lifecycle maintenance and vital to ensure a product registration is up to date. This practical CRED workshop will explain the principles of the EU Variations Regulation. This workshop also will cover intricacies of procedures for grouping and worksharing, and use examples to illustrate the guidelines on categorisation.VAR18
12/06/2018Webinar: Marketing Authorisation Procedure in TurkeyThis webinar is about how the Turkish Medicines and Medical Devices Agency (TMMDA) conducts marketing authorisation procedure in Turkey.WEBTURKEY
13/06/2018Introduction To Medical Device Regulation in Europe(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.INTROMD18
13/06/2018CMC SPIN Webinar & Q&A Session - Pharma Combination ProductsTOPRA CMC SPIN is pleased to introduce this free members-only webinar on ''Pharma Combination Products: Hot topics in evolving US/EU regulation'', which will be held on 13 June 2018 from 2-3.30 pm BST (British Summer Time).CMCJUNE18
14/06/2018Brexit Roundtable: New MAAs and Lifecycle MaintenancePharmaceutical New Product Applications and MA Lifecycle Management - The Clock is ticking. Should alarm bells be ringing? This is the second in a series of three Roundtable meetings to help our members prepare for Brexit. Focused on the biggest challenges for regulatory professionals, the meetings offer an opportunity to discuss the latest information and solutions for the many challenges you face.RTJUNE2018
21/06/2018TOPRA In Ireland MeetingTOPRA Members based in Ireland are invited to join this pertinent meeting covering some of the most relevant topics impacting Regulatory Affairs. A panel of experts will talk about key developments for Medical Devices, GDPR and the impact of Brexit on Regulatory Affairs in Ireland. The event is also an opportunity to meet TOPRA's Irish member network steering group and TOPRA's president, Angela Stokes.IREJUNE18
21/06/2018Essentials of European Medical Device Regulatory AffairsHeld in Ireland, this one-day course and will provide a comprehensive overview of regulatory requirements and considerations for medical devices.MEDBAS218
27/06/2018CRED 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.CD18
03/07/2018Webinar: The EU Novel Foods RegulationThis webinar will provide an understanding of when a new food product could be considered a novel food and will discuss the dossier requirements for the scientific risk assessment undertaken by the European Food Safety Authority (EFSA).WEBNOVFOOD
03/07/2018TOPRA Summit 2018The Regulatory Profession in a disrupted Health Care System – how to remain fit for purposeSUMMIT18
11/07/2018Webinar: Regulatory Requirements of JapanThis webinar will discuss regulatory requirements in JapanWEBJAPAN18
18/07/2018Webinar: Improving Writing for PatientsIn today's day and age, giving people usable information about their treatments has never been so important, as such, it is vital to know how to write and present this information. Attend this webinar learn the best way to communicate with patients.WEBSMPC
19/07/2018Brexit Roundtable: Clinical DevelopmentPharmaceutical Clinical Development/EU Clinical Trials Regulation – A Dire Need for Headache Pills! This is the third in a series of three Roundtable meetings to help our members prepare for Brexit. Focused on the biggest challenges for regulatory professionals, the meetings offer an opportunity to discuss the latest information and solutions for the many challenges you face.RTJULY2018
30/07/2018Essentials 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.BAS0818
30/07/2018TOPRA Summer SchoolAdvance your regulatory career this summer!  Take these two courses as a bundle and receive two free on-demand webinars.CREDSUMMER
31/07/2018CRED Practical Document Writing and ManagementA two-day, skills based, course on the theory and practice of writing optimal regulatory documents and communicationsDOC18
02/08/2018CRED Project Management for Regulatory Affairs ProfessionalsA two-day course providing an essential overview of project management relating specifically to regulatory affairs professionals.PM18
03/09/2018Drug-Device Combinations and Other TechnologiesModule 18 of the MSc (Medical Devices) and Masterclass: This module will enable you to consider and evaluate the practical regulatory aspects including the design, development and lifecycle of a medical device product.MC182018
07/09/2018CRED Advances in BiotechnologyThis course will provide an insight and overview on the new developments in biotechnology.BIOTECH18
11/09/2018Webinar: Updates on China Regulatory ReformThis is an update on China's recent regulatory reform from 2017. In the past 12 month, more draft regulations/guidelines have been finalised and gone into the implementation stage, which will change China's role in global drug development. Therefore, it is important to follow up to those changes, in order to fully explore China drug development potential.WEBCHINA2
20/09/2018CRED Electrical, Electronic and Software Medical DevicesThis course is designed to explain and illustrate the regulatory requirements of electrical, electronic, and software related devices.EE18
26/09/2018Regulatory Strategy From Development To the Market PlaceModule 6 of the MSc: This masterclass module 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 life-cycle and 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.MSCM62018
01/10/2018Medical Devices Symposium 2018 (Stockholm)The 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 requirementsMDSYM2018
01/10/2018Human Medicines Symposium 2018 (Stockholm)Speakers from across the industry 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.SYM2018
02/10/2018Veterinary Symposium 2018 (Stockholm)The 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 solutionsVETSYM2018
03/10/2018Regulatory Update for Small To Medium-Sized EnterprisesDesigned for small to medium-sized enterprises (SMEs), our 2018 regulatory update is a one-day event which will take place on 3rd October.SME2018
11/10/2018CRED Writing Effective 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.SMPC18
16/10/2018Webinar: EU Nutrition and Health Claim Regulation for FoodsThis webinar will provide an understanding of the dossier requirements for the nutrition and health claims scientific assessment undertaken by the European Food Safety Authority (EFSA).WEBNUTRITI
24/10/2018Regulatory and Related Activities in the Device LifecycleModule 17 of the MSc: This is the MSc module 'Regulatory Strategy in the Post-Market Phase'. It 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.MC172018