CRED: Continuing Professional Development

TOPRA's Continuing Regulatory Education and Development (CRED) Programme is a series of regulatory affairs courses designed to help professionals keep up to date or develop their career in new directions.

The CRED programme

The programme comprises a series of courses lasting one to two days, run over a two-year cycle.
  • Structured but flexible continuing regulatory education, allowing regulatory professionals to design training programmes to suit their individual needs 
  • A choice of 16 interactive workshops, covering eight core topics, providing regulatory professionals with the opportunity to build up a dossier of training demonstrating technical and practical knowledge 
  • A balance of theory and practice, equipping participants with practical skills that can be applied immediately 
  • Speakers drawn from both regulatory agencies and industry, offering different perspectives
  • Interactive sessions (often case studies) where participants and experts share ideas and experiences and address common problems faced in everyday situations.

If you have queries about the CRED programme, please email us.

Upcoming courses

Begin DateTitleDescription
13/02/2019Generics: Understanding the Regulatory ConsiderationsGeneric medicines are becoming increasingly important in the current healthcare environment and delivering these medicines to market as quickly as possible is critical.GEN19
05/03/2019Project Management for Regulatory Affairs ProfessionalsA two-day course providing an essential overview of project management relating specifically to regulatory affairs professionals.PM19
14/03/2019Optimising Interactions With RegulatorsA practical workshop covering interactions with EU and US health authorities and how to manage them effectively.ADVICE19
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.DOC19
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.ORPHAN19
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.DRUG19
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.VAR19
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.CT19
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.CMC19
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.DOSS19
17/10/2019Managing Veterinary VariationsThis 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.VETVAR19