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 DateTitleDescriptionCityCountry
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. This course will focus on synthetic molecules and provide a brief introduction to biologics.LondonUnited 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.LondonUnited KingdomDOSS19
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
19/11/2019Successful and Skilful CommunicationSkillful 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
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
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
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
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
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
22/10/2020CRED Understanding Digital Health and Electronic ProductsRegulation of electrical, electronic and software medical devices.LondonUnited KingdomEE20