CRED: Continuing Professional Development

The TOPRA 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 one-day courses, 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
3/13/2018CRED+ Optimising Interactions With RegulatorsThis is a practical workshop covering interactions with EU and US health authorities.ADVICE17
3/22/2018CRED Navigating European Regulatory ProceduresA course designed for individuals involved in developing European regulatory strategies for projects or wishing to gain the knowledge and skills to enable you to contribute to regulatory strategiesERP18
4/19/2018CRED Demonstrating Appropriate Dosage Form DesignA practical workshop on bioequivalence and biowaivers. This course bridges the gaps between the guidelines and the practicalities as well as the clinical aspects of bioequivalence and the quality/pharmacy aspects of dissolution.BIO18
5/21/2018CRED Getting the CMC Dossier RightThis two-day workshop led by regulators and industry experts will provide an insight into the preparation and management of the pharmaceutical (CMC) information within the regulatory dossier.CMC18
6/7/2018CRED 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 will cover also intricacies of procedures for grouping and worksharing, and use examples to illustrate the guidelines on categorisation.VAR18
6/27/2018CRED 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
10/11/2018CRED 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
11/14/2018CRED Compiling Successful Clinical Trial ApplicationsThis workshop based course will equip you with the key regulatory knowledge on Clinical TrialsCT18
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