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
6/7/2017CRED VariationsVariations 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.VAR17
6/15/2017CRED SmPC, Patient Information Leaflet & LabellingThis 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. SMPC17
7/11/2017CRED Regulatory Challenges of Successfully Developing ATMPsThis one-day workshop is perfect for regulatory professionals with an interest in working with ATMPs and for those who already work in this area.ATMP17
9/7/2017CRED Drug-Device Combination ProductsThere are exciting developments in combining medical device technology with medicinal products, this is increasingly in focus due to biotechnology and advanced therapy medicinal products.DDC17
10/11/2017CRED Generics: 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.GEN17
10/18/2017CRED Chemistry Manufacturing and Controls (CMC)This 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.CMC17
11/9/2017CRED+ Health Technology AssessmentUnderstanding and taking account of Health Technology Assessment (HTA) needs during your product development programme will result in a more efficient drug development process and a speedier return on investment.HTA17
11/22/2017CRED Clinical TrialsThis workshop based course will equip you with the key regulatory knowledge on Clinical TrialsCT17
12/13/2017CRED Regulatory Operations Including ECTDThis course will take you through the key functions of a regulatory operations department and how its effectiveness can be maximised.RO17
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