A practical & interactive training:

Regulatory Affairs Strategies

The course will provide you with practical information on effective drug registration processes, best practices for integrating regulatory requirements from early stages of development and advice on how to develop RA project teams and strategies that work for both you and the regulators.


1. Drug Discovery
  • New drug development
  • Target Product Profile (TPP)
    • Description and benefits of a TPP
    • Completing a TPP
    • Linkages with other initiatives
  • How to improve co-operation within R&D and the regulatory team
2. Clinical Phases
  • Clinical Development Phase I to III : requirements and applications across the EU
  • Reconciling manufacturing, non-clinical and clinical demands within the regulatory framework
  • Commercial imperatives
  • Guidelines on specific therapeutic areas
3. Approval of Marketing Authorization Applications (MAA)
  • Review of key legislation including the recent Directives and regulations
  • Scientific advice from EMA and national agencies
  • What are the requirements for a successful and readily approvable MAA/CTD?
  • Selecting the registration procedure: MRP, DCP or Centralised Procedure
4. Regulatory Affairs beyond the MAA
  • Regulatory Intelligence and competitive advantage
  • Optimising your product potential
  • How to be positive and a solution-seeker for your organisation - not a regulatory obstacle
  • Regulatory negotiations at senior management level
This training is a cooperation with PTI - a global interactive training partner committed to the personal progression of aspiring life science professionals.
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