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.

Agenda

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.

A cooperation with: