CRED Project Management for Regulatory Affairs Professionals

Why (?) – Operational Planning

 Learning Points/Future recommendations  Sponsor [Pharmaceutical Company] – Typically seeks Scientific Advice from US FDA and EMA for Protocol Design and CMC (Quality) and Pre-Clinical product Development strategy. ● If Sponsor decision is to not include all of the SA recommendations – Justifications for deviation from guidance obtained/protocol study design should be carefully considered. [People]  Country Specific Regulations & Guidelines ● Knowledge and Application of Regulatory requirements at Local Office/Affiliate level [People]  Adhering to Requests from Local Affiliates ● Sponsor accommodating requests to support accurate clinical trial applications – some resistance [Denmark PGx], affected delays [People]  Communication