Module 1 2021

25/06/2021

Practical Aspects - Personal Experiences …

What went wrong? … even though correct (stand-alone) RA assessments

• Change of Project Lead after Phase I • no hand over • Ignorance of potential relation of changes/ lack in coordination of parallel changes • Lack of Communication

Opportunity • Think above and beyond your responsibilities • Speak up even if it might not be your responsibility • Apply RA knowledge in a not strictly regulated environment to meet the patients’ requirements/ needs… leading to/ resulting in a successful outcome

39

The Organisation for Professionals in Regulatory Affairs The Organisation for Professionals in Regul tory Affairs

39

In this presentation we covered…

 RA professionals’ task in project planning

 How to organize Regulatory Project Planning & Submission Planning

– Relationship Regulatory Project Planning

– Regulatory Project Management/ Submission Planning

 Common Difficulties & Practical Aspects & Project Risks

40

The Organisation for Professionals in Regulatory Affairs

40

20