Module 1 2021

25/06/2021

Present/Future: Global Development Regulatory Programme

Pre-submission, submission and Q&A activities in narrower time-windows: concentrated global effort required

Approvals in a Narrower Time Window

Pre-registration Activities

U.S. SUBMIT

Q&A APPROVE

Q&A

SUBMIT

APPROVE

EUROPE

Q&A

SUBMIT

APPROVE

LA, APAC, MENA, AFRICA etc

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People

• Profile – Committed to Quality / Compliance

– Business oriented – Process-minded

• Need re-fillable pool • Central/virtual location for global support: off- shore/outsource? • Cost-effective • Effective and fast on-boarding/training • Opportunities for growth and development

The Organisation for Professionals in Regulatory Affairs

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