Module 1 2021

25/06/2021

RA Project Planning Some considerations ….

 Consider Global Picture

o Impact on filing schedule / delays o Strategic implications & risk assessment o Competing for resources o Effective use of different time zones  Cross-functional TEAMWORK o Involve the right functions/ people o Common platform to exchange documents (DMS, SharePoints, Teams, etc)

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

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Regulatory Project Management Plan

1. TOC 2. Purpose & Scope 3. Background

9. Clinical Plan (region/country specific?) 10. Risk Management (incl. delays) 11. Lifecycle Management Plan 12. Submission Administration 13. Regulatory Submission Content & Responsibilities 14. Open Topics 15. Launch 16. Revision History 17. Appendices

4. Source Documents 5. Product Description 6. Registration Plan (worldwide/ region/ country)? Pre-submission requirements (GMP certificate, Marketing Authorisation, DMF, PMF, PIP, SA CPP, RUT, format requirements etc.) 7. Labeling Plan 8. CMC Plan (region/ country specific)?

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

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