Module 1 2021

25/06/2021

RA professionals’ important roles cont’d

 Pharmacovigilance

 Reimbursement

 Project/ Submission Planning

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

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Submission Planning (RA projects ) Some considerations

 Contact and liaise with authorities from development to licensure & post-authorization activities  Prior to submission o Discuss & agree on procedural details & timing, share RA Strategy (Roadshow) o Manage presubmission activities  Clinical trials (global) – advise on countries, give input on numbers of patients per region, etc.  Advice on Licensing Strategy (global, US vs EU), → Pre-submission & dossier requirements  New MAAs – key document - Draft Product Information (regular revisits & revisions required, in line with “xTPP”) o Manage/ supervise the compilation of regulatory files

CTAs, PIPs, MAAs/ BLAs, amendments/ variations, Scientific Advice, Pre-submission meetings, etc.

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

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