Spring Intro 2023

16/02/2023

Learning outcomes were: Understand EU Regulatory lifecycle management :

Risk/benefit assessment • Conditional Marketing Authorisation (MA) • Renewals • Post-approval measures • Paediatric Investigation Plan (PIP) maintenance activities Maintaining Compliance • Sunset clause monitoring • GxP Inspections • Pharmacovigilance System Master File (PSMF)

Expanding Opportunities • Efficacy variations

Minimising Risks • Safety variations • Periodic Safety Update Reports (PSURs) • Risk Management Plan (RMP) incl.

Direct Healthcare Professional Communications (DHPCs) & Educational tools

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Reading list • European Medicines Agency post-authorisation procedural advice for users of the centralised procedure • CMDh Best Practice Guide for the Handling of Type II Variations in the Mutual Recognition Procedure EMA Referral Procedures

• Heads of Medicines Agencies: Questions & Answers (hma.eu) >Referrals

• Data exclusivity, market protection orphan and paediatric rewards

• Report from EC, 10 years of the EU Paediatric Regulation

• Paediatric medicines: Overview | European Medicines Agency (europa.eu)

• CMDh information on paediatric medicines

• CMDh Best practice guide on renewals November 2020 CMDh/004/2005, Rev.18

• Guideline on the processing of renewals in the centralised procedure (europa.eu)

• Post-authorisation safety studies (PASS) | European Medicines Agency (europa.eu)

• Scientific guidance on post-authorisation efficacy studies (europa.eu)

• CMDh QUESTIONS & ANSWERS POST-AUTHORISATION EFFICACY STUDIES (PAES) IN MRP/DCP

• Notifying a change of marketing status | European Medicines Agency (europa.eu)

• RMP publications (europa.eu)

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