Module 6

02/10/2024

Maintaining and Extending the Brand 4 key areas to maintain and extend the new medicinal product

Maximising Patients

• Special populations (renal, hepatic, ethnic, pregnancy, DDIs) • New clinical indication • New patient population (e.g. paediatrics, elderly) • New formulation

Benefit / Risk Assessment

• Conditional Marketing Authorisation (MA) obligations • Renewals • Post-approval commitments • Post-approval safety or efficacy studies, registry data

Minimising Risk

New safety updates (pharmacovigilance) Periodic Safety Update Reports (PSURs)

• •

• Risk Management Plan (RMP) incl. Direct Healthcare Professional Communications (DHPCs) & Education

Maintaining Compliance

Sunset clause monitoring

• • •

GxP Inspections

Pharmacovigilance System Master File (PSMF) • General maintenance: quality variations, labelling

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 2 – Maintain and Extend the Brand

49

Extend and Protect the Brand Look for opportunities to expand the potential of the new medicinal product

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 2 – Maintain and Extend the Brand

50

25