Module 6

03/10/2024

Standard for GPvP inspections MHRA Inspectorate ‘Purple Guide’ Manual on Good Pharmacovigilance Practice ● Becoming the reference standard for European inspections ● Interpretation of guidance for European authorisation holders on: con028494 https://www.gov.uk/guidance/good-pharmacovigilance-practice-gpvp

– Pharmacovigilance – Risk management

– Safety data evaluation – Management of labelling – Quality management system

– Interactions between DS&E and other functions – Post-authorisation studies and market research – Contracts and agreements

Trun, W; Kilgour-Christie, J; Corbel-Ecalard, C; Lewis DJ. Negotiating your way through the vigilance agreement maze – is there an easier way? Therapeutic Innovation & Regulatory Science (In press: TIRS-D-22-00221)

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Penalties under European Law

“Penalties Regulation” ● Regulation EC 658/2007 ● Regulation EU 488/2012 (+ PIP)

Directly linked to Regulation 726/2004

Applies to individuals (EU QPPV, Drug Safety Responsible Persons, Medical Director), MAH & Affiliates 40 Lewis, D.J. New Normal? Takeaways from a virtual regulatory inspection during COVID-19. Drug Information Association, Global Forum, April 2020. https://globalforum.diaglobal.org/issue/april-2020/new-normal-takeaways from-a-virtual-regulatory-inspection-during-covid-19/.

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