Module 6

04/10/2024

EMA Risk Management Approach

1. Risk Management Plans (RMPs) : These are detailed documents that outline the risk management system for a medicinal product. 2. Good Pharmacovigilance Practices (GVP) : These guidelines provide a framework for monitoring the safety of medicines and ensuring that any risks are promptly identified and managed. 3. Periodic Safety Update Reports (PSURs) : These reports are required at regular intervals and provide an update on the safety profile of a medicinal product. 4. Guidelines on ICT and Security Risk Management : These guidelines establish requirements for managing information and communication technology (ICT) risks, ensuring a consistent and robust approach across the EU. 5. Environmental, Social, and Governance (ESG) Risks : The European Banking Authority (EBA) has also issued guidelines on managing ESG risks, which include requirements for identifying, measuring, managing , and monitoring these risks. These guidelines are part of the broader efforts to ensure that medicines in Europe are safe, effective, and of high quality.

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EMA and other Agencies

EMA: FDA

Collaborative process since 2003, current format since 2010. Regular cluster meetings eg Pharmacovigilance teleconference every month Other agencies are involved in different clusters: Orphan drugs, Advance therapies, Biosimilars…

Its not an Ivory Tower….

European Medicines Agency (EMA) holds regular meetings by phone or videoconference with other non-EU regulators in so- called ‘clusters’..

(See Partners & networks ema.europe.eu)

Japanese - Pharmaceutical and medical Devices Agency (PMDA)

The type of information exchanged includes applications for marketing authorisation and extensions of indications, including risk-management plans and evaluation of safety signals.

Australia - Therapeutic Goods Administration (TGA)

Health Canada

They all talk regularly – so facts, data must be consistent

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Issues Management or Managed by Issues?

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