In this insightful webinar, Vjera Bilusic Vundac explores the critical role of Risk Management Plans (RMPs) in clinical drug development, with a particular focus on China’s evolving regulatory requirements. She breaks down the structure and key components of an RMP, emphasizing the importance of regular updates and adjustments throughout a medicinal product’s lifecycle.
Key highlights include:
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Definition and importance of RMPs – mandatory for all EU marketing authorizations since 2018.
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Clinical Risk Management Plans (CRMPs) in China – required during the clinical trial stage to define safety specifications, propose pharmacovigilance strategies, and implement risk minimization measures.
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Ongoing risk management – identifying new risks, refining existing ones, and ensuring that the benefits of a medicinal product consistently outweigh potential risks throughout its lifecycle.
This comprehensive overview provides actionable insights into the legal, procedural, and safety frameworks that shape pharmaceutical risk management, underscoring the importance of proactive measures in global drug development.
