Benefit-Risk Balance for Medicinal Products: New Challenges and Solutions in the Context of CIOMS XII

Explore the latest CIOMS XII guidance and its impact on benefit-risk assessment for medicinal products.

Key Takeaways:

1. Focus on a comprehensive life-cycle approach to benefit-risk evaluation
2. Emphasis on structured, quantitative analyses and patient perspectives
3. Importance of transparency in regulatory and clinical decision-making
4. Coverage of special scenarios: emergencies, accelerated approvals, and product repurposing
5. Introduction of new methodologies and pragmatic clinical designs
6. Strategies to ensure favourable benefit-risk balance accepted by stakeholders
7. Presented by a pharmacovigilance expert with 25+ years of experience

Testimonials

Which aspect of the webinar did you find most valuable?

IMI protected methodologies and the case study examples on how data could be analysed differently

1. AVP, PSRM Safety Surveillance and Risk Management and Clinical Safety ,A Leading Indian Pharma Company