This webinar will focus on the key new aspects, challenges, and possible solutions resulting from the latest CIOMS XII guidance. Topics will include the concept of an entire life-cycle approach using a structured benefit-risk assessment as a basis, complemented by quantitative analyses for complex issues, consideration of knowledge gaps and well-established products, as well as patient perspectives.
Special situations like emergencies, accelerated approval, or repurposing of medicinal products require additional considerations. New methodological approaches involving inclusion in clinical designs, and pragmatic, patient-centric perspectives will also be discussed.
Why Attend?
- Understand the evolving methodologies in benefit-risk assessment for medicinal products.
- Explore the latest CIOMS XII guidance and what it means for regulatory and clinical practice.
- Learn about the life-cycle approach to benefit-risk assessment, including structured and quantitative methods.
- Recognize the importance of transparency and stakeholder engagement throughout the assessment process.
- Gain insights into special scenarios, such as emergencies, accelerated approvals, and product repurposing.
- Appreciate the value of patient perspectives and pragmatic clinical designs in benefit-risk evaluation.
A favourable benefit-risk balance is a precondition to get a product authorised and marketed. Ultimately, any benefit-risk assessment requires acceptance by relevant stakeholders to ensure the use of a medicinal product that is intended to add value to patients’ lives.
This can be best achieved if it is performed transparently, highlighting the robustness of scientific evidence and uncertainties, as well as subjective judgments, so that it can be sufficiently challenged by all stakeholders. The methodology of benefit-risk assessment is constantly evolving, and the new CIOMS XII working group summarises current best practices.
About the Author
Dr. Frank Laschewski serves as the Qualified Person for Pharmacovigilance (QPPV) at APCER Life Sciences, based in Aachen, Germany, a role he has held since 2017.
With over 25 years of experience in the pharmaceutical industry, Dr. Laschewski brings comprehensive expertise across all facets of pharmacovigilance and medical affairs. As a physician specialized in internal medicine, he has eight years of clinical practice, providing a strong foundation for his work in drug safety. His extensive pharmacovigilance experience spans global development projects, post-marketing safety for both innovative and branded generic products, signal detection and risk management, as well as QPPV and GPO responsibilities. Dr. Laschewski has also led global pharmacovigilance organizations, ensuring the highest standards of patient safety and regulatory compliance.