How Do Medical Affairs and Regulatory Affairs Professionals Co-Create The Regulatory Strategy From The Beginning?
New ways clinical trials and real-world studies will be conducted…
New approaches in BR assessment to improve your PV process
What do transparent and robust benefit-risk assessments require?
Transparent and robust BR assessments require engagement from cross-functional experts, good planning and a well-designed process to ensure tracking and documentation of decisions.
How did the pandemic push pharmacovigilance to innovate?
The pandemic pushed PV processes including structured BR assessment to be much more agile to deliver analyses and assessments quicker (in real-time in some instances!) and with the relevant evidence to take immediate actions. Moreover, pandemic pushed the BR balance concept into everyone mind and brought higher level of expectations in term of easy-to-understand tools and messages.
What are the new approaches to benefit-risk assessment and how to apply them effectively?
The new approaches to BR assessment focus on various aspects impacting clinical development and require a very early planning of activities to be implemented during development. For example, integration of patient-centric approach into clinical development can be made to ensure that endpoints that matter the most for patients are measured, that patients’ trade-off are considered, and to address other relevant questions for patients.
Stephanie TCHERNY is a Global Head of Benefit-Risk Evaluation at Sanofi. She is a public health physician, with over 18 years of experience working in pharma companies on Pharmacoepidemiology and BR evaluation to support market access, pricing and risk management plans. Stephanie has led different roles in Global Pharmacovigilance & Epidemiology department at Sanofi including Head of Benefit-Risk evaluation since 2017. She is one of the leading experts in the qualitative and quantitative BR field and has conducted many benefit-risk analyses for development and marketed drugs.