Dr. Strom is Associate Director of Regulatory Affairs at Pearl Therapeutics. Dr. Strom has participated in multiple interactions with global health authorities and in the development of global regulatory strategies. She has overseen successful marketing applications and INDs in eCTD format.
A pharmacist with over 30 yrs of reg affairs experience in pharma and consultancy sectors. Overall, Jenny's experience covers both operational and strategic regulatory & development consultancy across a wide range of pharmaceutical, biological and biotechnological products in most therapeutic areas.
Cynthia Girman, DrPH, Sr Director of Epidemiology, has >30 years experience at Merck, including developing/validating endpoints for trials, epidemiological studies and comparative effectiveness research. She's published >200 scientific articles and is an adjunct Assoc Prof in Epidemiology at UNC.
Experience includes regulatory advice and consultancy support to pharma and biotech companies in EU and USA, including clinical trial applications, marketing authorisation applications for small molecules and biologicals, and Scientific Advice meetings with EU National Agencies and EMA.
Description
When a company seeks regulatory or scientific advice from multiple health authorities, the regulators can provide divergent recommendations. This session will discuss strategies to resolve differing feedback and develop a global development strategy.
Learning Objectives: Recognize common reasons for divergent scientific and regulatory recommendations from global health authorities Develop approaches to collaborate with health authorities to resolve different opinions Integrate feedback from health authorities into a unified global product development strategy.