Senior Director, Global Regulatory Sciences, Vaccines CMC Pfizer, Inc. Cary, North Carolina, United States
The unprecedented stress that COVID-19 has imposed on the global biopharmaceutical supply chain necessitates urgent action to implement flexible, but predictable, regulatory tools and approaches that will allow manufacturers to rapidly increase manufacturing capacity for the production of COVID-19 therapeutics and vaccines to meet global demand and avoid or mitigate drug shortages for non-COVID-19-related products, without compromising patient safety or product quality.
Learning Objectives:
Upon completion, the audience will appreciate the complexity and challenges associated with novel platforms.
Upon completion, the audience will learn Opportunities to Provide Benefits of Vaccines to Patients Earlier and More Efficiently.
Upon completion, the audience will learn the importance of regulatory science in setting the frame-work for novel product development
