Marketing application submissions, including NDAs, BLAs, and PMAs in the US, are the culmination of years of research and the final hurdle before a product makes it to market.  This webinar will help you understand what is involved in an NDA including regulatory strategy, data integration and readiness, and electronic publishing, and provide tips that can help you avoid common pitfalls in the submissions process.

Featured Speakers

David Shoemaker, Ph.D.

Senior Vice President, R&D

Dr. David Shoemaker has more than 25 years of experience in research and pharmaceutical development.  He has served as a Program Leader or Advisor for multi-disciplinary program teams and has been involved with products at all stages of the development process. Dr. Shoemaker has managed the regulatory strategy for programs involving multiple therapeutic areas, including hematology, oncology, cardiology, pulmonology, infectious diseases, genetic enzyme deficiencies, antitoxins, and anti-bioterrorism agents.  He has extensive experience in the preparation and filing of all types of regulatory submissions including primary responsibility for four BLAs and three NDAs.  

Meagan Spychala, Dr.P.H.

Assistant Vice President, Operations

Meagan Spychala holds a DrPH and MS in biostatistics from the University of North Carolina at Chapel Hill and a BS in mathematics from Washington and Lee University. Dr. Spychala currently serves as the co-PI for the Medical Countermeasures Clinical Studies Network (MCM-CSN), a federal contract that provides support for clinical studies relevant to the Biomedical Advanced Research and Development Authority’s (BARDA) vision to create a nation with the capability to respond quickly and effectively to deliberate, natural and emerging threats by providing a range of clinical study services. 


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