Tips for a Successful NDA Submission
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 share tips on regulatory strategy, data integration and readiness, and electronic publishing that can help you avoid common pitfalls in the submissions process.
David Shoemaker, Ph.D.
Senior Vice President, R&D
Dr. Shoemaker has been a trusted regulatory advisor to international clientele for close to 30 years providing regulatory and scientific expertise for integrated product development programs across a wide range of therapeutic areas. Dr. Shoemaker has extensive experience in all stages of investigational product development, has moderated dozens of regulatory authority meetings, and has managed and contributed to over one hundred INDs, over a dozen IMPDs, and dozens of successful marketing applications across the majority of reviewing divisions at FDA and several international regulatory authorities. At Rho, Dr. Shoemaker serves as an expert scientific and regulatory reviewer for documents destined…
Chief Strategist, Regulatory Biostatistics and Data Standards
Rob Woolson serves as Rho’s Chief Strategist for Regulatory Biostatistics and Data Standards. Mr. Woolson joined Rho in 2007 and has 20 years’ experience as an applied statistician. He has an extensive background working with small biotech and pharmaceutical companies to successfully bridge and navigate the biometrics, CDISC data standards, and regulatory requirements of drug and biologics development. He has advised and supported sponsor companies through 12 marketing applications in several therapeutic areas, including playing a vital role in numerous FDA and Advisory Committee meetings. Mr. Woolson brings this experience to his current role providing strategic guidance to sponsor companies…