Technical Event
FDA Policies and Procedures: What Academic Investigators and Small Business Should Know
30 January 2023 • 1:30 PM - 3:30 PM PST | Moscone Center, Room 312 (Level 3 South)
Workshop Chair:
Ramesh Raghavachari, U.S. Food and Drug Administration
Come hear speakers from industry and regulatory agencies share their perspectives and advice on incorporating regulatory requirements into product development and how to achieve successful regulatory strategies. In addition, small business owners will gain valuable business perspectives concerning 3rd party review and regulatory approval for medical devices.
1:30 pm Welcome, Ramesh Raghavachari, U.S. Food and Drug Administration
Speakers:
1:40 pm Regulatory science tools: a free FDA resource to help accelerate medical device evaluation
Zane Arp, Director, Division of BioMedical Physics, U.S. Food and Drug Administration (USA)
2:15 pm GDUFA science and research program: collaborating with the FDA research program
Priyanka Ghosh, Lead Pharmacologist, Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Centre for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (USA)
3:00 pm Discussion
Ramesh Raghavachari, U.S. Food and Drug Administration
Come hear speakers from industry and regulatory agencies share their perspectives and advice on incorporating regulatory requirements into product development and how to achieve successful regulatory strategies. In addition, small business owners will gain valuable business perspectives concerning 3rd party review and regulatory approval for medical devices.
1:30 pm Welcome, Ramesh Raghavachari, U.S. Food and Drug Administration
Speakers:
1:40 pm Regulatory science tools: a free FDA resource to help accelerate medical device evaluation
Zane Arp, Director, Division of BioMedical Physics, U.S. Food and Drug Administration (USA)
2:15 pm GDUFA science and research program: collaborating with the FDA research program
Priyanka Ghosh, Lead Pharmacologist, Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Centre for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (USA)
3:00 pm Discussion