May Event: Interacting With FDA for R
Interacting With FDA for Rare Disease Drug Development
Wednesday, May 20, 2020
Event Agenda:
Date: Wednesday, 20 May 2020
Time*:
6:00 – 6:05 PM ONLINE Welcome and Announcements
6:05 – 7:05 PM ONLINE Program Presentation
7:05 – 7:30 PM ONLINE Q & A *Times are approximate.
Speaker:
Vann P. Parker, PhD
Senior Director, Regulatory Affairs
Agility Clinical, Inc., Carlsbad, CA
Program Topic:
Interacting With FDA for Rare Disease Drug Development
Speaker Biography:
Dr. Vann Parker is currently a Senior Director of Regulatory Affairs at Agility Clinical, Inc., Carlsbad, CA. He has over 25 years of biopharmaceutical and drug development experience including regulatory affairs, leading Project Management and Product Development Teams in companies such as PAREXEL International, Ribozyme Pharmaceuticals and Amgen, Inc. He has worked in many therapeutic areas including Oncology, Rare Disease, Neurology, Inflammation, Autoimmunity, Metabolism and Infectious Diseases.
He has extensive experience in the preparation of documents for filings to various regulatory agencies, including NDAs, BLAs, 505(b)(2)s, INDs, annual reports, safety updates, formal meeting requests, orphan drug filings, pediatric plans, special protocol assessments, and informal communication. He has represented clients at all stages of development from preclinical through post-marketing. Dr. Parker has PhD in Molecular Biology from California Institute of Technology, Pasadena, CA and a Bachelor of Science in Chemistry and Biology from Duke University, Durham, NC.
Location:
Not applicable - This is an online event
Online registration (ends 19May2020): $10 SDRAN Member
$10 Non-Member
For Questions Email: programs@sdran.org
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