Saturday July 22, 2023 - Check Back for additional program details
**Program Subject to Change**
(Invitation Only)
Botanical Drugs: A Regulatory Approach on how FDA Reviews a Botanical Application
Moderator: Nandakumara Sarma, Ph.D., United States Pharmacopeia
Presenters
Rajiv Agarwal, Ph.D, Ph.D, Expert Regulatory Review Scientist (CMC of Botanicals), NDPB1, DNDP1/ONDP/OPQ/CDER/FDA – Botanicals as Drugs: CMC and Regulatory Challenges
Donna Christner, Ph.D, Branch Chief, DNDAPI, ONDP/OPQ/CDER/FDA – Drug Master Files for Botanical Drugs: What are They and How Does FDA Review Them?
Margaret M. Kober, R.Ph., M.P.A, Chief, Project Management Staff Division of Regulatory Operations for Urology, Obstetric, and Gynecology, DRORDPURM/ORO/OND/CDER/FDA – Understanding the FDA Application Process
Mark Hirsch, MD, Medical Team Leader, DUOG/ORPURM/OND/CDER/FDA – Clinical Considerations
Charles Wu, Ph.D, Pharmacognosist, Botanical Team/ONDP IO/ONDP/OPQ/CDER/FDA – Botanical Review Considerations
Sang Ki Park, PhD, DABT; Toxicologist; DPT-ID/OND/CDER/FDA – Non-Clinical Aspects of a Botanical Drug Review: What is Needed?
Biochemical and Biophysical Assay Design for Natural Product Discovery Campaigns
Presenters: Shilpa Shenoy Kurian (National Cancer Institute, National Institutes of Health) and Brice A. P. Wilson (National Cancer Institute, National Institutes of Health)
Current Topics in Botanical Safety
Presenters – Michelle Embry (HESI), Josh Kellogg (Penn State), Robin Marles, Barbara Sorkin (NIH), Charles Wu (USFDA)
Fungal Identification Using Molecular Tools
Presenters: Huzefa Raja (University of North Carolina at Greensboro)
Public Speaking for Scientists
Presenter: Nicholas Oberlies (University of North Carolina at Greensboro)
