FDA CDER Meetings, Conferences, and Workshops: October-November 2019
October 2019
- PQRI BTC 2019 Webinar Series: Holistic QbD to Enable Product Quality; Oct. 10 @ 10:30 am EDT
- SBIA Webinar: Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards; Oct.11 @ 1 pm EDT
- Antimicrobial Drugs Advisory Committee Meeting; Oct 16; Silver Spring MD; Live webcast available
- SBIA Regulatory Education for Industry: Pharmaceutical Quality Symposium; Oct. 16-17; College Park MD; Live webcast available
- SBIA REdI Electronic Drug Registration and Listing Using CDER Direct; Oct. 22; College Park, MD; Live webcast available
- Bone, Reproductive and Urologic Drugs Advisory Committee Meeting; Oct. 29; Silver Spring MD; Live webcast available
- Bone, Reproductive and Urologic Drugs Advisory Committee Meeting; Oct. 30; Silver Spring MD; Live webcast available
- ICH Global Meeting on ICH E8(R1) Guideline on General Considerations for Clinical Trials; Oct. 31; Silver Spring MD; Live webcast available
November 2019
- SBIA Webinar: Submitting IND Safety Reports to FDA Adverse Event Reporting System (FAERS); Nov. 1 @ 1pm EDT
- FDA Genetic Toxicology Workshop: How Many Doses of an DNA Reactive (Ames-positive) Drug can be Safely Administered to Healthy Subjects?; Nov. 4; Silver Spring MD; Live webcast available
- Health Canada and United States Food and Drug Administration Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Nov 4; Ottawa, Canada; Live webcast available
- FDA-MRA Approaches to Neoadjuvant Treatment in Melanoma: A Public Workshop; Nov 6; National Harbor MD; Live webcast available
- Promoting Effective Drug Development Programs: Opportunities and Priorities for FDA’s Office of New Drugs; Nov 7; Silver Spring MD; Live webcast available
- SBIA REdI Clinical Investigator Training Course; Nov. 12-14; College Park MD
- Endocrinologic and Metabolic Drugs Advisory Committee Meeting; Nov 14; Silver Spring MD; Live webcast available
- Development of Best Practices in Physiologically Based Pharmacokinetic Modeling to Support Clinical Pharmacology Regulatory Decision-Making; Nov 18; Silver Spring MD; Live webcast available
The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops.
http://www.fda.gov/cdersbia | http://www.fda.gov/cderlearn