CDER Meetings, Conferences & Workshops: October-November 2019

Find a complete list of events HERE.

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; Llive 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