CDER Meetings, Conferences & Workshops: September - October 2019

CDER Meetings, Conferences & Workshops: September - October 2019

Find a complete list of events HERE.

September 2019

• Developing Therapies for Primary Mitochondrial Diseases: Bridging the Gaps; Sept. 6, 2019; Silver Spring MD; Live webcast available
• Most Common Issues with CDISC-SEND Data in FDA Toxicology Review; Sept. 12, 2019; SBIA Webinar
• 2019 Parenteral Drug Association/U.S. Food and Drug Administration Joint Regulatory Conference -- Manufacturing Innovation, Quality, and Compliance: Achieving 20/20 Vision; Sept 16-18, 2019; Washington DC
• Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction; Public Hearing; Sept. 17, 2019; Silver Spring MD; Live webcast available
• Meeting of the Nonprescription Drugs Advisory Committee Meeting; Sept. 18, 2019; Silver Spring MD; Live webcast available
• SBIA Regulatory Education for Industry and CERSI Workshop:Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls; Sept. 23-25; College Park MD 
• SBIA Regulatory Education for Industry: 2019 Complex Generic Drug Product Development Workshop;  Sep. 25-26, 2019; College Park MD; Live webcast available

October 2019

• Developing Real-World Data and Evidence to Support Regulatory Decision-Making; Oct. 3, 2019; Washington DC
• PQRI BTC 2019 Webinar Series: Holistic QbD to Enable Product Quality; Oct 10, 2019; Webinar
• Antimicrobial Drugs Advisory Committee Meeting; Oct. 16, 2019; Silver Spring MD; Live webcast available
• SBIA Regulatory Education for Industry: Pharmaceutical Quality Symposium; College Park, MD; Oct. 16-17; College Park MD; Live webcast available
• Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting; Oct. 30, 2019; Silver Spring MD; Live webcast available
• ICH Global Meeting on ICH E8(R1) Guideline on General Considerations for Clinical Trials; Oct. 31, 2019; Silver Spring MD; Live webcast available