USFDA–CDSCO-DIA: “Workshop on Global Anti-Infective Drug Development: Challenges and Opportunities”

Learn from regulatory (USFDA, CDSCO) and Industry experts on Drug Development of Anti- Infectives

Agenda

8:00 AM — 9:00 AM Registration
9:00 AM — 9:30 AM Welcome and Opening Remark
9:30 AM — 12:00 PM Session 1: Advancing Regulatory Science and Innovation to Accelerate Global Anti-Infective Drug Development
12:00 PM — 1:00 PM Panel Discussion Session | How can US and India Regulators and Industry Work Together to Combat the Global Challenge of AMR?
2:00 PM — 3:30 PM Case Study #1- Regulatory and clinical considerations for developing drug products for treatment of multidrug resistant tuberculosis
3:30 PM — 4:45 PM Case Study #2- Regulatory and clinical considerations for developing drug products that address an unmet medical need for treatment of resistant gram negative infections
4:45 PM — 5:00 PM Closing Remarks