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

Day 1 Jan 18, 2019

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

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

Agenda

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