EFPIA DIA OPPI Regulatory Workshop

Agenda

Day 1 Jul 11, 2017

9:00 AM — 10:45 AM

Day 1 - Session 1: Welcome Message

9:30 AM — 10:00 AM

Day 1 - Keynote 1: Steps Undertaken/Planned by DCGI in India to Ensure Fast Access to New Treatments

10:00 AM — 10:30 AM

Day 1 - Keynote 2: Strengthening of Regulatory System as per WHO Good Regulatory

11:15 AM — 12:30 PM

Day 1 - Session 2: Accelerated Regulatory Pathway in India

2:00 PM — 4:00 PM

Day 1 - Session 3: PIII Clinical Trial Waiver in India

6:00 PM — 6:45 PM

Day 1 - Panel Discussion

Day 2 Jul 12, 2017

9:00 AM — 10:15 AM

Day 2 - Session 4: Welcome Message

10:45 AM — 12:15 PM

Day 2 - Session 5: Orphan Drug Regulation

1:30 PM — 3:15 PM

Day 2 - Session 6: Global trends and challenges on the regulations of the Biotherapeutics and Biosimilar products

3:45 PM — 6:00 PM

Day 2 - Session 7: An Overview of Early-Access or Named Patient Access Procedure

4:00 PM — 5:00 PM

Day 2 - Session 8: An Overview of Early-Access or Named Patient Access Procedure

5:00 PM — 5:45 PM

Day 2 - Panel Discussion

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