DIA Workshop on Optimising Variations Regulatory Framework

Towards EU Accession

Agenda

Day 1 Oct 29, 2020

1:30 PM — 1:40 PM

Log-in and Connect

1:40 PM — 2:00 PM

Introduction to the Workshop - How to Navigate the Platform

2:00 PM — 3:35 PM

Session 1: Learnings and Best Practices for Variations: The International Perspective

3:35 PM — 3:50 PM

Break

3:50 PM — 5:05 PM

Session 2: Towards EU Accession

5:05 PM — 5:20 PM

Wrap-up

5:20 PM — 6:20 PM

Networking Activity

Day 2 Oct 30, 2020

1:30 PM — 1:45 PM

Welcome to Day Two

1:45 PM — 3:00 PM

Session 3, Part I: Where are we now with Post-approval Changes?

3:05 PM — 3:30 PM

Keynote: What do Patients Expect?

3:30 PM — 3:40 PM

Break

3:40 PM — 4:45 PM

Session 3, Part II: Roundtable on Opportunities to Optimize the Post-approval System

4:45 PM — 5:00 PM

Wrap-up and Closing Remarks

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