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Virtual

Mar 15, 2021 9:00 AM - Mar 19, 2021 4:30 PM

(Central Europe Standard Time)

DIA EUROPE 2021

Agenda

Day 1 Mar 15, 2021

11:00 AM — 12:00 PM

Novel Manufacturing Approaches for Early Access and Sustained Supply

Day 2 Mar 16, 2021

11:00 AM — 12:00 PM

Opportunities for Regulatory Dialogue to Accelerate Innovation in the EU

4:30 PM — 5:30 PM

Harmonising Structured Data in Module 3 to Standardise Terminologies and Submission Standards

6:15 PM — 7:15 PM

GMPs for Investigational Products to Enable Rapid Patient Access

Day 3 Mar 17, 2021

1:00 PM — 2:00 PM

Early Access CMC Approaches: EMA Toolbox Guidance 2021

Day 4 Mar 18, 2021

10:45 AM — 12:00 PM

Alternative GMP/GDP Inspection Practices: Opportunities implementing Lessons Learned from a Pandemic Situation (COVID-19)

1:00 PM — 2:00 PM

Nitrosamines: Traceability / Sensitivity - What is Good Enough?

6:15 PM — 7:15 PM

Predictive Stability– How Do We Move To A Risk Based Approach For Providing Required Stability Data, Platform Data, Extrapolation etc Linking Bio/Chemical Approaches By Science

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