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Holiday Inn Mumbai Intl Airport

Aug 31, 2018 8:00 AM - Sep 01, 2018 5:30 PM

New Sakinaka Juction, Andheri Kurla Road, Anheri East, Mumbai 400072, Mah, India

Leveraging technology and RWE in the increasingly complex world of medical writing

Meet the legends of Medical writing, its an Excellent opportunity for learning and networking

Agenda

Day 1 Aug 31, 2018

8:30 AM — 10:00 AM

Day 1: Registration

10:00 AM — 1:00 PM

Day 1: WORKSHOP: “Risk Identification & Characterization : New EU Template for RMP’s"

2:15 PM — 3:00 PM

Day 1: OPENING PLENARY:GRAND PANEL DISCUSSION Managing Outsourcing Partners: Art, Science or Commerce?

3:30 PM — 4:45 PM

Day 1: Panel discussion: Challenges in Writing Submission Documents for Biologics Products

Day 2 Sep 01, 2018

9:30 AM — 11:00 AM

Day 2: Session 1: The Art of Writing Complex Safety Submission Document

11:30 AM — 1:00 PM

Day 2: Session 2: Complexities in Managing Regulatory Documents to Support Expedited Registration Pathways

2:00 PM — 2:45 PM

2:45 PM — 3:30 PM

Day 2: Session 3: Debate - GDPR vs EMA Policy 0070 - Dealing with Data Transparency

4:00 PM — 5:30 PM

Day 2: Session 4: Challenges in Writing Submission Documents for Small Molecules

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