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

アジェンダ

Day 1 2018年8月31日 (金)

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 2018年9月01日 (土)

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