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Clarion Hotel Dublin City

Oct 08, 2013 9:00 AM - Oct 09, 2013 5:30 PM

Excise Walk, IFCS, Dublin 1, Ireland

7th Annual Clinical Forum - Rebooting Clinical Development

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RISK MANAGEMENT PLANS

Session Chair(s)

Lisa Chamberlain-James, PhD

Lisa Chamberlain-James, PhD

Senior Partner

Trilogy Writing & Consulting, United Kingdom

The session will discuss different aspects of the challenges posed by the new RMP; from an Industry perspective, through to the difficulties of writing for the general public, and a comparison of the EU RMP with its US equivalent, the PV Plan.

Learning Objective : 1. The challenges posed by the new RMP and how we are dealing with them (as a summary of participant experiences shared) . 2. Similarities and differences between the RMP and the US PV Plan. 3. Practical tips on how to improve the quality and effectiveness of the RMP, in particular the lay summary.

Speaker(s)

An Industry Regulatory Perspective on Applying the New Legislation and Template

Lambert Creuwels, MD, PhD

H. Lundbeck A/S, Netherlands

sr. Medical Safety Adviser

Lisa Chamberlain-James, PhD

Addressing the Specific Challenges of writing the new Lay Summary (section 6) of the RMP

Lisa Chamberlain-James, PhD

Trilogy Writing & Consulting, United Kingdom

Senior Partner

The EU RMP Compared with the US REMS

Madhu Davies

United Kingdom

Consultant in Pharmaceutical Medicine and Devices

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