Monday, April 1, 2013

Cooperation Among Regulators: Impact on Stakeholders

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Hear Firsthand from FDA Commissioner Hamburg,
EMA Executive Director Rasi, and
Health Canada Assistant Deputy Minister Glover

Commissioner Hamburg
at Last Year's Annual Meeting
Hear views on important issues from the leaders of three of the most influential drug regulatory agencies: The Health Products and Food Branch of Health Canada, the European Medicines Agency, and the U.S. Food and Drug Administration. Join the regulators as they discuss current actions in public policy resulting from interagency actions and strategic communication.
Paul Glover, MBA
Assistant Deputy Minister of the Health Products and Food Branch
Health Canada
Marie Allison Dray, MA, MBA
International Regulatory Affairs Group LLC
Margaret A. Hamburg, MD
Commissioner, FDA 
Murray M. Lumpkin, MD, MSc
Commissioner's Senior Advisor and Representative for Global Issues, OC, FDA
Guido Rasi, MD
Executive Director
European Medicines Agency European Union

In this forum, leaders of two of the best known initiatives – TransCelerate Biopharma Inc (TransCelerate) and the Clinical Trials Transformation Initiative (CTTI) – will provide a status report on current projects, with additional perspectives provided by representatives of the FDA, CROs, and research sites.

TransCelerate’s Collaborative Approach to Risk-based Monitoring: The Methodology
Wednesday, June 26
TransCelerate BioPharma Inc. (TransCelerate) developed a methodology for monitoring that shifts monitoring processes from an excessive concentration on source data verification to comprehensive risk-driven monitoring. This philosophical shift in monitoring processes employs centralized and offsite mechanisms to identify and monitor important study parameters holistically and uses adaptive onsite monitoring to further support subject safety and data quality.

White Paper Showcase features the following two opportunities... Stay Tuned, More to Come!
Next Generation Medical Information Call Center
Tuesday, June 25

This session will discuss best practices for building a next generation medical information call center that expediently and efficiently delivers medical information on a global scale. We will discuss how advanced technology can enable and enhance critical patient and provider relationships.
This session will discuss the potential value of data sharing initiatives and what hurdles need to addressed to successfully create one. Learn what components are needed and how best to support or participate in this next step in the evolution of clinical research.
Coming Soon!
Innovation Theater Schedule to be Announced - Stay Tuned!
Keynote Speaker
Preconference Tutorials
Hotel & Travel
Daniel Kraft, MD
Executive Director, FutureMed
Register for 2 half-day or 1 full-day tutorial, save $100 on your registration
Book within the
DIA Room Block,
get special perks!
90% of the hall is SOLD. Reserve your booth today!

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