Hear
Firsthand from FDA Commissioner Hamburg,
EMA Executive Director Rasi, and
Health Canada Assistant Deputy Minister Glover
View Commissioner Hamburg
at Last Year's Annual Meeting
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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.
Speakers:
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Chairpersons:
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Paul Glover, MBA
Assistant Deputy Minister of the Health Products and Food Branch
Health Canada
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Marie Allison Dray, MA, MBA
President
International Regulatory Affairs Group LLC
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Margaret A. Hamburg, MD
Commissioner, FDA
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Murray M. Lumpkin, MD, MSc
Commissioner's Senior Advisor and Representative for Global Issues, OC,
FDA
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Guido Rasi, MD
Executive Director
European Medicines Agency European Union
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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
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Preconference
Tutorials
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Hotel
& Travel
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Exhibiting
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Register
for 2 half-day or 1 full-day tutorial, save $100 on your registration
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Book
within the
DIA Room Block,
get special perks!
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90%
of the hall is SOLD. Reserve
your booth today!
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