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As the premier life science and
regulatory affairs event this year, DIA 2012 48th Annual Meeting brings together life
science leaders from industry, academia, regulatory agencies, and
patient organizations from around the globe. Our June 25th session on Regulatory Collaboration/21st
Century Innovation will feature the
heads of the leading regulatory agencies – FDA, EMA and Health Canada.
This new session was created as a result of feedback
from senior regulators and regulatory executives to DIA’s
Strategic Planning Committee (of the Board of Directors). You asked for
high-level sessions where senior regulatory executives and leading
agency regulators might have candid dialogue about current topics
affecting global product development and regulation.
After brief introductory comments from each Head of
Agency, the session will be opened to your questions. You will have the opportunity to ask how these leaders are
directing their agencies in international communication with each other
on public health and application-specific matters.
We would like to invite you to save some time in your
busy schedule to attend this session which is scheduled for Monday, June 25th from
1:30-3:00 PM during the first full day of the Annual
Meeting. Philadelphia’s central location should make it relatively easy
for you to meet with your peers and senior regulators at this DIA
session.
Some other features of the conference in which you might
be interested include:
Tutorial:
Understanding and Navigating the Regulatory System in China
This tutorial will provide an overview of the regulatory
system in China, including the agencies and institutions at the
central government and provincial levels. Regulations for product
registration, clinical trials, and safety reporting will be
presented, and the regulatory pathways and strategic
considerations for clinical trial and marketing applications will
be discussed.
A roadmap of how to navigate the regulatory system in China for
clinical trial approval and product registration will also be discussed.
Environment for Health Care Decision Making: The Role of CER, Evidence-based Medicine, Quality, and Value The Role of CER, Evidence-based Medicine, Quality, and Value
All non-government professionals can take advantage of
one-day rates, while full-time government attendees will receive
discounted rates for the full meeting.
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