International Clinical Trials

Venue: Westin Grand Hotel

Location: Washington DC, United States

Event Date/Time: Nov 10, 2003 End Date/Time: Nov 12, 2003
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Description

The Institute for International Research is delighted to launch ICT 2003. International Clinical Trials, November 10-12, Washington DC, navigates key international regulation and logistical challenges to aid the strategic planning, initiation and management of global studies.

New Additional Workshop on Multinational Patient Recruitment Best Practices
See Pre-Conference Workshops section for more information


FEATURED SESSIONS, November 11:

Hear from key regulatory authorities and experts on Western, Central and Eastern Europe; Asia-Pacific; Latin America, Canada and the US talk about regulatory requirements, acceptance of foreign clinical data and GCP for conducting clinical trials in their regions:

Francis P. Crawley, Secretary General and Ethics Officer
EUROPEAN FORUM FOR GOOD CLINICAL PRACTICE (EFGCP)

Frieder Hackenberger, MD, Head of Unit Clinical Trials and GCP-Inspections, BfArM FEDERAL INSTITUTE FOR DRUGS AND MEDICAL DEVICES, GERMANY

Margarita Maskeliunaite, MD, GCP Inspectors Working Party
CADREAC (Collaboration Agreement between Drug Regulatory Authorities in European Union Associated Countries)
Senior specialist, Preclinical & Clinical Trials Division, STATE MEDICINES CONTROL AGENCY, LITHUANIA

Sérgio Nishioka, MD, PhD, Manager Office of New Drugs, Research and Clinical Trials
ANVISA, BRAZIL

Patricia Saidon, PhD, Clinical Studies Services
MINISTRY OF HEALTH, ARGENTINA

Jean Saint-Pierre, Coordinator, GCP, National Coordination Centre, Inspectorate Health Products & Food Branch
HEALTH CANADA

Followed by:

Open Panel Session: put your questions directly to the regulatory authorities
Interactive Roundtables: discuss information learned from the morning sessions and apply it directly to your own experience
SPECIAL STRATEGIC FOCUS, November 12:

Hear how to overcome logistical challenges within three key areas of international trials:
Patient Recruitment
Drug Supply Management and Distribution
Facilitating Study Start-Up
Key insights into optimizing strategies and processes for each of these areas is given by senior industry representatives, including:

Judith E. Beach, PhD, Esq, Associate General Counsel Regulatory Affairs, Chief Privacy Officer & Chair, Council on Data Protection, Coordinator, Global Government Relations and Health Policy
QUINTILES

Rafael Escandon, PhD, MSc, Senior Director, Clinical Operations
CV THERAPEUTICS

Marianne Mancini, Associate Director Global Clinical Operations
BAXTER BIOSCIENCE

Lawrence Meinert, MD, MPH, Global Sr. Vice President of Clinical Operations
COVANCE

John Needham, Senior Director Global Clinical Trials
JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT, LLC

Followed by:
Interactive Roundtables: discuss information learned from the morning sessions and apply it directly to your own experience

FOUR HALF-DAY WORKSHOPS, November 10:

An Introduction to:

The EU Clinical Trials Directive and How it Impacts Clinical Trials Processes
Conducting Clinical Trials in Central and Eastern Europe
Conducting Clinical Trials in Asia-Pacific
Conducting Clinical Trials in Latin America and North America
These workshops give the regulatory, logistical and cultural fundamentals of conducting clinical trials in their respective regions.

As a professional involved in international clinical trials you need to fully understand the regulation of key regions, its current status, what the implications for clinical trial processes are, what further revisions to regulation are likely and what you need to do to comply.

Such regulation also has to be understood in the context of FDA regulation with regards to their clinical data requirements. Currently there is very little opportunity for professionals like yourself to gain a direct understanding of key regulation to ensure that your clinical trial processes meet with compliance stipulations. This event is designed to meet your such needs. Therefore, take full advantage of this opportunity to meet with the presenters and your industry colleagues to share and explore solutions to the same concerns and challenges you are now facing with international clinical trials. Opportunities for interaction have been maximized with roundtable discussions, panel sessions, practical workshops, luncheons and refreshment breaks.

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