Improving Clinical Trial Sampling for Future Research: An International Approach

Venue: Sofitel Hotel

Location: Philadelphia, Pennsylvania, United States

Event Date/Time: Sep 20, 2011 End Date/Time: Sep 21, 2011
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Description

Pharmacogenetic and biomarker research is rapidly progressing to enable understanding
of human disease and drug response. During clinical drug development, the
pharmaceutical industry commonly requests collection of samples for future research in
order to investigate important new emergent scientific findings on how drugs relate to
human health and disease. These include studies to explore mechanisms of drug action,
response to therapies, and adverse events or to research subpopulations that emerge
during clinical trials. However, considerable challenges exist to the collection of future
use samples.
Meet with global industry, regulatory and academic leaders to investigate the current
barriers to the optimal collection of samples for future research related to drug response
or disease characterization. Identify best practices and needed actions to improve
current global collection of future use samples in clinical trials. This conference will be
divided into 3 working sessions to look at key issues for future use sample collection in
Japan, Europe, and the US/Canada.
who should attend
• Clinical Investigators
• Clinical Pharmacologists
• Regulatory Professionals
• IRB and Ethics Committee Professionals
• Academic Investigators
• Data Privacy Professionals
• Clinical Scientists
FEATURED TOPICS
• Health Authority/National Ethics Committee Restrictions on Sample
Collection
• Retention and Exportation of Samples
• Regulatory Restrictions on Data Collection, Access and Sharing
• IRB/EC Perspectives on Sample Collection in Your Region
• Patient Perspectives
• Consent and Authorization for Future Use of Samples
and Data
learning objectives
At the conclusion of this meeting, participants should be able to:
• Discuss concrete global strategies to improve clinical sampling
collection rates
• Identify best practices in the acquisition, storage, and exportation of
clinical samples and data
• Improve understanding of current laws and authorization
requirements for future use sample collection in key global regions
• Discuss methods to harmonize regulations on clinical sampling
among authorizing organizations within and across regions
who should attend
• Clinical Investigators
• Clinical Pharmacologists
• Regulatory Professionals
• IRB and Ethics Committee Professionals
• Academic Investigators
• Data Privacy Professionals
• Clinical Scientists

Event Code:
11032

Venue

Additional Information

Attendees may visit the tabletop exhibits during the event and receptions. Contact Jeff Korn, Exhibits Associate, Phone +1.215.442.6184 Fax +1.215.442.6199, email Jeff.Korn@diahome.org