2nd Legal and Regulatory Forum on Rigorously Conducting

International Clinical Trials

Producing Meaningful and Reliable Data for Marketing Approval and Protecting the Rights of Subjects

Thursday, February 28, 2008

About

Clinical trials undertaken by U.S. pharmaceutical, biotech, and medical device companies are increasingly being designed as international in scope. However, sponsoring international studies drastically increases the number of legal and regulatory exposures, liabilities, and risks inherent in conducting trials.

Trials in the have proven all the more difficult as clinical research professionals struggle to understand the framework of documents containing the requirements of the CT/GCP Directives. Further, accessing populations in India, China, Asia Pacific, Africa, Latin America, and Eastern Europe requires a keen ability to comply with regulatory nuances and overcome language barriers and cultural differences. In addition, the globalization of clinical research makes it doubly hard to determine what size and type of CRO to use. Plus, the variability in legal frameworks for advertising, recruiting, reimbursements, data privacy, and human subject protection has made negotiating informed consent documents and drafting international CTAs a constant struggle. With scrutiny by public, private, and political entities higher than ever, there is simply no room for error in spotting, correcting, and minimizing these exposures, liabilities, and risks.

In response, American Conference Institute, creator of the nine-time Clinical Trials conference, presents this publication from the 2nd Legal and Regulatory Forum on Rigorously Conducting International Clinical Trials. This one-of-a-kind title will provide practical and sophisticated strategies, on a region-by-region and country-by-country basis, on producing meaningful and reliable data for marketing approval and protecting the rights of those who participate as subjects. The distinguished faculty includes legal and compliance experts, inside and outside the U.S., from sponsors, CROs, hospitals and research institutions, as well as expert attorneys.

Contents & Contributors

About

Clinical trials undertaken by U.S. pharmaceutical, biotech, and medical device companies are increasingly being designed as international in scope. However, sponsoring international studies drastically increases the number of legal and regulatory exposures, liabilities, and risks inherent in conducting trials.

Trials in the have proven all the more difficult as clinical research professionals struggle to understand the framework of documents containing the requirements of the CT/GCP Directives. Further, accessing populations in India, China, Asia Pacific, Africa, Latin America, and Eastern Europe requires a keen ability to comply with regulatory nuances and overcome language barriers and cultural differences. In addition, the globalization of clinical research makes it doubly hard to determine what size and type of CRO to use. Plus, the variability in legal frameworks for advertising, recruiting, reimbursements, data privacy, and human subject protection has made negotiating informed consent documents and drafting international CTAs a constant struggle. With scrutiny by public, private, and political entities higher than ever, there is simply no room for error in spotting, correcting, and minimizing these exposures, liabilities, and risks.

In response, American Conference Institute, creator of the nine-time Clinical Trials conference, presents this publication from the 2nd Legal and Regulatory Forum on Rigorously Conducting International Clinical Trials. This one-of-a-kind title will provide practical and sophisticated strategies, on a region-by-region and country-by-country basis, on producing meaningful and reliable data for marketing approval and protecting the rights of those who participate as subjects. The distinguished faculty includes legal and compliance experts, inside and outside the U.S., from sponsors, CROs, hospitals and research institutions, as well as expert attorneys.

Contents & Contributors

EU CLINICAL TRIALS DIRECTIVE
Cristiana Spontoni, Squire, Sanders & Dempsey LLP (Brussels, Belgium)

ENSURING COMPLIANCE WITH THE EVOLVING CT/GCP DIRECTIVES AND GUIDELINES WHEN CONDUCTING CLINICAL TRIALS IN THE EU
Frank Schoneveld, McDermott Will & Emery/Stanbrook LLP (Brussels, Belgium)

SPOTLIGHT ON SAFETY IN THE EU: EVALUATING TIMELY REPORTING OF ADVERSE DRUG REACTIONS
Steven Clark, Dechert LLP (Philadelphia, PA)
Rachel Abramovitz, Taro Pharmaceuticals USA, Inc.

SECURING VALID INFORMED CONSENT AND STREAMLINING ETHICS REQUIREMENTS TO AVOID FUTURE COMPLICATIONS
Nermeen Varawalla, MD, DPhil (Oxon), MBA, PRA International (United Kingdom)

SECURING VALID INFORMED CONSENT AND STREAMLINING ETHICS REQUIREMENTS TO AVOID FUTURE COMPLICATIONS
Camille P. Wicher, Esq., RN, MSN, Roswell Park Cancer Institute (Buffalo, NY)

SECURING VALID INFORMED CONSENT AND STREAMLINING ETHICS REQUIREMENTS TO AVOID FUTURE COMPLICATIONS
Jill Alvarez, Nixon Peabody LLP (Washington, DC)

CATEGORIZING AND COMPLYING WITH REGULATORY NUANCES WHEN CONDUCTING TRIALS IN EMERGING REGIONS
Vijai Kumar, MD, Excel Life Sciences, Inc. (Durham, NC)

INTERNATIONAL CLINIC TRIALS – LEGAL AND ETHICAL ISSUES WHEN CONDUCTING TRIALS IN LATIN AMERICA AND AFRICA
Elizabeth M. Zechenter, J.D., Ph.D., GlaxoSmithKline (Philadelphia, PA)

CLINICAL TRIALS IN CENTRAL AND EASTERN EUROPE WITH AN EMPHASIS ON RUSSIA
Chris Wilson, Ergomed Limited (United Kingdom)
Dr. Sergei Drapkin, Ergomed Clinical Research Group (Russia)

ENSURING PROTECTION OF PERSONAL PRIVACY & TRANSFER OF DATA BETWEEN JURISDICTIONS
Stephen W. Bernstein, McDermott Will & Emery LLP (Boston, MA)

PARTNERING WITH CROS ABROAD: FINDING THE RIGHT ONE(S) AND BALANCING CONTRACTUAL CONTROL AND CONVENIENCE
Michael Rogovin, BS, JD, Shire Pharmaceuticals (Wayne, NJ)

PARTNERING WITH CROS ABROAD: FINDING THE RIGHT ONE(S) AND BALANCING CONTRACTUAL CONTROL AND CONVENIENCE
John Shillingford, PhD., Averion International Corp. (Southborough, MA)

PARTNERING WITH CROS ABROAD: FINDING THE RIGHT ONE(S) AND BALANCING CONTRACTUAL CONTROL AND CONVENIENCE
Natasha Leskovsek, Heller Ehrman LLP (Washington, DC)

ESTABLISHING AN INTERNATIONAL CTA TEMPLATE TO STREAMLINE NEGOTIATIONS WITH INVESTIGATORS AND INSTITUTIONS
Teresia Bost, Celgene Corporation (Summit, NJ)

ESTABLISHING AN INTERNATIONAL CTA TEMPLATE TO STREAMLINE NEGOTIATIONS WITH INVESTIGATORS AND INSTITUTIONS
Michael G. Eckstein, M+BIOLAW (Philadelphia, PA)

FORECASTING AND DEVELOPING CLINICAL BUDGETS FOR RUNNING TRIALS ABROAD
Michael G. Eckstein, M+BIOLAW (Philadelphia, PA)
Andrea F. Margiotta, Progenics Pharmaceuticals, Inc. (Tarrytown, NY)

COMPLYING WITH THE FCPA AND OVERCOMING PRACTICAL CONSTRAINTS TO SITE AND SUBJECT RECRUITMENT IN CHINA
M. Angella Castille, Baker & Daniels LLP (Indianapolis, IN)

COMPLYING WITH THE FCPA AND OVERCOMING PRACTICAL CONSTRAINTS TO SITE AND SUBJECT RECRUITMENT INTERNATIONALLY
Sarah A. Franklin, Covington & Burling LLP (Washington, DC)



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