About
With clinical trials undertaken by U.S. pharmaceutical and biotech companies increasingly being designed as international in scope, it is critical for sponsors to overcome the key legal and regulatory obstacles inherent in conducting such trials. The international variability in legal frameworks for recruiting, reimbursements, data privacy, and human subject protection has made drafting international CTAs and negotiating informed consent documents a constant struggle. And with indemnity requirements, IP protections, and publication rights varying by country and region, boilerplate contractual provisions must be carefully adapted to reflect specific concerns relating to the sites being utilized.
In addition, as acceptable payment practices differ in some countries, it is essential that companies be aware of how the Foreign Corrupt Practices Act relates to the practical issues that commonly arise during the course of clinical trials overseas. And there are important ways that companies can anticipate and manage their litigation risks, but first they must understand the applicable liability theories and who may have standing to sue. The globalization of clinical research, combined with Congress’ growing interest in clinical trial results and the FDA’s new rules for foreign clinical studies used in drug approval applications, have raised the bar for companies that operate overseas. It is far more than a question of overcoming language barriers.
In response, once again American Conference Institute, the creator of the ten-time Clinical Trials conference, presented its global companion: 3rd National Legal and Regulatory Forum on Conducting International Clinical Trials. This one-of-a-kind event provides those charged with managing legal and regulatory risks in conducting international trials with 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. This publication includes a 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.
About
With clinical trials undertaken by U.S. pharmaceutical and biotech companies increasingly being designed as international in scope, it is critical for sponsors to overcome the key legal and regulatory obstacles inherent in conducting such trials. The international variability in legal frameworks for recruiting, reimbursements, data privacy, and human subject protection has made drafting international CTAs and negotiating informed consent documents a constant struggle. And with indemnity requirements, IP protections, and publication rights varying by country and region, boilerplate contractual provisions must be carefully adapted to reflect specific concerns relating to the sites being utilized.
In addition, as acceptable payment practices differ in some countries, it is essential that companies be aware of how the Foreign Corrupt Practices Act relates to the practical issues that commonly arise during the course of clinical trials overseas. And there are important ways that companies can anticipate and manage their litigation risks, but first they must understand the applicable liability theories and who may have standing to sue. The globalization of clinical research, combined with Congress’ growing interest in clinical trial results and the FDA’s new rules for foreign clinical studies used in drug approval applications, have raised the bar for companies that operate overseas. It is far more than a question of overcoming language barriers.
In response, once again American Conference Institute, the creator of the ten-time Clinical Trials conference, presented its global companion: 3rd National Legal and Regulatory Forum on Conducting International Clinical Trials. This one-of-a-kind event provides those charged with managing legal and regulatory risks in conducting international trials with 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. This publication includes a 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
MINIMIZING PRODUCT LIABILITY AND OTHER LITIGATION RISKS WHEN CONDUCTING CLINICAL TRIALS OUTSIDE THE U.S.
Randall L. Christian, Clark Thomas & Winters PC (Austin, TX)
LITIGATION ARISING FROM CLINICAL TRIALS: LESSONS LEARNED
Alexander E. Dreier, Hogan & Hartson LLP (Washington, DC)
THE INTEGRITY OF THE PROCESS: SECURING VALID INFORMED CONSENT AND ENSURING THAT TRIALS ARE CONDUCTED IN AN ETHICAL MANNER
Camille P. Wicher, Esq. RN, MSN, Roswell Park Cancer Institute (Buffalo, NY)
ETHICS AND INTEGRITY IN THE CONDUCT OF FOREIGN CLINICAL TRIALS
Diane E. Lifton, Hughes Hubbard & Reed LLP (New York, NY)
SECURING INFORMED CONSENT AND CONDUCTING ETHICAL CLINICAL TRIALS IN EUROPE
Sally Shorthose, Bird & Bird (London, UK)
ENSURING PROTECTION OF PERSONAL PRIVACY & TRANSFER OF DATA BETWEEN JURISDICTIONS
Stephen W. Bernstein, McDermott Will & Emery LLP (Boston, MA)
COMPLYING WITH THE FCPA AND OVERCOMING PRACTICAL
CONSTRAINTS TO SITE AND SUBJECT RECRUITMENT INTERNATIONALLY
M. Angella Castille, Baker & Daniels LLP (Indianapolis, IN)
CLINICAL TRIALS IN THE EUROPEAN UNION: THE STEP-BY-STEP PROCESS
Eileen Smith Ewing, K & L Gates LLP (Boston, MA)
SPOTLIGHT ON THE EU
Anthony Warnock-Smith, Morgan Lewis & Bockius LLP (London, UK)
SPOTLIGHT ON SAFETY IN THE EU EVALUATING TIMELY REPORTING
OF ADVERSE DRUG REACTIONS
Jayne P. Bultena, Foley Hoag LLP (Washington, DC)
Steven Clark, Dechert LLP (New York, NY)
INVESTIGATOR CONTRACTING ISSUES IN CENTRAL & EASTERN EUROPE
John Herrmann, PRA International (Charlottesville, VA)
COMPLYING WITH REGULATORY NUANCES WHEN CONDUCTING
CLINICAL TRIALS IN EMERGING COUNTRIES - INDIA
Nermeen Varawalla, MD, DPhil (Oxon), MBA
PRA International (United Kingdom)
PARTNERING WITH CROS ABROAD: BALANCING CONTROL AND
CONVENIENCE
Angela Mann, Kriger Research Center (Toronto, ON)
C. Elizabeth O’Keeffe, Parexel International (Waltham, MA)
John Shillingford, PhD., Averion International (Southborough, MA)
Maria D. Buckley, Nutter McClennen & Fish LLP (Boston, MA)
PARTNERING WITH CROS ABROAD: BALANCING CONTROL AND
CONVENIENCE
Maria D. Buckley, Nutter McClennen & Fish LLP (Boston, MA)
INTERNATIONAL CLINICAL TRIALS: CTAS TO MINIMIZE RISK
Chris Johnson, Shook, Hardy & Bacon L.L.P. (San Francisco, CA)
FOREIGN CLINICAL TRIALS: NEGOTIATING KEY AGREEMENTS
Ben Haas, Latham & Watkins LLP (Washington, DC)
INTERNATIONAL CLINICAL TRIALS: INDEMNITY AND INSURANCE ISSUES
Marialuisa S. Gallozzi, Covington & Burling LLP (Washington, DC)
Julia Reynolds Johnson, K&L Gates LLP (Washington, DC)
Mary Beth Borgwing, Willis North America (New York, NY)
MAXIMIZING IP AND PUBLICATION RIGHTS OF U.S. SPONSORS
Ramasamy M. Mannan, J.D., Ph.D.
Publication Details