International Clinical Trials

About

In this tumultuous and volatile time, this is the ONLY event covering the complete clinical trials landscape – legislation, regulation, compliance, and litigation.

Developing a clinical strategy to maximize integrity and minimize risk is becoming more difficult by the day as a result of fast-evolving legislation, thereby increasing the risk of penalties and fines for noncompliance. New rules, such as the FDA Amendments Act of 2007 , have had profound implementation implications with respect to clinical trial registry and post-approval safety. Plus, drastic changes in reporting and registry requirements are happening at the state level. The daily management of clinical trials, from the challenges of ensuring properly structured recruiting incentives and overcoming key Medicare issues to the tightrope that is avoiding data privacy and security pitfalls, is a potential minefield of exposure.

This is the one place that industry professionals come to resolve these and other pressing concerns. The stellar faculty features front -line experts from pharmaceutical and medical device companies, hospital and research institutions, as well as expert attorneys and current and former government enforcers.

Recent legal complications only add to the confusion and cost of clinical trials:

• New clinical trial registry requirements carry stiff penalties for non-compliance
• Recent FDA guidance limiting reprint distribution including clinical trial results
• Current state laws restrict drug marketing practices and hinder clinical trial research
• Indemnification regulations for clinical trial contracts vary extensively by state

And these developments are in addition to the uncertainty facing any company engaged in clinical trials including preparing for the priorities of a new administration and compliance with FDAAA and clinicaltrials.gov. Plus, companies still must contend with the daily management of clinical trials, from maintaining adequate protections for the patients, ensuring security and intellectual property protections for the trial data, and securing Medicare approval. And the relationship with an off-site CRO is a constant tug of war between both sponsor and site, over issues ranging from financing to maintaining staff.

Given the costs invested in clinical trials, any legal snag along the way can be disastrous both financially for the company and the development of the drug itself, resulting in severe fines, litigation and even the cessation of the trial. In response, American Conference Institute’s 11th National Conference on Managing Legal Risks in Structuring and Conducting Clinical Trials was specifically designed to provide you with an intensive and thorough review of the critical issues that arise in ensuring proper management of your protocols, contracts, consents, and other documents. This premier event will offer attendees experienced in-house speakers, high level industry specialists, and government prosecutors and regulators who will present expert guidance and strategies to minimize the hazards associated with a clinical trial.

Contents & Contributors

Roadmap to Emerging Regions: Navigating the Regulatory and Legal Frameworks of Central & Eastern Europe, Latin America, Africa, India and the Middle East
Cristiana Spontoni, Partner, Squire, Sanders & Dempsey L.L.P. (Brussels, Belgium)

Ensuring Compliance with FDA Requirements When Conducting Global Trials
Michael A. Swit, Esq., Vice President, The Weinberg Group Inc. (Encinas, CA)
Vernessa T. Pollard, Counsel, Arnold & Porter LLP (Washington, DC)

GCP Challenges in Emerging Regions: Ensuring Ethical Integrity
Jose Luis Viramontes, MD, Director, PPD Mexico, Central America & Caribbean (Mexico City)
Melody Lin, Deputy Director, Office of Human Research Protections (OHRP) United States Department of Health and Human Services, (Rockville, MD)
Maureen Bennett Partner, Squire, Sanders & Dempsey L.L.P. (San Francisco, CA)
David Forster, JD, MA, CIP, Vice President, Office of Compliance, Western Institutional Review Board (Olympia, WA)

Navigating Key Contract Terms: Essential Provisions to Minimiza Risk & Maximize Profitability
Michael G. Eckstein, President, Topaz Clinical (Philadelphia, PA)
Catherine A. Mulligan, Assistant Vice President, William Gallagher Associates (New York, NY)

Complying with the FCPA & Overcoming Practical Constraints with Foreign Partners
John F. Kuckelman, Global Anti-Corruption & International Trade Counsel, Eli Lilly & Company (Indianapolis, IN)

Appearance is Reality: Minimizing Litigation Risks & the Appearance of Misconduct During & After the Trial
Thomas U. Pfennig, Counsel, Bayer Corporation (Pittsburgh, PA)
Joseph D. Piorkowski, Jr., Partner, The Piorkowski Law Firm (Washington, DC)

Data Protection & Maximizing IP Protection
Stephen W. Bernstein, Esq., Partner, McDermott Will & Emery LLP (Boston, MA)
Sonia Baldia, Partner, Business & Technology Sourcing,
Co-Chair, India Practice, Mayer Brown LLP (Washington, DC)