International Clinical Trials

Thursday, February 26, 2009

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

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)



DOCUMENT TYPES: PPT PDF PPTX PRESENTATIONS AVAILABLE: 16

8:00
Registration and Continental Breakfast
8:30
Co-Chairs' Opening Remarks
Ms. Elizabeth Zechenter
Senior Counsel‚ Legal Operations International
GlaxoSmithKline
Dr. Dorota Poklonska
Vice President‚ Global Clinical Development - Europe
Kendle International Sp. Z o.o.
8:45
Roadmap to Emerging Regions: Navigating the Regulatory and Legal Frameworks of Central & Eastern Europe‚ Latin America‚ Africa‚ India and the Middle East
Mr. Michael A. Swit
Vice President
The Weinberg Group‚ Inc.
1 file
Roadmap to Emerging Regions
9 MB 58 pages Presentation
PPT - Roadmap to Emerging Regions
Mr. Carlos F. Peza
Consultant
The Weinberg Group‚ Inc.
10:15
Morning Coffee Break
10:25
Ensuring Compliance with FDA Requirements When Conducting Global Trials
Mr. Michael A. Swit
Vice President
The Weinberg Group‚ Inc.
1 file
Ensuring FDA Compliance in International Clinical Trials
1.4 MB 38 pages Presentation
PPT - Ensuring FDA Compliance in International Clinical Trials
Ms. Vernessa T. Pollard
Counsel
Arnold & Porter
1 file
Legal & Regulatory Considerations in Conducting International Clinical Trials
582.5 KB 24 pages Presentation
PPT - Legal & Regulatory Considerations in Conducting International Clinical Trials
11:15
GCP Challenges in Emerging Regions: Ensuring Ethical Integrity
Mr. Jose Luis Viramontes, MD‚ MSc.
Director‚ Clinical Management
PPD Mexico‚ Central America & Carribean
1 file
GCP Challenges in Emerging Regions A Perspective from Latin America
1.3 MB 15 pages Presentation
PPT - GCP Challenges in Emerging RegionsA Perspective from Latin America
Ms. Melody Lin
Deputy Director‚ Office of Human Research Protections
United States Department of Health & Human Services
1 file
The What, Why, Where, and How of the International Research
883.5 KB 38 pages Presentation
PPT - The What, Why, Where, and How of the International Research
Maureen Bennett
Partner and Co-Chair, Healthcare & Life Sciences Industry Group
Squire Sanders (Boston, MA)
1 file
GCP Challenges in Emerging Regions; Ensuring Ethical Integrity
1.2 MB 12 pages Presentation
PPT - GCP Challenges in Emerging Regions; Ensuring Ethical Integrity
Mr. David Forster
Vice President‚ Office of Compliance
Western Institutional Review Board
1 file
IRB/Ethics Review of Research in Emerging Regions
136 KB 27 pages Presentation
PPT - IRB/Ethics Review of Research in Emerging Regions
12:40
Networking Luncheon for Speakers and Delegates
13:55
Navigating Key Contract Terms: Essential Provisions to Minimiza Risk & Maximize Profitability
Mr. Michael G. Eckstein
President
Topaz Clinical
1 file
Addressing Four Key Contract Terms
1.8 MB 43 pages Presentation
PDF - Addressing Four Key Contract Terms
Ms. Catherine A. Mulligan
Assistant Vice President
William Gallagher Associates
1 file
International Clinical Trials Master Class
926.5 KB 25 pages Presentation
PPT - International Clinical Trials Master Class
15:00
Afternoon Refreshment Break
15:10
Complying with the FCPA & Overcoming Practical Constraints with Foreign Partners
Mr. John Kuckelman
Global Anti-Corruption and International Trade Regulatory Counsel
Eli Lilly and Company
1 file
Complying with FCPA in Clinical Trials
2.5 MB 14 pages Presentation
PPT - Complying with FCPA in Clinical Trials
Mr. Karl Buch
Assistant General Counsel
Pfizer Inc.
16:10
Appearance is Reality: Minimizing Litigation Risks & the Appearance of Misconduct During & After the Trial
Mr. Thomas U. Pfennig
Counsel
Bayer Corporation
1 file
Appearance is Reality
410.2 KB 32 pages Presentation
PPTX - Appearance is Reality
Mr. Joseph D. Piorkowski, Jr.

The Piorkowski Law Firm‚ P.C.
3 files
TROVAN, KANO STATE CIVIL CASE - STATEMENT OF DEFENSE
23.2 KB 4 pages Presentation
PDF - TROVAN, KANO STATE CIVIL CASE - STATEMENT OF DEFENSE
Trovan Fact Sheet
88.6 KB 2 pages Presentation
PDF - Trovan Fact Sheet
Rabi Abdullahi v. Pfizer, Inc.
343.2 KB 89 pages Presentation
PDF - Rabi Abdullahi v. Pfizer, Inc.
17:00
Data Protection & Maximizing IP Protection
Mr. Stephen W. Bernstein, Esq.
Partner
McDermott Will & Emery LLP
1 file
Ensuring Protection of Personal Privacy & Transfer of Data Between Jurisdictions
387 KB 39 pages Presentation
PPT - Ensuring Protection of Personal Privacy & Transfer of Data Between Jurisdictions
Sonia Baldia
Partner‚ Business & Technology Sourcing
Mayer Brown LLP
1 file
Offshoring Global Clinical Trials to India
2.4 MB 41 pages Presentation
PPT - Offshoring Global Clinical Trials to India
18:00
Conference Adjourns