3rd Legal and Regulatory Forum on Rigorously Conducting

International Clinical Trials

Thursday, September 25, 2008

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

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.



DOCUMENT TYPES: PPT PDF PRESENTATIONS AVAILABLE: 19

8:00
Registration and Continental Breakfast
8:45
Co-Chairs' Opening Remarks
Ms. Marialuisa Gallozzi
Partner
Covington & Burling LLP
Mr. Francisco T. Rivas
Associate General Counsel
Alcon Laboratories
9:00
Setting the Stage: Minimizing Product Liability and Other Litigation Risks When Conducting Clinical Trials Outside the U.S.
Mr. Randall L. Christian
Shareholder
Clark‚ Thomas & Winters
1 file
Christian.R.UPDATED
1.5 MB 13 pages Presentation
PPT - Christian.R.UPDATED
Mr. Alexander E. Dreier
Partner
Hogan & Hartson LLP
1 file
Drier.A.1a
843 KB 14 pages Presentation
PPT - Drier.A.1a
Mr. Francisco T. Rivas
Associate General Counsel
Alcon Laboratories
10:15
Morning Coffee Break
10:30
The Integrity of the Process: Securing Valid Informed Consent and Ensuring That Trials Are Conducted in an Ethical Manner
Ms. Camille Wicher, Esq. RN‚ MSN
Asst. Vice President‚ Research Subject Protections
Roswell Park Cancer Institute
1 file
Wicher.C.1a
984.5 KB 39 pages Presentation
PPT - Wicher.C.1a
Moderator: Diane E. Lifton
Co-Chair Product Liability Group
Hughes Hubbard & Reed LLP
1 file
Lifton.D.1a
338.5 KB 26 pages Presentation
PPT - Lifton.D.1a
Ms. Sally Shorthose
Partner
Bird & Bird
3 files
Shorthose.S.1a
448 KB 32 pages Presentation
PPT - Shorthose.S.1a
Shorthose.S.1b
530 KB 38 pages Presentation
PDF - Shorthose.S.1b
Shorthose.S.1c
122.7 KB 11 pages Presentation
PDF - Shorthose.S.1c
11:45
Ensuring Protection of Personal Privacy and Effectively Transferring Data Between Countries
Mr. Stephen W. Bernstein, Esq.
Partner
McDermott Will & Emery LLP
1 file
Bernstein.S.1a
384.5 KB 39 pages Presentation
PPT - Bernstein.S.1a
12:35
Networking Luncheon for Speakers and Delegates
13:45
Complying with the FCPA and Overcoming Practical Constraints to Site and Subject Recruitment Internationally
Ms. M. Angella Castille
Partner
Baker & Daniels LLP
1 file
Castille.A.1a
374 KB 25 pages Presentation
PPT - Castille.A.1a
14:45
Afternoon Coffee Break
15:00
Spotlight on the EU: Documenting Compliance With Evolving Guidance When Designing Multi-Center/Country Studies and Examining Implementation Issues in Key Member States
Ms. Eileen Smith Ewing
Attorney
1 file
Smith.Ewing.E.1a
228.5 KB 3 pages Presentation
PPT - Smith.Ewing.E.1a
Mr. Anthony Warnock-Smith
Partner
Morgan Lewis & Bockius LLP
16:00
Overcoming the Challenges of Adverse Event Reporting in Multi-National Trials
17:00
Conference Adjourns
7:30
Continental Breakfast
8:20
Co-Chairs' Remarks
8:30
Complying With Regulatory Nuances When Conducting Trials in Emerging Regions
Mr. John Herrmann
Senior Manager‚ Investigator Contracting
PRA International
1 file
Herrmann.J.1a
201 KB 17 pages Presentation
PPT - Herrmann.J.1a
Dr. Nermeen Varawalla, MD‚ DPhil (Oxon)‚ MBA
Vice President‚ Scientific & Medical Affairs
PRA International
1 file
Varawalla.N.1a
738 KB 18 pages Presentation
PPT - Varawalla.N.1a
9:45
Morning Coffee Break
10:00
Partnering With CROs Abroad: Balancing Control and Convenience
Ms. C. Elizabeth O'Keeffe
Senior Business Unit Counsel - PCMS
Parexel International
3 files
OKeeffe.E.1a
936 KB 42 pages Presentation
PPT - OKeeffe.E.1a
OKeeffe.E.1b
1.3 MB 20 pages Presentation
PDF - OKeeffe.E.1b
OKeeffe.E.1c
208.5 KB 7 pages Presentation
PPT - OKeeffe.E.1c
Dr. John Shillingford
Global Head‚ Clinical Operations
Averion International Corp.
Ms. Maria D. Buckley
Of Counsel
Nutter McClennen & Fish LLP
1 file
Buckley.M.1a
217.5 KB 21 pages Presentation
PPT - Buckley.M.1a
11:15
Negotiating Clinical Trial Agreements that Minimize Regulatory and Business Risks
Mr. Amor Esteban
Partner
Shook‚ Hardy & Bacon L.L.P.
Mr. Ben Haas
Attorney
Latham & Watkins LLP
1 file
Haas.B.1a
201.5 KB 15 pages Presentation
PPT - Haas.B.1a
12:15
Networking Luncheon for Speakers and Delegates
13:30
Focusing On Indemnification and Insurance Provisions that Meet International Requirements
Ms. Marialuisa Gallozzi
Partner
Covington & Burling LLP
Ms. Julia Reynolds Johnson
Of Counsel
K&L Gates
Ms. Mary Beth Borgwing
Senior Vice President‚ National Life Sciences Practice
Willis North America
1 file
Borgwing.Gallozzi.Johnson.1a
503 KB 36 pages Presentation
PPT - Borgwing.Gallozzi.Johnson.1a
14:30
Maximizing IP and Publication Rights of U.S. Sponsors
Dr. Ramasamy Mannan
Attorney
McDermott‚ Will & Emery LLP
1 file
Mannan.R.1a
669 KB 15 pages Presentation
PPT - Mannan.R.1a
15:30
Conference Ends