Managing Legal Risks In Conducting & Promoting

Clinical Trials

Monday, February 27, 2006

About

Ensure Your Clinical Trial Strategy Factors In The Latest Legal Exposures, Liabilities, And Risks

The U.S. Attorneys' Office has indicated that it is moving aggressively into overseeing clinical trial compliance. This has compounded fear that the recent trend toward more vigorous reporting of clinical trial activities - both through PhRMA's new voluntary disclosure policy about trials for all diseases and the requirements of FDAMA 113 pertaining to serious or life-threatening diseases - will be the impetus for new court actions. Clinical trial transparency litigation already has been running rampant, as new enforcement theories have pervaded the environment. And regulatory activity concerning human research protections has continued to expand. As such, pharmaceutical, biotech, and medical device manufacturers must stay one step ahead of the latest legal exposures, liabilities, and risks associated with clinical trials.

Beyond awareness of the latest legal and regulatory trends, you also must be able to structure and put into effect practical strategies for minimizing risks in your trial promotion and data use. You must avoid vilification by public, private, and political entities (and the resulting bad publicity, fines, and damages), all while conducting your trials to maintain continuous and successful product pipelines and maximize profits. These challenges will only continue with increased public awareness.

American Conference Institute's Managing Legal Risks in Conducting & Promoting Clinical Trials publication will help you overcome these challenges by bringing you thoughtful, targeted, and in-depth analysis and commentary on the clinical trial regulatory, legislative, and litigation landscape. The experienced and senior faculty of health care, regulatory, food and drug, and product liability attorneys, as well as legal and compliance experts from pharmaceutical, biotech, and medical device companies, CROs, IRBs, and hospitals and research institutions, will provide you with first-hand, practical and comprehensive information on:
  • Reducing liability risks when disclosing clinical trial information for off-label promotion
  • Knowing whether you have adequately disclosed information regarding trials that the FDA is aware of but that may not have been publicly disclosed
  • Minimizing risks in clinical trial agreements
  • Identifying and managing GCP compliance risks
  • How clinical trial data is used to support and counter liability claims
  • HIPAA compliance in collection, storage, and access to subject information and tissue samples
  • Managing electronic data submission to ensure compliance
  • Conducting clinical trials internationally

Contents & Contributors

About

Ensure Your Clinical Trial Strategy Factors In The Latest Legal Exposures, Liabilities, And Risks

The U.S. Attorneys' Office has indicated that it is moving aggressively into overseeing clinical trial compliance. This has compounded fear that the recent trend toward more vigorous reporting of clinical trial activities - both through PhRMA's new voluntary disclosure policy about trials for all diseases and the requirements of FDAMA 113 pertaining to serious or life-threatening diseases - will be the impetus for new court actions. Clinical trial transparency litigation already has been running rampant, as new enforcement theories have pervaded the environment. And regulatory activity concerning human research protections has continued to expand. As such, pharmaceutical, biotech, and medical device manufacturers must stay one step ahead of the latest legal exposures, liabilities, and risks associated with clinical trials.

Beyond awareness of the latest legal and regulatory trends, you also must be able to structure and put into effect practical strategies for minimizing risks in your trial promotion and data use. You must avoid vilification by public, private, and political entities (and the resulting bad publicity, fines, and damages), all while conducting your trials to maintain continuous and successful product pipelines and maximize profits. These challenges will only continue with increased public awareness.

American Conference Institute's Managing Legal Risks in Conducting & Promoting Clinical Trials publication will help you overcome these challenges by bringing you thoughtful, targeted, and in-depth analysis and commentary on the clinical trial regulatory, legislative, and litigation landscape. The experienced and senior faculty of health care, regulatory, food and drug, and product liability attorneys, as well as legal and compliance experts from pharmaceutical, biotech, and medical device companies, CROs, IRBs, and hospitals and research institutions, will provide you with first-hand, practical and comprehensive information on:
  • Reducing liability risks when disclosing clinical trial information for off-label promotion
  • Knowing whether you have adequately disclosed information regarding trials that the FDA is aware of but that may not have been publicly disclosed
  • Minimizing risks in clinical trial agreements
  • Identifying and managing GCP compliance risks
  • How clinical trial data is used to support and counter liability claims
  • HIPAA compliance in collection, storage, and access to subject information and tissue samples
  • Managing electronic data submission to ensure compliance
  • Conducting clinical trials internationally

Contents & Contributors


COMPLIANCE WITH THE REGULATORY LANDSCAPE
David W. Feigal, M.D., M.P.H., NDA Partners, LLP, and Arizona State University

RISK MANAGEMENT OF CLINICAL STUDIES – OR RUN THE RISK?
Charma A. Konnor, R.Ph., RAC, Phoenix Regulatory Associates, Ltd.

LATEST DEVELOPMENTS WITH CLINICAL TRIAL REGISTRIES AND DATABASES: FDAMA 113 AND BEYOND
Marc J. Scheineson, Alston & Bird

CLINICAL TRIAL REGISTRIES AND DATABASES
Thomas E. Merchant, GlaxoSmithKline

THE MEDICAL DEVICE PERSPECTIVE ON CLINICAL TRIAL REGISTRIES AND DATABASES
Kathy DiGiorno, Medtronic

GUIDANCE FROM PHRMA: CLINICAL TRIALS
Erika King Lietzan, Covington & Burling

OVERCOMING OBSTACLES IN COMPLYING WITH CURRENT DISCLOSURE LAW AND AVOIDING CONFLICTS OF INTEREST AND INSIDER TRADING
Daniel Garen, Bayer Healthcare
Robert P. Brady, Hogan & Hartson LLP

WHAT EVERY IN HOUSE COUNSEL AND RISK MANAGER NEEDS TO KNOW ABOUT CLINICAL TRIALS AGREEMENTS
Dan O'Connor, Legal ImClone Systems Incorporated
Lee W. Farrow, ACE Medical Risk
Amor Esteban, Drinker Biddle & Reath LLP

CHALLENGES IN PARTNERING WITH CROS
Linda Hockersmith, Sensys Medical
Susan Flint, M.S., R.A.C., C.C.R.A., Cato Research Boston
Blaine Templeman, Mintz, Levin, Cohn, Ferris, Glovsky & Popeo

ADVERTISING OF AND RECRUITMENT FOR CLINICAL TRIALS
Barbara R. Binis, Reed Smith LLP
Steven J. Brotman, Wyeth Pharmaceuticals

IRB: ROLE & RESPONSIBILITY -- CONTINUING REVIEW
Camille P. Wicher, Esq., RN, MSN, Roswell Park Cancer Institute

THE IRB: ADVERSE EVENT AND RISK MANAGEMENT ISSUES
Cindy Gates, Western Institutional Review Board

TRUSTING DOCTORS: TRICKY BUSINESS WHEN IT COMES TO CLINICAL RESEARCH
Frances Miller, Boston Univ. School of Law, and Nutter McClennen & Fish, LLP

CONDUCTING INTERNATIONAL CLINICAL TRIALS: A PRACTICAL PERSPECTIVE ON ‘MINIMISING LEGAL RISK'
Patricia Lovell-Hoare, Chiltern International Limited

CONDUCTING CLINICAL TRIALS INTERNATIONALLY: PITFALLS AND SMART PRACTICES
Bryan Driscoll, Simmons & Simmons

USE OF CLINICAL TRIAL DATA TO COUNTER POTENTIAL POST-MARKETING CLAIMS
Joseph K. Hetrick, Dechert LLP

HYPOTHETICAL CASE: EVAID (RESPIRATORY SYNCYTIAL VIRUS VACCINE)
Charlene A. Gallagher, Wyeth Pharmaceuticals

WALKING THE LINE: APPROPRIATE DISCLOSURE/DISSEMINATION OF CLINICAL TRIAL DATA
Keith M. Korenchuk, McGuireWoods
Heather J. Stewart, Bristol-Myers Squibb

CLINICAL TRIALS LITIGATION
Laura Lewis Owens, Alston & Bird
Anna Aven Sumner, Alston & Bird

KEY ISSUES IN CLINICAL TRIALS LITIGATION
Wayne Bond, Womble Carlyle Sandridge & Rice, PLLC
Jessie C. Fontenot, Womble Carlyle Sandridge & Rice, PLLC

STATE REGULATION OF PHARMACEUTICAL CLINICAL TRIALS
John C. Serio, Brown Rudnick Berlack Israels LLP

THE LITIGATION LANDSCAPE IN CLINICAL TRIALS: PLAINTIFF AND DEFENSE THEORIES AND FEDERAL AND STATE REQUIREMENTS
Stephen Hanlon, Holland & Knight

GRAPPLING WITH ETHICS, REQUIREMENTS, AND FORMS IN THE INFORMED CONSENT PROCESS
Jill Alvarez, Nixon Peabody LLP

GRAPPLING WITH ETHICS, REQUIREMENTS, AND FORMS IN THE INFORMED CONSENT PROCESS
Michael R. Jacobs, Pharm.D., Temple University School of Pharmacy

INFORMED CONTENT: WHERE LIABILITY LURKS
Kate Duffy Mazan, Clinical Technology Transfer Group, P.L.L.C.

IP LITIGATION RISKS IN CLINICAL TRIALS
James F. Haley, Jr., Ropes & Gray LLP

HIPAA AND THE COMMON RULE: HANDLING HEALTH INFORMATION IN RESEARCH
Kristen Rosati, Coppersmith Gordon Schermer Owens & Nelson P.L.C

HUMAN RESEARCH PROTECTIONS: COMPLIANCE WITH THE HIPAA PRIVACY RULE AND ACCREDITATION PROGRAM(S)
Lynn A. Meyer, CIM, CIP, IntegReview Inc.

MANAGING ELECTRONIC DATA SUBMISSION TO ENSURE COMPLIANCES
Susan Nonemaker, Intrasphere Technologies, Inc.

IDENTIFYING & MANAGING GCP COMPLIANCE RISKS FOR THE PHARMACEUTICAL, BIOTECH & DEVICE INDUSTRIES
Karen Weaver, Epstein, Becker & Green

IDENTIFYING AND MANAGING GCP COMPLIANCE RISKS: STUDY REGULATORY RISK EQUATES TO SUSCEPTIBILITY TO LITIGATION
Douglas R. Mackintosh, DrPH, MBA, MsHyg, GCPA, Inc.
Vernette J. Molloy, MBA, RN, GCPA, Inc.

INITIAL TRIAL CONSIDERATIONS
Penny S. Smith, Thompson Hine, LLP
Suzanne E. LoGalbo, Thompson Hine, LLP
Kelly Dinglasan, BearingPoint



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0