9th National Conference on Managing Legal Risks in Structuring & Conducting

Clinical Trials

Tuesday, February 26, 2008

About

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.

The FDA Amendments Act of 2007, one of the most widely debated pieces of legislation in recent memory, has 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 (Vermont, West Virginia, District of Columbia, Maine, Michigan, Hawaii, Minnesota and California). In addition, a proposed new federal bill targeting industry gifts to physicians will only add to manufacturers’ clinical burdens.

Further, heightened government scrutiny and creative plaintiff attorneys continue to raise the stakes. And 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 publication from the American Conference Institute’s 9th National Conference on Managing Legal Risks in Structuring & Conducting Clinical Trials details all the pressing concerns. In this tumultuous and volatile time, this is the only event covering the complete clinical trials landscape – legislation, regulation, compliance, and litigation. Its front-line faculty includes experts from pharmaceutical and medical device companies, hospital and research institutions, as well as expert attorneys and current and former government enforcers.

Contents & Contributors

About

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.

The FDA Amendments Act of 2007, one of the most widely debated pieces of legislation in recent memory, has 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 (Vermont, West Virginia, District of Columbia, Maine, Michigan, Hawaii, Minnesota and California). In addition, a proposed new federal bill targeting industry gifts to physicians will only add to manufacturers’ clinical burdens.

Further, heightened government scrutiny and creative plaintiff attorneys continue to raise the stakes. And 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 publication from the American Conference Institute’s 9th National Conference on Managing Legal Risks in Structuring & Conducting Clinical Trials details all the pressing concerns. In this tumultuous and volatile time, this is the only event covering the complete clinical trials landscape – legislation, regulation, compliance, and litigation. Its front-line faculty includes experts from pharmaceutical and medical device companies, hospital and research institutions, as well as expert attorneys and current and former government enforcers.

Contents & Contributors

FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007: IMPLEMENTATION ISSUES
Sheldon Bradshaw, Hunton & Williams LLP (Washington, DC) (Former Chief Counsel, FDA)

FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007: A BRIEF OVERVIEW
Scott M. Lassman, WilmerHale (Washington, DC) (Former Senior Assistant General Counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA))

FOOD AND DRUG ADMINISTRATION AMENDMENT ACT OF 2007: A BRIEF OVERVIEW
Maria Pasquale, Celgene Corporation (Summit, NJ)

CLINICAL TRIALS REGISTRATION – NEW FEDERAL REQUIREMENTS
Aaron Rodriguez, Medtronic (Minneapolis, MN)

CLINICAL TRIAL REGISTRIES & RESULTS DATABASES: STATE LAW DEVELOPMENTS
Erika Lietzan, Covington & Burling LLP (Washington, DC)

PROMOTION, LIABILITY AND RISK REDUCTION: TRANSPARENCY ISSUES
Ralph F. Hall, University of Minnesota Law School; Baker & Daniels LLP (Indianapolis, IN)

CLINICAL SITE AND SUBJECT RECRUITMENT: ENSURING PROPERLY STRUCTURED INCENTIVES
Priya Mannan, Baxter Healthcare (Deerfield, IL)
Tamara O’Black, St. Paul Heart Clinic (St. Paul, MN)
Elizabeth Dallas Gobeil, Thompson Hine LLP (Atlanta, GA)

THIRD-PARTY PAYOR BILLING: WHAT YOU NOW MUST KNOW ABOUT CLINICAL TRIAL MEDICARE REIMBURSEMENT
Kirk Dobbins, King & Spalding LLP (Washington, DC)

RECOGNIZING INTELLECTUAL PROPERTY ISSUES DURING CLINICAL TRIALS
Clark G. Sullivan, Arnall Golden Gregory LLP (Atlanta, GA)

NEGOTIATING RISK ALLOCATION WITH LIMITATION OF LIABILITY, INDEMNIFICATION, AND INSURANCE PROVISIONS
Melissa G. Beare, Advanced Neuromodulation Systems, Inc. (Plano, TX)

ADVERSE EVENT REPORTING: REDUCING LITIGATION RISKS
Gary C. Messplay, Hunton & Williams LLP (Washington, DC)

ADVERSE EVENT REPORTING: REDUCING LITIGATION RISKS
Ann M. Begley, K&L Gates (Washington, DC)

POST-MARKETING STUDIES: IDENTIFYING AND MINIMIZING THE LITIGATION RISKS
Charlene A. Gallagher, Wyeth Pharmaceuticals (Collegeville, PA)

CLINICAL TRIAL DATA: EVIDENCE IN PRODUCT LIABILITY CLAIMS
Victoria M. Komarnicki, Bennett Bricklin & Saltzburg LLP (Philadelphia, PA)

POST-MARKETING STUDIES: IDENTIFYING AND MINIMIZING THE LITIGATION RISKS
Loren H. Brown, DLA Piper (New York, NY)

SPONSOR-CRO RELATIONSHIPS: MANAGING RISK WHEN CONTRACTING WITH SERVICE PROVIDERS AND ACHIEVING COHESIVE WORKING PARTNERSHIPS
Bradley Merrill Thompson, Epstein Becker & Green, P.C (New York, NY)



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0