3rd National Conference on

Medical Affairs

Thursday, December 01, 2005

About

With increased scrutiny over such matters as medical science liaisons, post-marketing clinical trials, publication, and medical education - as well as the rise in extensive state regulations and the imminent implementation of Medicare Part D - you must pay careful attention to the activities of your company's medical affairs department. To minimize risk and maintain scientific integrity, the medical affairs department's activities must be gauged against the always-changing regulatory environment.

The key to success lies in the ability of counsel, regulatory officers, and medical executives competently to identify behaviors and practices that put the company at risk of severe financial, punitive and criminal consequences. Armed with the proper tools to conduct this analysis, you can ensure your company's policies, procedures, and practices will allow the medical affairs department to flourish scientifically and successfully support your company's market.

American Conference Institute's 3rd National Conference on Ensuring Compliance, Effective Communications and Scientific Integrity in Medical Affairs provided need-to-know legal and regulatory developments that are changing the way medical affairs departments operate. The latest compliance strategies and effective business practices from leading in-house counsel, expert attorneys, and top scientists and medical affairs specialists from the pharmaceutical and medical device industries are included in the publication. The presentations include first-hand, practical, and comprehensive information on:
  • Using recent subpoenas and case law to evaluate your company's policies
  • Utilizing Medical Science Liaison programs to their maximum capacity
  • Understanding the appropriate role of medical affairs in post-marketing studies
  • Calculating your investment in medical affairs tools
  • Preparing for the implementation of Medicare Part D
  • Safeguarding against the negative impact of state regulations
  • Participating in ethical and permissible publication activity
  • Avoiding fraud and abuse claims in your medical education and research grants activities

Contents & Contributors

About

With increased scrutiny over such matters as medical science liaisons, post-marketing clinical trials, publication, and medical education - as well as the rise in extensive state regulations and the imminent implementation of Medicare Part D - you must pay careful attention to the activities of your company's medical affairs department. To minimize risk and maintain scientific integrity, the medical affairs department's activities must be gauged against the always-changing regulatory environment.

The key to success lies in the ability of counsel, regulatory officers, and medical executives competently to identify behaviors and practices that put the company at risk of severe financial, punitive and criminal consequences. Armed with the proper tools to conduct this analysis, you can ensure your company's policies, procedures, and practices will allow the medical affairs department to flourish scientifically and successfully support your company's market.

American Conference Institute's 3rd National Conference on Ensuring Compliance, Effective Communications and Scientific Integrity in Medical Affairs provided need-to-know legal and regulatory developments that are changing the way medical affairs departments operate. The latest compliance strategies and effective business practices from leading in-house counsel, expert attorneys, and top scientists and medical affairs specialists from the pharmaceutical and medical device industries are included in the publication. The presentations include first-hand, practical, and comprehensive information on:
  • Using recent subpoenas and case law to evaluate your company's policies
  • Utilizing Medical Science Liaison programs to their maximum capacity
  • Understanding the appropriate role of medical affairs in post-marketing studies
  • Calculating your investment in medical affairs tools
  • Preparing for the implementation of Medicare Part D
  • Safeguarding against the negative impact of state regulations
  • Participating in ethical and permissible publication activity
  • Avoiding fraud and abuse claims in your medical education and research grants activities

Contents & Contributors


THE USE OF MEDICAL SCIENCE LIAISONS IN INFORMATION DISSEMINATION: MINIMIZING LEGAL AND REGULATORY RISK
Alan G. Minsk, Arnall Golden Gregory LLP
OVERCOMING THE CHALLENGES OF ESTABLISHING AN EFFECTIVE, MEASURABLE MSL PROGRAM
John A. Ohman, Pharm.D., Solvay Pharmaceuticals, Inc.

CURRENT ENFORCEMENT TRENDS: A ROUNDTABLE DISCUSSION
David L. Douglass, Porter Wright Morris & Arthur, LLP

BEST PRACTICES: RISKS, BENEFITS & OBLIGATIONS OF CONDUCTING POST-MARKETING CLINICAL RESEARCH
Nancy Dreyer, Ph.D., Outcome
Jennifer Schranz, Wyeth

POST-MARKETING CLINICAL TRIALS
Charlene A. Gallagher, Wyeth

PREPARING FOR HEIGHTENED SCRUTINY OF POST MARKETING RESEARCH
Alison M. Duncan, Porter, Wright, Morris & Arthur, LLP

ESTABLISHING INTERNAL GUIDELINES FOR USING PHYSICIANS AS CONSULTANTS
Sujata T. Dayal, Abbott Laboratories
Thomas S. Schroeder, Faegre & Benson LLP

HOW TO PREPARE FOR EMERGING ENFORCEMENT AGAINST DEVICE COMPANIES
Jill Alvarez, Epstein Becker & Green

HOW TO PREPARE FOR EMERGING ENFORCEMENT AGAINST DEVICE COMPANIES
Sheva J. Sanders, Lindquist & Vennum P.L.L.P.

PLANNING FOR INCREASED STATE BY STATE REGULATION
Keith M. Korenchuk, McGuireWoods LLP

PLANNING FOR INCREASED STATE BY STATE REGULATION
Joseph Devaney, Sanofi Aventis

ENSURING YOUR MEDICAL AFFAIRS STAFF MAINTAINS SCIENTIFIC INTEGRITY IN PUBLICATIONS
Richard G. Cowart, Baker, Donelson, Bearman, Caldwell and Berkowitz, PC

PUBLICATION STRATEGIES AND PRODUCT LIABILITY RISKS: WHAT YOU'LL SEE IN COURT
Hope S. Freiwald, Dechert LLP

GUIDELINES RELATING TO CONTINUING MEDICAL EDUCATION
Connie A. Matteo, Porzio Bromberg & Newman

COMPLYING WITH NEW STANDARDS IN CONTINUING MEDICAL EDUCATION
Paul Minicozzi, PhD, Wyeth Pharmaceuticals

PREPARING YOUR MEDICAL AFFAIRS DEPARTMENT FOR THE IMPLEMENTATION OF MEDICARE PART D
Christine Bloomquist, Reed Smith LLP
Thomas E. Jeffry, Jr., Davis Wright Tremaine LLP



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0