4th National Conference on

Medical Affairs

Ensuring compliance, effective communications, and scientific integrity

Monday, May 22, 2006

About

Maximize Marketing Support Provided By Medical Affairs While Minimizing Compliance Risks

The role of the Medical Affairs department is more important, and more complex, than ever. Increased scrutiny over such matters as the duties and activities of medical science liaisons, CME sponsorship and support, and the dissemination of medical information, as well as the implementation of Medicare Part D and more extensive state regulation, has made it imperative for companies to evaluate their medical affairs practices in order to simultaneously minimize legal risk, maximize drug promotion, and maintain scientific integrity.

Although Medical Affairs and Marketing must each understand their respective roles and maintain a certain degree of separation, what should be a complementary relationship of collaboration and support can become one of conflict and lack of communication. Companies must implement effective strategies when developing, implementing, and monitoring the policies and practices of Medical Affairs to allow it to flourish scientifically while successfully maximizing the commercial potential of the company's core assets at various stages of their life cycles.

To help you achieve these goals, American Conference Institute publication of presentations from the 4th National Conference on Medical Affairs will provide you with the need-to-know legal and regulatory developments that were discussed by some of the industry's leading experts. This publication will provide you with firsthand, practical, and comprehensive information on:

  • Maintaining the required separation between marketing and medical affairs while effectively pursuing the same goals
  • The proper role of medical affairs in both early stage clinical trials and post-marketing studies
  • Using recent federal and state enforcement trends to benchmark your current practices
  • Strategies for compliance at CME events and with medical education grants
  • Avoiding pitfalls in the publication of medical articles and other dissemination of information
  • Best practices for pharmacovigilance in the United States and the EU
  • Minimizing risks when using health care professionals as consultants
  • How the implementation of Medicare Part D has affected medical affairs practices

Contents & Contributors

About

Maximize Marketing Support Provided By Medical Affairs While Minimizing Compliance Risks

The role of the Medical Affairs department is more important, and more complex, than ever. Increased scrutiny over such matters as the duties and activities of medical science liaisons, CME sponsorship and support, and the dissemination of medical information, as well as the implementation of Medicare Part D and more extensive state regulation, has made it imperative for companies to evaluate their medical affairs practices in order to simultaneously minimize legal risk, maximize drug promotion, and maintain scientific integrity.

Although Medical Affairs and Marketing must each understand their respective roles and maintain a certain degree of separation, what should be a complementary relationship of collaboration and support can become one of conflict and lack of communication. Companies must implement effective strategies when developing, implementing, and monitoring the policies and practices of Medical Affairs to allow it to flourish scientifically while successfully maximizing the commercial potential of the company's core assets at various stages of their life cycles.

To help you achieve these goals, American Conference Institute publication of presentations from the 4th National Conference on Medical Affairs will provide you with the need-to-know legal and regulatory developments that were discussed by some of the industry's leading experts. This publication will provide you with firsthand, practical, and comprehensive information on:

  • Maintaining the required separation between marketing and medical affairs while effectively pursuing the same goals
  • The proper role of medical affairs in both early stage clinical trials and post-marketing studies
  • Using recent federal and state enforcement trends to benchmark your current practices
  • Strategies for compliance at CME events and with medical education grants
  • Avoiding pitfalls in the publication of medical articles and other dissemination of information
  • Best practices for pharmacovigilance in the United States and the EU
  • Minimizing risks when using health care professionals as consultants
  • How the implementation of Medicare Part D has affected medical affairs practices

Contents & Contributors


ESTABLISHING, TRAINING AND AUDITING YOUR MEDICAL AFFAIRS DEPARTMENT TO ENSURE CONTINUING COMPLIANCE
Steven T. Guymon, Eli Lilly & Company

THE USE OF MEDICAL SCIENCE LIAISONS IN INFORMATION DISSEMINATION: MINIMIZING LEGAL AND REGULATORY RISK
Alan Minsk, Arnall Golden Gregory LLP

CREATING A COLLABORATIVE RELATIONSHIP BETWEEN MEDICAL AFFAIRS AND MARKETING WHILE MAINTAINING INDEPENDENCE
Donna P. Bergeson, Alston & Bird LLP
Dawnmarie R. Matlock, Alston & Bird LLP

THE IMPACT OF MEDICARE PART D ON YOUR MEDICAL AFFAIRS STRATEGIES
Keith Korenchuk, McGuire Woods LLP

TRENDS AND PRIORITIES IN FEDERAL AND STATE REGULATION AND ENFORCEMENT
Michelle L. Butler, Hyman, Phelps & McNamara P.C.

TRENDS IN FEDERAL ENFORCEMENT: IMPACT ON MEDICAL AFFAIRS
Peter O. Safir, Covington & Burling

BEST PRACTICES FOR MEDICAL AFFAIRS AT THE CLINICAL STAGE
Heather L. Fesko, Epstein Becker & Green P.C.
Nancy Lund-Moser, Community Foundation of Northwest Indiana, Inc.

PUBLICATION OF RESEARCH RESULTS: MANAGING THE COMPLEX ISSUES FACING THE INDUSTRY
Mark Lange, Eli Lilly & Company
Steven Benenson, Porzio Bromberg & Newman P.C.

DEVELOPING GUIDELINES FOR POST-MARKETING STUDIES
Alison Duncan, Porter Wright Morris & Arthur LLP

STRATEGIES FOR IMPLEMENTING EFFECTIVE PHARMACOVIGILANCE PRACTICES IN THE UNITED STATES AND INTERNATIONALLY
John Friend, MD, Akros Pharma Inc
Keith Korenchuk, McGuire Woods LLP

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

ENSURING APPROPRIATE DISSEMINATION OF OFF-LABEL INFORMATION
Jill C. Alvarez, Nixon Peabody LLP

OFF-LABEL PROMOTION: PHARMA RULES AND RISKS
Hope S. Freiwald, Dechert LLP



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0