5th National Pharma/Biotech Industry Conference on

Medical Affairs

Ensuring compliance, effective communications, and scientific integrity

Tuesday, November 14, 2006

About

Bridging the gap between clinical development and marketing while remaining within compliance constraints...

The struggle for balance in the Medical Affairs department's mission is unrelenting, and that struggle is even more pronounced as the government has targeted the department's activities. In its attempts to avoid liability in the contentious areas of scientific communications, off-label discussion, MSL compliance, and CME and education grants, Medical Affairs must constantly analyze its structure, allocation of resources, and internal procedures. How do you act as the scale of medical integrity in maintaining departmental separation, while also supporting the company's goals? Utilizing preventive strategies, maintaining and monitoring internal compliance, and avoiding behavior that will open the door to liability, Medical Affairs must endeavor to preserve independence in a market that is constantly under the microscope.

To aid you in achieving this goal, the American Conference Institute has created a publication from the 5th National Pharma/Biotech Industry Conference on Medical Affairs to provide you with the most up-to-date strategies and insights on how to manage your department and make it an example for others to follow. Take note as industry experts provide you with practical and comprehensive information on:

  • Managing risks and avoiding liability based on scientific communications
  • Implementing a consistent and structured training program to address off-label discussion
  • Specifying an internal hierarchy reporting structure who does medical affairs report to?
  • Avoiding off-label promotion: Role of the Med-Reg team
  • Balancing the Interface Between Sales and Marketing and Medical Affairs
  • Factors to consider when utilizing medical consultants

Contents & Contributors

About

Bridging the gap between clinical development and marketing while remaining within compliance constraints...

The struggle for balance in the Medical Affairs department's mission is unrelenting, and that struggle is even more pronounced as the government has targeted the department's activities. In its attempts to avoid liability in the contentious areas of scientific communications, off-label discussion, MSL compliance, and CME and education grants, Medical Affairs must constantly analyze its structure, allocation of resources, and internal procedures. How do you act as the scale of medical integrity in maintaining departmental separation, while also supporting the company's goals? Utilizing preventive strategies, maintaining and monitoring internal compliance, and avoiding behavior that will open the door to liability, Medical Affairs must endeavor to preserve independence in a market that is constantly under the microscope.

To aid you in achieving this goal, the American Conference Institute has created a publication from the 5th National Pharma/Biotech Industry Conference on Medical Affairs to provide you with the most up-to-date strategies and insights on how to manage your department and make it an example for others to follow. Take note as industry experts provide you with practical and comprehensive information on:

  • Managing risks and avoiding liability based on scientific communications
  • Implementing a consistent and structured training program to address off-label discussion
  • Specifying an internal hierarchy reporting structure who does medical affairs report to?
  • Avoiding off-label promotion: Role of the Med-Reg team
  • Balancing the Interface Between Sales and Marketing and Medical Affairs
  • Factors to consider when utilizing medical consultants

Contents & Contributors


MANAGING RISKS AND AVOIDING LIABILITY BASED ON SCIENTIFIC COMMUNICATIONS
Mary Ellen Allen, Genentech, Inc. (South San Francisco, CA)

AVOIDING OFF-LABEL PROMOTION: ROLE OF THE MED-REG TEAM
Mary Sullivan, Takeda Pharmaceuticals, North America (Deerfield, IL)

MEETING MEDICAL NEEDS WITHOUT CROSSING THE LINE: AVOIDING CONSEQUENCES FOR OFF-LABEL DISCUSSIONS
Jennifer A. Romanski, Porzio, Bromberg & Newman, P.C. (Morristown, NJ)

CREATING A CAREER PATH: RECRUITING, STAFFING, AND STRUCTURING YOUR MEDICAL AFFAIRS DEPARTMENT
John Rodzvilla, MD, Auxilium Pharmaceuticals, Inc. (Malvern, PA)

FACTORS TO CONSIDER WHEN UTILIZING MEDICAL CONSULTANTS
Deborah Livornese, Buc & Beardsley (Washington, DC)

ESTABLISHING CLEAR ROLES & DUTIES FOR YOUR MEDICAL SCIENCE LIAISONS
John A. Ohman, Solvay Pharmaceuticals, Inc. (Marietta, GA)

THE USE OF MEDICAL SCIENCE LIASONS IN INFORMATION DISSEMINATION: MINIMIZING LEGAL AND REGULATORY RISK
Alan Minsk, Arnall Golden Gregory LLP (Atlanta, GA)



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0