Medical Affairs

Thursday, December 06, 2007

About

Increased media scrutiny, pending legislation, and a general lack of public confidence in the ability of the FDA to regulate the pharmaceutical industry have made it more important for you to monitor the actions of your Medical Affairs department. What is the proper role of your company’s Medical Affairs department and how should it be defined?

Recent focus on educational grants, physician-industry relationships, and increased pressure on drug companies to more closely evaluate drug safety and efficacy places the Medical Affairs function at the heart of discourse on how you should be reforming policies and procedures. As the link between the Clinical and Scientific departments and Sales and Marketing, it is imperative that transparency is maintained in all business practices. Communications between these departments must constantly be monitored and checked for compliance. As tighter policing of drug makers takes hold, you must be prepared to pull back the veil on your Medical Affairs department’s activities in order to prove compliance.

To aid you in performing this task, the American Conference Institute brings you this publication from the sixth installment of Managing Legal Risks and Avoiding Conflicts of Interest in Medical Affairs. This publication provides you with thoughtful and targeted commentary and in-depth analysis from an outstanding faculty of in-house pharmaceutical counsel, medical affairs specialists and compliance officers as well as expert attorneys. Topics include:

  • Analyzing conflict of interest concerns that arise when giving independent and unrestricted grants
  • Revising your pharmacovigilance practices and procedures in light of the FDA Revitalization Act
  • Specifying clear boundaries for promotional scientific exchange between Medical Affairs and Sales and Marketing
  • Incorporating a compliance structure into the Medical Affairs function that includes monitoring and auditing metrics
  • Establishing an efficient procedure for monitoring market performance, side effects, and product safety
  • Setting qualifications for MSLs and identifying what they can and cannot do

Contents & Contributors

About

Increased media scrutiny, pending legislation, and a general lack of public confidence in the ability of the FDA to regulate the pharmaceutical industry have made it more important for you to monitor the actions of your Medical Affairs department. What is the proper role of your company’s Medical Affairs department and how should it be defined?

Recent focus on educational grants, physician-industry relationships, and increased pressure on drug companies to more closely evaluate drug safety and efficacy places the Medical Affairs function at the heart of discourse on how you should be reforming policies and procedures. As the link between the Clinical and Scientific departments and Sales and Marketing, it is imperative that transparency is maintained in all business practices. Communications between these departments must constantly be monitored and checked for compliance. As tighter policing of drug makers takes hold, you must be prepared to pull back the veil on your Medical Affairs department’s activities in order to prove compliance.

To aid you in performing this task, the American Conference Institute brings you this publication from the sixth installment of Managing Legal Risks and Avoiding Conflicts of Interest in Medical Affairs. This publication provides you with thoughtful and targeted commentary and in-depth analysis from an outstanding faculty of in-house pharmaceutical counsel, medical affairs specialists and compliance officers as well as expert attorneys. Topics include:

  • Analyzing conflict of interest concerns that arise when giving independent and unrestricted grants
  • Revising your pharmacovigilance practices and procedures in light of the FDA Revitalization Act
  • Specifying clear boundaries for promotional scientific exchange between Medical Affairs and Sales and Marketing
  • Incorporating a compliance structure into the Medical Affairs function that includes monitoring and auditing metrics
  • Establishing an efficient procedure for monitoring market performance, side effects, and product safety
  • Setting qualifications for MSLs and identifying what they can and cannot do

Contents & Contributors

INCREASING SCRUTINY OF THE EDUCATIONAL GRANT PROCESS: THE IMPACT ON MEDICAL AFFAIRS
Michael P. Bigelow, Eli Lilly and Company (Indianapolis, IN)

RESEARCH GRANTS AND CME: ENSURING SCIENTIFIC INTEGRITY
Stephen M. Shinall, PhD, Takeda Pharmaceuticals North America, Inc. (Deerfield, IL)
Kristin Rand, JD, Wyeth Pharmaceuticals, Inc. (Collegeville, PA)
Deborah Livornese, Buc & Beardsley (Washington, DC)

THE ROLE OF MEDICAL AFFAIRS IN CLINICAL TRIALS AND STRATEGIES FOR RISK REDUCTION
Beverly H. Lorell, MD, FACC, King & Spaulding LLP (Washington, DC)

ROLE OF MEDICAL AFFAIRS IN CLINICAL TRIALS
Jill Alvarez, Leader, Nixon Peabody LLP (Washington, DC)

RISKS AND BENEFITS OF POST-MARKETING CLINICAL RESEARCH: IMPLEMENTING BEST PRACTICES
Keith M. Korenchuk, Covington & Burling LLP (Washington, DC)

FEDERAL FRAUD AND ABUSE LAWS AND THE WORLD OF OFF-LABEL PROMOTION
Monica R. Chmielewski, Hall, Render, Killian, Heath & Lyman, PLLC (Troy, MI)

ASSESSING AND REDUCING RISKS ASSOCIATED WITH MEDICAL AND PRODUCT INFORMATION
Kathleen M. Sanzo, Morgan, Lewis & Bockius LLP (Washington, DC)

ASSESSING AND REDUCING RISKS ASSOCIATED WITH MEDICAL AND PRODUCT INFORMATION
Indrani M. Franchini, Worldwide Programs, Pfizer, Inc. (New York, NY)

FINE-TUNING INTERNAL PROCESSES TO MANAGE RISK, AVOID LIABILITY, AND ENSURE COMPLIANCE IN MEDICAL AFFAIRS
Gregory H. Levine, Arnold & Porter LLP (Washington, DC)

PHARMACOVIGILANCE REVISITED
William W. Vodra, Arnold & Porter LLP (Washington, DC) Former Associate Chief Counsel for Drugs, FDA

MSLs: DETERMINING THE APPROPRIATE QUALIFICATIONS, DUTIES, FUNCTIONS, AND TRAINING
Archie Stone, PhD, Allergan Medical Affairs (Fuquay-Varina, NC)

MSLs: DETERMINING APPROPRIATE QUALIFICATIONS, DUTIES, FUNCTIONS & TRAINING
Robin L. Winter-Sperry, MD, MSL Advantage, LLC (Bernardsville, NJ)

BALANCING THE INTERFACE BETWEEN SALES/MARKETING AND MEDICAL AFFAIRS
Linda Carlson, PhD, MBA, EMD Serono, Inc. (Rockland, MA)
Leigh-Ann Durant, Clinical and Medical Affairs



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0