About
Is Your Medical Affairs Department Putting Your Company at Risk?
What is the proper role of your company's medical affairs department and how should its functions be defined?
Traditionally, a medical affairs department provides scientific support for a pharmaceutical company's marketing efforts with the caveat that the basis for this support be independently conceived and not in anyway influenced by a marketing campaign. However, increasing scrutiny over such matters as the duties of medical science liaisons, the dissemination of information on off-label use, CME requirements and medical ghostwriting - all matters within the traditional purview of medical affairs - have raised questions about the real borders between medical affairs and sales and marketing. The issues surrounding last year's settlement illustrate this problem and the substantial financial and punitive consequences that result when the duties of medical affairs and sales and marketing are improperly co-mingled.
The OIG Guidance of 2003 was an attempt to clarify and delineate the respective roles and duties of medical affairs and sales and marketing in gray areas, yet confusion remains. Does your company have the necessary policies and procedures in place to ensure that the independence and integrity of its medical affairs department remain above reproach?
As counsel to, executive or compliance officer for a medical affairs department of a pharmaceutical company, you need a complete understanding of the latest legal and regulatory developments affecting medical affairs today. This cutting edge American Conference Institute publication will bring you thoughtful and targeted commentary and in-depth analysis from an outstanding faculty of leading in-house pharmaceutical counsel, medical affairs specialists and compliance officers as well as expert attorneys. The publication will provide you with valuable information on:
The impact of the OIG guidance in defining the duties of medical affairs
How the OIG guidance and PhRMA Code have impacted post marketing studies
Effective risk management techniques in MI/PI communications
The impact of new FDA guidelines for pharmacovigilance and the EU's push for international harmonization
Proper reimbursement structures for physician-consultants
The role of MSLs with respect to the dissemination of information regarding off-label use and other compliance issues
Criteria for the authorship of medical articles
Strategies for avoiding conflicts of interest for industry v. non-industry sponsored CME events
About
Is Your Medical Affairs Department Putting Your Company at Risk?
What is the proper role of your company's medical affairs department and how should its functions be defined?
Traditionally, a medical affairs department provides scientific support for a pharmaceutical company's marketing efforts with the caveat that the basis for this support be independently conceived and not in anyway influenced by a marketing campaign. However, increasing scrutiny over such matters as the duties of medical science liaisons, the dissemination of information on off-label use, CME requirements and medical ghostwriting - all matters within the traditional purview of medical affairs - have raised questions about the real borders between medical affairs and sales and marketing. The issues surrounding last year's settlement illustrate this problem and the substantial financial and punitive consequences that result when the duties of medical affairs and sales and marketing are improperly co-mingled.
The OIG Guidance of 2003 was an attempt to clarify and delineate the respective roles and duties of medical affairs and sales and marketing in gray areas, yet confusion remains. Does your company have the necessary policies and procedures in place to ensure that the independence and integrity of its medical affairs department remain above reproach?
As counsel to, executive or compliance officer for a medical affairs department of a pharmaceutical company, you need a complete understanding of the latest legal and regulatory developments affecting medical affairs today. This cutting edge American Conference Institute publication will bring you thoughtful and targeted commentary and in-depth analysis from an outstanding faculty of leading in-house pharmaceutical counsel, medical affairs specialists and compliance officers as well as expert attorneys. The publication will provide you with valuable information on:
The impact of the OIG guidance in defining the duties of medical affairs
How the OIG guidance and PhRMA Code have impacted post marketing studies
Effective risk management techniques in MI/PI communications
The impact of new FDA guidelines for pharmacovigilance and the EU's push for international harmonization
Proper reimbursement structures for physician-consultants
The role of MSLs with respect to the dissemination of information regarding off-label use and other compliance issues
Criteria for the authorship of medical articles
Strategies for avoiding conflicts of interest for industry v. non-industry sponsored CME events
Contents & Contributors
OIG GUIDANCE IMPACT
LaDonna L. Steiner, Purdue Pharma L.P.
WHAT IS THE APPROPRIATE ROLE OF MEDICAL AFFAIRS AT THE CLINICAL STAGE?
William Bertrand, MedImmune
Jeffrey Wasserstein, Hyman, Phelps & McNamara, P.C.
POST-MARKETING STUDIES: HOW TO FORM A SQUARE
Alison M. Duncan, Porter Wright Morris & Arthur LLP
ASSESSING AND REDUCING RISKS ASSOCIATED WITH THE PROVISION OF MEDICAL AND PRODUCT INFORMATION
Donna Bergeson, Alston & Bird
J. Andrew Lemons, Alston & Bird
Lisa D'Agostino, Emory University School of Medicine
GOOD PHARMACOVIGILANCE AND SAFETY PRACTICES: US AND INTERNATIONAL PERSPECTIVES
MC Ragsdale , Sidley Austin Brown & Wood LLP
GOOD PHARMACOVIGILANCE AND SAFETY PRACTICES: US AND INTERNATIONAL PERSPECTIVES
Robert Reder, MD, Purdue Pharma L.P.
MEDICAL SCIENCE LIAISONS ("MSLS"): QUALIFICATIONS, DUTIES AND FUNCTIONS
Peter O. Safir, Covington & Burling
AUTHORSHIP OF MEDICAL RESEARCH AND APPROPRIATE DISSEMINATION OF MEDICAL ARTICLES: HOW SCHOLARSHIP AND MARKETING CAN COEXIST IN THE PHARMACEUTICAL INDUSTRY
Howard L. Dorfman, Bayer Pharmaceuticals
Albert F. Cacozza, Ropes & Gray
COMPLYING WITH NEW STANDARDS IN CONTINUING MEDICAL EDUCATION
Paul Minicozzi, RPh, PhD, Wyeth Pharmaceuticals
ISSUES ARISING IN CONTINUING MEDICAL EDUCATION AND OTHER THIRD-PARTY EDUCATIONAL ACTIVITIES: AN UPDATE
Connie A. Matteo, Porzio Bromberg & Newman
Elizabeth A. Brophy, Porzio Bromberg & Newman
COUNSELING MEDICAL AFFAIRS AND SALES AND MARKETING ON APPROPRIATE INTERDEPARTMENTAL INTERFACES
Kelly B. Freeman, Ph.D., Eli Lilly and Company
Charlene A. Gallagher, Wyeth Pharmaceuticals
Publication Details