Developing the Most Comprehensive Program on

Global Pharmaceutical Compliance

Monday, June 27, 2005

About

Is Your Compliance Program Equipped to Address The Complexities of Today's Global Market?

In response to the government's unprecedented crackdown on the pharmaceutical industry for fraudulent practices in sales and marketing and pricing practices, many companies have implemented compliance programs which in large part have been based on the PhRMA Code and OIG Guidance. Until now, adherence to the Code and Guidance has been voluntary. With the passage of the recent California law, even more companies will be compelled to set up programs under the PhRMA/ OIG model as any drug maker wishing to do business in the state of California must have a compliance program in place that is based on these guidelines.

Despite the good intentions of mandates such as the California law, a compliance program based on the Code and/or Guidance alone is not sufficient to deal with the complexities of today's global market. The Code and the Guidance only address fraud and abuse in sales and marketing practices and pricing fraud. However, doing business in a global market dictates that many other matters such as FCPA violations, export controls, medical affairs, clinical trials, SOX obligations, government contracting and cGMPs now be incorporated into a larger infrastructure of global compliance. Increased scrutiny by government prosecutors and regulators in such matters has also added to this urgency and necessity.

Today, it is absolutely critical that pharmaceutical compliance executives and in-house counsel as well as those who advise them have a strong understanding of compliance obligations on a global scale and the strategies to fulfill them. They must have the competency to develop a comprehensive and thorough compliance program that covers all corporate, international and regulatory areas.

American Conference Institute has created a publication to provide you with an in-depth understanding of the infrastructure of a global compliance program and areas in which compliance cannot be ignored. Have access to the presentations of a faculty of leading in-house counsel and compliance officers and leading attorneys, bringing you the most up-to-date information on:

  • How to develop global compliance strategies
  • How FCPA applies to pharmaceutical companies and why it is essential that its provisions be addressed in your global compliance program
  • Special export concerns for pharmaceutical companies
  • Practical tips for incorporating key domestic and international antitrust components into your global compliance program
  • The implications of whistleblower provisions under SOX to your global compliance program
  • Compliance obligations relative to VA/DOD FSS and other government contracts
  • Medical governance: why it is an essential component of your global pharmaceutical and compliance program
  • Developing comprehensive guidelines for clinical trials
  • Internationally accepted drug safety measures

Contents & Contributors

About

Is Your Compliance Program Equipped to Address The Complexities of Today's Global Market?

In response to the government's unprecedented crackdown on the pharmaceutical industry for fraudulent practices in sales and marketing and pricing practices, many companies have implemented compliance programs which in large part have been based on the PhRMA Code and OIG Guidance. Until now, adherence to the Code and Guidance has been voluntary. With the passage of the recent California law, even more companies will be compelled to set up programs under the PhRMA/ OIG model as any drug maker wishing to do business in the state of California must have a compliance program in place that is based on these guidelines.

Despite the good intentions of mandates such as the California law, a compliance program based on the Code and/or Guidance alone is not sufficient to deal with the complexities of today's global market. The Code and the Guidance only address fraud and abuse in sales and marketing practices and pricing fraud. However, doing business in a global market dictates that many other matters such as FCPA violations, export controls, medical affairs, clinical trials, SOX obligations, government contracting and cGMPs now be incorporated into a larger infrastructure of global compliance. Increased scrutiny by government prosecutors and regulators in such matters has also added to this urgency and necessity.

Today, it is absolutely critical that pharmaceutical compliance executives and in-house counsel as well as those who advise them have a strong understanding of compliance obligations on a global scale and the strategies to fulfill them. They must have the competency to develop a comprehensive and thorough compliance program that covers all corporate, international and regulatory areas.

American Conference Institute has created a publication to provide you with an in-depth understanding of the infrastructure of a global compliance program and areas in which compliance cannot be ignored. Have access to the presentations of a faculty of leading in-house counsel and compliance officers and leading attorneys, bringing you the most up-to-date information on:

  • How to develop global compliance strategies
  • How FCPA applies to pharmaceutical companies and why it is essential that its provisions be addressed in your global compliance program
  • Special export concerns for pharmaceutical companies
  • Practical tips for incorporating key domestic and international antitrust components into your global compliance program
  • The implications of whistleblower provisions under SOX to your global compliance program
  • Compliance obligations relative to VA/DOD FSS and other government contracts
  • Medical governance: why it is an essential component of your global pharmaceutical and compliance program
  • Developing comprehensive guidelines for clinical trials
  • Internationally accepted drug safety measures

Contents & Contributors


PHARMA COMPLIANCE PROGRAM EFFECTIVENESS
Bert Weinstein, Purdue Pharma L.P.

GOVERNMENT PRICE REPORTING IN THE PHARMACEUTICAL INDUSTRY
John Shakow, King & Spalding

BEYOND THE HHS OIG GUIDANCE: ADVANCED ISSUES FOR PHARMACEUTICAL COMPLIANCE
John Bentivoglio, King & Spalding LLP

REVISING THE BLUEPRINT OF COMPLIANCE: DEVELOPING GLOBAL COMPLIANCE STRATEGIES
Gary Giampetruzzi, Pfizer

FCPA: AN INTEGRAL PART OF A GLOBAL COMPLIANCE PROGRAM
Michael Horowitz, Cadwalader, Wickersham & Taft LLP

EXPORT COMPLIANCE 101
Michael L. Burton, Miller & Chevalier Chartered

STAYING OUT OF COURT (AND JAIL): SUCCESSFUL STRATEGIES FOR GLOBAL ANTITRUST COMPLIANCE IN THE PHARMACEUTICAL SECTOR
David Hull, Covington & Burling

INCORPORATING SOX SAFEGUARDS INTO YOUR EXISTING COMPLIANCE PROGRAMS
Robert L. Hickok, Pepper Hamilton LLP

HOW TO INCORPORATE HEALTH DATA PRIVACY & SECURITY SAFEGUARDS INTO EXISTING COMPLIANCE POLICIES
Beth L. Rubin, Dechert LLP

WHY MEDICAL GOVERNANCE IS ESSENTIAL
Seth B. Whitelaw, GlaxoSmithKline

MANAGING COMPLIANCE RISKS IN CLINICAL TRIALS
Charlene A. Gallagher, Wyeth Pharmaceuticals

Gayatri Girwarr, M.D., Wyeth Pharmaceuticals GOOD PHARMACOVIGILANCE PRACTICES: DRUG SAFETY COMPLIANCE FROM AN INTERNATIONAL PERSPECTIVE
Nathan C. Sheers, Sidley Austin Brown & Wood LLP

SUSTAINING COMPLIANCE WITH CURRENT GOOD MANUFACTURING PRACTICES: QUALITY SYSTEMS
Thomas J. Stukane, Schering-Plough Corporation

CONDUCTING EFFECTIVE INTERNAL INVESTIGATIONS IN THE PHARMACEUTICAL INDUSTRY
Thomas M. Gallagher, Pepper Hamilton LLP



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