Eighth Annual Pharmaceutical Regulatory and Compliance Congress
Venue: Hyatt Regency Capitol Hill
|Event Date/Time: Nov 07, 2007||End Date/Time: Nov 09, 2007|
The PCF with the help of PricewaterhouseCoopers is undertaking a survey of pharmaceutical compliance practices in the following areas: Medical Affairs and Marketing, Managing a Pharmaceutical Compliance Program, and Drug Safety and Pharmacovigilence. The results of the survey will be presented at the Pharma Congress and discussed by expert panels.
The Pharma Congress will feature a number of unique learning exercises, including the Pharma Congress Hypothetical Compliance Vignettes and Response by Panel of Compliance Experts and the Pharmaceutical Compliance Family Feud-The Game with Real Life Implications for the Nation's Pharmaceutical Manufacturers.
The Pharma Congress will be interactive. In the plenary sessions each attendee will have a Meridia Audience response device with which he or she will be able to vote on questions put by the faculty. The attendee responses will be immediately projected on the session screens.
The Pharma Congress will feature two unique networking reception opportunities. The Wednesday evening opening reception will feature a company Best Auditing, Monitoring and Investigations Policy and Procedure Poster Board and Exchange throughout the Pharma Congress Exhibit Hall. The Thursday evening networking reception will feature an opportunity to meet a number of key federal and state regulators and Capitol Hill staff specializing in pharmaceutical policy.
At the Pharma Congress the PCF will award the First Annual Compliance Best Practice Awards. Categories of the awards in the large and small/medium sectors shall include the following in each sector: Best Practices in Training; Best Practices in Auditing/Monitoring; Best Practices in Communications; and Best Practices Overall.
The Pharma Congress will feature an extraordinary series of keynote speakers.
Who Should Attend
Pharmaceutical and Health Care Executives and Board Members
Health Plan, Health System and Physician Organizations
Purchasers, including Private Employers and Public Purchasers
Generic Pharmaceutical Manufacturers
Site Management Organizations
Clinical Research Organizations
Health Plans and Health Insurers
Wholesale, Retail, Mail Order and Internet Pharmacies
Health Care Attorneys and In-house Counsel
Food and Drug Law Attorneys
Health Care Regulators and Policy Makers
Health Services Researchers and Academics
The Congress Goals and Objectives
To report and analyze the results of the PCF survey of pharmaceutical compliance practices in the following areas: medical affairs and marketing, drug safety and pharmacovigilence, and managing a pharmaceutical compliance program
To utilize a hypothetical case studies and games as a means of assessing pharmaceutical regulatory and compliance risks and sharing best practice responses
To freely exchange company best auditing, monitoring and investigations policies and procedures
To identify and present awards to pharmaceutical companies in large and small/medium sectors as follows: Best Practices in Training; Best Practices in Auditing/Monitoring; Best Practices in Communications; and Best Practices Overall
To provide a forum for leading regulators and qui tam counsel to express views and concerns in order to enhance communication among actors in the compliance field
About the Pharmaceutical Compliance Forum
The Pharmaceutical Compliance Forum (PCF) is a coalition of senior compliance officials and legal counsel from more than 50 of the largest pharmaceutical manufacturers. The PCF was founded in early-1999 by compliance professionals from the pharmaceutical industry to promote effective corporate compliance programs. The organization is open to others in the industry and has more than doubled in membership since its founding. The members meet twice a year, for one to two days, focusing on open and informal sharing of compliance information, best practices, and current developments in the field. For membership information, contact Arjun Rajaratnam, Esq., Vice President and Compliance Officer, Global Pharmaceuticals, GlaxoSmithKline at 919-483-9938 or Arjun.X.Rajaratnam@gsk.com.
PCF Special Planning Committee
Lori Queisser, Vice President and Chief Compliance Officer, Eli Lilly and Company (Co chair)
Arjun Rajaratnam, Vice President and Compliance Officer, Global Pharmaceuticals, GlaxoSmithKline (Co chair)
Brenton L. Saunders, JD, MBA, Senior Vice President, Global Compliance and Business Practices, Schering-Plough Corporation (Co chair)
Bert Weinstein, Esq., Vice President, Corporate Compliance, Purdue Pharma LP (Co chair)
Ted Acosta, Principal, Ernst & Young LLP
John Alivernini, Esq., Vice President and Chief Compliance Officer, Wyeth Pharmaceuticals
David Beardsley, General Manager, Life Sciences, HCPro, Inc.
John T. Bentivoglio, Esq., Partner, King & Spalding LLP
David B. Chandler, Ph.D., DABT, Associate Director of Outcomes and Analysis Corporate Compliance, Amgen
William T. Fitzgerald, Vice President, Global Compliance, Alcon Laboratories
Robert A. Freeman, US Compliance Officer and Compliance Counsel, Serono, Inc.
Wendy C. Goldstein, Esq., Partner, Epstein Becker & Green
Peter N. Grant, JD, Ph.D., President, Health Care Conference Administrators, LLC
Keith M. Korenchuk, JD, MPH, Partner, Covington & Burling LLP
Steve Mohr, Esq., Deputy Compliance Officer, AstraZeneca
Jody Noon, RN, JD, National Leader for the Life Sciences & Health Care Regulatory Practice, Deloitte & Touche LLP
Brian Riewerts, Partner, Global Pharmaceutical Advisory Services Group, PricewaterhouseCoopers LLP
Catherine Sazdanoff, Divisional Vice President, Ethics and Compliance, Abbott Laboratories
Michael Shaw, Deputy Compliance Officer, Novartis Pharmaceuticals Corporation
Paul J. Silver, Managing Director, Life Sciences Leader, Huron Consulting Group
Jonathan K. Sprole, Chief Compliance Officer, Bristol-Myers Squibb Company