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Culture of Compliance: Cutting Through the Confusion

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Product Description

A few years after the Pharmaceutical Research and Manufacturers of America (PhRMA) code and the Office of the Inspector General (OIG) guidance, and the more recent implications of the Accreditation Council for Continuing Medical Education (ACCME) standards and FDA draft guidances regarding communication with healthcare providers, there is the perception that pharmaceutical companies are still struggling with compliance. But the issue for industry experts at pharmaceutical companies and service suppliers is not about being compliant, but rather the implications and application of the many regulations and guidances that apply to the marketing of their products. To complicate matters, the industry is being pummeled by bad press and increased scrutiny, where critics highlight exceptions in marketing compliance as reasons why the industry is failing in this area.
Experts say to appease critics and prevent further embarrassments, pharmaceutical companies need to go beyond simply following the rules and create a culture of compliance within their organizations to foster and promote an ethical atmosphere that will result in compliant behavior…

Sidebar:
The Many Mandates of Pharmaceutical Marketing

Thought Leaders
Ted Acosta. National Leader, Health Sciences, Investigative and Dispute Services, Ernst & Young, New York; Ernst & Young is a global professional services organization that helps companies deal with a broad range of business issues, including audit and risk-related services, tax, and transactions. For more information, visit ey.com.
Sherry Corson. Compliance Officer, Solvay Pharmaceuticals Inc., Marietta, Ga.; Solvay, a unit of Solvay SA, Brussels, Belgium, is a research-driven pharmaceutical company that seeks to fulfill unmet medical needs in the therapeutic areas of cardiology, gastroenterology, mental health, women’s health, and a select group of specialized markets, including men’s health. For more information, visit solvaypharmaceuticals-us.com.
Tracy Doyle. President and CEO, Phoenix Group Holdings, Warren, N.J.; Phoenix Group Holdings consists of two full-service medical-education companies: Phoenix Marketing Solutions, which specializes in the development and execution of promotional medical-education tactics and strategies, and DiMedix, which specializes in the development and execution of continuing education programs and enduring materials. For more information, visit phoenixmsolutions.com.
Robert Freeman. U.S. Compliance Officer and Compliance Counsel, Serono Inc., Rockland, Mass.; Serono, with global headquarters in Geneva, is a biotechnology leader focused on reproductive health, neurology, metabolism, growth, and psoriasis. For more information, visit seronousa.com.
John Kamp. Executive Director, Coalition for Healthcare Communication, New York; the Coalition for Healthcare Communication defends the right of health professionals and consumers to receive truthful information regarding pharmaceuticals and medical products. For more information, visit cohealthcom.org.
Rich Levy. Chief Operating Officer, Ferguson, Parsippany, N.J.; Ferguson is the founding professional advertising and promotion unit of CommonHealth. For more information, visit commonhealth.com.
Paul Nash. Group Publisher, HCPro Inc., Marblehead, Mass.; HCPro is a provider of integrated information, education, training, and consulting products and services in the vital areas of healthcare regulation and compliance. For more information, visit hcpro.com.
Jody Noon. National Practice Leader for the Life Sciences and Health Care Regulatory Practice, Deloitte & Touche LLP, New York; Deloitte is an organization of member firms around the world providing professional services and advice, focused on client service through a global strategy executed locally in 150 countries. For more information, visit deloitte.com.
Peter Pitts. Senior VP, Health Affairs, Manning Selvage & Lee Inc., New York; MS&L is a global public relations firm and a member of Publicis Groupe SA. For more information, visit mslpr.com. (Mr. Pitts also is a Senior Fellow, Healthcare Studies, at the Pacific Research Institute and is the former Associate Commissioner for External Relations at the FDA.)
Brent Saunders. Senior VP, Global Compliance and Business Practices, Schering-Plough Corp., Kenilworth, N.J.; Schering-Plough is a global science-based healthcare company with leading prescription, consumer, and animal health products. For more information, visit schering-plough.com.
Catherine Sazdanoff. Divisional VP, Ethics and Compliance, Abbott, Abbott Park, Ill.; Abbott is a global, broad-based healthcare company devoted to the discovery, development, manufacture, and marketing of pharmaceuticals and medical products, including nutritionals, devices, and diagnostics. For more information, visit abbott.com.
Lawrence Sherman. Executive VP, Jobson Education Group, New York; Jobson Education Group is comprised of five education and marketing services companies. For more information, visit jobson.com. (Mr. Sherman also is Executive VP, Postgraduate Institute for Medicine/Jobson Education Group.)
José A. Tabuena, J.D., CFE, CHC. Manager, KPMG Forensic, KPMG LLP, Dallas; KPMG is a global network of professional services firms providing audit, tax, and advisory services. For more information, visit kpmg.com. (As this issue went to press, Mr. Tabuena is now Manager at Deloitte & Touche LLP.)

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