Presentation by Pat Cerundolo, Partner, Foley Hoag LLP

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Code of Conduct - Allows• Provision of peer reviewed academic, scientific or clinical information• Advertising in journals• Drug samples for patients– Omits reference to medical device demonstration or evaluation units• Compensation for professional consulting services in connection with research andclinical trials• Expenses for technical training of a medical device if part of a purchase contract© 2008 2009 Foley Hoag LLP. All Rights Reserved.Presentation Title | 6
II.Compliance Requirement• Requires all PMDMCs that employ marketers to:– Comply with the DPH’s code– Adopt a training program on the code– Conduct annual audits to ensure compliance– Adopt policies and procedures to investigate noncompliance and totake corrective action– Identify a compliance officer– Submit annual reports to the DPH describing• Training program• Investigative policies• Identification of compliance officer• Audit and compliance certification© 2008 2009 Foley Hoag LLP. All Rights Reserved.Presentation Title | 7
Page 1 and 2: MGL c. 111N - Pharmaceutical andMed
Page 3 and 4: Overview• Section 14 of Cost Cont
Page 5: Code of Conduct - Prohibits• Paym
Page 9 and 10: Enforcement• Enforced by the Atto

Presentation by Pat Cerundolo, Partner, Foley Hoag LLP

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