The Massachusetts Pharmaceutical and Medical Device Marketing and Disclosure Regulations
Implementing Effective Compliance Programs and Surviving Enforcement
WHEN
- April 16, 2009 7:30 AM - 10:00 AM
WHERE
- Emerging Enterprise Center at Foley Hoag
- Bay Colony Corporate Center, North Entrance
- 1000 Winter Street - Suite 4000
- Waltham, MA 02451
- Map
DESCRIPTION
Event presented by Foley Hoag LLP in partnership with:
The Department of Public Health has recently promulgated final regulations on Pharmaceutical and Medical Device Manufacturer Conduct, 105 CMR 970.000. Biotechnology and medical device companies will need to comply by July 1, 2009 and beyond, or face enforcement actions by the Massachusetts Attorney General, the DA or the DPH. At this breakfast program, experienced Foley Hoag attorneys and industry executives will provide valuable insight into key issues facing the industry as it turns to compliance and avoiding, or surviving, possible investigations and enforcement actions. Interested attendees should include general and compliance counsel and executives.
Topics will include:
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The Statute and Regulations; Anticipated Targets of Enforcement
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How to Create and Implement an Effective Compliance Plan
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Enforcement Tools and Tactics of the Attorney General
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What To Do If You Uncover a Violation at Your Company
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How to Respond to an AG Enforcement Action: Fight or Submit
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Cooperation among State AGOs: Multistate Investigations
A panel discussion will follow the presentation.
Speakers and Panelists:
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Michele Adelman, Counsel, Foley Hoag LLP
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Roger W. Louis, Senior Vice President, Healthcare and Regulatory Counsel, and Chief Compliance Officer, Genzyme
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Dean Richlin, Partner, Foley Hoag LLP
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Colin Zick, Partner, Foley Hoag LLP
Moderator: Pat Cerundolo, Partner, Foley Hoag LLP