Marketing your pharmaceutical product or medical device while adhering to ever-changing state and federal laws can pose a signifcant challenge. For example, on March 11, 2009 the Massachusetts Department of Public Health issued requirements similar to those of other states, imposing restrictions on pharmaceutical and medical device manufacturers’ sales and marketing activities. This session looks at current state laws regulating the sales and marketing practices of pharmaceutical, biotech and medical device companies, with a particular emphasis on the new requirements in Massachusetts and Vermont.

In this conference, our speaker examines the federal legislation that regulates pharmaceutical and medical device sales and marketing, while also providing insight into how companies can develop compliance plans to take into account the "patchwork" of state laws, applicable federal laws and industry guidance.

This audio conference covers:

• State laws that affect your business
• Reporting requirements of these laws
• Developing a compliance plan that takes state laws into account
• How to track information that you are required to report
• Overview of the new "toughest in country" laws

About the speaker:

Maria D. Buckley is Of Counsel and a member of the Healthcare and Life Sciences practice groups with the Boston-based law firm Nutter McClennen & Fish. Maria has an extensive background in healthcare law, health insurance and managed care, with particular emphasis on contracts, reimbursement, and regulatory interpretation and compliance. Her clients have included hospitals, physician practices, ancillary services providers, HMOs and medical device, pharmaceutical and biotech companies.

Maria helps companies, institutions and investigators document the clinical trials process. She also regularly provides compliance advice and training with respect to pharmaceutical sales and marketing activities, and frequently speaks on various healthcare and research issues. She has been active in providing pro bono legal service and is a recipient of the Massachusetts Bar Association's Pro Bono for Law Firms Award. Maria received a J.D. degree from Suffolk University Law School and a B.S. from Boston University. She is an active member of the Health Law Section of the Boston Bar Association.

Who should attend?

• Attorneys
• Marketing Managers/Representatives
• Sales Managers/Representatives
• Medical Affairs Directors & Associates
• Communications Managers