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Massachusetts Biotechnology Council Massachusetts Pharmaceutical & Medical Device Marketing Regulations Michael Joachim Senior Corporate Counsel Genzyme Corporation April 9, 2009. Disclaimer. I am speaking on my own behalf today, and not on behalf of Genzyme Corporation. Overview. Approach

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  1. Massachusetts Biotechnology CouncilMassachusetts Pharmaceutical & Medical Device Marketing RegulationsMichael JoachimSenior Corporate CounselGenzyme CorporationApril 9, 2009

  2. Disclaimer • I am speaking on my own behalf today, and not on behalf of Genzyme Corporation.

  3. Overview • Approach • Code • Training • Disclosure

  4. Approach • Proper equipment is essential

  5. Equipment (alternative) • For some audiences . . .

  6. The Perspective from the Field • An Onslaught • Federal law • New PhRMA Code (and New AdvaMed Code) • Other State laws • Institution requirements • AAMC • Registration • Anger, Frustration, Disbelief

  7. General Approach • Acknowledge but be practical • Positive spin • Give context • Consultation

  8. Code/Written Guidance • New Documents • Marketing Code of Conduct • Written Guidance • A Group Project • Include affected business areas • Include management • Keep it Simple • Keep real world interactions in mind • Remember context and audience • No citations, quotes

  9. Training • Written • Oral • In-person • WebEx • Train the trainer • FAQs • Repetition • Be accessible – no question too small

  10. The Importance of Management • Tone at the top • Responsibility for compliance • Train the trainers

  11. Disclosure • Internal understanding • Who • Finance • Regulatory • Business Areas • Legal/Compliance • Disclosing the disclosure

  12. Questions, Comments • My contact information: • michael.joachim@genzyme.com

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