1 / 12

Disclaimer

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

zarek
Télécharger la présentation

Disclaimer

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related