Medical Device Communiqué: Q3 – 2009

Leaders in Life Science Learning Program Deemed a Success

This summer, we launched a new program called Leaders in Life Science Learning (LLL), a six-city road trip focused on best practices in compliance and quality training for pharma, biotech and device companies. The goal is to create a community of professionals that will share their best-in-class practices on implementing optimal quality and compliance programs with industry peers.

The LLL program began with an event in New Jersey and Boston, but continues in Chicago, Seattle and Northern California, finishing with another New Jersey event. Get more details and register for upcoming programs!

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Identify the Key Compliance Learning Issues Being Addressed by Leading Life Science Companies in 2009

We invite you to download a new whitepaper from Kaplan EduNeeering, in which we examined the usage trends of ComplianceWire, our web-based learning management system for FDA-regulated companies.

With more than 100 life science clients and over three million training assignments completed thus far in 2009, we believe these usage statistics identify activities that life science companies are addressing.

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Arriving next month: Basics of Massachusetts State Code Course

The Massachusetts Department of Public Health promulgated the Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Regulation in order to:

  • Promote cost containment, transparency, and efficiency in the delivery of quality health care
  • Benefit patients
  • Enhance the practice of medicine
  • Ensure that the relationship between pharmaceutical or medical device manufacturers and health care practitioners does not interfere with the independent judgment of health care practitioners

Although the regulation has similar provisions to the recently revised AdvaMed and PhRMA Codes of Ethics, it imposes a number of additional restrictions on pharmaceutical and medical device manufacturing companies' (including distributors') interactions with health care practitioners.

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