April 12-13 Conference on Commercial Compliance for Pharmaceutical and Medical Device Companies

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Event will focus on assessing the status of state and federal regulations and implementing a top-down culture of compliance.

marcus evans

marcus evans

meet with industry peers to discuss government trending towards individual responsibility, increased onus on the manufacturer to prevent product abuse, and meeting the upcoming disclosure requirements of the Sunshine Act.

In Washington, DC, April 12-13, 2010, event production company marcus evans will host the Conference on Commercial Compliance for Pharmaceutical and Medical Device Companies.

At this anticipated marcus evans event, more than 14 industry compliance leaders, in addition to key representatives from the Department of Justice and United States Senate Committee on Finance, will give insights on how to assess current state and federal regulations and implement a comprehensive plan to ensure compliance with those regulations by pharmaceutical and medical device companies. The goal is for these companies to implement a culture of compliance that is line with new health care regulations, which will include meeting the requirements of the Physician Payments Sunshine Act.

The Physician Payments Sunshine Act requires drug, biologic, and medical device manufacturers to report certain gifts and payments ("transfers of value") made to physicians. The information will be registered in a national and publicly accessible online database. Companies failing to report will incur financial penalties. All entities (and their subsidiaries and affiliates) that produce, prepare, propagate, compound, convert, process, market, or distribute drugs, devices, or medical supplies covered under Medicare, Medicaid, or SCHIP are required to disclose payments to all covered recipients including: compensation; food, entertainment or gifts; travel; consulting fees or honoraria; funding for research; funding for education; stocks or stock options; ownership or investment interest, and so on.

At April's Compliance Conference in Washington, practical, transferable insights will be provided by industry leaders on their approach to meeting upcoming disclosure requirements of the Sunshine Act including tactics to utilize best practices to protect themselves against Off-Label and FCPA prosecution, ensure compliance when using social media, and incorporate speaker programs.

For interview materials with keynote speaker Daniel Garen, Chief Compliance Officer and Senior Counsel at Siemens Healthcare Sector, you can check out following podcasts on the website.

Other key speakers of the event will include Kirk Ogrosky - Deputy Chief for Health Care Fraud, Fraud Section, Criminal Division, United States Department of Justice; Mark J. Wanda - SVP Legal Affairs and Deputy General Counsel, Sepracor Inc.; Kevin Espinoza - Global Compliance Officer, Stiefel, A GSK Company; Christopher Armstrong - Investigative Counsel, US Senate Committee on Finance; and Kris Curry -Sr. Director, Health Care Compliance Operations Pharmaceuticals Group, Johnson & Johnson PRD, LLC.

Key topics & features of the event will include:

  • Johnson & Johnson on Collaborating With Your Internal Functions to Implement Cost-effective Aggregate Spend Reporting
  • The DOJ on Analyzing Recent Trends in FCPA Prosecution to Protect Your Company from Litigation
  • Glaxo Smith Kline on Determining the correct level of transparency in the payment and R&D areas
  • Sepracor on Avoiding Off-Label Promotion Prosecution and Retaining Profit
  • Sanofi-Aventis on Insight into Changing State Regulations
  • Implementing proactive monitoring in all areas of your commercial compliance
  • Preparing for the Implications of the Immenent Sunshine Act
  • Securing a Handle on Aggregate Spend Reporting and Disclosure
  • Best Practices for Implementing a Seamless Global Compliance Program

According to the marcus evans website, this event will be the ideal opportunity to "meet with industry peers to discuss government trending towards individual responsibility, increased onus on the manufacturer to prevent product abuse, and meeting the upcoming disclosure requirements of the Sunshine Act," as well as to "ensure your organization has the necessary controls and monitoring in place to protect against Off-label and FCPA prosecution."

Event attendees can join the Commercial Compliance for Pharmaceutical and Medical Device Companies LinkedIn Group to start networking with other industry leaders before and after the conference.

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Michele Westergaard
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