Life Sciences Strategies for Anti-Corruption & FCPA Compliance 23-24 June Washington, DC

The National Law Review is  a proud media sponsor of the upcoming Life Sciences Strategies for Anti-Corruption & FCPA Compliance – which addresses  the Unique Challenges and Risk Areas Tied to FCPA and Corruption Faced by the Pharmaceuticals, Medical Device and Biotechnology Companies  

Pharmaceutical and medical device companies operating overseas are particularly vulnerable to FCPA violations because of the nature of public health systems in many foreign countries where health care systems are owned and operated by the government. Given the fact that employees are in constant contact with the health care providers at different touch points within the organization, there is a need to ensure all interactions are monitored and effective policies are in place to curb any potential violations.

Gain insights on how to deal with issues stemming from gifts and entertainment of government officials to develop effective training programs and best practices in operating in emerging countries as well as dealing with 3rd parties.

With a one-track focus, the Life Sciences Strategies for Anti-Corruption & FCPA Compliance Conference is a highly intensive, content-driven event that includes case studies, presentations and panel discussions over two full days. This conference targets industry leaders from the pharmaceutical, medical device and biotechnology and clinical research organizations in order to provide an intimate atmosphere for both the delegates and speakers.

key conference topics include:

  • Analyze the key provisions of the UK Bribery Bill and the impact on life sciences industries by Abbott Laboratories
  • Identify practical strategies to develop effective global anti-corruption compliance program from CareFusion
  • Assess the challenges of conducting and implementing effective global traning programs by Medtronic, Inc.
  • Develop robust internal controls for 3rd party due-diligence by Talecris Biotherapeutics, Inc.
  • Address FCPA and corruption risk stemming from sales and marketing activities and interaction from Covidien
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    key conference features include:

  • Expert Case Studies and Presentations by Industry Leading FCPA & Anti-Corruption Professionals
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  • Illuminating Roundtable Discussions Led by St. Jude Medical (June 23rd) and Johnson & Johnson (June 24th)
  • Earn up to 16 hours of CLE Credits
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    for more details and to register:


    The "Safer Products" Database: Reports of Harm Made Public on March 11, 2011

    Posted last week at the National Law Review by Mary C. Turke of Michael Best & Friedrich LLP – updated information on the U.S. Consumer Product Safety Commission’s Publicly Available Consumer Product Safety Information Database which is set to officially launch March 11, 2011: 

    The U.S. Consumer Product Safety Commission’s Publicly Available Consumer Product Safety Information Database (the “Database”) (found atwww.saferproducts.gov) will be launched officially on March 11, 2011. Mandated by the Consumer Product Safety Improvement Act of 2008 (the “Act”), the Database includes a new mechanism for consumers to report harm, or merely a risk of harm, involving consumer products (excluding food and drugs). The Database makes qualified reports of harm available to the public, in an online, searchable format. Prior to publication of any report, the Commission will allow manufacturers to comment and/or challenge reports containing materially inaccurate or confidential information. In certain cases, manufacturers’ comments may be published as well. Previously, reports of harm and responsive comments were not available to the public unless published in a Commission report or obtained through a Freedom of Information Act request.

    The Database is currently in “soft-launch” i.e., the Commission and stakeholders are testing the new reporting and response system with the knowledge that until March 11, 2011, nothing will be made publicly available in the Database. Indeed, consumer reports are being accepted through the website and any report meeting minimum requirements for publication are transmitted to registered manufacturers, importers and private labelers. These companies are able to provide comments online and challenge reports as containing inaccurate or confidential information.

    This practice time is valuable, particularly because the faster a company is able to respond to a negative consumer report, the better. Companies should use the soft-launch to establish protocols for dealing with reports of harm involving their products, including designating persons within the company to be notified of reports via email and identifying the single account holder who is allowed to submit comments. The Act does not require that reports be based on first-hand knowledge or that they be made within a certain time following the alleged harm. Thus, companies should carefully review all reports in which they are named and consider monitoring reports in the Database by industry — where no manufacturer is named. Perhaps most importantly, companies should develop procedures for responding to reports that contain materially inaccurate or confidential information. The Act requires that any request to remove information from a report be “timely” and accompanied by a certification to defend the Commission if the removal is later challenged. Thus, companies must be prepared to act quickly and accurately in responding to reports of harm. Practice and preparation during soft-launch will help in that endeavor.

    To succeed in an increasingly competitive business environment, manufacturing companies need to seize every available advantage. Whether negotiating a contract, moving an idea through the patent process or dealing with customers, getting your manufactured products to market requires expertly-coordinated efforts. Any delay can have a significant impact on your business. 

    © MICHAEL BEST & FRIEDRICH LLP

    FDA Commissioner Margaret Hamburg Key Note Speaker NYSBA Annual Meeting Food, Drug & Cosmetic Law Section Lunch Jan 27th

    The National Law Review would like to you know that the New York State Bar Association Food, Drug & Cosmetic Law Section is featuring FDA Commissioner Margaret Hamburg MD as their luncheon keynote speaker on Thursday January 27th as part of the NYSBA’s Annual Meeting being held at the Hilton New York in New York City from Jan 24th-29th. The lunch will be held on Thursday January 27th in the Trianon Ballroom on the 2nd floor. For Tickets and More Information, Please Click Here