CHI Announces Regulatory Approval of a Therapeutic & Companion Diagnostic: Nuts & Bolts Short Course

Jan. 3, 2013 - PRLog -- NEEDHAM, MASS. – Cambridge Healthtech Institute releases full details for its Regulatory Approval of a Therapeutic & Companion Diagnostic: Nuts & Bolts Short Course, which will take place on February 12, 2013 from 1:30-4:30 P.M. at the Moscone North Convention Center in San Francisco, CA.  This course will cover important topics related to regulatory compliance in companion diagnostics such as US requirements and processes, US government oversight of diagnostics, diagnostic clearance and approval pathways, co-development process & timelines, integration of Rx and Dx development plans, navigating the development process, co-development examples and lessons learned, approval path for devices ex-US and more.

Featured Speakers Include:

• Maham Ansari, MS, RAC, Senior Associate, Regulatory Affairs, Strategic Regulatory Services, OptumInsight, Inc. (UnitedHealth Group)
• Pamela L. Swatkowski, Director, Regulatory Affairs, Abbott Molecular, Inc.

Advance registration discounts are available until January 11, 2013. To view the entire conference agenda and to register, please visit http://www.triconference.com/clinical.

To inquire about sponsoring and/or exhibiting, contact Jon Stroup at 781-972-5483 or jstroup@healthtech.com, or Joseph Vacca at 781-972-5431 or jvacca@healthtech.com.

Writers and editors are encouraged to attend. To request a press pass, contact Lisa Scimemi at lscimemi@healthtech.com.


About Cambridge Healthtech Institute (www.healthtech.com)

Cambridge Healthtech Institute (CHI) is the preeminent life science network for leading researchers and business experts from top pharmaceutical, biotech and academic organizations. CHI’s portfolio of products includes Cambridge Healthtech Institute Conferences, Insight Pharma Reports, Cambridge Marketing Consultants, Barnett Educational Services, Cambridge Meeting Planners and Cambridge Healthtech Media Group.

Founded in 1992, Cambridge Healthtech Institute strives to develop quality information sources that provide valuable new insights and competing points of view while offering balanced coverage of the latest developments. Basic research related to commercial implications is covered, with heavy emphasis placed on end-user insights into new products and technology as well as coverage on the strategy behind the business.


About Molecular Med Tri-Conference 2013 (www.triconference.com)

The 20th International Molecular Med Tri-Conference is the leading drug discovery research event covering a broad spectrum of cutting-edge topics within molecular medicine with scientific, business and regulatory viewpoints. Join over 3,000 of your colleagues in interactive lectures, discussions, and various networking receptions to hear differing views and perspectives on poignant issues facing you and our industry today. Spanning five days, the Tri-Conference includes 5 Concurrent Symposia, the Emerging Molecular Diagnostics Partnering Forum, 15 Afternoon & Dinner Short Courses and 15 Conference Programs.

Contact:
Laura Norton
Cambridge Healthtech Institute
lnorton@healthtech.com