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| What's New |
| In-House and Audioconference Training Seminars |
| FDA increasingly is focusing on the importance of training in reviewing regulated operations. Given tight budgets, the solution to training your staff is to bring the trainer to you! We can reprise any of our topics for your team, either via an in-house training program or via audio conference. For more information, contact training@fdacounsel.com |
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News!
Michael A. Swit named to Expert Advisory Panel for 2012 edition of Barnett
International's treatise, Good Clinical Practice: A Question & Answer Reference Guide.
International's treatise, Good Clinical Practice: A Question & Answer Reference Guide.
Upcoming Presentations
Recent Presentations and Articles
The de novo 510(k) Process -- The Impact of the New 2011 FDA Guidance. FxTranslations
Audio Conference. February 15, 2012.
Biosimilars -- Wave of the Future or Child of The Privileged Few? Licensing Executives
Society San Diego Chapter. February 21, 2012.
How Do You Look in Stripes? FDA Enforcement Today. Joint FDA/Orange County
Regulatory Affairs (OCRA) Annual Conference. June 7, 2012. Irvine, CA.
FDA Enforcement. Pre-conference Tutorial at DIA Annual Conference. June 24, 2012.
Philadelphia.
Leaping the Valley of Death: Keys to Successfully Going From the Lab to the Clinic for
Pharmaceutical Products. Drug Information Association (DIA) Annual Conference, Session
Chair. June 25-28, 2012. Philadelphia.
Audio Conference. February 15, 2012.
Biosimilars -- Wave of the Future or Child of The Privileged Few? Licensing Executives
Society San Diego Chapter. February 21, 2012.
How Do You Look in Stripes? FDA Enforcement Today. Joint FDA/Orange County
Regulatory Affairs (OCRA) Annual Conference. June 7, 2012. Irvine, CA.
FDA Enforcement. Pre-conference Tutorial at DIA Annual Conference. June 24, 2012.
Philadelphia.
Leaping the Valley of Death: Keys to Successfully Going From the Lab to the Clinic for
Pharmaceutical Products. Drug Information Association (DIA) Annual Conference, Session
Chair. June 25-28, 2012. Philadelphia.
Crisis Management for Regulatory Professionals. Regulatory Affairs Professionals Society,
Rising Leaders Program. Audio Conference. December 15, 2011.
FDA Enforcement Activities In Clinical Trials Arena. FxTranslations Audio Conference.
November 3, 2011.
Get to the Clinic on Time. LARTA NIH-CAP Commercialization Workshop, November 1,
2011. Los Angeles.
Rising Leaders Program. Audio Conference. December 15, 2011.
FDA Enforcement Activities In Clinical Trials Arena. FxTranslations Audio Conference.
November 3, 2011.
Get to the Clinic on Time. LARTA NIH-CAP Commercialization Workshop, November 1,
2011. Los Angeles.