ACI’s FDA Boot Camp to Feature a “Who’s Who” of the FDA Regulatory Bar

NEW YORK - Dec. 19, 2014 - PRLog -- The American Conference Institute (ACI) is proud to announce that its industry leading FDA Boot Camp conference is returning to New York City on March 10-11, 2015.  Over the past 10 years, thousands of legal professionals – from Associates to Partners to GCs – have relied on ACI’s FDA Boot Camp to provide them with both a comprehensive overview of the basics of FDA law and current information on the status of regulatory law in the pharmaceutical, biotechnology, and medical device industries.  This year is no exception.

Join this group of domestic and international attendees as they gather in Boston to hone their practice and to hear from a stellar faculty, led by a “who’s who” of the nation’s food and drug lawyers, to help understand

- The application and approval processes for drugs, biologics, and devices
- The regulatory balance between brand name and generic products
- The complexities of the patent and IP landscape, including Hatch-Waxman, - Orange Book, 180-day exclusivity, 30-month stay, Paragraph IV, NDA, ANDA and 505(b)(2)
- The pivotal role of labeling in the drug and biologics approval process
- The importance of cGMPs to the post-approval regulatory process
- Advertising and Promotion, DTC Advertising, & Off-Label
- The protocols of adverse events monitoring, pharmacovigilance, and REMS
- Non-patent exclusivity, bioequivalency, and Follow-On Biologics
- Recalls, product withdrawals, and FDA oversight authorit

Geoffrey Levitt, , Associate General Counsel, Regulatory, Environmental and Global Supply at Pfizer Inc., who is co-chairing and speaking at this year’s conference, explains why FDA Boot Camp has remained such a draw for a decade:

“I’ve been privileged to participate in FDA Boot Camp as a co-chair and faculty member on a number of occasions over the years and I can truly say that this event offers a unique combination of experienced faculty, a comprehensive and up-to-date program, and concise and practical content.  For any practitioner in the FDA space who wants to get a powerful learning boost in a compact package, this is a great program to attend.”

Seth Mailhot, a partner at Michael Best & Friedrich LLP, also co-chairing and speaking this year, agrees:

“ACI’s FDA Boot Camp provides a detailed review of the U.S. Food and Drug Administration for life sciences companies.  Topics are presented by luminaries in the FDA bar who are able to provide real-world experience for attendees.  I strongly recommend the course for anyone new to FDA law."

Other program highlights include special tracks for patent litigators and product liability lawyers.  Save the phone calls to your colleagues or other regulatory counsel for the truly complicated issues; attend ACI’s FDA Boot Camp to boost your regulatory IQ.

To learn more, visit: http://americanconference.com/fdabootcamp

About American Conference Institute
A unique organization, the American Conference Institute is devoted to providing the business intelligence that senior decision-makers need to respond to challenges both here in the US, and around the world.

Staffed by industry specialists, lawyers and other professionals, American Conference Institute operates as a think tank, monitoring trends and developments in all major industry sectors, the law, and public policy, with a view to providing information on the leading edge.