FDLI

FDLI's 55th Annual Conference, the largest and longest-running legal conference for regulated industry was held on April 24-25, 2012. 

FDLI covered legal, regulatory, policy and economic issues spanning the gamut of the Food and Drug Administration's (FDA) authority, by bringing together experts from industry, Congress, and federal agencies. FDLI's Annual Conference provided a valuable educational opportunity to discuss and debate emerging issues.

Commissioner Margaret Hamburg kicked-off this year's program, followed by addresses from FDA Deputy Commissioners: Deborah Autor, Stephen Spielberg and Michael Taylor. Additionally, leadership from FDA's six product centers offered insight into their 2012 priorities and strategic plans. Concurrent breakout sessions offered attendees the opportunity to interact with industry leaders and delve into specific cutting-edge issues. In light of the election season, FDLI's Annual Conference covered the most important political, social and economic issues important to FDA-regulated industry.

Click here to view conference presentations and to purchase audio presentations.

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Why this is a Must-Attend Event Year-After-Year

• Hear Directly from FDA Leadership, Past and Present: Commissioner Hamburg, Deputy Commissioners, Product Center Directors, Chief Counsel and Former Chief Counsels
• Advance Your Career: FDLI's Annual Conference is the Largest Networking Opportunity for Food and Drug Law Professionals
• Network: Interact Shoulder-to-Shoulder with FDA Staff; in addition to Hundreds of other Professionals in the Food and Drug Law Community
• Engage in Hot Topic Sessions: Regulatory Science; Global Developments and Emerging Markets; Economic, Legal and Regulatory Challenges of Innovation; Social Media and Mobile Apps

Conference Article Recaps

Reproduced with permission from Life Sciences Law & Industry Report, 6 LSLR 524 (May 6, 2012). Copyright 2012 by The Bureau of National Affairs, Inc. (800-372-1033) <http://www.bna.com>

Regulatory Policy- CBER Importance Boosted With Attention To Biologic Drugs, Biosimilars, Speakers Say

Reproduced with permission from Life Sciences Law & Industry Report, 6 LSLR 525 (May 6, 2012). Copyright 2012 by The Bureau of National Affairs, Inc. (800-372-1033) <http://www.bna.com> 

Regulatory Policy- Top Priorities of Drug Office Include User Fees, Globalization, FDA Official Says

Reproduced with permission from Life Sciences Law & Industry Report, 6 LSLR 526 (May 6, 2012). Copyright 2012 by The Bureau of National Affairs Inc. (800-372-1033) <http://www.bna.com>

Litigation- Attorneys, Legal Experts Discuss Key Cases Affecting FDA-Regulated Industries in 2012

Reproduced with permission from Life Sciences Law & Industry Report, 6 LSLR 526 (May 6, 2012). Copyright 2012 by The Bureau of National Affairs, Inc. (800-372-1033) <http://www.bna.com>

Manufacturing Practices- FDA Inspections in Global Marketplace Need to Be Done Differently, Official Says

Reproduced with permission from Life Sciences Law & Industry Report, 6 LSLR 527 (May 6, 2012). Copyright 2012 by The Bureau of National Affairs, Inc. (800-372-1033) <http://www.bna.com>

IPQ International Pharmaceutical Quality

May 15, 2012

Former FDA Chief Counsels Examine the Shifting Sands of FDA Enforcement Policy