Foley Hoag LLP

WHEN

September 22 7:30 AM - September 23, 2008 5:00 PM

WHERE

Sheraton Boston Hotel
Prudential Center
39 Dalton Street
Boston, MA 02199

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SUMMARY

ACI’s FDA Boot Camp has been designed to give products or patent litigators, as well as patent prosecutors and life sciences investment and securities experts, a strong working knowledge of core FDA regulatory competencies, including the nuances of FDAAA.

A distinguished faculty of top FDA regulatory experts — a “Who’s Who of the FDA Bar” — will share their knowledge and give you critical insights on:

• The organization, jurisdiction, functions, and operations of the FDA
• The essentials of the approval process for drugs, biologics, and devices, including:
• NDAs
• INDs
• BLAs
• OTC approval
• 510 K submissions
• PMA process
• Clinical trials for drugs and biologics and the clearance process for devices
• The classification of devices and the concept of “risk-based” classification
• The role of the Hatch-Waxman Act in the patenting of drugs and biologics
• Labeling in the drug and biological products approval process
• cGMPs and other manufacturing concerns relative to products liability
• Proactive adverse events monitoring
• Recalls, product withdrawals, and FDA oversight authority

WHEN

September 22 12:00 PM - September 24, 2008 12:00 PM

WHERE

The Latham Hotel Georgetown
3000 M Street, NW
Washington, DC 20007

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SUMMARY

Now in its 4th successful year, the American Conference Institute’s Advanced Forum on Import Compliance, is the event that import compliance professionals rely on for comprehensive, insightful and practical guidance on how to set up a successful import compliance program. Benefit from the practical perspective of senior corporate customs compliance executives including Del Monte, Hasbro, IBM, Raytheon, Hitachi, General Electric, Nestle, Target, Tyco International, and Williams-Sonoma. Get an update on 10+2, ACE, ISA, C-TPAT validations and import safety standards, and hear from top CBP representatives on enforcement priorities.

Foley Hoag Partner Jayne Bultena will lead a presentation titled "Fundamentals of FDA Compliance: What You Need to Know When Importing Food, Drugs and Devices."

WHEN

September 23 7:30 AM - September 24, 2008 2:45 PM

WHERE

Radisson Hotel Boston
200 Stuart Street
Boston, MA 02116

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SUMMARY

American Conference Institute’s 10th National Conference on Managing Legal Risks in Structuring & Conducting Clinical Trials is the one place that industry professionals can come to resolve these and other pressing concerns. At a time when the pressure on and outcry against the industry have never been greater and negative reports continue to flood the media, this is the only event that will allow you to respond to the increased demand for more transparency in the clinical research process from every angle: legislation, regulation, compliance, and litigation. Its front-line faculty includes experts from sponsors, CROs, hospitals and academic research institutions, as well as expert attorneys and current and former government enforcers.

WHEN

September 25 8:00 AM - September 26, 2008 3:30 PM

WHERE

Radisson Hotel Boston
200 Stuart Street
Boston, MA 02116

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SUMMARY

With clinical trials undertaken by U.S. pharmaceutical and biotech companies increasingly being designed as international in scope, it is critical for sponsors to overcome the key legal and regulatory obstacles inherent in conducting such trials. The international variability in legal frameworks for recruiting, reimbursements, data privacy, and human subject protection has made drafting international CTAs and negotiating informed consent documents a constant struggle. And with indemnity requirements, IP protections, and publication rights varying by country and region, boilerplate contractual provisions must be carefully adapted to reflect specific concerns relating to the sites being utilized.

In addition, as acceptable payment practices differ in some countries, it is essential that companies be aware of how the Foreign Corrupt Practices Act relates to the practical issues that commonly arise during the course of clinical trials overseas. And there are important ways that companies can anticipate and manage their litigation risks, but first they must understand the applicable liability theories and who may have standing to sue. The globalization of clinical research, combined with Congress’ growing interest in clinical trial results and the FDA’s new rules for foreign clinical studies used in drug approval applications, have raised the bar for companies that operate overseas. It is far more than a question of overcoming language barriers.

In response, once again American Conference Institute, the creator of the ten-time Clinical Trials conference, presents its global companion: 3rd National Legal and Regulatory Forum on Conducting International Clinical Trials. This one-of-a-kind event will provide those charged with managing legal and regulatory risks in conducting international trials with practical and sophisticated strategies, on a region-by-region and country-by-country basis, on producing meaningful and reliable data for marketing approval and protecting the rights of those who participate as subjects. The distinguished faculty includes legal and compliance experts, inside and outside the U.S., from sponsors, CROs, hospitals and research institutions, as well as expert attorneys.

WHEN

October 19 6:00 PM - October 22, 2008 12:30 PM

WHERE

Washington State Convention & Trade Center
800 Convention Place
Seattle, WA 98101

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SUMMARY

Foley Hoag is a proud Gold Sponsor of the ACC's 2008 Annual Meeting. Visit our booth on the exhibition floor, and attend sessions featuring Foley Hoag lawyers.

• Session 113: In-house Counsel as Circus Ringmaster, on Monday, October 20 from 11:00 a.m.-12:30 p.m. Michael Keating from Foley Hoag will join this panel in the Global/International Legal Affairs program track.
• Session 202: The Tricks & Traps of Corporate Intrapreneurship & Entrepreneurial Investment: Getting the Most Out of a New Business, on Monday, October 20 from 2:30-4:00 p.m. This program will be moderated by Foley Hoag Partner Peter Rosenblum and will be presented as part of the Small Law Department track. 

Stay tuned to this page for more information on what Foley Hoag has planned for ACC's 2008 Annual Meeting.