MONDAY, 15 SEPTEMBER
Trends in FDA Enforcement
Professional Levels: ll, lll,
1:30 - 3:00 pm | Room 311
It is essential for regulatory strategists to understand the major trends in enforcement by the US Food and Drug Administration (FDA) and the Department of Justice (DOJ).
This panel discussion will explore significant trends in enforcement by FDA and DOJ, including DOJ’s recent emphasis on “off-label” cases brought within the context of the False Claims Act and FDA’s recent renewed interest in more “traditional” enforcement through Warning Letters and Consent Decrees.
Session Leader:
Meredith Manning, JD, attorney, Hogan & Hartson LLP
Speakers:
Deborah M. Autor, JD, director, Office of Compliance, Center for Drug Evaluation and Research, US Food and Drug Administration
Meredith Manning, JD, attorney, Hogan & Hartson LLP
TUESDAY, 16 SEPTEMBER
Risk Communication
Professional Levels: ll, lll, IV
3:30 - 5:00 pm | Level 3 Ballroom
Public perception has a profound impact on an organization’s success. It often plays a key role in determining the resolution of high concern, high stress or emotionally charged issues and is an important factor for regulatory professionals to bear in mind.
This session will inform you about industry and agency perspectives on how messages are communicated and lessons learned from past experiences. You will hear discussion of successful and unsuccessful messages and learn about pitfalls to avoid.
Session Leader:
Meredith Manning, JD, attorney, Hogan & Hartson LLP
Speakers:
Geoffrey M. Levitt, JD, vice president and chief regulatory counsel, Wyeth Pharmaceuticals
Steven F. Osborne, MD, medical officer, office of prescription drugs, Center for Drug Evaluation and Research, US Food and Drug Administration
The Importance of Global Regulatory Strategy
Professional Levels: l, ll, lll
3:30 - 5:00 pm | Room 306
Developing and implementing an effective global regulatory strategy is critical to the success of a product and, ultimately, a company’s long-term success.
This session will provide you with in-house and external perspectives on global regulatory intelligence and tools that outside counsel use to stay abreast of regulatory trends in approvals, advertising, etc. You will explore the importance of monitoring untitled and Warning Letters, Summary Basis of Approvals, etc. You will hear examples of important changes in regulatory standards and learn how some companies have incorporated regulatory intelligence into their decision-making process.
Session Leader:
Sarah J. Powell, RAC, executive director, regulatory strategies, Thomson Reuters
Speaker:
Sarah J. Powell, RAC, executive director, regulatory strategies, Thomson Reuters
WEDNESDAY, 17 SEPTEMBER
Emerging Opportunities/Challenges in Product Lifecycle Management in the US
Professional Levels: ll, lll,
8:30 - 10:00 am | Room 310
Staying apprised of the latest product lifecycle management strategies is critical in today’s competitive market. This session will focus on issues related to the US market.
In this session, you will gain insight on such issues as the US Food and Drug Administration’s frequent denials of orphan designation, the narrow scope of three-year marketing exclusivity as applied to 505(b)(d) products, and changes to pediatric and new chemical entity marketing exclusivity under the Food and Drug Administration Amendments Act of 2007.
Session Leader:
Brian R. McCormick, JD, attorney, Hogan & Hartson LLP
Speakers:
Brian R. McCormick, JD, attorney, Hogan & Hartson LLP
Kenneth W. Peist, senior director, intellectual property, Amicus Therapeutics Inc.
Emerging Opportunities/Challenges in Product Lifecycle Management in Asia and Europe
Professional Levels: ll, lll,
10:30 am - 12:00 pm | Room 310
Staying apprised of the latest product lifecycle management strategies is critical in today’s competitive market. This session will focus on issues related to the Asian and European markets.
In this session, experts will provide you with insights on the re-emergence of over-the-counter and behind-the-counter switches and recent EU guidance on new indication marketing exclusivity among other important developments.
Session Leader:
Brian R. McCormick, JD, attorney, Hogan & Hartson LLP
Speaker:
TBD