The FDA in a Post-Gottlieb World
Gottlieb’s Accomplishments, New Policies — and a Look Ahead

Wednesday, May 22, 2019 · 1:30 p.m. - 3:00 p.m. EDT

The FDA’s leadership is changing and it’s time to take a look at what’s ahead for you.

Join us for a detailed analysis about whether the changes and reforms advanced in the past two years will remain and whether it will affect your product development and approval applications.

Webinar Takeaways:

  • Policy decisions on generic drug approvals
  • Reorganization of the Office of New Drugs
  • Changes in orphan drug policy
  • New initiatives dealing with the effort to reduce drug prices
  • Further changes in FDA’s policies on advertising and promotion regulation
  • Changes in FDA standards for clinical trials

Gain an expert perspective on the Gottlieb years, the key issues addressed, regulations and guidances issued, and the way that these issues will be handled in the future. Join us by registering today.

Who Will Benefit

  • Regulatory professionals
  • Quality assurance professionals
  • FDA Attorneys
  • Marketing Executives

Webinar plus USB Audio Recording/Transcript
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$487

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Webinar only
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$287

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24/7 Encore plus USB Audio Recording/Transcript
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$487

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24/7 Encore Presentation
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$287

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USB Audio Recording/Transcript
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$287

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Meet Your Presenters

Wayne L. Pines

President
Health Care, APCO Worldwide

Wayne Pines provides strategic counsel to clients facing crises or media, legislative, regulatory or marketing challenges. Mr. Pines has worked on health care and regulatory issues; litigation; product approvals; advertising issues; recalls; and congressional issues involving the regulation of pharmaceuticals, medical devices and food. Mr. Pines served 10 years in senior positions at the FDA. He was FDA’s chief of consumer education and information, chief of press relations and associate commissioner for public affairs. He was the chief media spokesman for the FDA for seven years and was the founding editor of FDA consumer magazine.

Kevin Madagan

Partner
Reed Smith, LLP

Kevin Madigan is a health care and FDA regulatory attorney and member of the Life Sciences Health Industry Group. He advises clients across the life sciences and health care spectrum about health care and FDA regulatory issues related to the manufacturing, distribution, and sale of drugs (Rx, OTC, homeopathic), biologics, devices (Rx and OTC), and dietary supplements. His clients include suppliers, manufacturers; repackagers; wholesale and private label distributors; pharmacies (503A, 503B, nuclear); and health care providers.

Kalah Auchincloss, J.D., M.P.H.

Senior Vice President, Regulatory Compliance and Deputy General Counsel
Greenleaf Health

Kalah has more than a decade of food and drug legal, policy, and regulatory experience at the FDA, on Capitol Hill, and in the private sector. Kalah spent six years at FDA, most recently, as Deputy Chief of Staff for two FDA Commissioners: Dr. Robert Califf and Dr. Scott Gottlieb. As Deputy Chief of Staff, Kalah worked with senior FDA leadership to manage crises, develop policy decisions, implement communications strategies, and liaise with the Department of Health and Human Services, the White House, and other agencies. Kalah was also a primary point of contact in the immediate Office of the Commissioner for the six FDA Centers and other components of the Commissioner’s Office. Prior to that role, Kalah spent time on Capitol Hill as the FDA detailee to the Senate Committee on Health, Education, Labor, and Pensions, working on the 21st Century Cures Act and other FDA-related legislation. She has also served in FDA’s Center for Drug Evaluation and Research (CDER) as a regulatory counsel in the Office of Regulatory Policy, and as Director of CDER’s Office of Unapproved Drugs and Labeling Compliance in the Office of Compliance, leading a team of more than 50 staff working on pharmacy compounding, unapproved drugs, over-the-counter drugs, and other enforcement issues. Before joining FDA, Kalah was an associate at the law firm Foley Hoag LLP, in the firm’s health care practice group. Kalah holds a B.A. with honors from Williams College, a J.D. with honors from Georgetown University Law Center, and an M.P.H. from Harvard University.

 

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