Why Attend?

Preliminary Agenda
CLE

Join key government regulators and industry experts to explore current issues and trends surrounding Title I – the Compounding Quality Act – of the Drug Quality and Security Act (DQSA). Title I has had a significant impact on pharmaceutical products compounded by outsourcing facilities and traditional pharmacies. This conference will discuss FDA’s compounding policy priorities, including state licensing issues, recent guidance documents on bulk substances, FDA’s Memorandum of Understanding with states, compounding by hospitals, and related enforcement actions and litigation.

Keynote Speaker: Frances (Gail) Bormel, Associate Director for Compounding, CDER, FDA

Register

Industry & Firms

$699
  • +$300 for non-members

Non-Profit

$599
  • +$100 for non-members

Government

$599
  • +$100 for non-members

Academic

$599
  • +$100 for non-members

Student

$99
  • full-time students only
Coming Soon

 

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Sponsors

Sponsorship opportunities are available. Please let us know if you would like more information.

Planning Committee

Chair

Rachael Pontikes, Partner, Reed Smith LLP

Committee Members 

AJ Day, Director of Clinical Services, Professional Compounding Centers of America
Julie Dohm, of Counsel, Covington & Burling LLP
Andrew Harrison, Attorney, Hall, Render, Killian, Heath & Lyman, PC
Karla L. Palmer, Director, Hyman, Phelps & McNamara, PC
Lee Rosebush, Chairman, Outsourcing Facilities Association and Partner, BakerHostetler
Eli Tomar, Counsel, Akin Gump Strauss Hauer & Feld LLP