Why Attend

Preliminary Agenda

CLE

9:15 – 9:20 AM
Welcome and Opening Remarks 
Laura Brown, Director, Educational Programs, Food and Drug Law Institute
Rachael Pontikes, Partner, Reed Smith LLP and Chair, DQSA – Updates in Compounding Conference

9:20 – 10:00 AM
Keynote Address – Title I (Compounding Quality Act) Implementation – Pharmacy Compounding in 2020
Frances (Gail) Bormel, Associate Director for Compounding, CDER, FDA 

10:00 – 10:15 AM
Break 

Clay Alspach, Principal, Leavitt Partners, LLC
Gina Besteman, Director of Compounding and Dispensing, Women’s International Pharmacy/Pet Health Pharmacy
Julie Dohm, Of Counsel, Covington & Burling LLP

J. Andrew Harrison, Attorney, Hall, Render, Killian, Heath & Lyman, P.C
Gregg Jones, Compliance Senior Manager, National Association of Boards of Pharmacy (NABP)
Caroline D. Juran, Executive Director, Virginia Board of Pharmacy

12:00 – 1:00 PM
Lunch Break

A.J. Day, Vice President of Clinical Services, Professional Compounding Centers of America (PCCA)
Michael Koch, Senior Vice President, Professional Services, Central Admixture Pharmacy Services, Inc.
Karla L. Palmer, Director, Hyman, Phelps & McNamara, PC

2:00 – 2:15 PM
Break

2:15–3:45 PM
What to Watch in 2020: Recent and Upcoming FDA Guidance and Actions

Lee Rosebush, Partner, BakerHostetlerv

Caryn Belisle, Director of Pharmacy Regulatory Compliance, Quality, and Safety, Brigham & Women’s Hospital
Jillanne Schulte-Wall, Senior Director, Health and Regulatory Policy, American Society of Health-System Pharmacists (ASHP)
Moderated by Eli Tomar, Counsel, Akin Gump Strauss Hauer & Feld LLP

Matt Martin, Clinical Services Manager, Professional Compounding Centers of America (PCCA)
Rachael Pontikes, Partner, Reed Smith LLP and Chair, DQSA – Updates in Compounding Conference
Steven M. Solomon, Director, Center for Veterinary Medicine, FDA

John Claud, Assistant Director, Consumer Protection Branch, US Department of Justice
Neil P. Di Spirito, Member of the Firm, Epstein Becker & Green, P.C.
Frances Zipp, President & CEO, Lachman Consultant Services, Inc.

4:45 PM
Conference Adjournment