Join panels of key government regulators and industry experts to explore current issues surrounding the DQSA’s Title I (Compounding Quality Act) and II (Drug Supply Chain Security Act) – four years after implementation. Title I has had a significant impact in compounding pharmaceutical products by outsourcing facilities and traditional pharmacies. Review the changes in the law, FDA’s current guidance, regulatory responses and related state actions involving compounding. Title II has and will continue to have a significant impact on drug manufacturers, wholesalers and pharmacies, especially as they implement the next phases of the DSCSA and await additional FDA guidance.

FDA Speakers:
Ilisa B.G. Bernstein, Deputy Director, Office of Compliance, CDER
Julie Dohm, Senior Science Advisor for Compounding, CDER

Highlighted Topics

Title I – Compounding Quality Act (CQA)
Recent FDA guidances and enforcement discretion, an analysis on what’s on the horizon for compounders from a regulatory (FDA and state inspections) and legal (actions for non-compliance) perspective

Title II – Drug Supply Chain Security Act (DSCSA)
Recent FDA guidances, pilot projects, serialization and other related hot topics such as licensure of wholesale distributors and 3PL’s, and preemption issues

FDLI thanks

for hosting.

Register

Industry & Firms

$599
  • +$200 for nonmembers
  • +$100 after 10/19/2017

Non-Profit

$499
  • +$100 for nonmembers
  • +$100 after 10/19/2017

Government

$499
  • +$100 for nonmembers
  • +$100 after 10/19/2017

Academic

$499
  • +$100 for nonmembers
  • +$100 after 10/19/2017

Student

$99
  • +$100 for nonmembers
  • +must provide transcripts

Agenda

Preliminary Agenda will be Announced in September

Day 1

8:30-9:15 AM
Registration and Continental Breakfast

9:15-9:20 AM
Welcome and Opening Remarks

9:20-10:00 AM
Keynote Address 

10:00-10:40 AM
Keynote Address 

10:40-11:00 AM
Networking Break

11:00-12:05 AM
Concurrent Breakout Sessions 

12:05-1:10 PM
Luncheon with Guest Speaker

1:10-2:15 PM
Concurrent Breakout Sessions

2:15-2:25 PM
Networking Break

2:25-4:00 PM
Plenary Session

4:00 PM
Adjournment

Planning Committee

Committee Chair

Karla L. Palmer, Director, Hyman, Phelps & McNamara

Committee Members

Ilisa B.G. Bernstein, Deputy Director, Office of Compliance, CDER, FDA
William A. Garvin
, Partner, Buchanan Ingersoll & Rooney PC
Abraham Gitterman, Associate, Arnold & Porter Kaye Scholer LLP
Elizabeth Jungman, Director, Public Health Programs, The Pew Charitable Trusts
Rachael G. Pontikes, Partner, Reed Smith LLP
Christopher Pruitt, Associate Chief Counsel, OCC, FDA
Lee Rosebush, Partner, BakerHostetler

Continuing Legal Education

FDLI applies for CLE credits in Ohio, Pennsylvania, and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.

Location and Overnight Accommodations

Location

Skadden, Arps, Slate, Meagher & Flom LLP
1440 New York Avenue, NW
Washington, DC 20005

Overnight Accommodations

The following hotels are within walking distance of the meeting location:

Sofitel Lafayette Square Hotel, 806 15th Street, NW
J.W. Marriott Washington1331 Pennsylvania Avenue NW
Grand Hyatt Washington, 1000 H Street NW
Willard Intercontinental, 1401 Pennsylvania Avenue NW

Driving, Parking, and Public Transportation

Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.