Agenda | Materials

subject to change

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

9:15 – 9:20 AM
Welcome and Opening Remarks
Laura Brown, Director, Educational Programs, Food and Drug Law Institute
Lee Rosebush, Chairman, Outsourcing Facilities Association; Partner, BakerHostetler; and Chair, Drug Quality and Security Act Conference

9:20 – 10:00 AM
Keynote Address – Title I (Compounding Quality Act) Implementation Pharmacy Compounding in 2018 | Speakers Slides
Julie Dohm, Senior Science Advisor for Compounding, CDER, FDA

10:00 – 10:40 AM
Keynote Address – Title II (Drug Supply Chain Security Act) Implementation Track and Trace Issues in 2018 | Speakers Slides
Ilisa Bernstein, Deputy Director, Office of Compliance CDER, FDA

10:40 – 11:00 AM
Coffee and Networking Break

11:00 – 12:00 AM
Concurrent Breakout Sessions

Title I (CQA) – Review of Quality Standards for Compounders | Speakers Slides
Panelists will address the new Insanitary Conditions Draft Guidance, which applies to both Section 503A and 503B “compounding facilities;” cGMP regulations and guidance applicable to Section 503B facilities; and USP guidelines and FDA guidance for Section 503A compounders.” Recent policy statements by FDA on changes that will be made by the end of this year will also be discussed.

Jennifer Devine, Vice President, Global Legal Affairs, Standards, USP
Ruey C. Ju
, Senior Advisor for Compounding Compliance and Enforcement, CDER, FDA

Title II (DSCSA): – Implementation of Serialization | Speakers Slides
Serialization is finally here. During this panel, the various types of products that are now in commerce as of the November implementation deadline will be discussed, including the recent guidance documents on grandfathered products and product identifiers. Speakers will also address technical capabilities, master data, and data aggregation.

Tish Eggleston Pahl, Principal Attorney, Olsson Frank Weeda Terman Matz PC
Chris Smith, Director, Federal Public Policy, National Association of Chain Drug Stores (NACDS)

12:00 – 1:15 PM
Luncheon Address

1:15-2:15 PM
Concurrent Breakout Sessions

Title I – Bulk Substances and Essential Copies: Draft Guidance and Recent Litigation | Speakers Slides
Earlier this year, FDA released a guidance document on the Evaluation of Bulk Drug Substances, which outlines a revised bulks nomination process. FDA also released two final guidance documents on the compounding of commercially available drugs that applies to both 503A and 503B compounders. This session will address the implications and challenges of these related guidance documents, as well as developments in the closely linked Endo/Par v. FDA litigation.

Elizabeth Jungman, Director, Public Health Programs, The Pew Charitable Trusts, and Member, FDLI Board of Directors
Karla Palmer, Hyman, Phelps & McNamara PC
Eli Tomar, Counsel, Akin Gump Strauss Hauer & Feld LLP

Title II – Preparing for the Future | Speakers Slides
DSCSA requires the development of an electronic, interoperable system to identify and trace certain drugs as they move through the US supply chain, which will ensure product traceability down to the unit level. Speakers will discuss updates on FDA’s pilot projects in this area, as well as what can be done now to prepare for interoperability and the implications it will have on recalls and suspect products. Lessons learned from the November deadline and preparing for deadlines through 2023 will also be discussed.

Elizabeth A. Gallenagh, Senior Vice President, Government Affairs and General Counsel, Healthcare Distribution Management Association
Mark Hendrickson, Senior Director, Sciences & Regulatory Affairs, Association for Accessible Medicines
Eric Marshall, Senior Director, Levitt Partners, LLC
Dave Mason, AD Serialization ESO/Supply Chain, Sandoz, Inc.

2:15 – 2:30 PM
Coffee and Networking Break

2:30 – 3:30 PM
Concurrent Breakout Sessions

Title I  Update on Recent FDA Actions and Guidance Documents | Speakers Slides
Over the past year, FDA has released a slew of guidance documents and policy statements relating to compounded products. During this session, speakers will delve into the impacts of these actions, including the revised MOU with states, USP’s labeling materials, and recent discussions on adverse event reporting.

Matt Martin, Clinical Compounding Pharmacist, PCCA
Rachael Pontikes
, Partner, Reed Smith LLP
Lee Rosebush, Chairman, Outsourcing Facilities Association; Partner, BakerHostetler; and Chair, Drug Quality and Security Act Conference
Sara Rothman, Senior Policy Advisor, Office of Unapproved Drugs and Labeling Compliance, CDER, FDA

Title II – FDA Exemptions and Waiver Process | Speakers Slides
In May, FDA released a draft guidance document to help trading partners in the supply chain request waivers, exemptions, or exceptions from the DSCSA requirements. Speakers will discuss when to request a waiver, as well as address other considerations for this process including consideration of what constitutes a “product,” “transaction,” and “wholesale distribution.” FDA’s recent guidance on Verification systems will also be discussed.

Abraham Gitterman, Associate, Arnold & Porter LLP
Christine E. Kirk, Associate, Arnall Golden Gregory LLP
Moderated by Christina M. Markus, Deputy Chair, FDA & Life Sciences Practice, King & Spalding LLP

3:30 PM-4:30 PM
Concurrent Breakout Sessions

Title I – Inspections and Enforcement in the Compounding World | Speakers Slides
FDA partnerships with states, DOJ actions, and warning letters – these are a few of the variety of enforcement and inspection activities happening within the compounding world. FDA and DOJ enforcement actions and consent decrees, product seizures, how to survive a shutdown, and predictions for the future will be discussed.

John W.M. Claud, Trial Attorney, US Department of Justice (DOJ)
Patrick C. Gallagher, Partner, Duane Morris LLP
Colleen M. Heisey, Partner, Jones Day

Title II – Inspections and Enforcement
Under the new track-and-trace rules, manufacturers, distributors, and dispensers must set forth the process for reporting and investigating suspect and illegitimate products, and methods for notifications for these products. Speakers will provide an update on this and other areas where FDA has been actively enforcing, as well as how requirements in other countries can impact imported products.

Todd Halpern, Partner, Venable LLP
John Murphy, Deputy General Counsel, Biotechnology Innovation Association
Moderated by James R. Johnson, Partner, Hogan Lovells US LLP

4:30 PM
Conference Adjournment