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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) – five years after implementation.

Title I has had a significant impact on pharmaceutical products compounded by outsourcing facilities and traditional pharmacies. This Conference will discuss the steps made in furthering FDA’s Compounding Policy Priorities Plan, including recent guidance documents on bulk substances and related litigation. 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. FDA’s waiver process, the impending enforcement deadline for product serialization requirements, importation issues, and inspections under the DSCSA will be discussed.

FDA Keynote Addresses:

Title I – Compounding Quality Act (CQA)

  • Recent FDA Guidance Documents and Policy Initiatives
  • What’s on the Horizon for Compounders from a Regulatory Perspective
    Julie Dohm, Senior Science Advisor for Compounding, CDER

Title II – Drug Supply Chain Security Act (DSCSA)

  • Serialization Implementation and Enforcement
  • Recent FDA Guidance Documents, Including FDA’s Waiver Process
    Ilisa B.G. Bernstein, Deputy Director, Office of Compliance, CDER

venue sponsor

Sponsorship Opportunities

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

Agenda

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

9:20 – 10:00 AM
Keynote Address – Title I (Compounding Quality Act) Implementation Pharmacy Compounding in 2018

Julie Dohm
, Senior Science Advisor for Compounding, CDER, FDA
Introduced by Lee Rosebush, Chairman, Outsourcing Facilities Association; Partner, BakerHostetler; and Chair, Drug Quality and Security Act Conference

10:00 – 10:40 AM
Keynote Address – Title II (Drug Supply Chain Security Act) Implementation Track and Trace Issues in 2018

Ilisa Bernstein, Deputy Director, Office of Compliance CDER, FDA
Introduced by James R. Johnson, Partner, Hogan Lovells US LLP

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
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
Caroline D. Juran, Executive Director, Virginia Board of Pharmacy
Alexander Pytlarz, Owner/Director of Pharmacy, The Compounding Center

Title II (DSCSA): – Implementation of Serialization
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
Sandra Cha Sifferlen, Assistant General Counsel, Regulatory Legal Team, Eli Lilly and Company
Chris Smith, Director, Federal Public Policy, National Association of Chain Drug Stores (NACDS)

12:00 – 1:00 PM
Networking Luncheon

1:00 – 2:00 PM
Concurrent Breakout Sessions

Title I – Bulk Substances and Essential Copies: Draft Guidance and Recent Litigation
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, Director, Hyman, Phelps & McNamara, PC
Eli Tomar, Counsel, Akin Gump Strauss Hauer & Feld LLP

Title II – Preparing for the Future
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, Leavitt Partners, LLC
Dave Mason, AD Serialization ESO/Supply Chain, Sandoz, Inc.

2:00 – 2:15 PM
Coffee and Networking Break

2:15 – 3:15 PM
Concurrent Breakout Sessions

Title I  Update on Recent FDA Actions and Guidance Documents
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
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

3:15 PM – 4:15 PM
Concurrent Breakout Sessions

Title I – Inspections and Enforcement in the Compounding World
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 Organization (BIO)
Moderated by James R. Johnson, Partner, Hogan Lovells US LLP

4:15 PM
Conference Adjournment

Planning Committee

Commitee Chair

Lee Rosebush, Chairman, Outsourcing Facilities Association and Partner, BakerHosteler

Planning Committee 

Chris Smith, Director, Federal Public Policy, National Association of Chain Drug Stores
Ilisa Bernstein, Deputy Director, Office of Compliance CDER, FDA
Abraham Gitterman, Associate, Arnold & Porter LLP
Andrew Harrison, Vice President of Legal & Compliance, PharMEDium Services, LLC
David J. Horowitz, Partner, Hogan Lovells LLP
Karla L. Palmer, Director, Hyman, Phelps & McNamara, PC
Anne Marie Polak, Senior Director, Leavitt Partners, LLC
Rachael Pontikes, Partner, Reed Smith LLP

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.

Pennsylvania: approved for 5.0 CLE credit hours
Ohio: approved for 9.0 CLE credit hours

Location and Overnight Accommodations

Conference Location

Hogan Lovells US LLP
555 13th St., NW, Washington, DC 20004

 

 

2018-12-10T10:01:29+00:00