FDLI--Drug Quality Security Act Conference November 15 I Washington, DC

Drug Quality Security Act Conference November 15 I Washington, DC Register by October 19 to SAVE! Hear from key government regulators and industry experts as they explore recent FDA announcements, guidance documents, and other current issues surrounding the DQSA’s Title I (Compounding Quality Act) and Title II (Drug Supply Chain Security Act).

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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, FDLI

9:20-10:00 AM 
Keynote Address – Title I (Compounding Quality Act) Implementation – Pharmacy Compounding in 2017

Julie Dohm, J.D., Ph.D., 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 2017

Ilisa Bernstein, Pharm D., J.D. Deputy Director, Office of Compliance CDER, FDA

10:40-11:00 AM
Networking Break

11:00-12:00 AM 
Concurrent Breakout Sessions

Title I (CQA) – Industry Update: FDA’s Significant Guidance Documents and Industry Actions/Reactions on Regulation of Compounding

In this breakout session, speakers will review FDA’s guidance for traditional compounders and outsourcing facilities under sections 503A and 503B, their practical applicability, and effects on both types of entities.

Title II (DSCSA): – Industry Update: Recent Developments and Unanswered Questions Concerning Implementation of the DSCSA.

In this breakout session, speakers will discuss next steps in DSCSA implementation, including FDA guidance and regulatory developments and its effect on industry, the grandfather designation and product identifiers, FDA’s working groups/case studies process, and lingering questions, such as applicability of Title II to 503B repackaging facilities.

12:00-1:30 PM
Luncheon Presentation: Compounding Policy in the States

Update on states’ increased roles in the licensing and regulation of compounding and outsourcing facilities  

1:30-2:45 PM
Concurrent Breakout Sessions

Title I – FDA and Inspections:  What to Consider When FDA Visits Your Facility

Panelists will discuss FDA’s inspection guidance, generally how to prepare for an inspection, what FDA may be looking for, and how to respond to Agency inquiries and observations.

Title II – Licensure of wholesale distributors and 3PL’s: Where does FDA stand, where do states stand, what about VAWD, and what can you to do about it?

Speakers will discuss the hurdles to licensure on the state and federal level for wholesalers and distributors, and will attempt to provide some answers.

2:45-3:00 PM
Networking Break

3:00-4:00 PM
Concurrent Breakout Sessions

Title I – Enhanced Enforcement Activity in the Compounding World

In this breakout session, speakers will explore recent enforcement activities by FDA and states involving compounding pharmacies and outsourcing facilities – what FDA and states seem to consider when determining whether and how to pursue certain compounding practices – with at least one “real world” case study.

Title II – Serialization and Enforcement

Panelists will focus on product identifiers and verification, FDA’s guidance delaying enforcement for one year, public meetings and FDA’s pilot project.  Suspect packaging reporting will also be addressed.              

4:00 PM
Conference Adjournment