Pharmaceutical Track and Trace Virtual Conference Agenda

Pharmaceutical Track and Trace
From California to Congress, Implementation Concerns Grow
An FDAnews Virtual Conference
Wednesday, Aug. 14, 2013 • 10:00 a.m. – 3:00 p.m. EDT

10:00 a.m. – 10:10 a.m.

Introduction to the Virtual Conference

Chairperson, Bill Fletcher, Managing Director, Pharma Logic Solutions

10:10 a.m. – 11:00 a.m.

California’s 2015 ePedigree Requirement — View from the Top
Envisioning a track-and-trace system for the supply chain has been a long time coming – nearly 25 years at the federal level and nearly nine years in California. California’s program will take effect on a staggered basis from January 1, 2015, through July 1, 2017: 50 percent of a manufacturer’s products by 2015; the remaining 50 percent of the manufacturer’s products by 2016. Other involved parties must comply by 2017. The serialization requirements are not easy and take time to perfect. There will be no further extensions of time for compliance in California. This presentation will help you understand how the California State Board of Pharmacy expects to work with industry and provide an opportunity for you to ask questions.

Attendees will:

  • Hear updates from the June 24 E-Pedigree meeting and get a survey of what the Sept. 26 meeting will cover.
  • Discover the exceptions and exemptions to the requirements — and other issues — for example, drop shipments — that are still being debated.
  • Receive a status report about pending and future regulations to implement these requirements.

Virginia Herold, Executive Officer, California State Board of Pharmacy

11:00 a.m. – 11:10 a.m.


11:10 a.m. – 12:00 p.m.

How Will the Ever Changing House and Senate Legislation Affect Your Track-and-Trace Strategy?
This presentation will focus on pending legislation that would establish a new national traceability system for pharmaceutical companies as well as their partners in the supply chain. Bills in both the House and Senate generally require various entities in the supply chain to pass on transaction information, history and statements when there is a change in drug ownership. Plus, they set national standards for prescription drug wholesale distributors (“wholesalers”) and third-party logistics providers (“3PLs”). At the present time, there’s been no talk of reconciliation yet because the full Senate hasn’t passed its bill.

Attendees will learn:

  • Current updates on the pending legislation in the House and Senate. If passage has occurred by Aug. 14, attendees will learn what the final requirements are and what was cut out.
  • If the bill has not passed, attendees will hear the latest from Capitol Hill as to what the sticking points are, how they might be resolved and when the bill’s passage might occur.
  •  What agencies — and third-party entities — are responsible for implementation of the bill’s requirements and how drugmakers might be interacting with them.

Gabrielle Cosel, Project Manager, Drug Safety Project, The PEW Charitable Trusts

12:00 p.m. – 1:00 p.m.

Lunch Break

1:00 p.m. – 1:50 p.m.

Coping with the Diversity of Serialization Requirements in the International Market
While California’s requirements are the best defined and time sensitive, national and international regulations are also actively under development. Understanding the importance of taking an end-to-end approach to serialization and track-and-trace can minimize total cost of ownership and at the same time minimize risks. Without proper global planning, manufacturers could face situations where what they develop to comply with one set of regulations could put them in violation of another. This presentation will help attendees view track-and-trace on a global basis and see how it can minimize wasted time and capital investment.

Attendees will learn:

  • Best practices to minimize risk in implementation on a global scale.
  • How to successfully make an organizational change without major hiccups.
  • How to minimize the implementation cost of serialization and track-and-trace.
  • The difficulties and challenges in implementing a serialization and track-and-trace program.

Torben Vogt, Industry Expert, Life Science Solutions, NNIT

1:50 p.m. – 2:00 p.m.


2:00 p.m. – 2:50 p.m.

Lessons Learned from 17 Traceability Program Roll-Outs
In this presentation, expert Bill Fletcher will walk attendees through the lessons learned from the 17 (18 and 19 pending!) company traceability program roll-outs he has helped implement in some of the leading pharmaceutical companies. Each successful roll-out involved thousands of man-hour and potentially millions in capital investment. Learning from the success — and being alerted to trouble spots — from past roll-outs reduces costs and minimized risk. Whether it’s who should be on your roll-out team to tips on standardizing your data with existing standards to finally flipping the switch and auditing the system, this presentation will provide invaluable lessons.

Attendees will learn:

  • The Dos and Do Nots for a successful program roll-out.
  • Best practices for implementing a global traceability program.

Bill Fletcher, Managing Director, Pharma Logic Solutions

2:50 p.m. – 3:00 p.m.

Closing Comments and Adjournment

Bill Fletcher, Managing Director, Pharma Logic Solutions