Ensuring Distribution Readiness Before FPI: A Simple Guide to De-Risking

Clinical Trials, Life Sciences, Pharma Manufacturing and Supply Chain, Pharmaceutical,
  • June 12, 2013

Sponsors today are faced with many challenges in successfully completing clinical trials especially now that trials are more global extending into developing countries. Patient enrolment and retention is a consistent challenge, but once a Sponsor is confident that patient pools are ready to participate in their trials, the real challenge is in getting adequate clinical trial supplies to the patient on-time, in-full and in the right condition.

This webinar will discuss ways in which we can ensure “distribution readiness” by having a real understanding of the pre-FPI planning and preparation as well as country rollout post approval, including:

  • Clear definition of roles & responsibilities
  • Using feasibility data and enrolment forecasting
  • Documentation preparation in advance
  • Careful selection of logistics providers
  • Risk avoidance across the supply chain

The result is a well defined, smooth and sustainable process, mitigating risk from beginning to end.

Keywords:

Speakers

Elizabeth Gallagher, Director Global Logistics, Fisher Clinical Services

Ms. Gallagher is a seasoned Pharmaceutical professional with experience and in-depth knowledge of clinical supplies packaging, labeling and distribution. Before joining Fisher Clinical Services, Elizabeth was Director Clinical Supply Operations for Daiichi Sankyo Pharma Development, the U.S. Research and Development operation of the global Pharmaceutical company Daiichi Sankyo, Inc. Prior experience includes Director of Clinical Logistics at ImClone Systems a wholly-owned subsidiary of Eli Lilly and Company. She also worked in Johnson & Johnson’s Consumer Health and BioPharmaceutical divisions where she held a number of positions of increasing responsibility in clinical supplies throughout her 20-year career.

In 2012 Elizabeth Gallagher joined Fisher Clinical Services, a Division of Thermo Fisher Scientific, Inc as Director Global Logistics Accounts. Based in the US in Allentown, PA, she is responsible for supporting the technical aspects of Global Clinical Supply Distribution and Transportation within the Fisher Clinical Services Global network.

Who Should Attend?

Senior level executives in R&D, Clinical Supply and Supply Chain Logistics functions for pharmaceutical/biotech companies worldwide.

Xtalks Partners

Fisher Clinical Services

Fisher Clinical Services is the world’s leading provider of clinical supply chain services.

With a network of cGMP facilities strategically located across the globe to support the conduct of clinical trials, we offer worldwide support for all aspects of clinical supply management including comparator, co-medication and ancillary supply sourcing, packaging, labeling, distribution, storage, through to returns and destruction. With more than twenty years of experience exclusively focused on clinical trials, we can offer guidance and full logistics support across all types of clinical programs and projects.

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