InnovationShare Webinar Series

Our InnovationShare webinar series will offer monthly educational sessions led by thought leaders within the cold chain industry. Each webinar series will feature key relevant topics and best practices for clinical and commercial supply chain management.

Learn more about each free webinar below and register today!

Points to Consider when selecting or creating thermal lane profiles

Date: July 21, 2021
Time: 11:00AM EST
Presenter: Paul Harber, Parenteral Supply Chain

About the Speaker

Paul Harber

Parenteral Supply Chain

Paul Harber has worked in the area of transport validation for over 25 years. His scope of work has ranged from validation of active and passive shippers for numerous clients. In 2014, project work with NGOs in the evaluation of cold chain operations at Ebola vaccine clinical trial sites in Zone 4 countries was a personally rewarding addition to scope of work.

For 16 years the scope of Paul’s work at Eli Lilly and Company (Lilly) focused on the qualification of both active and passive shippers in support of clinical and commercial transportation of temperature labile products. He had major roles in defining and specifying the cold chain components and practices necessary to support the commercialization of four Lilly products.

While at Lilly, Paul was the interface to all regulatory agencies on issues of transport package qualification. Paul has provided tech transfer support to implement numerous changes and improvements across the supply chain in support of the API supply strategy. 

Paul received his Bachelor of Science in Agriculture Engineering and has a Master of Science in Engineering from Purdue University.

Paul is the 2008 recipient of Eli Lilly Engineering Excellence Award, a peer selected award acknowledging lifetime engineering achievements at Eli Lilly and Company.

Clinical Trial Regulation (CTR) and the Role of Clinical Supply Chain Transparency

Date: September 23, 2021
Time: 11:00AM EST
Presenter: Steve Jacobs

The Clinical Trial Regulation will have an impressive impact on the clinical supply chain.  It has been delayed, from its original launch date in May of 2016, and will soon become law in Europe.

The issue stemming from transparency has created a requirement to put retest dates on primary and secondary containers of Investigational Medicinal Products (IMP), required better data sharing of clinical trials and drove higher expectations of clinical supplies returns and reconciliation.

What you will learn:

  • Compare and contrast the Clinical Trial Directive with the Clinical Trial Regulation
  • Explain the impact of having to put retest dates on primary containers of IMP
  • Describe the reasons returns and reconciliation have become a key focus in the CTR