September InnovationShare: Clinical Trial Regulation in Europe

Sep 21, 2021

InnovationShare offers educational webinars led by thought leaders within the cold chain industry. Each session features key topics and best practices for clinical and commercial supply chain management.
On September 23, Steve Jacobs of Global Pharma Solutions will help attendees navigate the new Clinical Trial Regulation (CTR) in Europe and prepare for its launch. Set to take effect in early 2022, the CTR creates a favorable environment for conducting clinical trials, ensures the highest standards for safety and transparency, and builds cooperation among member states. Though CTR is multifaceted, Jacobs will cover:

  • The difference between the Clinical Trial Directive and the CTR
  • The impact of requiring retest dates on primary containers of IMP
  • The reasons returns and reconciliation have become a key focus in the CTR

Jacobs has been heavily involved in clinical supply chain operations for the past 25 years. He has worked with IMPs, cGMPs, cGCPs, cGDPs, clinical development and quality (ICH Q8, Q9 & Q10) for pharmaceuticals, and biotech products. He also sits on the board of the Global Clinical Supplies Group. 
Jacobs is a successful trainer, business leader, executive coach, consultant and speaker, with experience as a CEO and COO, president and Global Chief Operating Officer of a multinational clinical supply chain contract organization, and head of US clinical supply operations for Johnson & Johnson.
Register for September's InnovationShare webinar here.