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
About the Speaker
Global BioPharm Solutions
Steve is a successful trainer, business leader, consultant, executive coach and speaker. For the past 25 years he’s been heavily involved in clinical supply chain operations, IMPs, cGMPs, cGCPs, cGDPs, clinical development and quality (ICH Q8, Q9 & Q10) for pharmaceuticals, and biotech products.
He sits on the Board of Directors of the largest professional clinical supply organization in the world, the Global Clinical Supplies Group. His expertise also includes success in innovation, global cultural dynamics, organizational development, and high performing teams.
In the past he has been a CEO and COO, as well as the president and Global Chief Operating Officer, of a multinational clinical supply chain contract organization that served companies like Novartis, Eisai, Lilly and others in the pharmaceutical and biotech sector. Before that he was head of US clinical supply operations for Johnson & Johnson.
Steve was also a logistics and aviation officer, in the U.S. Army, where he rose to the rank of Major and was a maintenance test pilot, and pilot in command, for both helicopters and fixed wing aircraft.
His undergraduate degree is in Pharmacy from the University of the Sciences in Philadelphia and his MBA is from the University of Phoenix with a specialization in global management.