2016 EU Pre-Conference Workshop – Clinical Supplies Foundations
The GCSG committee is delighted to introduce a clinical trial supplies Boot Camp, to be held in conjunction with the GCSG 2016 European Conference.
This concentrated 6 hour session will be held on Tuesday 18th October from 09:00 – 15:00, prior to the start of the main conference, and will give new-comers to our industry the opportunity to learn about key clinical supply concepts from experienced professionals.
The fundamentals of clinical supply management will be presented, allowing attendees to grow their knowledge base while meeting and networking with their peers in an interactive classroom setting.
During this interactive training, the following topics will be reviewed:
- An overview of drug development and where Clinical Supplies fits in
- Definitions of terminology and acronyms, to demystify our IMP world
- Where cGMPs come from and why they are essential in all we do
- Quality and risk management for manufacturing drug product, packaging, labeling, storing and distributing Clinical Supplies globally
- The relationships between Production, Project Management, Quality, Regulatory Affairs, Pharmaceutical Development and Analytical Development and why collaboration is a requirement for managing timelines and deliverables
- New trends in Good Distribution Practices (GDPs) and the Clinical Trial Regulation
Bring your questions! Questions are welcome and encouraged throughout the entire Boot Camp!
This workshop will be delivered by Steve Jacobs, a successful trainer, business leader, consultant, executive coach and speaker. Steve has been heavily involved in clinical supply chain operations, IMPs, cGMPs, cGCPs, clinical development and quality for pharmaceuticals, and biotech products. He sits on the Board of Directors of the largest professional clinical supplies 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. He has presented globally on leadership, management, forecasting, planning, creativity, making global teams successful, emotional intelligence, generational differences, human error prevention, clinical supplies logistics, project management, problem solving and contract negotiations.
In the past he has been the CEO and COO of a start up company as well as the president and Global Chief Operating Officer of a multinational contract organization that served companies like Novartis, Eisai, Lilly and others in the pharmaceutical and biotech sector.
His ability to lead, drive outcomes, and bring teams together to deliver products and services on time and on budget was honed and developed as the head of US clinical supply operations for Johnson & Johnson. This was part of his 20 years of experience in clinical supplies, clinical development and global team leadership.
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 Army 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.