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2016 Presentations

Advantages and Risks of Outsourcing Panel Presentation Outsourcing has become the norm in our industry, yet we still see issues on both sides of the table.  This presentation, given by a panel of representatives from both contract and pharma companies, will provide insights into how to decrease risk and increase success when partnering.
FDA Perspective on the Challenges of Expanded Access Supplies Presentation Expanded Access and Named Patient Programs are on the rise in the world of drug development. To truly understand their impact on how we manage clinical supplies, an FDA expert will talk about the FDA’s perspective on them and what they’re looking for to ensure control and supply chain success.
Navigating the Challenges of Investigational Medicinal VAT Presentation Over $4 billion is left on the table every year due to unrecovered Value Added Tax (VAT). Recovering these costs for clinical supplies has become a high priority for our companies. This session will present important aspects in determining where VAT is necessary, when to account for it in planning and budgeting, and how to recover it.
Investigational Sites – Packaging to Patient Presentation We sometimes forget that the patient is our ultimate customer.  The stakeholders that interface with that customer are our clinical sites. Supplying IP that will meet the needs of our patients and our clinical sites is essential.  In this session a clinical site representative will provide insights into what happens at a clinic conducting clinical trials besides dispensing medication.
Patient Testimonial – An Inside Look at the Impact of an Oncology Clinical Trial Presentation Have you ever wondered why we do what we do?  We positively influence the lives of our patients.  This presentation, given by a patient who has been on a clinical trial, will provide a unique opportunity to see how our work directly impacts the lives of those who are on the receiving end of our work.
Patient Testimonials – “An Inside Look at Friedreich’s Ataxia” Presentation Have you ever wondered why we do what we do? We positively influence the lives of our patients. This presentation, given by a patient who has been on a clinical trial, will provide a unique opportunity to see how our work directly impacts the lives of those who are on the receiving end of our work
ISPE Patient Survey in Action Presentation Come and get an update on what ISPE is working on in 2016 and how they are putting their survey results to work!
CTS Boot Camp 6 hour long event This 6 hour long class is geared toward people new to the clinical trial supplies world.  Attendees will be provided with an overview of drug development and what goes into planning for and delivering the study drug for a clinical trial.  Included in the training will be the reason behind cGMPs, phases of new drug development and approval, randomizing and blinding clinical trial materials, Quality Assurance & documentation, protocol interpretation, patient CTM compliance, labeling, SOPs, stability, Good Distribution Practices, returned drug accountability, and changing regulations in the EU and ROW. This is an informal workshop that will give attendees a massive amount of information in a fun and interactive atmosphere.
New Attendee Orientation Presentation Is this your first time attending the Global Clinical Supplies Conference?  This informal 1 hour discussion will provide you with an overview of the conference and tips on how to get the most out of it while you’re here.

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