The Future Vision of Clinical Studies and Investigational Products – Technology and Innovation
Join the ISPE Investigational Products Community during the 2014 ISPE Annual Conference to advance your knowledge on Clinical Trial Supply, Regulatory Issues, Expanded Access or Compassionate Use, and New Technologies. All of which can impact this crucial step in the pharmaceutical lifecycle. Clinical trials are fundamental to the development of innovative medicine, vaccines and devices to treat illnesses. A common challenge is ensuring clinical supplies are available when and where they are needed while maintaining, labelling and shipping of clinical supplies. In addition, new regulatory issues such as the Physician Payment Sunshine or Open Payments Program, which now requires manufacturers of drugs, medical devices and biologicals to report payments and item of values to physicians and teaching hospitals, have added another layer of time and risk in bringing needed medicines and treatments to market.
Day One – Playing the Winning Hand – the Future Vision of Clinical Studies provides attendees education on Clinical Trials and Supplies and familiarizes attendees with the regulatory issues that impact how clinical trials are conducted. Attendees will end day one with a list of strategies to help streamline supply chain sourcing, establish robust clinical trial data management systems, expedite approvals of new therapies and keep company investments safe and predictable. As pharmaceutical trials expand to involve emerging markets with diverse stakeholders, manufacturers face varied opportunities for sourcing. New technologies and innovations in ambient and cold chain distribution carry new risks and the new generation of clinical trial supplies is driving clinical supply management into an idealistic future.
Day Two of the track is focused on technology and innovation and will explore the topic of Expanded Access and new technologies and innovations that improve the supply chain. Attendees will also be exposed to a variety of case studies from companies who’ve implemented early access programs, which allow patients under specific circumstances access to medicines and treatments not yet approved for distribution, and their impact on the clinical trial arena. Register for this course and learn about new methods and strategies for streamlining your clinical trial experience and implementing new technologies necessary to improve the experience for all involved – patients, researcher and manufactures.
Learn more about the 2014 ISPE Annual Meeting here.
Attendance at this day and a half course earns attendees 7.25 ACPE credits. The University of Florida, College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education