2nd Annual Maximize Investigator-Initiated Studies
Maintain Compliance, Improve Investigator Selection and Ensure Study Completion
March 27 – 28, 2006 * Philadelphia, PA
Visit the conference website for more information and to register.
Investigator-initiated studies are important programs because these studies provide narrative insights into medicines, biological pathways and disease states. In addition, these IIS programs are note worthy because few other avenues of support are available for clinical investigators to explore genuine scientific questions in humans. However, there is risk for pharmaceutical companies investing in these programs due to studies that are poorly conducted. The conduct of the investigator-initiated studies clearly requires a transparent contract between the academic and the pharmaceutical company in which both parties fully acknowledge and accept the risks involved. This conference provides you with the opportunity to hear case studies from industry leaders on the challenges they have faced, solutions they have developed and successes they have had in maximizing investigator-initiated studies. Hear best practices on utilizing medical science liaisons in the IIS process and how to manage risk and legal issues regarding the safety and ethical conduct of IIS.
Hear 14 industry executives address:
- Aligning an IIS study with the company’s business goals and objectives
- Controlling indirect costs and maintaining overall IIS budget
- Regulatory issues – OIG, GCP and IND indications
- Overcoming process bottlenecks – Preparing for and managing unexpected changes
- Leveraging IIS for early and late stage clinical development by reviewing real-life examples
- Dealing with an FDA inspection
- Strategies for working closely with Research and Development to align IIS with R&D goals
Hear what some of our previous attendees had to say:
“A very necessary and relevant course.”
– Jodi Fenlon, Scientific Communication Specialist, MGI Pharma
“Gave me a sense of what is being done at different companies with regards to IIS and how Review Committees are set up.”
– Diana Isom, Clinical Science Manager, The Medicines Company
“Best meeting I have ever attended”
– Kathleen Grace Lomax, Associate Director, Medical Affairs, Eisai Inc.
For more information or to register, please contact the Center for Business Intelligence toll free by phone at 1-800-817-8601 or via e-mail at firstname.lastname@example.org or visit the conference website.