Overcoming Regulatory and Logistical Hurdles When Conducting Clinical Trials in India
Recorded Webinar
IP Series
Recorded: 23 January 2008, 11.00 EST
Purchase from ISPE's On-line Store
India is a fast growing market and a rapidly changing country. Requirements for conducting clinical trials emerge at a rapid pace. Learn how to identify specific hurdles and examine ways to avoid common pitfalls through review of cultural, infrastructural, and regulatory challenges for conducting clinical studies in India.
Speaker
Barbara H. Ost, Vice President, Quality Assurance & Compliance, Bilcare, Inc.
Currently employed by Bilcare, Inc., as the Vice President of Quality Assurance and Regulatory Compliance, Ost is responsible for global compliance for Bilcare sites in the US, India, and Wales. Prior to joining Bilcare, she was the associate director of Worldwide GMP Compliance at Merck in the areas of quality systems and clinical packaging with oversight of the clinical packaging release function, labeling, distribution, and contract packaging. In addition, she worked for Johnson & Johnson for 14 years in three different operating companies (McNeil Consumer Healthcare, J&J*Merck, and Advanced Care Products). During that time she held a variety of positions including quality release, quality assurance, quality process improvement, and regulatory affairs for devices, diagnostics, pharmaceutical product, and Rx-to-OTC switch candidates. Ost is a graduate of Cedar Crest College, Allentown, Pennsylvania, US, and hold a BS in Biology. From 1991-1994 she served on the Board of the Food, Drug and Cosmetic Division for the American Society of Quality and was the Board chair in 1994.
Who Should Participate
Project management, quality assurance, and regulatory affairs professionals, and those with more than five years of business in clinical trails, or interest in conducting studies in foreign countries.
Tentative Agenda Topics
- Today's challenges (infrastructure, IP, and regulatory/government)
- Cultural considerations
- Clinical supplies challenges
- Regulatory information specific to India
Take Back to Your Job
- Knowledge of what is currently happening in India (most of us read about what is happening)
- Possibilities for trials in India
COP(s)
IP
What is a Recorded Webinar?
Previously held webinars are available as recorded sessions, which you can view at your convenience. Registration orders are processed within two business days, after which participants will receive an e-mail confirmation with a link to the Recorded Webinar. After receiving the link to the Recorded Webinar, you have 15 days to view it.
What are CPIPSM Recorded Webinars?
CPIPSM Recorded Webinars are a group of Recorded Webinarswas developed to help individuals in preparation for the Certified Pharmaceutical Industry ProfessionalSM (CPIPSM) examination..
The Certified Pharmaceutical Industry ProfessionalSM (CPIPSM) credential recognizes “change agents” as the necessary ingredient to foster industry innovation and enhance drug product quality. The credential establishes a global competency standard for industry professionals, and candidates are assessed through demonstrated education, experience, and a rigorous examination. Completion of any of these seminars does not guarantee successful completion of the CPIP certification exam, and these seminars do not include every subject to the depth of what will be covered on the CPIP exam.
See all available Recorded Webinars
Technical Requirements and FAQs
