Understanding how to best utilize global expedited regulatory options is imperative to making an informed decision about the best ways to accelerate drug development. On January 28-29 at the Sheraton Pentagon City Hotel in Arlington, VA, ExL's 2nd Innovative Regulatory Pathways Summit will be held. It is a must attend event - the only platform for industry professionals to discuss and compare the current regulatory pathways that allow for expedited attention to drugs that have promise in treating life-threatening conditions. Learn to navigate the global regulatory landscape and effectively anticipate the future accelerated options. Discuss the implications of breakthrough therapy designation, PRIME, and Sakigake Designation on development pipelines. Network with worldwide leading regulatory experts who have experience leveraging the increased consideration that comes with utilizing an expedited development pathway. Discuss regulatory strategies to optimize product development timelines. Learn about best practices to liaise with the FDA, EMA, and PDMA about expedited regulatory approvals.
Time: 08:00 to 14:45
Speakers: Dr. Brian Harvey, Usha Ramesh, Dr. Long Wang, Jim Wang, PH.D., MBA, Dr. Henrietta Ukwu, Martine Zimmermann, Mark Stewart, William K. Sietsema, PH.D. , Lawrence Liberti
Early Bird Pricing- Register by 12/14/18: USD 1895.0,
Standard Pricing: USD 2095.0,
Onsite Pricing: USD 2295.0
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2nd Innovative Regulatory Pathways Summit
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