Date(s) - 09/12/2017
12:00 pm - 5:30 pm JST
Nihonbashi Life Science HUB
NAMSA’s MRO Summit program brings thought leadership and industry professionals to you. These complimentary, intimate gatherings allow for expert discussions and shared experiences in medical device development. Within a few hours’ time, you will hear presentations, panel conversations and experiential learning, and will be a part of a day devoted to the art of efficient medical device development. Ultimately, you will leave the summit with recommendations, updates, guidance and resources critical to your device development process, as well as tools to help you on the path to becoming the expert.
This event will take place at the Nihonbashi Life Science HUB with registration beginning at 12:00 PM. The program will be begin at 1:30 PM Japan Standard Time.
Topics to be Covered:
Preclinical Study Design and Strategies for Regenerative Medicine Products
Presented by: Dr. Jack Risdahl DVM, PhD (Director Preclinical Functional Studies, NAMSA)
Preclinical research is a powerful emerging tool for medical device manufacturers of regenerative medicine products. We will discuss the unique challenges throughout the medical device development process in regenerative medicine and provide information on how to successfully meet these challenges head-on, as well as provide suggested strategies on how to avoid mistakes throughout development. This presentation will also highlight the specific requirements of the U.S. Food & Drug Administration (FDA) for regenerative medicine product applications.
Manufacturing Release Testing for Regenerative Medicine
Presented by: Sherry Zachariah (Laboratory Operations Manager – Quality Control, NAMSA)
Regenerative medicine manufacturers must demonstrate that bone filler products are sufficiently osteoinductive. Learn about the latest in lot release testing for bone filler products, the sterility control of cadaveric tissue and how sterility testing is performed on human tissue batches prepared for implantation. This presentation will also include information on NAMSA’s state-of-the-art assays that can accurately determine the strength of bone filler osteoinductivity.
Who Should Attend:
- Product Development
- Research & Development
- Regulatory Affairs Specialist, Managers, Director
- Quality Assurance Specialist, Managers, or Director
- Operations Management
- Laboratory Manager
- Design Engineers
- Marketing Manager/Director
Reservations are closed for this event.