From the FDA’s Guidance on ISO10993 to the EU Medical Device Regulation, there have been some significant changes lately that affect pre-clinical safety testing for combination products or medical devices. Staying up-to-date is crucial to moving your product to market. As WuXi AppTec’s Director of Technical and Regulatory for Medical Devices/Combination Products, Sherry Parker is a leading expert on regulation. She will speak about recent regulatory changes and resulting trends that she is seeing emerge. Bring your questions; there will be plenty of time for Q&A.
Where and When
Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
5:00 to 6:30 PM, Thursday, March 1
Agenda
5:00 - 5:30 pm: Networking
5:30 - 6:30 pm: Talk and Q&A
About the Speaker
Dr. Parker has over 19 years of toxicology and medical device research experience, and is an expert in analytical, pharmacological, and toxicological evaluations of devices and novel combination products. After receiving her Ph.D. in Molecular and Cellular Pharmacology from the University of Miami, Dr. Parker spent 10 years in toxicology research for the University of Miami, the U.S. EPA (Neurotoxicology Division) and RTI International before moving into the medical device industry, where for more than six years she was involved with device development, safety and efficacy testing and regulatory submissions for OrbusNeich Medical. In her current position as WuXi AppTec’s Director of Technical and Regulatory for Medical Devices/ Combination Products, Dr. Parker provides manufacturers with guidance on global regulatory and technical requirements and testing program design. Dr. Parker is currently an internationally recognized expert by ISO and US Delegate for TC 194, the technical committee for ISO 10993. She is currently the Vice President-Elect for the Medical Device and Combination Products Specialty Section of the Society of Toxicology.