Topic
Regulatory Pathways to Markets
Meet a panel of experts discussing various regulatory pathways to China, Japan, US, and EU for Medical Devices.
Speakers
Akhihiro Takahashi
is a Regulatory Affairs Manager at MicroVention who develops and executes regulatory strategies to obtain approvals for marketing reimbursements of medical devices in Japan. He has over 25 years of experiences of medical devices industry and over 20 years of regulatory Affairs to obtain approvals of Class IV medical devices and C1 category reimbursement in Japan.
Yiqun Zhou
is a lead medical writer at MicroVention. Yiqun has 6 years CER experience in medical device industry, including Medtronic and MicroVention. Yiqun’s expertise is in EU MDR CER, NMPA CER, medical publication. Yiqun holds Ph.D in immunology and published 20 articles in peer-reviewed journals. Before entering medical device industry, Yiqun worked in Roche Pharmaceutical.
Sindhu Sridhar
is a seasoned regulatory affairs leader & professional with 10+ years of experience in the medical device industry. She currently serves as a Sr. Manager of Regulatory Affairs at Vyaire Medical. Prior to joining Vyaire Medical, Sindhu held several roles in Regulatory Affairs & Quality at multiple companies including Medtronic and Acutus Medical. Her experience includes working on various classes of neurovascular, cardiovascular, respiratory, electrical & software devices. She holds a master’s in food Safety and Technology.
When
16 Nov 2023 (Thursday)
5:00-7:00 PM (PST) onsite
5:30-7:00 PM (PST) Zoom
Where
Zoom meeting and
930 Roosevelt, suite 122-128, Irvine, CA 92620 (Free parking and light international refreshment)
Free Registration
registration link for onsite
registration link for Zoom
Questions
Email: Sabpa.ocla@gmail.com
