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

http://www.sabpa-ocla.org

Email:   Sabpa.ocla@gmail.com