May 7, 2021
12:00 - 1:00 ET
12:00 – 1:00 pm ET Medical Device Research, Regulations and Path to Marketplace
Kathi Durdon, MA, CCRP, Executive Director at CNY Biotech Accelerator, Upstate Medical University
Ms. Durdon will start this SOCRA virtual mini-series off with an overview of medical device regulations and how risk plays a prominent role in product development, regulatory submission and ultimately use by patients and caregivers. This presentation will provide a brief history of medical device regulatory history, device classification, relevance of clinical trials and design for FDA submission, and the total product lifecycle of medical devices (TPLC).
Friday, May 14, 2021 - The Types of Device Trials, Billing and Reimbursement
Friday, May 21, 2021 - The Promise and Complications of "Broad Consent"
Registration Fees for entire Series:
Member Fee- $90
Non-Member Fee- $165*
*Non-Member Fees include a non-refundable one-year membership in SOCRA
SOCRA designates this educational activity for a maximum of 3 Continuing Education Credits for SOCRA CE and Nurse CNE. SOCRA designates this live activity for a maximum of 3 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.