Office Hours: David France & Carol Ryerson, PhD. Regulatory Affairs & Compliance
Do you need advice on regulatory affairs or compliance? Apply for a one-on-one session with David France or Carol Ryerson of Regulatory and Clinical Research Institute (RCRI).
Our office hours are hosted by leading experts who have generously offered their services pro bono to our entrepreneurs.
If your application is approved, we will invite you to choose a timeslot and require a $100 credit card deposit. The deposit will be refunded the day after you attend. No-shows will not receive a refund. Please be punctual; arrivals late by more than 15 minutes will be considered no-shows.
If you find that you are unable to attend, you may request a refund up to 48 hours in advance. (This will give us time to offer the slot to the first person on the waitlist.) We regret that we cannot honor requests made at a later time.
Where and When
Suite 214, Byers Hall, UCSF Mission Bay (1700 4th Street, San Francisco)
Monday, October 8
Applications accepted through Monday, October 1.
About David France
David France is a Principal Advisor at RCRI. He provides leadership as an overall project advisor and manager, serving as a strategic consultant and providing regulatory and clinical guidance both internally and externally. With 31+ years of experience in the industry, David has served in leadership roles in clinical affairs, regulatory affairs, and training for both small and large companies. His extensive and successful experience in a wide variety of clinical and regulatory settings and geographies includes, but is not limited to, strategic planning (including Class III active implantable devices), protocol development, enrollment strategies, and report authorship, FDA advisory panel preparation, extensive site and investigator management, and publication strategy development and support. David has built and managed numerous clinical study teams both in-house and in the field, and has utilized his training experience to strengthen clinical operations and to provide highly technical product education to physician customers, sales teams, and field engineers.
About Carol Ryerson
Carol Ryerson is a Senior Principal Advisor at RCRI. She has over 30 years of experience in the IVD and medical device industry with expertise in regulatory affairs, clinical affairs, and research and development. In addition to extensive regulatory strategy and submission work, she has established and managed regulatory affairs, and clinical research departments for medical device companies. Carol assists RCRI’s clients with determining global regulatory strategies, drafting submissions and negotiating their approval with FDA, and other regulatory bodies. Carol has worked with project teams during all phases of product development providing global regulatory strategy, clinical study design, submission preparation, and guidance on preparation of compliant labelling and advertising materials. Carol has supported product registrations for clinical chemistry systems and reagents, coagulation systems and reagents, infectious disease IVDs, imaging devices in mammography, oncology, and general radiology. Based in Boston, Massachusetts, Carol holds a Bachelor’s degree in Chemistry from the College of the Holy Cross, and a Ph.D. in Biochemistry from the Massachusetts Institute of Technology.
About RCRI Inc.
Regulatory and Clinical Research Institute (RCRI Inc.) is a strategic consulting company supporting the entire medical device product lifecycle. RCRI Inc. assists clients with regulatory affairs, quality compliance, clinical strategy & execution, market landscape analysis and reimbursement.