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Complimentary Webinar

November 24, 2021 | 11:00 a.m. - 12:00 p.m. ET

From Manual to Automated Literature Reviews form CER & PER Submissions:

A Faster Path to Compliance

CERs and PERs are frequently seen as a time-consuming hurdle medical device manufacturers have to face in order to check the compliance box for notified bodies on their go-to-market path. 

In this webinar, we will look at how manufacturers are keeping up with the unprecedented pace evidence-based research is being produced, ways to optimize manual literature review processes and shifting the CER/PER submission mindset from hurdle to opportunity.

SPEAKERS

Marc Dufresne
Senior Vice-President, Strategic Growth
Evidence Partners

For more than 20 years, Marc has led results-oriented teams and initiatives to consistently exceed targets with an emphasis on building long-term relationships. Marc has been instrumental in accelerating the adoption of DistillerSR by identifying new market opportunities. He was an OBJ Top 40 under 40 recipient in 2008 and holds a BA from Laurentian University.

Dr. Sara Paquette
Sr. Medical Writing Manager
Medtronic

Dr. Sara Montminy Paquette is a Senior Manager in Renal Care Solutions at Medtronic, managing their medical writing team for clinical evaluations. She has been with Medtronic for seven years both as a manager and as a writer herself. Sara holds a PhD in Biomedical Sciences from the University of Massachusetts Medical School, and prior to working in medical devices she was a researcher in infectious disease and immunology.

Shelley Jambresic
Clinical Evaluation Manager

Geistlich Pharma

Shelley Jambresic is a Clinical Evaluation Manager at Geistlich Pharma, responsible for clinical evaluation of class III products of animal origin. She has conducted clinical evaluation on class III medical devices under MDR and MDD. She is experienced in planning and conducting pre- and post-market clinical trials with medical devices. Shelley is a microbiologist by training and a science communicator with extensive experience in medical and science writing.

Alison Ramsey
Director/Head, Clinical Evaluations

Alcon

Alison leads the clinical evaluation efforts for Alcon’s ophthalmic medical devices, with a specific focus on the organization’s transition from MDD to MDR for the EU.  Alison has worked at Alcon for 18 years. Prior to joining Alcon, she practiced optometry in Salt Lake City, Utah. Alison earned a BS degree in Cellular and Molecular Biology from the University of West Florida, an OD degree from the University of Missouri – St. Louis College of Optometry, and an MS degree in Clinical Vision Research from Nova Southeastern University College of Optometry.

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