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Post-Market Literature Surveillance: Systematic Literature Review and Case Study
Joining Criterion Edge's President Laurie Mitchell, is our guest speaker, Queenita Fernandes, Medtronic's Medical Safety Manager, Patient Monitoring & Respiratory Interventions​. In this webinar, we will discuss how to deploy systematic literature review in order to augment post market clinical surveillance, and share our best tips on a robust systematic literature review process. Following this, our guest speaker will share an informative case study illustrating more.

Who should attend?
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Clinical Evaluation Reports for EU MDR submission, or anyone interested in learning more about MDR requirements for CERs.

Jan 19, 2022 11:00 AM in Pacific Time (US and Canada)

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Speakers

Laurie Mitchell
President @Criterion Edge
Founder/President of Criterion Edge, a global regulatory writing services firm serving the medical device, pharmaceutical, and biotech industries. She has over 25 years experience in medical writing, pharmacovigilance management, and regulatory reporting. Prior to Criterion Edge, Laurie founded Mitchell Research Group, a successful site management organization, and acted as a Clinical Safety consultant for Abbott Vascular for almost a decade. Laurie brings extensive experience creating and training Data Safety Monitoring Boards and Clinical Event Committees and working with global cross-functional teams. Having worked for three of the four major medical device sponsors, she maintains expertise in many therapeutic areas. She holds a BS in Nursing and an MS as a Cardiopulmonary Clinical Nurse Specialist from UCLA.
Queenita Fernandes
Medical Safety Manager @Medtronic
Queenita Fernandes graduated with a Medical Degree in wholistic medicine from the Maharashtra State University, India and is a Certified Healthcare Practitioner & Patient Safety Professional. She has been working with Medtronic for 8 years in different roles and capacities. Her expertise ranges from medical and regulatory writing and promotional writing to complaint handling and research. In her current role as Medical Safety Manager she and her team focus on post-market literature surveillance in a proactive effort to identify patient safety events.