MDR Clinical Evaluation Reports: Key Elements and Lessons Learned for Successful Compliance
About
Date/Time
February 25, 2021Access On-Demand Webinar Here.
As the MDR mandatory implementation date approaches, several manufacturers continue to question their preparedness for compliance. To date, NAMSA has supported numerous clients through MDR transitions and as a result, has gained unique perspectives from these projects, including Notified Body feedback.
NAMSA invites you to join us for this webinar, which will include a panel discussion with our medical writing experts. Attendees will walk away with unique solutions and strategies for successful MDR planning to meet the May 25, 2021 conformity date.
Highlighted will be discussion on:
- Insights and lessons learned from real-world client and Notified Body experiences
- How to expertly apply requirements for Clinical Evaluation Reports (CERs)
- Helpful considerations as the medical device industry approaches MDR deadlines
There will also be an opportunity to address the panel in a Q&A session during the last 15 minutes of the webinar. If you have a topic or question you would like to submit prior to the webinar, you can do so by contacting us at communications@namsa.com.
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Speaker
Adrian Keene, BSc (Hons)
Associate Vice President of Global Biological Safety & Validation and EMEA Consulting ServicesAdrian has more than 30 years of experience in product development and registration within the medical device industry, with manufacturer, regulatory agency, and consultancy perspectives. Adrian’s knowledge of new product development combined with EU regulatory requirements enables him to provide a balanced and pragmatic interpretation of the needs and expectations of both regulators and manufacturers. Before working at NAMSA, Adrian was Head of Notified Body for the UK Notified Body SGS and spent 10 years in the Notified Body sector, where he was responsible for conformity assessment activities of high-risk (class III) devices under the Medical Device Directive (MDD).
He is a toxicologist by training and worked for several years in the Research and Development (R&D) sector of the medical device industry, providing toxicological and risk management strategies to expedite product launches for multiple global registrations.
Severine Oudin-Fantin
Principal Medical WriterSeverine Oudin-Fantin has 15+ years experience as a Medical Writer with 10+ of those years focused in the medical device industry. She has been involved in the preparation of numerous Clinical Evaluation Reports for medical devices under MDD requirements, MEDDEV 2.7.1 Rev.4 and now MDR 2017/745. With a wide range of working knowledge in several therapeutic areas, Severine has been involved in the development of procedures and templates for clinical evaluation process and is involved in the training of the Medical Writing team at NAMSA. She received her PhD in 2004.
Federica Colonna
Principal Medical WriterFederica provides strategy and execution as part of NAMSA’s North American Medical Writing Services team with a focus on clinical evaluations and meta-analyses, assisting clients globally and across multiple medical fields. Prior to joining NAMSA, she worked in industry, specializing in Clinical Evaluation Reports (CERs) and publications. Earlier on, she spent a decade in scholarly publishing, managing a bio-medical publication and working with different publishers and academic organizations. She leverages her experience in medical and regulatory writing to help clients navigate interactions with Notified Bodies and prepare submissions. She has a Master’s of Science in Health Communications from Ecole Normale Superieure (Paris Saclay, formerly Cachan) and a Master’s of Science in Biology and Society from Arizona State University.