How the Medical Device Industry Can Prepare for the EU Regulatory Changes Ahead

Medical Device, Medical Device Safety and Regulation,
  • May 23, 2013 | 10am BST (UK) / 11am CEST (EU-Central) / 5am EDT (NA)
  • 0 min

Recording not available for this webinar

On 26 September 2012, the European Commission announced the release of a draft revision to regulations that will impact medical device and medical diagnostic manufacturers in the EU and abroad. These revisions will bring stricter requirements for clinical trial evidence and demand greater data quality. Is your organization prepared to comply?

Join this webinar to learn what all medical device companies need to know—hear it straight from expert authority, Janette Benaddi, CEO, Medvance, as she navigates through the proposed changes. Then, hear from trial management expert, Marcus Thornton, Senior Director, CTMS, Medidata Solutions to find out what tools are available to support compliance.

Topics include:

  • Requirements for clinical evidence
  • Potential regulatory notification changes
  • The emphasis on post market clinical follow up
  • Class II devices and regulatory clinical investigations
  • Tools available to support quality and compliance

Speakers

Janette Benaddi, RGN, BSc, MICR, CSci, CDir, MIOD, CEO, Medvance

Janette Benaddi is the CEO of Medvance™. The company provides clinical research and regulatory consulting services to the medical device and in-vitro diagnostic industries. Janette has over 20 years experience of managing pre and post market clinical studies in both devices and Pharmaceuticals. Prior to founding Medvance 14 years ago, Janette worked in Paris for a medical device consultancy group as Project Director in Clinical/Regulatory Affairs. Janette has also worked with several multinational organizations in various clinical, regulatory and marketing roles. She has extensive experience of conducting clinical studies with medical device products.

Janette is a registered nurse, has a BSc in Management studies, a Diploma in Company Direction, a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist. She is Chairman of the Knowledge Transfer Network Clinical Studies Special Interest Group. Janette has published several articles and sits on a number of committees involved in the regulation and standardization of medical device studies.

Marcus Thornton, Senior Director, CTMS, Medidata Solutions

Marcus Thornton is Senior Director of CTMS at Medidata Solutions. Marcus came to Medidata Solutions with over two decades of experience in the life science industry and currently serves as senior director, CTMS. Marcus has dedicated his career to creating efficiencies in the clinical trial process. He worked at two biotechnology companies in the 1990’s and established a life sciences communications company working with Large Pharma, which he merged with an international e-solutions consultancy in Europe. Most recently, Marcus co-founded Clinical Force, innovating the development of clinical trial management systems.

Who Should Attend?

  • Medical device clinical research professionals
  • Medical diagnostic clinical research professionals
  • Clinical operations
  • Professionals from CROs that specialize in medical device or diagnostic trials

Xtalks Partners

Medidata

Medidata Solutions is a leading global provider of cloud-based clinical development solutions that enhance the efficiency of clinical trials. Medidata’s advanced platform of technology, data and analytics lowers the total cost of clinical development across study activities, including study design, planning, execution and decision-making. Its industry-leading technology and analytics are used throughout the life sciences industry, including at more than 20 of the top 25 global Pharmaceutical companies as well as organizations of all sizes developing life-enhancing medical treatments and diagnostics.

Medvance

Medvance is a full service contract research organisation (CRO) specialized in medical devices, in-vitro diagnostics (IVDs), and combination products. For 15 years Medvance has been helping medical device companies to provide patients with quality medical technology that improves health and quality of life.

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