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Sponsored Webcast: Clinical Evaluations for Unique Product Types Under the EU MDR

1.5
RAC Credits
Wednesday, 11 November 2020 (11:00 AM) - Wednesday, 11 November 2020 (12:30 PM) Eastern Time (US & Canada)


The EU MDR (EU 2017/745) date of application, 26 May 2021, is quickly approaching, meaning expanded requirements for clinical evaluations. This webcast will provide an examination of the clinical evidence for unique product types and therapeutic areas, including combination products, software as a medical device (SaMD), and legacy devices. We will also discuss the new draft guidelines and requirements along with our teams approach for creating the necessary templates for these products. Following the presentation there will be a Q&A Panel for questions from the audience. This event will include a collection of individuals from the field. A representative from a Notified Body, subject matter expert, regulatory consultant, and others, will be partaking in our presentation and discussion panel to provide a comprehensive perspective on the challenges and solutions in preparing Clinical Evaluations.

Learning Objectives:

  • Overview of CE requirements for EU MDR Compliance
  • Strategies and approaches to consider for specific product types
  • Updates on regulations and guidance documents

Who Should Attend:

  • Quality Managers
  • Regulatory Affairs Team Members
  • Manufacturers’ Clinical Managers
  • Product Development Managers
  • Project Managers

Speakers:

·        Dr. Pratibha Mishra, Associate Manager of Medical Device Services, Celegence

Dr. Pratibha Mishra is an associate manager, Medical Device Services for Celegence where she leads a team of qualified medical writers. She has a Master’s degree in Oral Medicine and Maxillofacial Radiology and has written and reviewed regulatory documentation for medical devices covering a wide range of therapeutic areas – dentistry, ophthalmology, thoracopulmonology, gastroenterology, endoscopy, urology and dialysis, general surgery, electrosurgery, female reproductive health, cosmetic surgery, diagnostic and interventional radiology, and cardiology. Her team has successfully conducted clinical evaluations for complex devices including software as a medical device (SaMD) and drug-device combination products. She is experienced in developing MDR compliant templates for CER, CEP, PMCF Plan, and PMCF Report, and drafting responses to notified body observations on clinical evaluation.

·        Dr. Matthias Fink, Clinical Focus Team Manager - North America, TUV SUD

Dr. Matthias Fink is board-certified orthopedic and trauma surgeon with over 17 years of experience in orthopedic, trauma and reconstructive surgery and extensive training in cardiovascular and thoracic surgery. He has expert knowledge in the field of orthopedic implants and cardiac devices. Dr. Fink has also worked as a Clinical Reviewer for the Clinical Centre of Excellence for TÜV SÜD Product Service in Germany before joining TÜV SÜD America in 2017.  He is the Global Team Leader for the Ortho, Trauma and Dentistry Team within the Clinical Centre of Excellence of TÜV SÜD and the Team Manager of the Clinical Focus Team in North America. He has been a presenter at national and international conferences on the clinical requirements and the implementation of the EU MDR. Dr. Fink is also an external trainer on clinical and post-market aspects under the MDR for TÜV SÜD America. During his clinical career he has been an investigator and co-investigator in national and international clinical studies for medical devices and Phase III and IV clinical trials for pharmaceuticals.

·        Sharma Pokkuluri, Medical Device Regulatory Consultant, Celegence

Sharma Pokkuluri is an accomplished, analytical, and highly organized QMS auditor and regulatory affairs management professional with over 8 years of frontline experience successfully overseeing the drug pipeline and legal compliance of a leading CRO and ensuring stringent quality standards across diverse pharmaceutical research and market analysis.

·        Dr. John Bradsher, Medical Device Regulatory Expert, Celegence

John Bradsher is an RAC holder and subject-matter expert on regulatory affairs and quality assurance of medical devices for Celegence. He has a background in the EU MDR that is both broad and deep; he has managed the program for MDR compliance at a medium-sized manufacturer of vascular medical devices and managed the development of clinical evaluation documents for a global manufacturer, BauschHealth. His strong science and biotechnology background combined with his mastery of regulatory offers him a unique and knowledgeable perspective. He has cleared several 510(k)s and has worked on products in EU classes I-III in his 27 years of project management.

Audience Learning Level: Advanced

This webcast content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.

 

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