Clinical Evaluation Reports: A Dive Into The World Of CERs And MedDev 2.7/1 Rev 4
May 12 @ 3:00 pm - 5:00 pm UTC-7$10 – $100
Clinical Evidence Reports (CERs) represent a key component to technical files, registration, and compliance in many countries. CERs are meant to provide a comprehensive overview of the medical device design and composition, intended usage and applications, clinical trials analysis and outcomes, relevant literature reviews, protocols and instructions for use. All of the supporting clinical evidence should be closely reviewed through a systematic critical appraisal process. The transition to MDR and IVDR in Europe has accelerated the need for up-to-date Clinical Evaluation Reports (CERs) that pass muster with multiple requirements including MedDEv 2.7/1 REV. This applies to every medical device sold in Europe irrespective of the risk classification and experience in the market. In the presentation, we will cover the nuances to meet requirements for the major countries/regions: including Europe’s Notified Bodies, Australia’s TGA, China’s NMPA, Brazil’s ANVISA, and Canada’s Health Canada. We will share about best practices and lessons learned for each of these regulatory reviews. We will also cover the new post-market surveillance requirements required by MDR that affect the CER.
*Feel free to email questions ahead of time! [email protected]
TOPICS COVERED INCLUDE:
- Best practices for the 4 key elements of the CER: Literature Review, Clinical Evidence, Equivalence, Post Market Surveillance
- Lessons learned from recent reviews under MDR, TGA, NMPA and ANVISA
- Strategies for global compliance
- Key differences between regulatory expectations
- Mengping Zhu, PhD, RAC, Global Clinical Science Manager, MicroVention, Inc
- Yiqun Zhou, PhD, Senior Medical Writer, Medical Affairs, MicroVention, Inc
- Zhu Hongyan, PhD/MD, Senior Medical Writer, MicroVention, Inc
- Eri Hirumi, Manager of International Regulatory and Compliance, MicroVention, Inc
- TJ Theil, RAC, Director and Principal Consultant, Brandwood CKC
PROGRAM MANAGER: LUIS JIMENEZ, MBA OCRA PAST-PRESIDENT, BRANDWOOD CKC
Mengping Zhu, Global Clinical Science Manager at MicroVention, Inc.
With a PhD degree in Chemistry, Mengping transitioned to Medical Device industry seven years ago. Through the years, he has accumulated broad experiences in regulatory science, clinical science, and medical affairs. Prior to joining MicroVention, he worked as a regulatory scientist at Cook Medical, supporting the global registration of all interventional radiology products. At MicroVention, Mengping supports China/EU/Australia CERs, PMCF projects, pre-market and post-market clinical studies, and real-world evidence generation for all MicroVention products.
Yiqun Zhou, Senior Medical Writer, MicroVention. Inc
Yiqun is a medical affair professional. In her 8 year healthcare industry experience, she works for Roche, Medtronic and Microvention from China to U.S. In her recent roles, she serves as a medical writer, supporting regulatory affairs for neurovascular medical devices to get approval in EU and China. Yiqun holds a Ph.D in immunology and published 20 articles in peer-reviewed journals.
Hongyan Zhu, Sr. Medical Writer at MicroVention, Inc
Hongyan drafts China/EU/Austrialian CERs to support regulatory submission and approval of MicroVention products. She has over ten years’ writing experience in academic and medical device fields. Her experience includes a blend of clinical, scientific, medical, and technical writing. Hongyan holds a medical degree from Nanchang University of China and a Ph.D. in Molecular Virology from Nagoya University School of Medicine of Japan.
Eri Hirumi, Manager of International Regulatory and Compliance for MicroVention, Inc.
She manages the global registration of neurovascular and peripheral implants and access catheters. Armed with over 25 years of experience in the Medical Device industry, she continues to expand her regulatory knowledge in pre and post-market regulatory requirements in the global market. Strong labeling and clinical knowledge aid in the facilitation of submissions for these high-risk products.
Terrance (TJ) Thiel, Director and Principal Consultant / Consulting Operations Brandwood CKC
TJ Thiel has worked in quality and regulatory affairs in the Australian, US and European medical device and diagnostics industries for more than 20 years. From major multinationals to small start-ups, TJ has deep experience with global regulatory approvals and registration, providing clients with planning and strategy suitable for both local and world-wide product launches. TJ has prepared, submitted and achieved significant approvals for medical devices – including active implantables (AIMDs), implantables and Software as Medical Device (SaMD) – and in vitro diagnostics including point-of-care, self-testing and laboratory devices. TJ holds Regulatory Affairs Certification (RAC) and has delivered regulatory approvals including FDA 510(k), PMA and De Novo; CE-marking; Health Canada; TGA; PMDA and NMPA.
- OCRA Members: $25
- Non-Members: $100, includes 1-year OCRA membership
- Government and Student Members: $10, with student/government ID
- Non-Member Government and Student Rate: $45, includes 1-year OCRA members
OCRA Registration Instructions
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OCRA’s non-profit Federal Tax ID# 33-0630455
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