The EU MDR & IVDR Online Summit will guide you through the latest challenging updates on MDR and IVDR, including successful and competitive strategies, regardless of you’ve fully transitioned, just getting started, or planning to enter the EU market in the future.
Are ready to hit the IVDR deadline on 26 May 2022? This event will prepare you for the rapidly approaching deadline, answer your questions on quality and risk management, clinical evaluation, NB successful submission, and post-market surveillance.
Join us to explore industry case studies, Notified Body feedback, and discussions with device development professionals and pharma leads!
The Main Topics
Current status of implementation MDR and IVDR
Number of available NB and their scope of designation
Initial certification experience with both regulations
Recommendations to improve your submission and reduce the certification timelines
Challenges and Requirements under IVDR
IVDs state of play
Post-market performance follow-up and post-market surveillance under IVDs
COVID-19 pandemic and its impact on IVDR implementation
Effective Management of Risk and Clinical/Performance Evaluation in a global regulatory environment
Regulatory Dynamics from EU and some other countries
Key challenges in managing different or similar requirements
Some thoughts in optimizing the management on Risk and Clinical Evaluation
Dr. Philippe Auclair
Senior Director Regulatory Strategy
Philippe joined Abbott in 1994.
He represents European Industry in various European Commission expert groups and actively participates as trainer in programs organized by Regulatory Authorities around the world. Since 2015 he is an Industry advisor to the Asian Harmonization Working Party Technical Committee.
He is Chairman or co-chair of the Post Market Surveillance, the Notified Body, the International Regulatory and the clinical Working Groups of the European medical device manufacturers’ trade association Medtech Europe.
He is a member of the European Advisory Committee and of the board nominating committee of the Regulatory Affairs Professional Society (RAPS). Philippe received the “Global Leadership Award” from RAPS in 2010, has been elected “RAPS Fellow” in 2012.
Philippe is also the proud recipient of an FDA CDRH Director’s “Special Citation” for his work at Global Harmonization Task Force
Executive Director, Combination Products,
Devices, Diagnostics & Digital Health Regulatory Affairs,
Susan Neadle recently joined Amgen as Head of Devices, Combination Products, Digital Health, and IVD Regulatory Affairs. Prior to Amgen, Susan had a distinguished 25+ year-career at Johnson & Johnson, including integral leadership roles in R&D and Quality Engineering, spanning medical devices, pharmaceuticals, consumer products, and the Enterprise. In her most recent role, Sr. Director, Global Value Chain Quality Design, she served as Chair of J&J’s Design Council, advancing world-class practices in product and process design and development to drive robust, customer-centric health care solutions across J&J. She also led J&J’s Combination Products Community of Practice. Among several achievements, Susan led the team that defined and implemented the globally integrated busi- ness model to meet Combination Products regulations at Janssen, J&J’s Pharmaceutical sector. She was awarded the Janssen Supply Chain Inclusion Award in recognition of her global cross-functional leadership and collaboration. She has applied her Design Excellence Blackbelt skills to drive and develop impactful new products and positive business outcomes, for which she was awarded the Johnson Medal, J&J’s highest honor for innovation excellence. She holds numerous patents and publications and frequently speaks in public venues. Susan is actively engaged in multiple industry working groups on a range of Combination Products topics, including, among others, ASTM International, CPC, EFPIA, AdvaMed, Xavier/FDA Combination Products Summit Planning Committee, DIA Programming Committee, PDA, and ISPE. She serves as Chair of the ISPE Combination Products Community of Practice and as Vice-Chair of the Combination Products Coalition PMSR Working Group. Susan earned an M.S. in polymer science & engineering, and a B.S. in biology/ chemistry, as well as a Fellowship in the American Academy of Optometry.
Dr. Claudia Dollins
Precision Medicine & Companion Diagnostics
Dr. Weiping Zhong
Risk Management/HHE, Clinical Evaluation,
Cybersecurity Safety, Statistics
Dr. Weiping Zhong is the Global Director of Risk Management for GE Healthcare, leading risk management, cybersecurity-safety risk management and clinical evaluation for all GEHC device products covering imaging, patient care and digital healthcare. Prior to joining GEHC in 2012, Weiping held multiple positions in Bayer Healthcare – Diabetes Care from 2002, including QA/RA head for APAC, Statistician, Reliability and Quality Engineer. He graduated from the University of Michigan and Dalian University of Technology in the fields of Mechanical Engineering, Industrial/Operations Engineering and Electric Engineering.
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