The Medical Devices and IVD Conference will launch for the first time in London, UK on November 14-15. The conference will examine the evolving regulatory landscape for digital health software.
Industry professionals will discuss post-marketing surveillance and vigilance, clinical evaluations and investigations, regulatory affairs for medical devices in global markets and much more.
Interested parties can register at http://www.medicaldevices-ivd.com/PR2PP – register by September 30 to save £100.
Delegates will have the chance to:
• Collaborate with Notified Body and Competent Authority representatives to meet key MDR and IVDR requirements
• Get insights from pharma regulatory experts on compliance and companion diagnostics
• Understand the latest guidelines on IVD regulations to overcome common challenges, in addition to considering changing global regulations
• Review post-market expectations for surveillance and vigilance of your medical devices
• Dig into advances in medical device digitization and the regulatory considerations surrounding it
SAE Media Group has released the keynote presentations that will take place at the Medical Devices & IVD conference, see below for an overview:
From Medical Device Development to Commercialization: Collaborations and Regulations presented by Amanda Matthews, Senior Director, Pfizer, which will cover:
•What are the biggest challenges when collaborating between medical device and pharmaceutical companies?
• What works well when collaborating across lifecycle management?
• Clarification of fundamental terms to improve communication (between manufacturers, regulators and pharmaceutical companies)
• Discussion on the impact of EU MDR and IVDR and how collaboration can be improved to optimize processes
The IVDR: What’s Learned So Far presented by Anne Whalen, former director of Novartis, it will cover:
• Discussion of current industry experience with deployment of IVDR
• Requirements for additional advice in Europe and other interpretations of the IVDR
• Explore the role of Notified Bodies with EMA – what is this consultation process?
• Review challenges and relationships with stakeholders (NB/manufacturers/EMA)
EU MDR Clinical Aspects: Review The Progress Of Implementation presented by Tom Melvin, Former Competent Authority Chair, Clinical Investigation and Evaluation Working Party, European Commission, the focus will be on:
• Evaluate EU MDR clinical aspects and compliance best practices
• Address common challenges for new devices versus old devices
• Looking Ahead: Gaps in Current Guidance and How to Address Them
Complying with the Medical Device Regulations: Strategies presented by Jim Leamon, Director, Jazz Pharmaceuticals, he will focus on:
• How can pharmaceutical companies work with Notified Bodies on endpoint expectations for MDR and IVDR compliance?
•Define the medical device product: what do I have?
• Life cycle management of medical devices
• The impact of the implementation of the new IVDR regulations and combination products and discussion of their strategies to extend the quality management system to meet manufacturers’ requirements
EU Regulatory Update: Software as a Medical Device presented by Sandra Beltran Rodil, Associate Director, Teva Pharmaceutical, this will cover:
• Explore the regulatory landscape of software as medical devices under the MDR (classification)
• Engage with a notified body
• Examine the life cycle management of software as medical devices
To learn more about the expert speakers joining the Medical Devices and IVD Conference, please visit: http://www.medicaldevices-ivd.com/PR2PP
For sponsorship enquiries, please contact Andrew Gibbons on +44 (0)20 7827 6156 or email [email protected]
For media inquiries or a press pass contact Marketing, Nikisha Galoria on +44 (0)20 7827 6154 or email [email protected]
Medical Devices and IVD Conference
November 14-15, 2022
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About SAE Media Group Conferences:
SAE Media Group Conferences connects global communities with targeted networking conferences. We provide our clients with solutions through industry knowledge and collaboration that enable our participants to return to their organizations better equipped to overcome their key business challenges. Our key events focus on defense and aerospace, pharmaceutical and medical. Each year, we bring together more than 5,000 top professionals at our conferences. http://www.smgconferences.com
SAE Media Group (SMG), a subsidiary of SAE International, brings the latest technological advances and design innovations to a global audience of nearly one million engineers, researchers and business leaders. SMG provides the essential information these professionals need to develop new and improved products and services.