Navigating new legislations and strategies to comply with regulatory requirements

SMi is proud to announce the launch of their Medical Devices and IVD conference to be held in London in November 2021.

The MDR and IVDR updates will have a profound impact on the medical device industry, bringing certain products into regulatory scope that were previously excluded, introducing new manufacturing requirements, and increasing the burden for post-market surveillance. What does this mean for the future of the Medical Devices and IVD industry?

SMi’s inaugural Medical Devices and IVD conference will provide insight into the latest updates in EU MDR and IVDR regulations and will discuss strategies for how to best comply with these new regulations. In addition, the conference will examine MHRA Guidance on Post-Brexit IVD Regulations and consider the evolving regulatory landscape for digital health software. Join Europe’s leading Medical Device and IVD Conference which will address post-market surveillance and vigilance, clinical evaluations and investigations, medical device regulatory affairs in global markets, and much more.

BENEFITS OF ATTENDING:

• Engage with notified body and competent authority representatives addressing key MDR and IVDR requirements
• Gain insights from pharma regulatory experts in compliance and companion diagnostics
• Understand the latest guidance on Post-Brexit IVD Regulations to overcome common challenges, in addition to considering evolving global regulations
• Examine post-market expectations for surveillance and vigilance of your medical devices
• Delve into how COVID-19 has impacted the MDR and IVD regulations

View the full agenda and speaker line-up online: www.medicaldevices-ivd.com/pjwl

Plus, post-conference workshop will be taking place on 17^th November in London:

Implementing the EU MDR and Article 117, An Industry Perspective

Workshop Leader: Blake Green, Senior Manager Regulatory Affairs, Amgen

EARLY-BIRD RATES:

• BOOK BY 30^TH JUNE AND SAVE £200
• BOOK BY 30^TH SEPTEMBER AND SAVE £100

Registrations can be made on the event website at: www.medicaldevices-ivd.com/pjwl

CHAIR FOR 2021:

Andreas Stange, Vice President, TÜV SÜD

HEAR FROM EXPERT INDUSTRY SPEAKERS:

• Jessica Wilkerson, Cyber Policy Advisor, FDA
• Susan Neadle, Executive Director, Combination Products, Devices, Diagnostics & Digital Health Regulatory Affairs, Amgen
• Claudia Dollins, Head, Precision Medicine & Companion Diagnostics, Bristol Myers Squibb
• Michael Benecky, Senior Director, Global Regulatory Affairs, UCB Biosciences
• Christophe Driesmans, Head of the Materiovigilance Entity, Federal Agency for Medicines and Health Products (FAMHP)
• Melanie Donguy, Head Regulatory Affairs EMEA, Bayer Radiology
• Marc Moal, Head of Product Delivery & Project Management, Merck Connected Health & Devices
• Jim Leamon, Director of Biologics Device Development, Jazz Pharmaceuticals
• Louise Place, Director, Devices, GlaxoSmithkline
• Stefan Strasser, Head of Department, Austrian Medicines and Medical Devices Agency