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All times GMT |
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Delegates have the option to follow an MD stream or an IVD stream for the next two sessions. |
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9:00 – 10:30 |
MD3: Navigating the Regulatory Maze: Challenges of Medical Device Software
Session Leader:
Dr. Célia Cruz – Chief Regulatory Affairs Officer, Complear Health, Portugal
As the healthcare industry rapidly embraces digital transformation, medical device software has gained significant momentum. However, with the implementation of the Medical Devices Regulation (MDR), manufacturers and different stakeholders are faced with many challenges. This panel brings together industry experts to shed light on the complex landscape of regulation from the medical device software perspective. Discover how to navigate the MDR's rigorous classification process, ensure robust clinical evaluations, and address the unique challenges associated with medical device cybersecurity and privacy. Through practical insights and expert advice, this panel aims to equip attendees with the knowledge and strategies needed to overcome obstacles and thrive in the evolving landscape of medical device software.
Speakers will include:
Mariana Madureira – Senior Officer at Health Products Directorate, Infarmed, Portugal
Introduction, concepts and challenges from Competent Authority perspective, including qualification medical device software and hardware-software interaction.
Abtin Rad – Global Director Functional Safety, Software and Digitization, TÜV SÜD Product Service GmbH, Germany
Concepts and challenges from Notified Body perspective, including cybersecurity and artificial intelligence.
Erik Vollebregt – Partner / Attorney-at-Law, Axon Lawyers, the Netherlands
Concepts and challenges from the industry perspective, including artificial intelligence challenges and economic operators.
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| 9:00 – 10:30 |
IVD3: IVDR: The Current State
Session Leaders:
Amanda Brown – Director of Quality and Regulatory Affairs, HP, Germany
Ashleigh Batchen – Regulatory Strategy Principal (UK), TÜV SÜD, UK
Now that IVDR has accumulated in the last few years, this session offers an update on the current status of IVDR progression and implementation within the European Union. During this session we will hear perspectives from a range of stakeholders covering what has been observed so far, lessons learned, and what is coming in the future.
Speakers will include:
Olga Tkachenko – Policy Officer, European Commission, Belgium
Stefan Burde – Director Global Focus Team IVD, TÜV SÜD Product Service, US
Dr. Lena Björk – Director Supervision, Läkemedelsverket/Medical Products Agency (MPA), Sweden
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10:30 – 11:00
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Networking break
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11:00 – 12:30 |
MD4: Challenges and opportunities for small companies and start ups
Session Leader and Chair:
Margareth Jorvid – Chief Executive Officer, Methra Uppsala AB, Sweden
Bringing a medical device to market is a challenge, especially as a small company or startup. This session will address the challenges faced by small companies based in Europe but also in other regions, share experience of implementation of the new Regulation (EU) 2017/745 (MDR) and discuss how to CE mark your device. How to do the right things from the start and use the right tools. How to approach and talk to a Notified Body. In the end it is making your device available to the benefits of patients that counts.
Speakers will include:
Martin Witte – Senior Director, TÜV SÜD GmbH, Germany
There will be an MDR update, coverage timelines and a discussion on how to support innovation. Notified body perspectives will be explored and guidance on what to do and not do.
Hasnaa Fatehi – Founder and Principal Consultant, Qaralogic Consulting, Inc., Canada
The EU-MDR Experience will be covered with accounts from Canada to Taiwan.
André Fazenda – Regulatory Affairs, Peek Health, S.A., Portugal
Sharing experiences of Medical Device Regulation (MDR) from a local company in Portugal.
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| 11:00 – 12:30 |
IVD4: How to Manage Diverging Regulatory Strategies within a Global Market (China, US, and EU)
Session Leaders:
Amanda Brown – Director of Quality and Regulatory Affairs, HP, Germany
Ashleigh Batchen – Regulatory Strategy Principal (UK), TÜV SÜD, UK
The global focus and distribution strategies of many IVD companies, combined with diverging international regulatory requirements, leave many regulatory professionals challenged with how to meet commercial launch timelines. This session will compare some of the regulations and requirements for submission across selected global markets, and discuss possible options to optimize efficiencies.
Speakers will include:
Maurizio Suppo – Vice President – Principal Consultant, QARAD - QbD Group, Belgium
Hamish King – Chief Executive Officer, Cisema, Hong Kong
Dr. Karin A. Hughes – Senior Vice President, Global Regulatory and Quality, Beaufort, US
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12:30 – 14:00 |
Lunch |
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14:00 – 15:30 |
MD5: Post-market challenges
Session Leader:
Natasha Bankowski – Director of Regulatory Affairs and Quality Assurance, Beyond Air Ireland Ltd, Ireland
For IVD and Medical Device manufacturers, post-market and vigilance challenges, as well as maintaining regulatory intelligence have increased significantly with the MDR, IVDR and other global changes. The impact of these challenges places a huge burden on companies and resources to keep up with these complex challenges.
Post-market surveillance activities even for the lowest risk classes have dramatically increased along with your vigilance requirements. Keeping a product state of the art and on the market post-launch may prove to be even more difficult for some companies than actually launching the product.
This session will bring together key stakeholders from the competent authority, notified body and industry to discuss these challenge and provide some guidance on solutions that may help going forward.
Speakers will include:
Maria Raquel Alves – Healthcare Products Vigilance Unit Director, Infarmed, Portugal
Vigilance and Reporting challenges for Medical Devices and IVDs.
- Vigilance a part of Post-market Surveillance System
- Vigilance reporting according MDR and IVDR
- Some of the main challenges on vigilance reporting according MDR and IVDR
Alice Forde – Director, Regulatory Affairs Europe, Bausch + Lomb, Ireland
Maintaining Regulatory Intelligence post-market.
- Shared challenges – multinationals, SMEs and everything in between
- Local vs Regional requirements – what happens when they don’t align?
- Importance of being connected to your network
Richard Vincins - VP Global Regulatory Affairs, Oriel STAT A MATRIX, United Kingdom
Post Market Surveillance challenges and solutions
- PMS Planning – Addressing timing of reports and correct source input
- Economic Operator challenges and their role in the PMS system
- Linkages of Risk Management and Significant changes to the PMS system
- Case study in relation to a PMS report
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| 14:00 – 15:30 |
IVD5: Class D IVDs
Session Leader:
Amanda Brown – Director of Quality and Regulatory Affairs, HP, Germany
Ashleigh Batchen– Regulatory Strategy Principal (UK), TÜV SÜD, UK
This session will look at the challenges, solutions and requirements.
Due to the increased risk associated with specific IVDs, the IVDR places additional regulatory scrutiny on these products. This session will navigate some of these additional complexities for class D IVDs, including reference laboratories, post-market surveillance requirements, and how to manage conformity assessment.
Speakers will include:
Maurizio Suppo – Vice President - Principal Consiltant, QARAD - QbD Group, Belgium
Stefan Burde – Director Global Focus Team IVD, IVD Focus Team, TÜV SÜD, US
Dr. Stefan Scheib - Global Head of Regulatory Affairs (Network), Core Lab, Roche Diagnostics (RDS), Germany
Thomas McDonagh - Associate Director Regulatory Affairs (IVDR), Abbott Core Diagnostics, Ireland
Panellists will include:
Olga Tkachenko – Policy Officer, European Commission, Belgium
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End of the Medical Devices/IVDs Symposium
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