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Day Two – 11 June 2024 - CEST (Cent Europe Summer, GMT+2)
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Day Two – 11 June 2024 - CEST (Cent Europe Summer, GMT+2)
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European Medical Device Regulations
08:30 - 08:40
Chairperson’s Opening Remarks: European Medical Device Regulations
- James Shearn - Director, Regulatory & Quality Compliance (EMEA), Steris
08:40 - 09:40
Optimising the Regulatory Space: A New World of MDR?
- A review of the current regulatory ecosystem within Europe
- Is this the most effective way to get devices onto the market?
- What hurdles are there with the current system?
- Which solutions are there for increasing efficiency?
- The future of regulatory
- What opportunities and risks are there with a more centralised approach?
- How would this affect regulatory teams?
- What would the knock-on affect for the wider population be?
- Erik Vollebregt - Partner, Axon Lawyers
- Alice Forde - Director, Regulatory Affairs Europe at Bausch & Lomb., Bausch & Lomb
- Oliver Hartmann - Regulatory and Legal Affairs Director, Association of the European Self-Care Industry (AESGP)
09:40 - 10:10
Device Registry in Europe: EUDAMED & Beyond
EUDAMED is coming with mandatory usage from Q4 2025, do not be fooled it takes a long time to correctly prepare for EUDAMED. This session will highlight some of the pitfalls, experiences to date, and what is needed to submit your data to EUDAMED while keeping budgets as low as possible.
- Richard Houlihan - Founder & CEO, EirMed
10:10 - 10:40
MDR: Is It Really as Bad as You Think?
- Experience with MDR as of today
- Challenge(s) accepted! How far are the solutions?
- Perspectives on running a study in the EU
- Amie Smirthwaite - Senior Vice President, Scientific Affairs, RQM+
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European Medical Device Regulations
11:10 - 12:10
Power Hour: Maintaining and Repairing Legacy Devices
- With the abundance of MDD devices and components still available on the market, is MDR certification always commercially necessary for a legacy device?
- What kind of maintenance and repairs can be performed without triggering a significant change?
- Planning ahead: creating a plan for maintenance and transition
- Erik Vollebregt - Partner, Axon Lawyers
12:10 - 12:40
The role and responsibilities of the PRRC
- Regulatory requirements
- Who needs to have a PRRC
- Qualifications to be a PRRC
- Responsibilities and Liability of a PRRC
- Knowledge gained from interactions with Notified Bodies and Competent Authorities
- Elem Ayne - President, TEAM-PRRC
Showing 1 of 1 Streams
European Medical Device Regulations
14:10 - 14:15
Chairperson’s Afternoon Remarks: European Medical Device Regulations
- James Shearn - Director, Regulatory & Quality Compliance (EMEA), Steris
14:15 - 14:45
Regulatory Submission and Documentation: Path, Pitfalls and The Use of Artificial Intelligence
- Exploring the most common regulatory submission preparation pathways
- Discussing concerns regarding the current method of submission
- Looking at where regulatory submission and AI interlink and how this can streamline submissions
- Uncovering which parts of the regulatory submissions process can utilize AI most effectively
- Sharing resources and practical tips for implementation
- Priya Bhutani - CEO, RegDesk
14:45 - 15:15
The Latest News: European Health Data Space (EHDS)
- With the approval timeline expected in Q2 2024, what do we already know about the EHDS?
- Expected responsibilities of regulators, notified bodies and manufacturers
- Where does this link into the MDR & IVDR?
- Link to pharmaceutical industry
- Putting the EHDS into practice: a working example
- Cécile van der Heijden - Senior Attorney-at-Law, Axon Lawyers
15:15 - 15:45
GS1 and UDI Implementation under the EU MDR
- Introduction to GS1 as Issuing Agency
- Implementation of GS1 standards for Medical Devices. How to verify that the UDI-DI and B-UDI are valid? Latest information on Master UDI-DI.
- GS1 Belgium & Luxembourg solution to publish B-UDI and UDI-DI to the EUDAMED module Devices
- Patrick Ponsaerts - Manager Healthcare, GS1 Belgium & Luxembourg
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European Medical Device Regulations
16:15 - 16:45
The Current Challenges in the Benefit-Risk Determination of Medical Devices
- Berkin Güler, B. Sc. - Manager Medical Device Consulting & Lead Auditor, NSF Medical Device & IVD Consulting
16:45 - 17:15
Recruitment & Retainment: Ensuring Sustainability from the Inside Out
- With MDR now in full swing, how are teams coping with the workload?
- Impact of MDR on budgets and recruitment
- How can teams ensure employees remain happy and healthy at work?
- Strategies for coping with increased workloads on the same teams
- Giacomo Cargnello - Head of Quality & Regulatory, Connect&Control Solutions, Varex Imaging
- Tatsiana Ripich - Head of Regulatory Affairs, enmodes GmbH
17:15 - 18:00
EU MDR Open Forum: Ask the Experts
Have burning questions left over from the last 2 days? Take the opportunity to connect with our speakers and raise those final questions in our ‘Ask the Experts’ panel!
- Gert Bos - Executive Director & Partner, Qserve Group
- Giacomo Cargnello - Head of Quality & Regulatory, Connect&Control Solutions, Varex Imaging
- Daniel Delfosse - Executive Board Member, Director Regulatory Affairs, Swiss Medtech
- Tatsiana Ripich - Head of Regulatory Affairs, enmodes GmbH
- Richard Houlihan - Founder & CEO, EirMed
- Patrick Ponsaerts - Manager Healthcare, GS1 Belgium & Luxembourg
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