Day Two – 11 June 2024 - CET/CEST (Cent Europe Summer, GMT+2)
Day Two – 11 June 2024 - CET/CEST (Cent Europe Summer, GMT+2)
- James Shearn - Director, Regulatory & Quality Compliance (EMEA), Steris
- 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 Vollegbret - Partner, Axon Lawyers
- Alice Forde - Director, Regulatory Affairs Europe at Bausch & Lomb., Bausch & Lomb
- Oliver Hartmann - Legal and Regulatory Affairs Manager, Association of the European Self-Care Industry (AESGP)
- Nadine Nasr - Senior Manager, Regulatory Affairs, Intuitive Surgical
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
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
- 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 Vollegbret - Partner, Axon Lawyers
- Daniele Bollati - Product Conformity Assessment, IMQ
- 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
- James Shearn - Director, Regulatory & Quality Compliance (EMEA), Steris
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
- 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
- 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
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
- 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
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