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Day 3 - Wednesday 17th June - CEST Time Zone
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Day 3 - Wednesday 17th June - CEST Time Zone
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Global Markets - Day 3
08:55 - 09:00
Chairperson Remarks
09:00 - 09:45
Navigating Medical Device & IVD Regulation in Emerging Market Opportunities
- Strategies for navigating diverse regulatory frameworks while ensuring compliance and market access
- Dealing with infrastructure gaps - how to leverage local partnerships and adapting to regional requirements to capitalize on emerging market growth
- IP risk and ensuring protection
- Sharing perspectives on cost-reduction
- Goran Adburrahman - Senior IVD Product Specialist, TÜV Rheinland
- Ed Woo - Regulatory Consultant, Independent
- Menna Bahr - Regional Regulatory Affairs GCC, Medtronic
- Priscilla Lemes - Regulatory Affairs Specialist - Product Life Cycle EMEACLA, Edwards Lifesciences
10:15 - 11:00
US Political Climate - Steering Through Supply Chain Turbulence
- Analysing the impact of the current US political climate on the MedTech regulatory landscape
- Discussing strategies for navigating supply chain disruptions and ensuring regulatory compliance amidst geopolitical and economic challenges - what new perspectives are there to supply chain management?
- How can we future-proof? What considerations need to be made in 2026 to stay ahead?
- Rene Zoelfl - Senior Director, Global Industry Advisor Life Science, PTC
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Global Markets - Day 3
11:30 - 12:00
Spotlight Presentation Opportunity
For more information, please contact Neha Singh at neha.singh@informa.com
12:00 - 13:15
Designing for Approval: Meeting FDA Expectations in Device Development
- Outlining key FDA expectations for medical device design and development, focusing on aligning innovation with regulatory requirements.
- Discussing strategies for integrating regulatory considerations early in the design process to streamline approval pathways.
- Practical take-aways for best practices to balancing device functionality, safety, and compliance to meet FDA standards effectively.
- Steve Weber - Assistant Professor, The Johns Hopkins School of Medicine
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