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MedTech Summit US
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MedTech Summit US
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8:00am - 9:00am60 mins
Registration
9:00am - 9:10am10 mins
US FDA Updates
Opening remarks from the Chairperson
- Ted Wilson - Partner, Hogan Lovells US LLP
9:10am - 9:15am5 mins
EU MDR Implementation
Opening remarks from the Chairperson
- Khaudeja Bano - Head of Medical Affairs, Abbott Molecular, US
9:10am - 9:45am35 mins
US FDA Updates
FDA’s increasing use of De Novo requests
- Lina Kontos - Counsel, Hogan Lovells US LLP
9:15am - 10:15am60 mins
EU MDR Implementation
EU Medical Device Regulations, Notified Body overview and update from BSI
- Jonathan Biss - Vice President of Sales and Services, Regulatory Services, Americas, BSI
9:45am - 10:20am35 mins
US FDA Updates
Understanding the changes affecting 510K device approval
- Reginald Swift - Senior Consultant, RQMIS Inc., USA
10:20am - 10:50am30 mins
Morning coffee and networking
10:50am - 11:25am35 mins
US FDA Updates
Scrutiny and inspection-readiness: Success strategies to prepare for FDA inspections
- Mercedes Bayani - Global Director Clinical and Regulatory Affairs, Bioness
10:50am - 11:25am35 mins
EU MDR Implementation
Sourcing and Selecting the Best Regulatory Writers and Consultants for Your Medical Device Operations
- Shelsea Stone - Manager – CER Writing, Global Medical Writing and Translation
11:25am - 12:25pm60 mins
EU MDR Implementation
Panel discussion: Sharing experiences of implementing the MDR
- Tanya Klaslo - Vice President, Corporate Regulatory Operations, BD
- Marcia A Orozco - Associate Director, Alcon
- Hugo Xi, MD, MBA - Director, Medical Affairs, Abbott Quality & Regulatory, Abbott Laboratories
11:25am - 11:55am30 mins
US FDA Updates
Panel discussion: How to use Real World Evidence to get your product on the market and to support your reimbursement strategy
- Joseph Sierra - Global Manager, Reimbursement, Health Economics & Health Policy, Medtronic
- Leora Schiff - Principal, Altius Strategy Consulting
11:55am - 12:25pm30 mins
US FDA Updates
FDA enforcement and postmarket safety surveillance
- Lina Kontos - Counsel, Hogan Lovells US LLP
12:25pm - 2:00pm95 mins
Networking lunch
2:00pm - 2:35pm35 mins
EU MDR Implementation
Optimizing Data Collection, Triage, and Output for CER Literature Reviews
- Peter O'Blenis - CEO, Evidence Partners
2:00pm - 2:35pm35 mins
US FDA Updates
Reimbursement: Assessing strategies for developing clinical evidence to demonstrate an effective product
- Joseph Sierra - Global Manager, Reimbursement, Health Economics & Health Policy, Medtronic
2:35pm - 3:10pm35 mins
EU MDR Implementation
Industry case study: Practically implementing the MDR (large company perspective)
- Marcia A Orozco - Associate Director, Alcon
2:35pm - 3:10pm35 mins
US FDA Updates
An update on the Medical Device Single Audit Program (MDSAP): Providing clarity on how the FDA is using MDSAP reports
- Maham Ansari - Director of Regulatory Affairs, Synaptive Medical, Canada
3:10pm - 3:40pm30 mins
Networking afternoon refreshments
3:40pm - 4:25pm45 mins
EU MDR Implementation
Strategies for maintaining your products on a global market
- Jennifer Bolton - Senior Fellow. Regulatory Affairs, Boston Scientific
3:40pm - 4:25pm45 mins
US FDA Updates
Strategies for maintaining your products on a global market
- Jennifer Bolton - Senior Fellow. Regulatory Affairs, Boston Scientific
4:25pm - 5:00pm35 mins
EU MDR Implementation
ISO 13485:2016 – Quality Management Systems (QMS) and the MDR: what’s new and how can industry prepare?
- Greg Jones - Business Sector Manager Medical Devices, SGS
4:25pm - 5:00pm35 mins
US FDA Updates
ISO 13485:2016 – Quality Management Systems (QMS) and the MDR: what’s new and how can industry prepare?
- Greg Jones - Business Sector Manager Medical Devices, SGS
5:00pm - 5:45pm45 mins
EU MDR Implementation
Panel discussion: Developing a successful global regulatory strategy: Best practice for gaining product approval in the US and the EU
- Maham Ansari - Director of Regulatory Affairs, Synaptive Medical, Canada
- Mercedes Bayani - Global Director Clinical and Regulatory Affairs, Bioness
- Judith A Svarczkopf - Principal Technical Advisor, Genentech, Inc., USA
5:00pm - 5:45pm45 mins
US FDA Updates
Panel discussion: Developing a successful global regulatory strategy: Best practice for gaining product approval in the US and the EU
- Maham Ansari - Director of Regulatory Affairs, Synaptive Medical, Canada
- Mercedes Bayani - Global Director Clinical and Regulatory Affairs, Bioness
- Judith A Svarczkopf - Principal Technical Advisor, Genentech, Inc., USA
5:45pm - 5:55pm10 mins
EU MDR Implementation
Chairperson's closing remarks
5:45pm - 5:55pm10 mins
US FDA Updates
Chairperson's closing remarks
6:35pm - 7:35pm60 mins
Networking Drinks - Exhibition Hall
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