19 - 23 June 2023
Sheraton Brussels Airport HotelBrussels, Belgium (Hybrid Event)keyboard_arrow_right
Search & Filter keyboard_arrow_right
keyboard_arrow_left Hide
Day 1 - CET/CEST (Cent Europe Summer, GMT+2)
keyboard_arrow_leftSearch & Filter
search
Free / Premium
Streams
Formats
Day 1 - CET/CEST (Cent Europe Summer, GMT+2)
search
Free / Premium
Streams
Formats
08:00 - 08:3030 mins
Conference Registration
08:30 - 08:4010 minsFree
European Medical Device Regulations
Chairperson’s Opening Remarks
08:40 - 09:1535 minsFree
European Medical Device Regulations
MDR State of Play: Current Wins & On-Going Work
09:00 - 09:1010 minsFree
Medical Device Law and Compliance Track
Chairperson’s Opening Remarks & Welcome to Conference
- Fatima Sanfourche - Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer Pharma, Germany
09:00 - 09:1010 mins
Biocompatibility Workshop: Biological Evaluation Execution and Authorship Training
Chairperson’s Opening Remarks
- Beau Rollins - Director, Quality Services, ConvaTec
09:10 - 09:4030 minsFree
Medical Device Law and Compliance Track
Legal Perspective of the Changing Medical Device Landscape – Lessons learnt from EU MDR, application and areas of continued contention
- Elvan Sevi Bozoglu - Partner, Bozoglu Izgi Attorney Partnership
09:10 - 10:1565 mins
Biocompatibility Workshop: Biological Evaluation Execution and Authorship Training
Foundations to Biological Evaluations
- Beau Rollins - Director, Quality Services, ConvaTec
09:15 - 09:4530 minsFree
European Medical Device Regulations
SwissMed Update: Latest Regulatory Updates for the Swiss Market
- Daniel Delfosse - Executive Board Member, Director Regulatory Affairs, Swiss Medtech
09:40 - 10:1030 minsFree
Medical Device Law and Compliance Track
Legal Considerations when using in vitro Diagnostics in Clinical Trials
- Hilary Jones - Senior Director, Legal Pharmaceutical Regulation, BioNTech UK Limited
09:45 - 10:1530 minsFree
European Medical Device Regulations
UKCA: Where Are We Now?
- Steve Lee - Director, Diagnostics Regulation, Association of British HealthTech Industries (ABHI)
10:15 - 10:4530 mins
Coffee and Networking Break
10:45 - 11:3045 minsFree
European Medical Device Regulations
Industry Panel: Adhering to all European Requirements
- Trine Osterby - Director, Regulatory Affairs ImmunoAssay, Radiometer
- Klien van Dam - Director, Quality and Regulatory Affairs EMEA, Avanos Medical
- Alice Forde - Director, Regulatory Affairs Europe - Medical Devices, Bausch & Lomb
- Natasha Bankowski - Director of Regulatory Affairs and Quality Assurance, Beyond Air
- Nadine Nasr - Regulatory Affairs Manager, Intuitive Surgical
10:45 - 11:1530 minsFree
Medical Device Law and Compliance Track
Preparing for The New Product Liability Directive
- Andrew Austin - Partner, Global Co-Head of Consumer & Healthcare, Freshfields Bruckhaus Deringer
- Harriet Hanks - Senior Associate, Freshfields Bruckhaus Deringer
10:45 - 11:3045 mins
Biocompatibility Workshop: Biological Evaluation Execution and Authorship Training
Process in creating a Biological Evaluation Plan
- Beau Rollins - Director, Quality Services, ConvaTec
11:15 - 12:0045 minsFree
Medical Device Law and Compliance Track
What will AI mean for Product Liability, Health Data and Submission?
- Josefine Sommer - Associate, Sidley Austin, Belgium
- Monika Zdzieborska - Senior Managing Associate, Sidley Austin
- Ulrich Juknat - Legal Director – Regulatory Law, Johnson & Johnson
11:30 - 12:0030 minsFree
European Medical Device Regulations
Spotlight Session: Navigating European Medical Device Regulations
11:30 - 12:3060 mins
Biocompatibility Workshop: Biological Evaluation Execution and Authorship Training
Test design for BEP
- Beau Rollins - Director, Quality Services, ConvaTec
12:00 - 12:3030 minsFree
European Medical Device Regulations
1 Year On: MDCG 2022-5 Guidance on Borderline Products
- Oliver Hartmann - Legal and Regulatory Affairs Manager, Association of the European Self-Care Industry (AESGP)
12:00 - 12:3030 minsFree
Medical Device Law and Compliance Track
Market Access Considerations for Digital Health Technologies
- Sarah Cowlishaw - Partner, Covington & Burling LLP
- Raj Gathani - Associate, Covington & Burling LLP
12:30 - 14:0090 mins
Networking Luncheon
14:00 - 14:055 minsFree
European Medical Device Regulations
Chairperson’s Afternoon Remarks
14:00 - 14:055 minsFree
Medical Device Law and Compliance Track
Chairperson’s Afternoon Remarks
- Fatima Sanfourche - Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer Pharma, Germany
14:00 - 14:055 mins
Biocompatibility Workshop: Biological Evaluation Execution and Authorship Training
Chairperson’s Afternoon Remarks
- Beau Rollins - Director, Quality Services, ConvaTec
14:05 - 14:3530 minsFree
European Medical Device Regulations
Lessons Learned by Industry: Documenting Intended Purpose Consistently
- Mira Leiwant - Vice President Regulatory Affairs, Clinical Affairs and Quality Assurance, Anika Therapeutics, Inc.
14:05 - 14:3530 minsFree
Medical Device Law and Compliance Track
Status Update: Overcoming Electronic IFU Labelling Obstacles
- Ricardo Rocha - Senior Associate, PLMJ
14:05 - 14:5045 mins
Biocompatibility Workshop: Biological Evaluation Execution and Authorship Training
Understanding and interpreting test results
- Beau Rollins - Director, Quality Services, ConvaTec
14:35 - 15:0530 minsFree
European Medical Device Regulations
Experiences with being the Person Responsible for Regulatory Compliance (PRRC)
- Bettina Möbius - Head of Regulatory Affairs - Quality & Regulatory Affairs, Medical Division, Drägerwerk AG & Co. KGaA
14:35 - 15:0530 minsFree
Medical Device Law and Compliance Track
Legal Guidance around Medical Device and IVD Advertising Standards
- Erik Vollegbret - Partner, Axon Lawyers
14:50 - 15:3545 mins
Biocompatibility Workshop: Biological Evaluation Execution and Authorship Training
Transitioning into a Biological Evaluation Report
- Beau Rollins - Director, Quality Services, ConvaTec
15:05 - 15:3530 minsFree
European Medical Device Regulations
Is the EU MDR Extension a Blessing or a Curse?
- Joseph-Richardson Larbi - Regulatory Affairs Expert – Medical Devices, Celegence, Celegence
15:05 - 15:3530 minsFree
Medical Device Law and Compliance Track
Developments in Healthcare Data & Privacy: Compliance Considerations and Legal Implications for Device & IVD Manufacturers
- Elisa Stefanini - Partner, Portolano Cavallo
- Laura Liguori - Partner, Portolano Cavallo
15:35 - 16:0530 mins
Coffee and Networking Break
16:05 - 16:3530 minsFree
European Medical Device Regulations
Industry Perspective: Undergoing Conformity Assessments
- Robert van Boxtel - Principal Consultant, Medical Device Project B.V., The Netherlands
16:05 - 16:3530 minsFree
Medical Device Law and Compliance Track
Legal Case Study: TBC
16:05 - 16:5550 mins
Biocompatibility Workshop: Biological Evaluation Execution and Authorship Training
Toxicology Section
- Beau Rollins - Director, Quality Services, ConvaTec
16:35 - 17:0530 minsFree
European Medical Device Regulations
Best Practices: Keeping Technical Documents Up To Date
- Shaloo Sood - Product Development & RDI Academy, Straumann Group
16:35 - 17:3560 minsFree
Medical Device Law and Compliance Track
Industry Panel: Dealing with Regulatory Change
- Erik Vollegbret - Partner, Axon Lawyers
- Phillip Schmidt - Senior Legal Counsel EMEA, Zimmer Biomet
- Janine Reudt-Demont - Counsel, Niederer Kraft Frey (NKF)
- Fatima Sanfourche - Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer Pharma, Germany
16:55 - 17:4550 mins
Biocompatibility Workshop: Biological Evaluation Execution and Authorship Training
Life of the Biological Evaluation
- Beau Rollins - Director, Quality Services, ConvaTec
17:05 - 17:4540 minsFree
European Medical Device Regulations
Industry Panel: Interpreting the MDR
- Gert Bos - Executive Director & Partner, Qserve Group
- Nadine Nasr - Regulatory Affairs Manager, Intuitive Surgical
- Rina Sant - Principal Clinical Scientist EU MDR, Abbott
- Melanie Donguy - Head of Regulatory Affairs, Bayer
- Natasha Bankowski - Director of Regulatory Affairs and Quality Assurance, Beyond Air
17:45 - 18:4560 mins
Close of Day One
Get the Latest Event Updates
Sign up to get the latest event updates and information.
Filter
Free / Premium
Streams
Formats