keyboard_arrow_right
Search & Filter keyboard_arrow_right
keyboard_arrow_left Hide
DAY TWO
keyboard_arrow_leftSearch & Filter
search
Streams
Formats
DAY TWO
search
Streams
Formats
8:00am - 9:00am60 mins
Conference Registration
9:00am - 9:05am5 mins
Medical Device Regulation and Implementation
Chairperson's Opening Remarks
- Sara Paquette - Director, Medical Communications, Integra Lifesciences
9:00am - 9:05am5 mins
Biocompatibility
Chairperson's Opening Remarks
- Stephanie Taylor - Principal Scientist - Biocompatibility, Abbott
9:05am - 9:35am30 mins
Medical Device Regulation and Implementation
IMDRF Keynote: International Medical Device Regulatory Harmonization and Convergence
- Melissa Torres - Associate Director for International Affairs, CDRH, FDA
9:05am - 9:50am45 mins
Biocompatibility
Key Updates for the Revision of ISO 10993
- Justin Tettenborn - Manager Biocompatibility, Sterilization, & Microbiology, Fresenius Medical Care
9:35am - 10:05am30 mins
Medical Device Regulation and Implementation
Across the Pond: Status Update on UK Regulations for Medical and In Vitro Devices
- Steve Lee - Director, Diagnostics Regulation, ABHI
9:50am - 10:35am45 mins
Biocompatibility
Multi-Stakeholder Panel: Interaction of EU MDR and Biocompatibility
- James Lyons - Manager Biocompatibility, Abbott
- Nicole Soucy, Ph.D., DABT - Director, Global Toxicology and Biocompatibility, Boston Scientific
- Boopathy Dhanapal - Staff Scientist, Zimmer Biomet
10:05am - 10:35am30 mins
Medical Device Regulation and Implementation
Expert Session by Celegence
10:35am - 11:05am30 mins
Coffee and Networking Break
11:05am - 11:50am45 mins
Medical Device Regulation and Implementation
Industry Panel: Shared Experiences of Submitting under EU MDR
- Mike Wallenstein - Global Head Novartis MDR Implementation, External Engagement & DD&C Compliance, Novartis Pharma AG
- Dona O'Neil - Associate Director, Medical Affairs, BD
11:05am - 11:35am30 mins
Biocompatibility
Spotlight Session: Navigating Biocompatibility for Medical Devices
11:35am - 12:05pm30 mins
Biocompatibility
Global ‘de-harmonization’ of Biocompatibility Expectations”
- Nicole Soucy, Ph.D., DABT - Director, Global Toxicology and Biocompatibility, Boston Scientific
11:50am - 12:35pm45 mins
Medical Device Regulation and Implementation
Notified Body Feedback: Identifying and Demonstrating Intended Purpose under MDR and IVDR
- Sean O'Callaghan - Senior Scientific Officer-Certification & Inspection, Medical Devices, National Standards Authority of Ireland (NSAI)
12:05pm - 12:35pm30 mins
Biocompatibility
Spotlight Session: Navigating Biocompatibility for Medical Devices
12:35pm - 1:35pm60 mins
Networking Luncheon
1:35pm - 1:40pm5 mins
Medical Device Regulation and Implementation
Chairperson’s Afternoon Remarks
- Sara Paquette - Director, Medical Communications, Integra Lifesciences
1:35pm - 1:40pm5 mins
Biocompatibility
Chairperson’s Afternoon Remarks
- Robert Shulfer - Global Biocompatibility Director, Abbott
- Xiaoling (Sharlene) Dai, PhD, DABT - Senior Principal Toxicologist, Abbott
1:40pm - 2:30pm50 mins
Medical Device Regulation and Implementation
Panel: Guidance on Accessing the Medical Device Market in APAC
- Jack Wong - Lead, RAPV, NEA, Organon
- Ed Woo - Senior Director, Regulatory Affairs APAC, Varian, a Siemens Healthineer Company
1:40pm - 2:20pm40 mins
Biocompatibility
TBC
- Ted Heise, PhD, RAC - Vice President Regulatory & Clinical Services, MED Institute
2:20pm - 3:00pm40 mins
Biocompatibility
Practical Applications and Case Studies on ISO 10993-18
- Siyi Zhang, PhD - Principal Chemist, and Scott Citrowske, Sr. Chemistry Manager, Abbott
2:30pm - 3:00pm30 mins
Medical Device Regulation and Implementation
Expert session by Acolad
3:00pm - 3:40pm40 mins
Medical Device Regulation and Implementation
Practical Application for Managing Global Regulatory Intelligence
- Rene Hardee - Regulatory Affairs Manager, Hologic, Inc
3:00pm - 3:40pm40 mins
Biocompatibility
Revisions to ISO 10993-17 and Expectations of Regulatory Authorities
- Ron Brown - Owner and Prinicipal Toxicologist, Risk Science Consortium, LLC
3:40pm - 4:10pm30 mins
Coffee and Networking Break
4:10pm - 5:10pm60 mins
Medical Device Regulation and Implementation
Multi-Stakeholder Panel: Dealing with Capacity Concerns
- Andreas Stange - Vice President,, TÜV SÜD
- Sean O'Callaghan - Senior Scientific Officer-Certification & Inspection, Medical Devices, National Standards Authority of Ireland (NSAI)
- Steve Lee - Director, Diagnostics Regulation, ABHI
4:10pm - 4:50pm40 mins
Biocompatibility
Practical considerations and case studies on the implementation of final draft ISO 10993 Part 17 in biological safety risk evaluation
- Xiaoling (Sharlene) Dai, PhD, DABT - Senior Principal Toxicologist, Abbott
- Jean Bendaly, PhD, DABT - Principal Toxicologist, Medtronic
4:50pm - 5:35pm45 mins
Biocompatibility
Multi-Stakeholder Panel: Shared Experiences of Navigating Regulatory Challenges on Chemical Characterization & Toxicological Risk Assessments
- Robert Shulfer - Global Biocompatibility Director, Abbott
- Xiaoling (Sharlene) Dai, PhD, DABT - Senior Principal Toxicologist, Abbott
- Ron Brown - Owner and Prinicipal Toxicologist, Risk Science Consortium, LLC
- Siyi Zhang, PhD - Principal Chemist, and Scott Citrowske, Sr. Chemistry Manager, Abbott
- Jean Bendaly, PhD, DABT - Principal Toxicologist, Medtronic
- Ted Heise, PhD, RAC - Vice President Regulatory & Clinical Services, MED Institute
5:10pm - 5:50pm40 mins
Medical Device Regulation and Implementation
Utilising Real World Evidence (RWE) in Regulatory Decision Making
- George Faithfull - Director, George Faithfull Advisory
- Stephen Weber - Assistant Professor, The Johns Hopkins School of Medicine
5:50pm - 6:50pm60 mins
Close of Day Two and Networking Reception
Get the latest news.
As it happens
Sign up to get the latest on the agenda and speakers.
Filter
Streams
Formats
Choose Day