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December 6 - 8, 2022
Intercontinental Chicago Magnificent MileChicago, ILkeyboard_arrow_right
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DAY TWO
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DAY TWO
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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
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