Speakers
Chris Doherty
Senior Lead GRA Software & Cybersecurity
Fresenius Medical Care Deutschland
Day Two
Thursday 27th June 2024
10:00 am | Panel Discussion: Where is AI Today & What is the Chance that Regulatory Bodies will Catch Up?
Pre Conference Track 1 AM
Tuesday 25th June 2024
9:00 am | Workshop A: Complying with FDA’s Guidance for Cybersecurity to Ensure Secure Product Development & Reduce the Likelihood of a Delayed Product Delivery
Nathan Sabich
Vice President, Head of Global Regulatory Affairs
Butterfly Network Inc.
Pre-Conference Track 2 AM
Tuesday 25th June 2024
12:00 pm | Workshop E: Exploring Strategies for Harmonized Compliance to Overcome Regulatory Variation in Global Product Development
Joshua Guo
Associate Director, Lead - Emerging Technologies Regulatory and Quality
Biogen
Pre-Conference Track 2 PM
Tuesday 25th June 2024
3:00 pm | Workshop F: Understanding the Terminology for the Different Types of Digital Health & How They Fit Together
Mary Ann Smith
Vice President Quality, Regulatory and Clinical
Chronus Health
Pre-Conference Track 2 PM
Tuesday 25th June 2024
3:00 pm | Workshop F: Understanding the Terminology for the Different Types of Digital Health & How They Fit Together
Michael Chibbaro
Vice President, Quality Assurance & Regulatory Affairs (QA & RA)
AppliedVR Inc.
Pre-Conference Track 2 PM
Tuesday 25th June 2024
3:00 pm | Workshop F: Understanding the Terminology for the Different Types of Digital Health & How They Fit Together
Ephrat (Ephi) Most
Sr Quality Systems Engineering Manager
Medtronic
Pre-Conference Trach 1 PM
Tuesday 25th June 2024
3:00 pm | Workshop C: Exploring the Latest & Greatest Techniques Related to Software Risk Management to Optimize Your Process
Sruti Lahkar
Senior Lead - Quality
Genentech
Pre-Conference Track 2 AM
Tuesday 25th June 2024
12:00 pm | Workshop E: Exploring Strategies for Harmonized Compliance to Overcome Regulatory Variation in Global Product Development
Damien Sharp
Director of Global Quality - Device Quality (Software)
AstraZeneca
Pre-Conference Track 2 AM
Tuesday 25th June 2024
12:00 pm | Workshop E: Exploring Strategies for Harmonized Compliance to Overcome Regulatory Variation in Global Product Development
William Sammons
Senior Manager Regulatory Affairs
Baxter BioPharma Solutions
Pre-Conference Track 2 AM
Tuesday 25th June 2024
9:00 am | Workshop D: Submission Pitfalls & Strategic Planning for Regulatory Success
Marc Neubauer
Director of Regulatory Affairs, Software
Baxter International Inc.
Pre-Conference Track 2 AM
Tuesday 25th June 2024
9:00 am | Workshop D: Submission Pitfalls & Strategic Planning for Regulatory Success
Canwen Liu
Senior Manager of Software Quality
Mevion Medical Systems
Pre Conference Track 1 AM
Tuesday 25th June 2024
12:00 pm | Workshop B: Evaluating & Managing Security Risks: CVSS vs STRIDE Methodologies
Leo Park
Sr. Dir of Cyber
Click Therapeutics
Pre Conference Track 1 AM
Tuesday 25th June 2024
12:00 pm | Workshop B: Evaluating & Managing Security Risks: CVSS vs STRIDE Methodologies
9:00 am | Workshop A: Complying with FDA’s Guidance for Cybersecurity to Ensure Secure Product Development & Reduce the Likelihood of a Delayed Product Delivery
Kevin Stevens
Head, Global Regulatory Affairs Device, PDT
Takeda Pharmaceutical Co. Ltd.
Pre Conference Track 1 AM
Tuesday 25th June 2024
9:00 am | Workshop A: Complying with FDA’s Guidance for Cybersecurity to Ensure Secure Product Development & Reduce the Likelihood of a Delayed Product Delivery
Monika McDole-Russell
Sr. Director, Regulatory Affairs
Medtronic
Day Two
Thursday 27th June 2024
1:30 pm | Exploring the Potential of Predetermined Change Control Plans (PCCP) in Medical Device Authorization
Mike Nakagawa
Research, Algorithm & AI Engineer
Philips
Day Two
Thursday 27th June 2024
11:30 am | Exploring AI Regulatory Requirements for FDA Submissions
Katrina Claflin
Software Systems Engineer
Abbott Laboratories
Day One
Wednesday 26th June 2024
9:00 am | Exploring Challenges & Solutions in Preventing Data Poisoning & Corruption in Medical Device Software Development
Pre-Conference Trach 1 PM
Tuesday 25th June 2024
3:00 pm | Workshop C: Exploring the Latest & Greatest Techniques Related to Software Risk Management to Optimize Your Process
Sabyasachi Roy
Head of Innovation & Strategy, Software Systems Design & Regulatory Affairs
Philips N.V.
Day Two
Thursday 27th June 2024
3:00 pm | Panel: Transforming Software Engineer Education for Industry Success
10:00 am | Panel Discussion: Where is AI Today & What is the Chance that Regulatory Bodies will Catch Up?
Stephen Odaibo
CEO & Founder
RETINA-AI Health, Inc
Day Two
Thursday 27th June 2024
12:00 pm | Navigating the Impact of Generative AI on Medical Device Manufacturers
10:00 am | Panel Discussion: Where is AI Today & What is the Chance that Regulatory Bodies will Catch Up?
8:50 am | Opening Remarks
Saloni Shah
Lead Engineer – Compliance
ResMed
Day Two
Thursday 27th June 2024
9:30 am | Leveraging Artificial Intelligence within QMS to Optimize Compliance for SaMD & SiMD Products
Pre-Conference Trach 1 PM
Tuesday 25th June 2024
3:00 pm | Workshop C: Exploring the Latest & Greatest Techniques Related to Software Risk Management to Optimize Your Process
Hasan Palaz
Principal Cyber Security Architect
GE Healthcare
Day One
Wednesday 26th June 2024
8:50 am | Chair’s Remarks
Day Two
Thursday 27th June 2024
9:00 am | AI/ML Security: Navigating Offensively & Defensively Uses
Jia Huang
Associate Director
Merck & Co
Day One
Wednesday 26th June 2024
4:00 pm | Keeping Up with Evolving Guidance & Regulations Related to Software Development
GANESH KIRAN
Principal Software Systems Test Engineer
Medtronic
Day One
Wednesday 26th June 2024
3:30 pm | Navigating Build-Test-Learn Cycles in a Regulated Environment to Balance Innovation & Compliance
Ginny Hu
Director, Regulatory Affairs
Dexcom
Day One
Wednesday 26th June 2024
2:30 pm | Roundtable Discussion: Building out a Software Bill of Materials for Embedded Packages, Open Source & Third-Party Software to Meet FDA Requirements & Ensure Regulatory Approval
Pre-Conference Track 2 PM
Tuesday 25th June 2024
3:00 pm | Workshop F: Understanding the Terminology for the Different Types of Digital Health & How They Fit Together
Kimberly Colasanti
Senior Manager – Regulatory Affairs
Baxter BioPharma Solutions
Day One
Wednesday 26th June 2024
2:00 pm | Best Practises for Streamlining Your Documentation Process to Save Time Whilst Complying with Regulatory Requirements
Pre-Conference Track 2 AM
Tuesday 25th June 2024
9:00 am | Workshop D: Submission Pitfalls & Strategic Planning for Regulatory Success
Aruna Thyagarajan
Senior Manager Robotics Software V&V
Johnson & Johnson Services, Inc
Day One
Wednesday 26th June 2024
12:30 pm | Roundtable Discussion: Transition of Security Risk to Patient Risk: From a Security Standpoint
Pre-Conference Trach 1 PM
Tuesday 25th June 2024
3:00 pm | Workshop C: Exploring the Latest & Greatest Techniques Related to Software Risk Management to Optimize Your Process
Gerald Rigdon
Fellow, Software Engineering
Boston Scientific
Day One
Wednesday 26th June 2024
11:30 am | Understanding the FDA Cybersecurity Final Guidance
Randy Horton
Co-Chair of Cloud Working Group and Technical Information Report
AAMI
Day One
Wednesday 26th June 2024
10:00 am | Ensuring Cloud Security & Regulatory Compliance: Strategies for Monitoring & Testing
David Nathans
Chief Information Security Officer
Siemens Healthcare GmbH.
Day One
Wednesday 26th June 2024
12:00 pm | Navigating Remote Services: A Comprehensive Approach to Security & Compliance
Brett Harris
Cybersecurity Officer, Americas
Siemens Healthcare GmbH.
Day One
Wednesday 26th June 2024
12:00 pm | Navigating Remote Services: A Comprehensive Approach to Security & Compliance
Irvin Mangwiza
Associate Director - SAMD Systems Engineering
Novo Nordisk
Day One
Wednesday 26th June 2024
9:30 am | Discussing Supply Chain Risk Management & its Implementation within the Medical Device Quality Management System
Day Two
Thursday 27th June 2024