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Wednesday, Oct 4th
10:45 AM – 11:10 AM EDT
Sponsored Presentation: A combination Products Perspective on IDMP Implementation
Location/Room: Exhibit Hall: Discover! Stage (Booth 123)
Speaker: Padma Govindaiah – ArisGlobal
Presented by
Wednesday, Oct 4th
10:45 AM – 11:10 AM EDT
Sponsored Presentation: Considerations for Successful PMCF Survey Implementation
Location/Room: Exhibit Hall: Spark! Stage (Booth 323)
Speaker: Marcus Torr, MSci – Purdie Pascoe
Presented by
Wednesday, Oct 4th
10:45 AM – 11:10 AM EDT
Sponsored Presentation: Talent Management Strategies: The Hiring and the Hired
Location/Room: Exhibit Hall: Ignite! Stage (Booth 623)
Speaker: Darwin Shurig, RRT, MBA – Shurig Solutions, Inc
Presented by
Wednesday, Oct 4th
11:15 AM – 11:40 AM EDT
Sponsored Presentation: Improve Time to Value with Integrated Product and Regulatory Data
Location/Room: Exhibit Hall: Spark! Stage (Booth 323)
Speaker: Cameron Carr – Kalypso: A Rockwell Automation Company
Speaker: Mohammed Islaih – Zimmer Biomet
Presented by
Wednesday, Oct 4th
11:15 AM – 11:40 AM EDT
Sponsored Presentation: How AI will Power the Future of Proofreading in Pharma
Location/Room: Exhibit Hall: Discover! Stage (Booth 123)
Speaker: Arpad Lehoczki – GlobalVision
Speaker: Gabriella Naguib – GlobalVision
Presented by
Wednesday, Oct 4th
11:15 AM – 11:40 AM EDT
Sponsored Presentation: Using AI/ML Technology to Improve Regulatory Efficiency by 60%
Location/Room: Exhibit Hall: Ignite! Stage (Booth 623)
Speaker: Naushad Kapasi – Clarivate
Presented by
Wednesday, Oct 4th
11:45 AM – 12:10 PM EDT
Sponsored Presentation: Improving Operational Excellence and Patient Safety with MDDAP
Location/Room: Exhibit Hall: Spark! Stage (Booth 323)
Speaker: Kim Kaplan, BS, MA – ISACA
Presented by
Wednesday, Oct 4th
11:45 AM – 12:10 PM EDT
Sponsored Presentation: Steps to Prepare for Effective EUDAMED Product Data Syndication
Location/Room: Exhibit Hall: Ignite! Stage (Booth 623)
Speaker: Jay Crowley, MS – USDM Life Sciences
Speaker: Scott Brown – 1WorldSync, Inc.
Presented by
Wednesday, Oct 4th
11:45 AM – 12:10 PM EDT
Sponsored Presentation: UDI Essentials for Regulatory Affairs Teams
Location/Room: Exhibit Hall: Discover! Stage (Booth 123)
Speaker: James Gianoutsos, MBA – Rimsys
Presented by
Wednesday, Oct 4th
12:15 PM – 12:40 PM EDT
Sponsored Presentation: Global SSCP/SSP Implementation: Navigating the Challenges, Solutions, and Best Practices
Location/Room: Exhibit Hall: Discover! Stage (Booth 123)
Speaker: Nynne DeNiro – Acolad Life Sciences
Speaker: Stephane Millet – Acolad Life Sciences
Presented by
Wednesday, Oct 4th
12:15 PM – 12:40 PM EDT
Sponsored Presentation: How to Optimize a MDSAP/EU compliant QMS, including feedback on common issues
Location/Room: Exhibit Hall: Spark! Stage (Booth 323)
Speaker: Ken Pilgrim – Emergo by UL
Presented by
Wednesday, Oct 4th
12:15 PM – 12:40 PM EDT
Sponsored Presentation: Reimagine Regulatory Affairs in The Era of Generative AI
Location/Room: Exhibit Hall: Ignite! Stage (Booth 623)
Speaker: Michelle Wu – NyquistAI
Sponsored By
Wednesday, Oct 4th
12:45 PM – 1:10 PM EDT
Sponsored Presentation: Synergies for the EU Authorised Representative, UK Responsible Person and Swiss Authorised Representative
Location/Room: Exhibit Hall: Discover! Stage (Booth 123)
Speaker: Ludger Moeller – MDSS GmbH
Presented by
Wednesday, Oct 4th
12:45 PM – 1:10 PM EDT
Sponsored Presentation: Unlocking China's Market: A Guide to Overcome Access Barriers for Medical Devices
Location/Room: Exhibit Hall: Ignite! Stage (Booth 623)
Speaker: Jocelyn Zhu – BradyKnows Medical Group
Presented by
Wednesday, Oct 4th
12:45 PM – 1:10 PM EDT
Sponsored Presentation: Unveiling MoCRA: Revolutionizing Cosmetics Regulation and Empowering Manufacturers
Location/Room: Exhibit Hall: Spark! Stage (Booth 323)
Speaker: Melissa Stefko, MBA, MS, RAC, ASQ CPGP & CQA – The FlexPro Group
Speaker: Lisa Hawkins, ASQ CMQOE – Network Partners
Speaker: Philipp Papadopoulos – The FlexPro Group
Presented by
Thursday, Oct 5th
10:45 AM – 11:10 AM EDT
Sponsored Presentation: Risk Strategy & Risk Management for Medical Devices
Location/Room: Exhibit Hall: Ignite! Stage (Booth 623)
Speaker: Marielle Lejcher, CORe-Credential of Readiness in Business from Harvard Business School (HBS) – Fang Consulting
Presented by
Thursday, Oct 5th
10:45 AM – 11:10 AM EDT
Sponsored Presentation: What’s Next: The Evolution of Regulatory Submissions and Technology
Location/Room: Exhibit Hall: Spark! Stage (Booth 323)
Speaker: Heather Graham – Certara
Speaker: Trevor Standish – Certara
Presented by
Thursday, Oct 5th
10:45 AM – 11:10 AM EDT
Sponsored Presentation: Drive on the Regulatory Autobahn – Stretch Your Team with No Speed Limit
Location/Room: Exhibit Hall: Discover! Stage (Booth 123)
Speaker: Susan E. Carino, FRAPS, MBA, MS, PMP, RAC, SSM – Integrated Project Management Company, Inc.
Speaker: Rani Maloney, MBA, PMP, RAC – Integrated Project Management
Presented by
Thursday, Oct 5th
11:15 AM – 11:40 AM EDT
Sponsored Presentation: Crossing the eSTAR Chasm: How to Transition to FDA’s Mandatory 510(k) eSTAR Submission Process
Location/Room: Exhibit Hall: Ignite! Stage (Booth 623)
Presenter: Dhritikshama Roy, PhD – Essenvia
Presenter: Soumya Mahapatra – Essenvia
Presented by
Thursday, Oct 5th
11:15 AM – 11:40 AM EDT
Sponsored Presentation: FDA Forecast: The Biggest Issues Facing the FDA in 2024
Location/Room: Exhibit Hall: Discover! Stage (Booth 123)
Speaker: Alexander Gaffney, MS, RAC – POLITICO's AgencyIQ
Speaker: Laura DiAngelo, MPH – POLITICO's AgencyIQ
Presented by
Thursday, Oct 5th
11:15 AM – 11:40 PM EDT
Sponsored Presentation: Optimizing CER and PMS Document Writing with Technology and AI
Location/Room: Exhibit Hall: Spark! Stage (Booth 323)
Speaker: Waylon Wright – Celegence
Speaker: Joy Greidanus – Celegence
Presented by
Thursday, Oct 5th
11:45 AM – 12:10 PM EDT
Sponsored Presentation: PMS Beyond Regulations
Location/Room: Exhibit Hall: Spark! Stage (Booth 323)
Speaker: Claire Dyson – DQS Medizinprodukte UK Ltd
Speaker: Szymon Kurdyn – DQS Medizinprodukte GmbH
Presented by
Thursday, Oct 5th
11:45 AM – 12:10 PM EDT
Sponsored Presentation: Pharmaceuticals, Medical Devices, OTC’s and now Cosmetics – What to watch out for when managing a Product Recall
Location/Room: Exhibit Hall: Ignite! Stage (Booth 623)
Speaker: Ryan Gooley, MBA – Sedgwick
Presented by
Thursday, Oct 5th
11:45 AM – 12:10 PM EDT
Sponsored Presentation: Sustainability: potential challenges and solutions for the MedTech industry, Notified Bodies and auditing organizations.
Location/Room: Exhibit Hall: Discover! Stage (Booth 123)
Speaker: Linda Moon, MPhil. – BSI Group
Presented by
Thursday, Oct 5th
12:15 PM – 12:40 PM EDT
Sponsored Presentation: Managing regulatory change
Location/Room: Exhibit Hall: Spark! Stage (Booth 323)
Speaker: Bridget Wiseman – IQVIA
Presented by
Thursday, Oct 5th
12:15 PM – 12:40 PM EDT
Sponsored Presentation: The 80/20 Rule: How Digital Transformation & AI Are Changing Regulatory Intelligence
Location/Room: Exhibit Hall: Ignite! Stage (Booth 623)
Speaker: Immo Zdrojewski – Moderna
Presented By
Thursday, Oct 5th
12:15 PM – 12:40 PM EDT
Sponsored Presentation: Unlocking the Power of Retrospective PMCF Studies for EU MDR Compliance
Location/Room: Exhibit Hall: Discover! Stage (Booth 123)
Speaker: Jonathan Gimbel, PhD – RQM+
Speaker: Torrie DeGennaro – RQM+
Presented by
Thursday, Oct 5th
12:45 PM – 1:10 PM EDT
Sponsored Presentation: Global Medical Device UDI Status and How to Best Manage Diverse Compliance Rules
Location/Room: Exhibit Hall: Ignite! Stage (Booth 623)
Speaker: Gary Saner – LexisNexis Reed Tech
Presented by
Thursday, Oct 5th
12:45 PM – 1:10 PM EDT
Sponsored Presentation: The Future of Change Management for Cloud-Based AI/ML Medical Software
Location/Room: Exhibit Hall: Spark! Stage (Booth 323)
Speaker: Erez Kaminski, MS, MBA – Ketryx Corporation
Presented by