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Securing AI Solutions in Medtech Products

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Xander C.W Heemskerk, ing CISSP CCSK – Royal Philips ### 1187568###Presenter###Director Product Security###Royal Philips###
Presenter: Xander C.W Heemskerk, ing CISSP CCSK – Royal Philips
###
SESSION IS FULL Circle: Essentials of EU Regulatory Intelligence; Overview of Key Aspects of Regulatory Intelligence

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Denis Burkhalter, MSc (he/him/his) – Novartis ### 2177825###Presenter###Regulatory Policy and Intelligence, AD###Novartis###
Presenter: Denis Burkhalter, MSc (he/him/his) – Novartis
### he/him/his
SESSION IS FULL Repeat: Solutions Circle: RA-GPT – The Future of the Regulatory Profession
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Florian Tolkmitt – PRO-LIANCE GLOBAL SOLUTIONS GmbH ### 2016361###Presenter###Managing Director###PRO-LIANCE GLOBAL SOLUTIONS GmbH###
Presenter: Florian Tolkmitt – PRO-LIANCE GLOBAL SOLUTIONS GmbH
###
SESSION IS FULL: Solutions Circle: RA-GPT – The Future of the Regulatory Profession

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Florian Tolkmitt – PRO-LIANCE GLOBAL SOLUTIONS GmbH ### 2016361###Presenter###Managing Director###PRO-LIANCE GLOBAL SOLUTIONS GmbH###
Presenter: Florian Tolkmitt – PRO-LIANCE GLOBAL SOLUTIONS GmbH
###
Solutions Circle: Cyber Security – Pitfalls for IVDR Technical File Submission

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Alexander Stock (he/him/his) – TÜV SÜD ### 1827167###Presenter###Project Manager IVD Medical Device Testing###TÜV SÜD###
Presenter: Alexander Stock (he/him/his) – TÜV SÜD
### he/him/his
Solutions Circle: Effective Strategies for High-Quality Clinical Data Collection Through Post-Market Clinical Follow-Up (PMCF) Surveys and Medical Device Registries

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Catarina Carrão – BioSciPons ### 1828303###Presenter###Clinical Evaluation Specialist###BioSciPons###
Presenter: Catarina Carrão – BioSciPons
### @@@ Marcus Torr, MSci – Purdie Pascoe ### 1550370###Presenter###PMCF / MDR Lead###Purdie Pascoe###
Presenter: Marcus Torr, MSci – Purdie Pascoe
###
Solutions Circle: Effective Strategies When Approaching Regulatory Due Diligence Under the MDR

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Matt Royle, PhD – NAMSA ### 907121###Presenter###Principal Regulatory Consultant###NAMSA###
Presenter: Matt Royle, PhD – NAMSA
###
Solutions Circle: How Does the SSCP Improve Patient Safety in Less Than 100 Pages?

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Florian Tolkmitt – PRO-LIANCE GLOBAL SOLUTIONS GmbH ### 2016361###Presenter###Managing Director###PRO-LIANCE GLOBAL SOLUTIONS GmbH###
Presenter: Florian Tolkmitt – PRO-LIANCE GLOBAL SOLUTIONS GmbH
###
Solutions Circle: How to Distinguish General and Specific PMCF Activities

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Ivan Stoyanov – SGS Notified Body, 1639 ### 2179081###Presenter###In-house clinician###SGS Notified Body, 1639###
Presenter: Ivan Stoyanov – SGS Notified Body, 1639
###
Solutions Circle: Intended Purpose, Device Classification, NB Codes, and Corresponding Types of Devices/Sampling TD Under the IVDR

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Marta Carnielli, PharmD – TUV Sud GmbH ### 1187616###Presenter###Head of Certification IVD###TUV Sud GmbH###
Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
###
Solutions Circle: Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF) According to The IVDR

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Marta Carnielli, PharmD – TUV Sud GmbH ### 1187616###Presenter###Head of Certification IVD###TUV Sud GmbH###
Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
###
Solutions Circle: The Time is Now: The Journey to Becoming RCC Certified!

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Jennifer Naughton, MEd, ICE-CCP, SPHR, CAE – RAPS ### 1763591###Presenter###Director of Credentialing###RAPS###
Presenter: Jennifer Naughton, MEd, ICE-CCP, SPHR, CAE – RAPS
###
Solutions Circle: What Can Manufacturers Learn From Effective PMS/PMPF Strategies to Strengthen Their Clinical Evidence With The IVDR Transition Deadline Approaching?

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Warren Jameson, Bsi, PhD, MTOPRA – NAMSA ### 1529415###Presenter###Senior Manager, Regulatory and Quality###NAMSA###
Presenter: Warren Jameson, Bsi, PhD, MTOPRA – NAMSA
###
Sponsored Presentation: 3 Changes Affecting MedTech Regulatory Teams

Sponsored By
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Priya Paul – RegDesk, Inc. ### 2315849###Presenter###Founder and CEO of RegDesk###RegDesk, Inc.###
Presenter: Priya Paul – RegDesk, Inc.
###
Sponsored Presentation: Clearing Up EUDAMED Confusion for MedTech Regulatory Teams

Sponsored By
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Adam Price, MBA – Rimsys ### 1428928###Presenter###Director of Regulatory and Technical Programs###Rimsys###
Presenter: Adam Price, MBA – Rimsys
###
Sponsored Presentation: Consolidating Economic Operators for Market Access Globally

Sponsored By
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Daniëlle Sleegers – MedEnvoy Global ### 2290126###Presenter###Director Regulatory Affairs & PRRC###MedEnvoy Global###
Presenter: Daniëlle Sleegers – MedEnvoy Global
###
Sponsored Presentation: How It Works: Your Questions About Notified Bodies and Testing Houses Answered

Sponsored By
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Martin Witte – TÜV SÜD Medical & Health Services ### 1187576###Presenter###Senior Director Strategic Business Development###TÜV SÜD Medical & Health Services###
Presenter: Martin Witte – TÜV SÜD Medical & Health Services
###
Sponsored Presentation: How To Accelerate Global Market Entry and To Reduce Time-To-Market? A Notified/Certification Body Perspective

Sponsored By
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Nabil Riahi – GMED SAS ### 2304183###Presenter###Sales Director###GMED SAS###
Presenter: Nabil Riahi – GMED SAS
### @@@ Thomas Lloret – GMED ### 2304184###Presenter###Group Key Account Manager###GMED###
Presenter: Thomas Lloret – GMED
###
Sponsored Presentation: MDR Has Come: A Call for a Proactive Boost in Medtech Innovation Industry

Sponsored By
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Alessandro Malaspina, MA (he/him/his) – 1 MED ### 2290120###Presenter###Head of Regulatory Affairs###1 MED###
Presenter: Alessandro Malaspina, MA (he/him/his) – 1 MED
### he/him/his
Sponsored Presentation: Navigating The Future - Insights From The 2024 State Of Medtech Report

Sponsored By
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Eric Gaidis – Greenlight Guru ### 2304185###Presenter###Account Executive - Team Lead###Greenlight Guru###
Presenter: Eric Gaidis – Greenlight Guru
###
Sponsored Presentation: Objective-Driven Systems: How To Build Effective and Continuous Regulatory Intelligence and Clinical Surveillance

Sponsored By
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Ivan Perez Chamorro – MedBoard ### 1949784###Presenter###CEO###MedBoard###
Presenter: Ivan Perez Chamorro – MedBoard
###
Sponsored Presentation: PMCF Surveys: From Plan to Action

Sponsored By
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Marcus Torr, MSci – Purdie Pascoe ### 1550370###Presenter###PMCF / MDR Lead###Purdie Pascoe###
Presenter: Marcus Torr, MSci – Purdie Pascoe
### @@@ Tonika R. Chester – Purdie Pascoe ### 2179082###Presenter###PMCF Manager###Purdie Pascoe###
Presenter: Tonika R. Chester – Purdie Pascoe
###
Sponsored Presentation: Raising the Bar on Cybersecurity: Understanding New Regulations and How IEC 81001-5-1 Can Help Navigate

Sponsored By
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Michelle Jump, RAC – MedSec LLC ### 1827177###Presenter###CEO###MedSec LLC###
Presenter: Michelle Jump, RAC – MedSec LLC
###
Sponsored Presentation: Regulatory Intelligence: From Information Overload to Strategic Decision-Making

Sponsored By
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Diogo Geraldes, PhD MEng – Veeva Systems ### 2290123###Moderator###Director Regulatory Strategy###Veeva Systems###
Moderator: Diogo Geraldes, PhD MEng – Veeva Systems
### @@@ Olga Van Grol-Lawlor, MPHIL (she/her/hers) – Boston Scientific ### 1534231###Presenter###Sr. Global Regulatory Intelligence & Advocacy Manager###Boston Scientific###
Presenter: Olga Van Grol-Lawlor, MPHIL (she/her/hers) – Boston Scientific
### she/her/hers @@@ João Martins – Abbott ### 2290124###Presenter###Associate Director of Regulatory Strategy###Abbott###
Presenter: João Martins – Abbott
###
Sponsored Presentation: Regulatory Transformation: Leveraging AI and Digital Transformation to Enable Regulatory Excellence

Sponsored By
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Dhriti Roy, PhD (she/her/hers) – Essenvia ### 2122585###Presenter###Vice President of Regulatory Affairs Transformation ###Essenvia###
Presenter: Dhriti Roy, PhD (she/her/hers) – Essenvia
### she/her/hers @@@ Soumya Mahapatra (he/him/his) – Essenvia ### 2122586###Presenter###CEO & Founder###Essenvia###
Presenter: Soumya Mahapatra (he/him/his) – Essenvia
### he/him/his
Sponsored Presentation: State of the art and the medical device lifecycle

Sponsored By
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Ed Ball, Msc, CEng (he/him/his) – RQM+ ### 2094360###Presenter###Manager, Intelligence and Strategic Execution###RQM+###
Presenter: Ed Ball, Msc, CEng (he/him/his) – RQM+
### he/him/his
Sponsored Presentation: The Challenge of the Transition: A Practical Guide on How To Use Data Historicity To Produce Correct Rationales and Deal Effectively With the Transition From MDD to MDR

Sponsored By
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Marianna Mastroroberto, MD (she/her/hers) – Kiwa ### 2290125###Presenter###Internal Clinical Expert – Kiwa Cermet Italia NB 0476###Kiwa ###
Presenter: Marianna Mastroroberto, MD (she/her/hers) – Kiwa
### she/her/hers
Sponsored Presentation: The top gotchas when expanding your clinical development into the US

Sponsored By
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Gretchen Miller Bowker – Pearl Pathways ### 2317952###Presenter###Chief Executive Officer###Pearl Pathways###
Presenter: Gretchen Miller Bowker – Pearl Pathways
###
Sponsored Presentation: Transitional Provisions of the IVDR – Can I Sit Back and Relax?

Sponsored By
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Pieter Bogaert, PhD (he/him/his) – Qarad ### 2237172###Presenter###Senior Consultant IVD - Regulatory Affairs###Qarad###
Presenter: Pieter Bogaert, PhD (he/him/his) – Qarad
### he/him/his
Sponsored Presentation: Leveraging AI for Successful Clinical Evaluation and PMCF Strategies

Sponsored By
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Shruti Sharma – Celegence ### 2122587###Presenter###Product Specialist – Regulatory Services###Celegence###
Presenter: Shruti Sharma – Celegence
### @@@ Anushree Singh – Celegence ### 2290122###Presenter###Associate Manager, Medical Device Services###Celegence###
Presenter: Anushree Singh – Celegence
###
Sponsored Presentation: Using Clock Stops Wisely to Appropriately Address CHMP Issues – Why Time Matters

Sponsored By
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Bert Regeer, MD – 3D Communications ### 720656###Presenter###Senior Science Lead###3D Communications###
Presenter: Bert Regeer, MD – 3D Communications
### @@@ Lee Mullin, PhD, RAC – 3D Communications ### 2290121###Presenter###Senior Medical Writer###3D Communications###
Presenter: Lee Mullin, PhD, RAC – 3D Communications
###
Structured Dialogue: Innovative Pathways in Europe and UK: A Legal, Manufacturer’s, and Notified Bodies Perspective

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Darren J. Thain – Smith+Nephew ### 2177906###Presenter###Director, Regulatory Affairs###Smith+Nephew###
Presenter: Darren J. Thain – Smith+Nephew
### @@@ Alex Denoon (he/him/his) – Bristows LLP ### 2177907###Presenter###Partner###Bristows LLP###
Presenter: Alex Denoon (he/him/his) – Bristows LLP
### he/him/his @@@ Richard G. Holborow, MSCST RCCP (he/him/his) – Notified Body (BSI) ### 1523592###Presenter###Global Heal of Clinical Compliance###Notified Body (BSI)###
Presenter: Richard G. Holborow, MSCST RCCP (he/him/his) – Notified Body (BSI)
### he/him/his @@@ Alberto Ganan, PhD – European Medicines Agency ### 2262977###Panelist###Head of Committees and Quality Assurance Department###European Medicines Agency###
Panelist: Alberto Ganan, PhD – European Medicines Agency
###
Supply Chain/Shortage

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Rachel Harte – CAI ### 1615665###Presenter###Associate Director Regulatory Affairs###CAI###
Presenter: Rachel Harte – CAI
### @@@ Sarbajit Chakrabarti, MTech, MSc (he/him/his) – Parexel International India Safety Services Private Limited ### 2177829###Presenter###Regulatory Affairs Associate###Parexel International India Safety Services Private Limited###
Presenter: Sarbajit Chakrabarti, MTech, MSc (he/him/his) – Parexel International India Safety Services Private Limited
### he/him/his @@@ Siegfried Schmitt, PhD – Parexel ### 907098###Presenter###Vice President Technical###Parexel###
Presenter: Siegfried Schmitt, PhD – Parexel
### @@@ Monica Dias, PhD (she/her/hers) – EMA ### 2278314###Presenter###Head of Supply and Availability of medicines and medical devices###EMA###
Presenter: Monica Dias, PhD (she/her/hers) – EMA
### she/her/hers