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Randomized Clinical Trials vs. Validation Cohort Studies of AI/ML-Based SaMDs: What Are the Differences and Guidelines for Appraisal of the Clinical Evidence?

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Catarina Carrão – BioSciPons ### 1828303###Presenter###Clinical Evaluation Specialist###BioSciPons###
Presenter: Catarina Carrão – BioSciPons
### @@@ Zuzanna Kwade, PhD (she/her/hers) – Dedalus ### 2237168###Presenter###Clinical Evaluation Lead###Dedalus###
Presenter: Zuzanna Kwade, PhD (she/her/hers) – Dedalus
### she/her/hers
Regulators and Industry Perspective on Use of Artificial Intelligence in the Drug Development Lifecycle

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Stefanie Faßhauer, MBA – Vita Green Group ### 943172###Session Leader###Global Head Regulatory Affairs###Vita Green Group###
Session Leader: Stefanie Faßhauer, MBA – Vita Green Group
### @@@ Khushboo Sharma, MBA – Accumulus Synergy ### 1660692###Session Leader/Speaker###Chief Regulatory Innovation Officer###Accumulus Synergy###
Session Leader/Speaker: Khushboo Sharma, MBA – Accumulus Synergy
### @@@ Claire Harrison ### 2277736###Presenter#########
Presenter: Claire Harrison
### @@@ Florian Lasch, PhD (he/him/his) – European Medicines Agency ### 2279656###Presenter###Biostatistics Specialist###European Medicines Agency###
Presenter: Florian Lasch, PhD (he/him/his) – European Medicines Agency
### he/him/his @@@ Helena Corte-Real Correia, PhD – F.Hoffmann-La Roche, Ltd. ### 2288762###Presenter###VP, Regulatory Portfolio Data and Content Lead###F.Hoffmann-La Roche, Ltd.###
Presenter: Helena Corte-Real Correia, PhD – F.Hoffmann-La Roche, Ltd.
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Regulatory Intelligence and Policy Strategy; Dynamic Regulatory Assessment as a Case Study

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Kasia A. Nowok, MSc – UCB ### 2177824###Presenter###Regulatory Intelligence Lead EU###UCB###
Presenter: Kasia A. Nowok, MSc – UCB
### @@@ Rüdiger Faust, PhD – UCB ### 1828296###Presenter###Global Regulatory Intelligence & Policy Lead###UCB###
Presenter: Rüdiger Faust, PhD – UCB
### @@@ Nasir Hussain, BPharm, MBA, PhD (he/him/his) – Gilead ### 2177839###Presenter###EU Regulatory Policy Lead###Gilead###
Presenter: Nasir Hussain, BPharm, MBA, PhD (he/him/his) – Gilead
### he/him/his
Regulatory Leadership: Digitization and Digital Health – There is NO Turning Back!

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Olga Van Grol-Lawlor, MPHIL (she/her/hers) – Boston Scientific ### 1534231###Session Leader/Speaker###Sr. Global Regulatory Intelligence & Advocacy Manager###Boston Scientific###
Session Leader/Speaker: Olga Van Grol-Lawlor, MPHIL (she/her/hers) – Boston Scientific
### she/her/hers @@@ Sinead Keogh, PhD – IBEC ### 2177904###Presenter###Head of Sectors Ibec, Director Irish MedTech Association,incoming Director BioPharmaChemical Ireland###IBEC###
Presenter: Sinead Keogh, PhD – IBEC
### @@@ Amra Racic – Veeva Systems ### 535477###Presenter###Sr. Director Global Government Affairs###Veeva Systems###
Presenter: Amra Racic – Veeva Systems
### @@@ Damien Sherlock, MSc – Boston Scientific ### 2232815###Presenter###Senior Quality Manager, Global Digital Health###Boston Scientific###
Presenter: Damien Sherlock, MSc – Boston Scientific
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