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UK Market: PMS and Vigilance Requirements for IVDs

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Christèle East (she/her/hers) – Namsa ### 1828312###Presenter###Senior Regulatory Consultant, IVD###Namsa###
Presenter: Christèle East (she/her/hers) – Namsa
### she/her/hers
UK MDR: Current State of Play and Future Perspectives

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Giovanni Di Rienzo – Edwards Lifesciences ### 907127###Moderator###Director, Regulatory Affairs UK###Edwards Lifesciences###
Moderator: Giovanni Di Rienzo – Edwards Lifesciences
### @@@ Monisha Phillips, PhD (she/her/hers) – TUV SUD ### 2177812###Presenter###Head of Approved Body###TUV SUD###
Presenter: Monisha Phillips, PhD (she/her/hers) – TUV SUD
### she/her/hers @@@ Vishal Thakker, MEng (he/him/his) – BSI ### 1614543###Presenter###Head of the UK Approved Body###BSI###
Presenter: Vishal Thakker, MEng (he/him/his) – BSI
### he/him/his @@@ Joseph Burt ### 2314800###Presenter#########
Presenter: Joseph Burt
###
Unveiling Insights: Navigating the Public Disclosure of Clinical Trials in an Evolving Industry

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Christopher Bamford, PhD (he/him/his) – IQVIA ### 2177854###Presenter###Director, Clinical Trials Regulatory###IQVIA###
Presenter: Christopher Bamford, PhD (he/him/his) – IQVIA
### he/him/his @@@ Anaya Rehman, MBBS, MSc – Certara ### 2177823###Presenter###Sr. Transparency Specialist###Certara###
Presenter: Anaya Rehman, MBBS, MSc – Certara
### @@@ Lene Grejs Petersen, M.Pharm – Danish Medicines Agency ### 2262341###Presenter###Senior Adviser###Danish Medicines Agency###
Presenter: Lene Grejs Petersen, M.Pharm – Danish Medicines Agency
### @@@ Radu Popescu, MD (he/him/his) – European Medicines Agency ### 2271496###Panelist###Transparency Officer###European Medicines Agency###
Panelist: Radu Popescu, MD (he/him/his) – European Medicines Agency
### he/him/his
Usability and Human Factors Studies – Considerations During Pre-Market Submission, Similarities and Differences Between the US and Europe

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Taly Vider Cohen, BSc – Regulatory Affairs and IP Director ### 2177867###Presenter###Regulatory Affairs and IP Director###Regulatory Affairs and IP Director###
Presenter: Taly Vider Cohen, BSc – Regulatory Affairs and IP Director
###
Use of Real World Evidence for Regulatory Making for Medical Devices and Diagnostics in EU: A Practical Guide

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Richard G. Holborow, MSCST RCCP (he/him/his) – Notified Body (BSI) ### 1523592###Session Leader/Speaker###Global Heal of Clinical Compliance###Notified Body (BSI)###
Session Leader/Speaker: Richard G. Holborow, MSCST RCCP (he/him/his) – Notified Body (BSI)
### he/him/his @@@ Estelle Frappe (she/her/hers) – Aetion ### 2177814###Presenter###Director RWE MD&D###Aetion###
Presenter: Estelle Frappe (she/her/hers) – Aetion
### she/her/hers @@@ Tom Melvin, MB, BCh, BAO, LRCPI & SI, BCL LLM (NUI) – Trinity College Dublin ### 1344660###Panelist###Associate Professor of Medical Device Regulatory Affairs###Trinity College Dublin###
Panelist: Tom Melvin, MB, BCh, BAO, LRCPI & SI, BCL LLM (NUI) – Trinity College Dublin
### @@@ Richard Dujmovic, MSEM (he/him/his) – Boston Scientific ### 2260434###Panelist###Vice President, Regulatory Affairs###Boston Scientific###
Panelist: Richard Dujmovic, MSEM (he/him/his) – Boston Scientific
### he/him/his