Moderator: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
Moderator: Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service
Panelist: Ilona Reischl, PhD – Austrian Medicines Agency, AGES MEA
Panelist: Falk Ehmann, MD, PhD, MSc, – European Medicines Agency
Panelist: Christelle Bouygues, PharmD – EMA
Panelist: Silvy Da Rocha Dias – European Medicines Agency
Panelist: Marta Carnielli, PharmD – TUV Sud GmbH
Panelist: Suzanne Halliday, MSc. D.Phil. – BSI
Panelist: Lammert Meinders – Dutch Health and Youth Care Inspectorate
Panelist: Flora Giorgio – European Commission
Moderator: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
### @@@ Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service ### 1187581###Moderator###Regulatory Strategy Principal###TÜV SÜD Medical Health Service###Moderator: Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service
### @@@ Ilona Reischl, PhD (she/her/hers) – Austrian Medicines Agency, AGES MEA ### 1897482###Panelist###Assessor###Austrian Medicines Agency, AGES MEA###Panelist: Ilona Reischl, PhD (she/her/hers) – Austrian Medicines Agency, AGES MEA
### she/her/hers @@@ Falk Ehmann, MD, PhD, MSc, – European Medicines Agency ### 716669###Panelist###Chair Innovation Task Force###European Medicines Agency###Panelist: Falk Ehmann, MD, PhD, MSc, – European Medicines Agency
### @@@ Christelle Bouygues, PharmD (she/her/hers) – EMA ### 1318405###Panelist###Regulatory Affairs Senior Officer###EMA###Panelist: Christelle Bouygues, PharmD (she/her/hers) – EMA
### she/her/hers @@@ Silvy Da Rocha Dias – European Medicines Agency ### 1922318###Panelist######European Medicines Agency###Panelist: Silvy Da Rocha Dias – European Medicines Agency
### @@@ Marta Carnielli, PharmD – TUV Sud GmbH ### 1187616###Panelist###Head of Certification IVD at TuV Sud###TUV Sud GmbH###Panelist: Marta Carnielli, PharmD – TUV Sud GmbH
### @@@ Suzanne Halliday, MSc. D.Phil. – BSI ### 535446###Panelist###Regulatory Director###BSI###Panelist: Suzanne Halliday, MSc. D.Phil. – BSI
### @@@ Lammert Meinders – Dutch Health and Youth Care Inspectorate ### 1981132###Panelist###Senior Inspector Medical Technology###Dutch Health and Youth Care Inspectorate###Panelist: Lammert Meinders – Dutch Health and Youth Care Inspectorate
### @@@ Flora Giorgio (she/her/hers) – European Commission ### 1930380###Panelist###Acting Head of Unit###European Commission###Panelist: Flora Giorgio (she/her/hers) – European Commission
### she/her/hersModerator: Giovanni Di Rienzo – Qserve Group
Presenter: Richard A. Vincins, RAC-MD, CMDA, CQA – Oriel STAT A MATRIX
Presenter: Matthias Bellmann, MA – TÜV SÜD Product Service GmbH
Medical Devices
Domain: Post Approval/Post Market
Knowledge Area: Recordkeeping, Monitoring
Moderator: Giovanni Di Rienzo – Qserve Group
### @@@ Richard A. Vincins, RAC-MD, CMDA, CQA – Oriel STAT A MATRIX ### 1254352###Presenter###VP Global Regulatory Affairs###Oriel STAT A MATRIX###Presenter: Richard A. Vincins, RAC-MD, CMDA, CQA – Oriel STAT A MATRIX
### @@@ Matthias Bellmann, MA (he/him/his) – TÜV SÜD Product Service GmbH ### 1828310###Presenter###Director Global Focus Team Cardiovascular###TÜV SÜD Product Service GmbH###Presenter: Matthias Bellmann, MA (he/him/his) – TÜV SÜD Product Service GmbH
### he/him/hisModerator & Presenter: Kevin Cunningham, PhD – European Medicines Agency
Presenter: Els Caenen, PharmD – Janssen Pharmaceutical Companies of Johnson & Johnson
Presenter: Nadege Le Roux – Bristol-Myers Squibb
Presenter: Francesca Cerreta
Presenter: Ilona Reischl, PhD – Austrian Medicines Agency, AGES MEA
Pharmaceuticals
Domain: Regulatory Frameworks & Strategy
Knowledge Area: Market Strategy
Moderator & Presenter: Kevin Cunningham, PhD – European Medicines Agency
### @@@ Els Caenen, PharmD (she/her/hers) – Janssen Pharmaceutical Companies of Johnson & Johnson ### 1967239###Presenter###Director, EMEA Regulatory Lead Multiple Myeloma###Janssen Pharmaceutical Companies of Johnson & Johnson###Presenter: Els Caenen, PharmD (she/her/hers) – Janssen Pharmaceutical Companies of Johnson & Johnson
### she/her/hers @@@ Nadege Le Roux – Bristol-Myers Squibb ### 1967241###Presenter###Senior Director of Regulatory Policy and Intelligence###Bristol-Myers Squibb###Presenter: Nadege Le Roux – Bristol-Myers Squibb
### @@@ Francesca Cerreta ### 1967242###Presenter#########Presenter: Francesca Cerreta
### @@@ Ilona Reischl, PhD (she/her/hers) – Austrian Medicines Agency, AGES MEA ### 1897482###Presenter###Assessor###Austrian Medicines Agency, AGES MEA###Presenter: Ilona Reischl, PhD (she/her/hers) – Austrian Medicines Agency, AGES MEA
### she/her/hersModerator: Amie Smirthwaite, BEng, PhD – RQM+
Presenter: Nancy J. Morrison, RAC – RQM+
Presenter: Abtin Rad, Dr. – TÜV SÜD Product Services
Medical Devices
Domain: Product Development & Registration
Knowledge Area: Regulatory Guidance
Moderator: Amie Smirthwaite, BEng, PhD – RQM+
### @@@ Nancy J. Morrison, RAC – RQM+ ### 757434###Presenter###Vice President, Intelligence and Innovation###RQM+###Presenter: Nancy J. Morrison, RAC – RQM+
### @@@ Abtin Rad, Dr. – TÜV SÜD Product Services ### 1187617###Presenter###Global Director Functional Safety, Software, and Digitization###TÜV SÜD Product Services###Presenter: Abtin Rad, Dr. – TÜV SÜD Product Services
###Moderator: Alex Laan, Dipl.-Ing. – BSI
Presenter: Kristiane Schmidt, PhD – Qserve Group
Presenter: Mohamed-Salah GAROUACHI, PhD, PharmD – Constency Healthcare
Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
IVD
Domain: Post Approval/Post Market
Knowledge Area: General
Moderator: Alex Laan, Dipl.-Ing. – BSI
### @@@ Kristiane Schmidt, PhD (she/her/hers) – Qserve Group ### 1828297###Presenter###Senior Consultant###Qserve Group###Presenter: Kristiane Schmidt, PhD (she/her/hers) – Qserve Group
### she/her/hers @@@ Mohamed-Salah GAROUACHI, PhD, PharmD – Constency Healthcare ### 1828323###Presenter###Managing Director###Constency Healthcare###Presenter: Mohamed-Salah GAROUACHI, PhD, PharmD – Constency Healthcare
### @@@ Marta Carnielli, PharmD – TUV Sud GmbH ### 1187616###Presenter###Head of Certification IVD at TuV Sud###TUV Sud GmbH###Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
###Moderator: Gert W. Bos, FRAPS, MSc, PhD, FRAPS – Qserve Group
Presenter: Sophie Tabutin, PharmD, MSc – W.L. Gore & Associates
Presenter: Gavin Quigley, MBChB FRCS MBA – BSI
Presenter: Joshua Bridgens, MBBS FRCS – DePuy Synthes (J&J)
Medical Devices
Domain: Regulatory Frameworks & Strategy
Knowledge Area: Data Management & Analysis
Moderator: Gert W. Bos, FRAPS, MSc, PhD, FRAPS – Qserve Group
### @@@ Sophie Tabutin, PharmD, MSc – W.L. Gore & Associates ### 907081###Presenter###EMEA Regulatory Affairs Leader###W.L. Gore & Associates###Presenter: Sophie Tabutin, PharmD, MSc – W.L. Gore & Associates
### @@@ Gavin Quigley, MBChB FRCS MBA – BSI ### 1827173###Presenter###Internal Clinician###BSI###Presenter: Gavin Quigley, MBChB FRCS MBA – BSI
### @@@ Joshua Bridgens, MBBS FRCS – DePuy Synthes (J&J) ### 1897475###Presenter###Medical Director###DePuy Synthes (J&J)###Presenter: Joshua Bridgens, MBBS FRCS – DePuy Synthes (J&J)
###Moderator & Presenter: Ashleigh C. Dawley, RAC – Integrated DNA Technologies, Inc., a Danaher Company
Presenter: Melissa Finocchio – SOPHiA GENETICS
Presenter: Alex Laan, Dipl.-Ing. – BSI
IVD
Domain: Regulatory Frameworks & Strategy
Knowledge Area: Regulatory Strategy Development
Moderator & Presenter: Ashleigh C. Dawley, RAC – Integrated DNA Technologies, Inc., a Danaher Company
### @@@ Melissa Finocchio (she/her/hers) – SOPHiA GENETICS ### 1828313###Presenter###SVP, Chief Regulatory Officer###SOPHiA GENETICS###Presenter: Melissa Finocchio (she/her/hers) – SOPHiA GENETICS
### she/her/hers @@@ Alex Laan, Dipl.-Ing. – BSI ### 1141533###Presenter###Head of IVD Notified Body - Regulatory Services###BSI###Presenter: Alex Laan, Dipl.-Ing. – BSI
###Moderator: Giovanni Di Rienzo – Qserve Group
Presenter: Phil Brown
Presenter: Vishal Thakker, MEng – BSI Group
Presenter: Jillan Hussein, MEng – MHRA
Medical Devices
Moderator: Giovanni Di Rienzo – Qserve Group
### @@@ Phil Brown ### 1855142###Presenter#########Presenter: Phil Brown
### @@@ Vishal Thakker, MEng (he/him/his) – BSI Group ### 1614543###Presenter###Head of UK Approved Body & Senior Regulatory Lead###BSI Group###Presenter: Vishal Thakker, MEng (he/him/his) – BSI Group
### he/him/his @@@ Jillan Hussein, MEng – MHRA ### 1570677###Presenter###Senior Regulatory Policy Manager###MHRA###Presenter: Jillan Hussein, MEng – MHRA
###Moderator & Presenter: Rebecca Lumsden, PhD – Sanofi
Presenter: Marjon Pasmooij – Medicines Evaluation Board
Presenter: Frank Pétavy, MSc – European Medicines Agency
Pharmaceuticals
Domain: Business Acumen
Knowledge Area: Project Management
Moderator & Presenter: Rebecca Lumsden, PhD – Sanofi
### @@@ Marjon Pasmooij – Medicines Evaluation Board ### 1955235###Presenter###Head of Science Department###Medicines Evaluation Board###Presenter: Marjon Pasmooij – Medicines Evaluation Board
### @@@ Frank Pétavy, MSc (he/him/his) – European Medicines Agency ### 1957026###Presenter###Head of Methodology###European Medicines Agency###Presenter: Frank Pétavy, MSc (he/him/his) – European Medicines Agency
### he/him/hisPresenter: Ivan Perez Chamorro – MedBoard
Sponsor Presentation
Presenter: Ivan Perez Chamorro – MedBoard
###Presenter: Bianca Lutters – QServe Group
Presenter: Sue Spencer – Qserve group
Sponsor Presentation
Presenter: Bianca Lutters – QServe Group
### @@@ Sue Spencer – Qserve group ### 1187575###Presenter###IVD Lead/ Principal Consultant###Qserve group###Presenter: Sue Spencer – Qserve group
###Presenter: Pierre Stanislawski – Ennov
Presenter: Sean Carpenter – Ennov
Sponsor Presentation
Presenter: Pierre Stanislawski – Ennov
### @@@ Sean Carpenter – Ennov ### 1949783###Presenter###Product Manager###Ennov###Presenter: Sean Carpenter – Ennov
###Presenter: Charlene Boumard – Veeva MedTech
Sponsor Presentation
Presenter: Charlene Boumard – Veeva MedTech
###Presenter: Alaric Jackson, CISSP – RQM+
Presenter: Francesco Palma – Giotto.ai
Presenter: Amie Smirthwaite, BEng, PhD – RQM+
Presenter: Nancy J. Morrison, RAC – RQM+
Sponsor Presentation
Presenter: Alaric Jackson, CISSP (he/him/his) – RQM+
### he/him/his @@@ Francesco Palma – Giotto.ai ### 1949780###Presenter###Co-Founder and VP of Product###Giotto.ai###Presenter: Francesco Palma – Giotto.ai
### @@@ Amie Smirthwaite, BEng, PhD – RQM+ ### 1071119###Presenter###Senior Vice President, Intelligence & Innovation###RQM+###Presenter: Amie Smirthwaite, BEng, PhD – RQM+
### @@@ Nancy J. Morrison, RAC – RQM+ ### 757434###Presenter###Vice President, Intelligence and Innovation###RQM+###Presenter: Nancy J. Morrison, RAC – RQM+
###Moderator & Presenter: Susana de Azevedo Wäsch – Ypsomed
Presenter: Patrik J. Spirig, MA – Konapharma
Regulatory Business
Domain: Business Acumen
Knowledge Area: General
Moderator & Presenter: Susana de Azevedo Wäsch – Ypsomed
### @@@ Patrik J. Spirig, MA (he/him/his) – Konapharma ### 1827176###Presenter###CFO###Konapharma###Presenter: Patrik J. Spirig, MA (he/him/his) – Konapharma
### he/him/hisModerator & Presenter: Alexander Stock, PhD – TÜV SÜD Product Service GmbH
IVD
Domain: Product Development & Registration
Knowledge Area: Data Management & Analysis
Moderator & Presenter: Alexander Stock, PhD – TÜV SÜD Product Service GmbH
###Moderator: Leo Louis, RAC, PMP – Philips
Presenter: Keti S. Agostino, n/a – BSI
Presenter: Michelle Sullivan – Boston Scientific
Medical Devices
Domain: Scientific & Health Concepts
Knowledge Area: Healthcare Leadership
Moderator: Leo Louis, RAC, PMP – Philips
### @@@ Keti S. Agostino, n/a – BSI ### 1614397###Presenter###Regulatory Lead###BSI###Presenter: Keti S. Agostino, n/a – BSI
### @@@ Michelle Sullivan (she/her/hers) – Boston Scientific ### 1970397###Presenter###Head of Public Affairs###Boston Scientific###Presenter: Michelle Sullivan (she/her/hers) – Boston Scientific
### she/her/hersModerator: Kate Stockman
Moderator: Rüdiger Faust, PhD – UCB
Presenter: Solange Corriol-Rohou, MD – AstraZeneca
Presenter: Marie Teil, MD – UCB Pharma
Presenter: Corinne de Vries, MA MSc PhD FISPE – European Medicines Agency
Pharmaceuticals
Domain: Product Development & Registration
Knowledge Area: Regulatory Guidance
Moderator: Kate Stockman
### @@@ Rüdiger Faust, PhD – UCB ### 1828296###Moderator###Global Regulatory Intelligence & Policy Lead###UCB###Moderator: Rüdiger Faust, PhD – UCB
### @@@ Solange Corriol-Rohou, MD (she/her/hers) – AstraZeneca ### 1828324###Presenter###Sr Global Policy Director###AstraZeneca###Presenter: Solange Corriol-Rohou, MD (she/her/hers) – AstraZeneca
### she/her/hers @@@ Marie Teil, MD – UCB Pharma ### 1828299###Presenter###Global Head WoCBA Program###UCB Pharma###Presenter: Marie Teil, MD – UCB Pharma
### @@@ Corinne de Vries, MA MSc PhD FISPE – European Medicines Agency ### 1922323###Presenter###Head of Translational Sciences###European Medicines Agency###Presenter: Corinne de Vries, MA MSc PhD FISPE – European Medicines Agency
###Moderator: Robert A. van Boxtel – Medical Device Project B.V.
Presenter: Kevin Madden – BSI Group
Presenter: Martin Witte – TÜV SÜD Product Service GmbH
Presenter: Paul Kosters, PhD – DEKRA Certification BV
Medical Devices
Domain: Regulatory Frameworks & Strategy
Knowledge Area: Data Management & Analysis
Moderator: Robert A. van Boxtel – Medical Device Project B.V.
### @@@ Kevin Madden – BSI Group ### 1828338###Presenter###Head of Professional Development###BSI Group###Presenter: Kevin Madden – BSI Group
### @@@ Martin Witte – TÜV SÜD Product Service GmbH ### 1187576###Presenter###Senior Director###TÜV SÜD Product Service GmbH###Presenter: Martin Witte – TÜV SÜD Product Service GmbH
### @@@ Paul Kosters, PhD (he/him/his) – DEKRA Certification BV ### 1855542###Presenter###Knowledge management manager / project manager###DEKRA Certification BV###Presenter: Paul Kosters, PhD (he/him/his) – DEKRA Certification BV
### he/him/hisModerator & Presenter: Michelle Jump, RAC – MedSec LLC
Medical Devices
Domain: Product Development & Registration
Knowledge Area: Market Strategy
Moderator & Presenter: Michelle Jump, RAC – MedSec LLC
###Moderator: Siegfried Schmitt, CSci CChem FRSC – Parexel
Presenter: Yingying Liu – CSL Behring AG
Presenter: Thomas Larsson, MSc, BSc – European Medicines Agency
Pharmaceuticals
Domain: Product Development & Registration
Knowledge Area: Regulatory Guidance
Moderator: Siegfried Schmitt, CSci CChem FRSC – Parexel
### @@@ Yingying Liu – CSL Behring AG ### 1187559###Presenter###Associate Director, GRA CMC Lead Plasma Fractionation Global Regulatory Affairs CMC###CSL Behring AG###Presenter: Yingying Liu – CSL Behring AG
### @@@ Thomas Larsson, MSc, BSc – European Medicines Agency ### 1650183###Presenter###Senior Scientific Specialist###European Medicines Agency###Presenter: Thomas Larsson, MSc, BSc – European Medicines Agency
###Moderator: Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service
Moderator: Anja Wiersma, PhD – mi-CE consultancy
Presenter: Andreas Stange – TUV SUD JAPAN LTD
Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
Presenter: Elizabeth Harrison, PhD – BSI Group
Presenter: Liz Gommans, PhD – DEKRA Certification B.V.
Presenter: Tom Patten – NSAI
IVD
Domain: Regulatory Frameworks & Strategy
Knowledge Area: Process & Procedures
Moderator: Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service
### @@@ Anja Wiersma, PhD (she/her/hers) – mi-CE consultancy ### 574723###Moderator###CEO / senior consultant###mi-CE consultancy###Moderator: Anja Wiersma, PhD (she/her/hers) – mi-CE consultancy
### she/her/hers @@@ Andreas Stange – TUV SUD JAPAN LTD ### 1187582###Presenter###SVP Medical Health Services Regulatory & Quality###TUV SUD JAPAN LTD###Presenter: Andreas Stange – TUV SUD JAPAN LTD
### @@@ Marta Carnielli, PharmD – TUV Sud GmbH ### 1187616###Presenter###Head of Certification IVD at TuV Sud###TUV Sud GmbH###Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
### @@@ Elizabeth Harrison, PhD (she/her/hers) – BSI Group ### 1401973###Presenter###Global Head – IVD Medical Devices###BSI Group###Presenter: Elizabeth Harrison, PhD (she/her/hers) – BSI Group
### she/her/hers @@@ Liz Gommans, PhD (she/her/hers) – DEKRA Certification B.V. ### 1967230###Presenter###Technical specialist and RA specialist###DEKRA Certification B.V.###Presenter: Liz Gommans, PhD (she/her/hers) – DEKRA Certification B.V.
### she/her/hers @@@ Tom Patten – NSAI ### 1141749###Presenter###Certification & Inspection Officer - IVD###NSAI###Presenter: Tom Patten – NSAI
###