*Program and presenters subject to change. Please check back frequently for updates.
Session Leader: Jeff Holzman (he/him/his) – Item Alignment Inc.
### he/him/his @@@ Jay Crowley, MS – USDM Life Sciences ### 1631712###Presenter###Vice President Medical Device Solutions and Services###USDM Life Sciences###Presenter: Jay Crowley, MS – USDM Life Sciences
###Presenter: Jay E. Sirois, PhD – Consumer Health Products Association
### @@@ Joseph Chan, RPh (he/him/his) – Bayer ### 2014522###Presenter###Senior Regulatory Affairs Manager###Bayer###Presenter: Joseph Chan, RPh (he/him/his) – Bayer
### he/him/his @@@ Gerry Harrington ### 2099591###Presenter#########Presenter: Gerry Harrington
### @@@ Amanda Wong, RAC – Haleon Canada ### 2099590###Presenter###Senior Director, R&D Lead and Regulatory Affairs###Haleon Canada###Presenter: Amanda Wong, RAC – Haleon Canada
###Presenter: David Hinds, MHS (he/him/his) – BioMarin Pharmaceutical Inc.
### he/him/his @@@ Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency ### 573431###Presenter###Head of Scientific Office###Austrian Medicines and Medical Devices Agency###Presenter: Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency
### @@@ Mayss Naccache, MSc (she/her/hers) – World Federation of Hemophilia ### 2082117###Presenter###Manager, Gene Therapy###World Federation of Hemophilia###Presenter: Mayss Naccache, MSc (she/her/hers) – World Federation of Hemophilia
### she/her/hers @@@ Kelly Plueschke (she/her/hers) – European Medicines Agency (EMA) ### 2125762###Presenter (Remote)###Scientific Administrator###European Medicines Agency (EMA)###Presenter (Remote): Kelly Plueschke (she/her/hers) – European Medicines Agency (EMA)
### she/her/hers @@@ Jewell Martin, MA, MBA, PMP, RAC – BioMarin Pharmaceuticals, Inc. ### 1946971###Moderator###Director for US Regulatory Policy###BioMarin Pharmaceuticals, Inc.###Moderator: Jewell Martin, MA, MBA, PMP, RAC – BioMarin Pharmaceuticals, Inc.
###Moderator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
### @@@ Bassil Akra, phD (he/him/his) – Akra Team GmbH ### 535482###Moderator###Chief Executive Officer###Akra Team GmbH###Moderator: Bassil Akra, phD (he/him/his) – Akra Team GmbH
### he/him/his @@@ Peter Bischoff-Everding – European Commission, Directorate-General Health and Food safety ### 2122609###Presenter (Remote)###Legal officer###European Commission, Directorate-General Health and Food safety ###Presenter (Remote): Peter Bischoff-Everding – European Commission, Directorate-General Health and Food safety
### @@@ Gert W. Bos, MSc, PhD, FRAPS – Qserve Group ### 535440###Presenter###CSO###Qserve Group###Presenter: Gert W. Bos, MSc, PhD, FRAPS – Qserve Group
### @@@ Suzanne Halliday, MSc. D.Phil. – BSI ### 535446###Presenter###VP Regulatory###BSI###Presenter: Suzanne Halliday, MSc. D.Phil. – BSI
###Moderator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
### @@@ Bassil Akra, phD (he/him/his) – Akra Team GmbH ### 535482###Moderator###Chief Executive Officer###Akra Team GmbH###Moderator: Bassil Akra, phD (he/him/his) – Akra Team GmbH
### he/him/his @@@ Suzanne Halliday, MSc. D.Phil. – BSI ### 535446###Presenter###VP Regulatory###BSI###Presenter: Suzanne Halliday, MSc. D.Phil. – BSI
### @@@ Alexey Shiryaev, MD PhD – DNV Product Assurance AS ### 1645653###Presenter###Global Head of Clinical and Regulatory Affairs###DNV Product Assurance AS###Presenter: Alexey Shiryaev, MD PhD – DNV Product Assurance AS
### @@@ Andreas Stange (he/him/his) – TUV SUD ### 1187582###Presenter###SVP Medical Health Services Regulatory & Quality###TUV SUD###Presenter: Andreas Stange (he/him/his) – TUV SUD
### he/him/his @@@ Catherine Holzmann – GMED Certification Division ### 1828311###Presenter###IVDMD Department Manager###GMED Certification Division###Presenter: Catherine Holzmann – GMED Certification Division
###
