*Program and presenters subject to change. Please check back frequently for updates.
Presenter: AJ Acker – Annexon Biosciences
### @@@ Kunal Kanani, PharmD, MBA – Annexon Biosciences ### 1945989###Presenter###Executive Director, Head of Regulatory Affairs###Annexon Biosciences###Presenter: Kunal Kanani, PharmD, MBA – Annexon Biosciences
### @@@ Mary Jo Salerno, MS PT, MPH (she/her/hers) – US Food and Drug Administration ### 1946967###Presenter###Science Policy Analyst###US Food and Drug Administration###Presenter: Mary Jo Salerno, MS PT, MPH (she/her/hers) – US Food and Drug Administration
### she/her/hers @@@ Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease ### 1945996###Presenter###Vice President, Regulatory Affairs###Alexion, AstraZeneca Rare Disease###Presenter: Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease
###Presenter: Jamie L. Robinson, RAC, MBA (she/her/hers) – Genentech, Inc.
### she/her/hersModerator: Amra Racic – Veeva Systems
### @@@ Razan Asally (she/her/hers) – Saudi Food and Drug Authority ### 2102871###Presenter###Head of In-vitro diagnostics evaluation section###Saudi Food and Drug Authority###Presenter: Razan Asally (she/her/hers) – Saudi Food and Drug Authority
### she/her/hers @@@ Abhijit Ghosh ### 2105492###Presenter (Remote)#########Presenter (Remote): Abhijit Ghosh
### @@@ Evangeline Loh, Ph.D., RAC (US, EU) – Emergo by UL ### 1773497###Presenter###Manager, Quality & Regulatory Affairs###Emergo by UL###Presenter: Evangeline Loh, Ph.D., RAC (US, EU) – Emergo by UL
###Session Leader: Kamali G. Chance, PhD, MPH, RAC – KC Biopharmaceutical Consulting
### @@@ Paul Brown, PhD (he/him/his) – Food and Drug Administration ### 2102964###Presenter (Remote)###Associate Director for Pharmacology and Toxicology###Food and Drug Administration###Presenter (Remote): Paul Brown, PhD (he/him/his) – Food and Drug Administration
### he/him/his @@@ Thibault Honegger – NETRI ### 2064600###Presenter (Remote)###CEO & Co-founder###NETRI###Presenter (Remote): Thibault Honegger – NETRI
### @@@ Abhijit P. Pangu, M. Pharm, RAC – Pharnext ### 1945629###Presenter###VP, Regulatory Affairs###Pharnext###Presenter: Abhijit P. Pangu, M. Pharm, RAC – Pharnext
###Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
### @@@ Tom Patten – NSAI ### 1141749###Presenter###Certification & Inspection Officer - IVD###NSAI###Presenter: Tom Patten – NSAI
### @@@ Catherine Holzmann – GMED Certification Division ### 1828311###Presenter###IVDMD Department Manager###GMED Certification Division###Presenter: Catherine Holzmann – GMED Certification Division
### @@@ Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V. ### 1945990###Presenter###Head of IVD notified body###BSI Group The Netherlands B.V.###Presenter: Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V.
###Session Leader: Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V.
### @@@ Amélie Chollet ### 2008932###Presenter#########Presenter: Amélie Chollet
### @@@ Erik R. Vollebregt – Axon Lawyers ### 535481###Presenter###Partner###Axon Lawyers###Presenter: Erik R. Vollebregt – Axon Lawyers
###