*Program and presenters subject to change. Please check back frequently for updates.
Session Leader: Daniëlle Motta, MSc. – Qserve Group BV
### @@@ Balazs Bozsik – SGS North America Inc. ### 1614547###Presenter###Technical Director - MDD/MDR/UKCA###SGS North America Inc.###Presenter: Balazs Bozsik – SGS North America Inc.
### @@@ Phil Brown (he/him/his) – ABHI ### 1855142###Presenter###Director, Regulatory and Compliance###ABHI###Presenter: Phil Brown (he/him/his) – ABHI
### he/him/hisSession Leader: Cassandra T. San Jose, MS-RA/QA, RAC, PMP, SPMC, CPM (she/her/hers) – Biogen
### she/her/hersSession Leader: Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A.
### @@@ Patrick Axtell, PhD – FDA ### 1000137###Presenter (Remote)###Assistant Director, Tools and Templates Team###FDA###Presenter (Remote): Patrick Axtell, PhD – FDA
### @@@ Kathy Herzog, BSME – DuVal & Associates, P.A. ### 1614392###Presenter###Sr. Regulatory, Quality and Compliance Consultant###DuVal & Associates, P.A.###Presenter: Kathy Herzog, BSME – DuVal & Associates, P.A.
###Session Leader: Aman Khera, EMBA, FRAPS, FTOPRA (she/her/hers) – Worldwide Clinical Trials
### she/her/hers @@@ Linda Bowen, MSc, RAC, FRAPS (she/her/hers) – Seagen Inc. ### 1615689###Presenter###Executive Director and Head of the Regulatory Centers of Excellence###Seagen Inc.###Presenter: Linda Bowen, MSc, RAC, FRAPS (she/her/hers) – Seagen Inc.
### she/her/hersSession Leader: Mallory O'Connor, MPH – Mallinckrodt
### @@@ Jesse D. Mendelsohn (he/him/his) – Model N ### 2094361###Presenter###Senior Vice President###Model N###Presenter: Jesse D. Mendelsohn (he/him/his) – Model N
### he/him/his @@@ Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho ### 1642067###Moderator###Sr. Director, Reg. Affairs###QuidelOrtho###Moderator: Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – QuidelOrtho
###Moderator: Renee Marie Mitchell, MT (ASCP), CLS (NCA) – Boston Scientific
### @@@ Scott Goates, PhD. (he/him/his) – Abbott ### 1946000###Presenter###Director, Health Economics, Global Data Science and Analytics###Abbott###Presenter: Scott Goates, PhD. (he/him/his) – Abbott
### he/him/his @@@ Korinne Jew, PhD (she/her/hers) – Medtronic ### 1945998###Presenter###Senior Director, Enterprise Clinical Research & Medical Science###Medtronic###Presenter: Korinne Jew, PhD (she/her/hers) – Medtronic
### she/her/hers @@@ Alexandra Massoud (she/her/hers) – Exact Sciences ### 1945999###Presenter###VP, Clinical Affairs###Exact Sciences###Presenter: Alexandra Massoud (she/her/hers) – Exact Sciences
### she/her/hers @@@ Michelle Tarver, MD, PhD (she/her/hers) – U.S. Food and Drug Administration/ CDRH ### 1052823###Presenter (Remote)###Deputy Center Director, Transformation###U.S. Food and Drug Administration/ CDRH###Presenter (Remote): Michelle Tarver, MD, PhD (she/her/hers) – U.S. Food and Drug Administration/ CDRH
### she/her/hers
