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Browse Sessions by Title

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What are the Requirements for an IND Submission?

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Hagit Marchaim, PhD MBA (she/her/hers) – HMC-Regulation ### 1947145###Workshop Leader###Owner and principal consultant at Dr. Hagit Marchaim RA Consulting (HMC-regulation)###HMC-Regulation###
Workshop Leader: Hagit Marchaim, PhD MBA (she/her/hers) – HMC-Regulation
### she/her/hers @@@ Lina Jamis, MS (she/her/hers) – Synthego Corporation ### 2099003###Presenter###Associate Director, Regulatory Affairs###Synthego Corporation###
Presenter: Lina Jamis, MS (she/her/hers) – Synthego Corporation
### she/her/hers @@@ Tyler C. Vandivort, PhD, RAC, DABT (he/him/his) – Amplicore Inc ### 1546697###Presenter###Director Regulatory Affairs and Operations###Amplicore Inc###
Presenter: Tyler C. Vandivort, PhD, RAC, DABT (he/him/his) – Amplicore Inc
### he/him/his
What can Legacy Manufacturers Learn from Effective PMS and PMPF Implementation in Order to Prepare to Become IVDR compliant?
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Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V. ### 1945990###Session Leader###Head of IVD notified body###BSI Group The Netherlands B.V.###
Session Leader: Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V.
### @@@ Susanne Klum, PhD – Dr. Ebeling & Assoc. GmbH ### 2043917###Presenter###Head of Medical Devices###Dr. Ebeling & Assoc. GmbH###
Presenter: Susanne Klum, PhD – Dr. Ebeling & Assoc. GmbH
### @@@ Robin McMillan – Abbott ### 2122612###Presenter###Senior Regulatory Affairs Specialist###Abbott###
Presenter: Robin McMillan – Abbott
### @@@ Tom Patten – NSAI ### 1141749###Presenter###Certification & Inspection Officer - IVD###NSAI###
Presenter: Tom Patten – NSAI
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When to “Factor” in Human Factors

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Niedre M. Heckman, PhD, MPH, FRAPS, RAC, CQA (she/her/hers) – Takeda ### 1976559###Program Committee###Director, Global Regulatory Affairs###Takeda###
Program Committee: Niedre M. Heckman, PhD, MPH, FRAPS, RAC, CQA (she/her/hers) – Takeda
### she/her/hers @@@ Rita Lin (she/her/hers) – Agilis by Kymanox ### 2128307###Presenter###Dir. of Human Factors Engineering###Agilis by Kymanox###
Presenter: Rita Lin (she/her/hers) – Agilis by Kymanox
### she/her/hers
Will EU IVDR implementation benefit from MDCG 2022-14 and if so, HOW?

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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 @@@ Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD ### 1083897###Moderator###Global Director Regulatory Strategy###TÜV SÜD###
Moderator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
### @@@ 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
### @@@ 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
### @@@ Azam Khorshidi – DEKRA ### 2129976###Presenter###Technical File Reviewer###DEKRA ###
Presenter: Azam Khorshidi – DEKRA
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