*Program and presenters subject to change. Please check back frequently for updates.
Speaker: Jennifer Naughton, MEd, ICE-CCP, SPHR, CAE – RAPS
### @@@ Emily Nesbitt ### 2160140###Speaker#########Speaker: Emily Nesbitt
###Speaker: Jennifer Naughton, MEd, ICE-CCP, SPHR, CAE – RAPS
###Speaker: Thomas Hutchinson, MS RAC FRAPS – QRE MedTech LLC
### @@@ Lindsey Summers, MBA – Day One Biopharmaceuticals ### 802197###Speaker###Sr Talent Acquisition Partner###Day One Biopharmaceuticals###Speaker: Lindsey Summers, MBA – Day One Biopharmaceuticals
###Presenter: Gert W. Bos, MSc, PhD, FRAPS – Qserve Group
### @@@ Elena Kyria (she/her/hers) – Elemed ### 1083155###Presenter###CEO & Founder###Elemed###Presenter: Elena Kyria (she/her/hers) – Elemed
### she/her/hers @@@ Daniëlle Motta, MSc. – Qserve Group BV ### 1649497###Presenter###Head of Global Registrations###Qserve Group BV###Presenter: Daniëlle Motta, MSc. – Qserve Group BV
### @@@ Kimberly A. Trautman, MS – MEDIcept ### 1945643###Presenter###Managing Director and Vice President###MEDIcept###Presenter: Kimberly A. Trautman, MS – MEDIcept
### @@@ Susan Bain, DRSc – University of Southern California ### 2125647###Presenter###Assistant Professor, Department of Regulatory and Quality Sciences###University of Southern California###Presenter: Susan Bain, DRSc – University of Southern California
###Session Leader: Janet Vaughn – Teva Pharmaceuticals
### @@@ Victor S. Pribluda, PhD (he/him/his) – United States Pharmacopeia ### 1946097###Presenter###Senior International Regulatory Intelligence Manager###United States Pharmacopeia###Presenter: Victor S. Pribluda, PhD (he/him/his) – United States Pharmacopeia
### he/him/his @@@ Chaitanya Koduri, MTech (he/him/his) – United States Pharmacopeia ### 1946105###Presenter###International Government & Regulatory Engagement Director###United States Pharmacopeia###Presenter: Chaitanya Koduri, MTech (he/him/his) – United States Pharmacopeia
### he/him/hisModerator: Adriana Racolta, PhD, RAC (she/her/hers) – Seagen, Inc
### she/her/hers @@@ Iordanis Gravanis, MD, PhD (he/him/his) – European Medicines Agency ### 2098106###Presenter###Head of Scientific Advice###European Medicines Agency###Presenter: Iordanis Gravanis, MD, PhD (he/him/his) – European Medicines Agency
### he/him/his @@@ Christine Mayer-Nicolai, PhD (she/her/hers) – Merck KGaA, Darmstadt, Germany ### 2123255###Presenter###VP; Global Head Regulatory & Scientific Policy###Merck KGaA, Darmstadt, Germany###Presenter: Christine Mayer-Nicolai, PhD (she/her/hers) – Merck KGaA, Darmstadt, Germany
### she/her/hers @@@ Mike Wierzba, PhD (he/him/his) – GSK ### 2014252###Presenter###Director, Global Regulatory Affairs, Precision Medicine and Digital Health###GSK###Presenter: Mike Wierzba, PhD (he/him/his) – GSK
### he/him/hisPresenter: Purvi S. Patel, PhD, CEng, MIMechE (she/her/hers) – BSI Group
### she/her/hers @@@ 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 @@@ Rachel Mead, BEng MIET (she/her/hers) – BSI Group ### 2016362###Presenter###Clinical Regulatory Lead###BSI Group ###Presenter: Rachel Mead, BEng MIET (she/her/hers) – BSI Group
### she/her/hers @@@ 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
### @@@ Gareth Enright, MEng – National Standards Authority of Ireland ### 2074276###Presenter###Certification & Inspection Officer ###National Standards Authority of Ireland###Presenter: Gareth Enright, MEng – National Standards Authority of Ireland
###Presenter: Corinne Delorme, MS, RAC – nexialist
### @@@ Vincent Castéras, PhD – nexialist ### 1543942###Presenter###CEO and Founder###nexialist###Presenter: Vincent Castéras, PhD – nexialist
### @@@ Florianne Torset-Bonfillou, MS, RAC – GMED North America ### 579831###Presenter###Senior International Regulatory Project Manager ###GMED North America###Presenter: Florianne Torset-Bonfillou, MS, RAC – GMED North America
###Presenter: Judith Prevoo (she/her/hers) – BSI
### she/her/hers @@@ Iordanis Gravanis, MD, PhD (he/him/his) – European Medicines Agency ### 2098106###Presenter###Head of Scientific Advice###European Medicines Agency###Presenter: Iordanis Gravanis, MD, PhD (he/him/his) – European Medicines Agency
### he/him/his @@@ James Hewitt (he/him/his) – TÜV SÜD ### 2098107###Presenter###Business Line Manager (IVD)###TÜV SÜD###Presenter: James Hewitt (he/him/his) – TÜV SÜD
### he/him/his @@@ Chelsea Welch (she/her/hers) – ARUP Laboratories ### 2128163###Presenter###Quality and Regulatory Affairs Project Manager###ARUP Laboratories###Presenter: Chelsea Welch (she/her/hers) – ARUP Laboratories
### 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
###Presenter: Derecka Alexander, MPH, DVM (she/her/hers) – American Association for the Advancement of Science/USDA
### she/her/hers @@@ Marcus S. Delatte, PhD – Allucent ### 1946005###Presenter###Vice President, Regulatory Strategy###Allucent###Presenter: Marcus S. Delatte, PhD – Allucent
### @@@ Owen McMaster, PhD – Food and Drug Administration ### 1946008###Presenter###Senior Pharmacologist/Toxicologist###Food and Drug Administration###Presenter: Owen McMaster, PhD – Food and Drug Administration
###Moderator: Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease
### @@@ Susan Stewart, JD, LLM, RAC, FRAPS (she/her/hers) – Candel Therapeutics ### 1698805###Moderator###Chief Regulatory Officer###Candel Therapeutics###Moderator: Susan Stewart, JD, LLM, RAC, FRAPS (she/her/hers) – Candel Therapeutics
### she/her/hers @@@ John Borg, Prof, PhD, Technical Director, Medicines Authority Malta – Malta Medicines Authority ### 1757708###Panelist###Post-Licensing Director###Malta Medicines Authority###Panelist: John Borg, Prof, PhD, Technical Director, Medicines Authority Malta – Malta Medicines Authority
### @@@ Alysha Croker, PhD (she/her/hers) – Health Canada ### 1728926###Panelist###Director, Centre for Policy, Pediatrics and International Collaboration###Health Canada###Panelist: Alysha Croker, PhD (she/her/hers) – Health Canada
### she/her/hers @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Panelist###Principal Scientific Administrator###European Medicines Agency###Panelist: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
### @@@ Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD ### 1083897###Panelist###Global Director Regulatory Strategy###TÜV SÜD###Panelist: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
### @@@ Karl-Heinz Huemer, MD, PhD (he/him/his) – khhconsulting ### 573393###Panelist###Consultant###khhconsulting###Panelist: Karl-Heinz Huemer, MD, PhD (he/him/his) – khhconsulting
### he/him/his @@@ Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency ### 573431###Panelist###Head of Scientific Office###Austrian Medicines and Medical Devices Agency###Panelist: Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency
### @@@ Anabela Marcal – European Medicines Agency ### 1061464###Panelist###EMA Liaison Official to FDA###European Medicines Agency###Panelist: Anabela Marcal – European Medicines Agency
### @@@ Janet Woodcock, MD – United States Food and Drug Administration ### 596742###Panelist###Principal Deputy Commissioner###United States Food and Drug Administration###Panelist: Janet Woodcock, MD – United States Food and Drug Administration
### @@@ Peter W. Marks, MD, PhD – United States Food and Drug Administration ### 574711###Presenter (Remote)###Director, Center for Biologics Evaluation and Research###United States Food and Drug Administration###Presenter (Remote): Peter W. Marks, MD, PhD – United States Food and Drug Administration
###Moderator: Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease
### @@@ Susan Stewart, JD, LLM, RAC, FRAPS (she/her/hers) – Candel Therapeutics ### 1698805###Moderator###Chief Regulatory Officer###Candel Therapeutics###Moderator: Susan Stewart, JD, LLM, RAC, FRAPS (she/her/hers) – Candel Therapeutics
### she/her/hers @@@ Iordanis Gravanis, MD, PhD (he/him/his) – European Medicines Agency ### 2098106###Panelist###Head of Scientific Advice###European Medicines Agency###Panelist: Iordanis Gravanis, MD, PhD (he/him/his) – European Medicines Agency
### he/him/his @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Panelist###Principal Scientific Administrator###European Medicines Agency###Panelist: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
### @@@ Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD ### 1083897###Panelist###Global Director Regulatory Strategy###TÜV SÜD###Panelist: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD
### @@@ Sally Prawdzik (she/her/hers) – Health Canada ### 2119758###Panelist###Acting Director of Policy and International Programs###Health Canada###Panelist: Sally Prawdzik (she/her/hers) – Health Canada
### she/her/hers @@@ Kimberly A. Trautman, MS – MEDIcept ### 1945643###Panelist###Managing Director and Vice President###MEDIcept###Panelist: Kimberly A. Trautman, MS – MEDIcept
###
