Session Leader: Maria E. Donawa, MD – Donawa Lifescience
Speaker: Daniela Karrer – Donawa Lifescience
Speaker: Matteo Mosso – Donawa Lifescience
Session Leader/Speaker: Luc Van Hove, MD, PhD – MARACA International bvba
Speaker: Menno Prins, PhD – Eindhoven University of Technology
Speaker: Angel Delpozo, MSC – BioKeralty Research Institute
Speaker: Quentin Pankhurst
Session Leader: Michael Maier, MBA, RAC – Medidee Services SA
Speaker: Tim Farley, PhD – Medidee Services SA
Speaker: Sandra Klompmaker, PhD – Medidee Services
Speaker: Hilary A. Baldwin – Caris Life Sciences
Chair: Luc Van Hove, MD, PhD – MARACA International bvba
Speaker: Armin Ritzhaupt, PhD, MPH – European Medicines Agency
Session Leader/Speaker: Rachel Kennedy, RAC – LabCorp.
Session Leader: Gert Willem Bos, FRAPS – Qserve Group (Netherlands)
Panelist: Armin Ritzhaupt, PhD, MPH – European Medicines Agency
Panelist: Andreas Stange, PhD – TÜV SÜD Japan
Panelist: Tom Patten – NSAI
Panelist: Sue Spencer – Qserve Group (United Kingdom)
Panelist: Simon Richards, PhD – Abbott Rapid Diagnostics
Session Leader: Anja Wiersma, PhD – mi-CE consultancy
Speaker: Jacques J.M van Dongen, MD, PhD – Leiden University Medical Center (LUMC)
Session Leader/Speaker: Anne Van Nerom, DVM, PhD – Sciensano
Session Leader: Michael Maier, MBA, RAC – Medidee Services SA
Speaker: Robyn Meurant – NSF International
Speaker: Rima Padovani, PhD – Medidee Services SA
Speaker: Mark Lanigan – World Health Organization
Session Leader/Speaker: Luc Van Hove, MD, PhD – MARACA International bvba
Session Leader/Speaker: Hilary A. Baldwin – Caris Life Sciences
Moderator: Amanda Maxwell, BA – Medtech Insight
Speaker: Sabina Hoekstra-van den Bosch, PharmD, FRAPS – TUV SUD Product Service GmbH
Speaker: Gert Willem Bos, FRAPS – Qserve Group (Netherlands)
Speaker: Erik Vollebregt
Session Leader: Jayanth K. Katta, PhD – BSI
Speaker: Jane Arnold-Round, B.Eng Msc.
Speaker: Jonathan Sutch, PhD – BSI
Speaker: Armin Ritzhaupt, PhD, MPH – European Medicines Agency
Speaker: Stephan Affolter – Ypsomed AG
Session Leader/Speaker: Sophie Tabutin, PharmD, MSc – W.L. Gore & Associates
Speaker: Jayanth K. Katta, PhD – BSI
Speaker: Rainer Voelksen, FRAPS – VOELKSEN Regulatory Affairs
Session Leader/Speaker: Jan-Paul van Loon, MSc, PhD – Qserve Consultancy BV
Speaker: Jane Arnold-Round, B.Eng Msc.
Session Leader/Speaker: Lena Cordie-Bancroft – Qualitas Professional Services, LLC
Speaker: Hans Strobel – dokspot GmbH, Zurich, Switzerland
Speaker: Reinhart Seibl
Speaker: Alex Laan – NAMSA
Session Leader/Speaker: John C. Lockwood, CBA, RAC, CSQE – Pearl Pathways
Speaker: John Van Hoven, MS – Rocky Mountain Regulatory and Quality Partners
Session Leader/Speaker: Keith Morel, PhD – Qserve Group Inc. - ENTERPRISE
Speaker: Leonard Buchner, MS – Qserve Group
Session Leader/Speaker: Jason R. Krzeszak, MSE, MBA – NAMSA
Speaker: Deepa Arora, MD – Clinexel Life Sciences Private Limited
Speaker: Melissa Walker, MS, RAC, FRAPS – Graematter, Inc.
Session Leader/Speaker: Natascha J. Cuper, PhD – DARE Medical Certifications
Speaker: Robert van Boxtel, MSc. – Medical Device Project B.V.
Session Leader: Ludger Johannes Moeller – Medical Device Safety Service GmbH
Speaker: Erik Vollebregt
Speaker: Thomas Sproho, Dipl.-Kfm. – Chubb
Speaker: Chad Reynolds – Maetrics
Session Leader: Lena Cordie-Bancroft – Qualitas Professional Services, LLC
Speaker: Yingying Liu, M.Sc. – CSL Behring
Session Leader/Speaker: Adrian Keene, BSc (Hons) – NAMSA
Speaker: Daniela Karrer – Donawa Lifescience
Session Leader: Lena Cordie-Bancroft – Qualitas Professional Services, LLC
Speaker: Joalin Lim, BSc, MSc, PhDc, CCRP, ISO13485:2016 Lead Auditor – Agape-Life Support System Pte Ltd (Agape-Life MedTech Group)
Session Leader/Speaker: Lena Cordie-Bancroft – Qualitas Professional Services, LLC
Speaker: Joyce Hansen – Johnson & Johnson
Session Leader/Speaker: Leo Hovestadt – Elekta
Speaker: Gert Willem Bos, FRAPS – Qserve Group (Netherlands)
Speaker: Giovanni Di Rienzo – Qserve Consultancy
Speaker: Julien Senac
Session Leader/Speaker: Matt Royle, PhD – NAMSA
Session Leader: Sabina Hoekstra-van den Bosch, PharmD, FRAPS – TUV SUD Product Service GmbH
Speaker: Steve Eglem, MSc – AFMPH (Competent Authority of Belgium)
Speaker: Wiebe Postma, PhD – Qserve Group B.V.
Session Leader/Speaker: Diana Nogueira, MSc, PhD – Qserve Group Deutschland GmbH
Speaker: Karen Bannick McQuoid, MA, FRAPS, RAC – Bannick LLC
Speaker: Giovanni Di Rienzo – Qserve Consultancy
Speaker: Pat Baird, MBA, MS – Philips
Speaker: Abtin Rad
Session Leader/Speaker: Kimberly Ann Trautman, MS
Speaker: Richard Bassett, LLM, Msc, Bsc – NAMSA
Author: Rod Beuzeval – Meddev Solutions
Author: Rod Beuzeval – Meddev Solutions
Speaker: Aimad Torqui – MSD
Chair: Colette Shortt, MSc,PhD, MBA
Speaker: Elizabeth Scanlan, MSc, PhD – European Medicines Agency
Chair: Colette Shortt, MSc,PhD, MBA
Speaker: Camille Piriou, PharmD – BlueReg
Speaker: Maria Mercedes Bertoli, PhD – Self-employee
Chair: Jennifer Neff, PhD – bess AG
Speaker: Mridula Shukla, Masters in Biotechnology – Arcutis Biotherapeutics Inc.
Chair: Jennifer Neff, PhD – bess AG
Speaker: Kristina Larsson, MSc – European Medicines Agency
Session Leader: Siegfried Schmitt, PhD CSci CChem FRSC – Parexel
Speaker: Stephanie O. Omokaro, MD – U.S. Food & Drug Administration
Speaker: Anthony Humphreys – European Medicines Agency
Session Leader/Speaker: Mridula Shukla, Masters in Biotechnology – Arcutis Biotherapeutics Inc.
Speaker: Patrick Celis, PhD – European Medicines Agency
Session Leader/Speaker: Peter Lassoff, PharmD – Syneos Health
Speaker: John S. Klein, MS MBA – NorthCoast Clinical Consulting, LLC
Speaker: Siegfried Schmitt, PhD CSci CChem FRSC – Parexel
Session Leader: Peter Lassoff, PharmD – Syneos Health
Session Leader/Speaker: Tracy Meffen, MS, CQA, RAC – Genevant Sciences
Speaker: Andreas N. Kuhn, Dr – BioNTech RNA Pharmaceuticals GmbH
Speaker: Ana Hidalgo-Simon, MD, PhD – European Medicines Agency
Speaker: Yingying Liu, M.Sc. – CSL Behring
Chair: Pallavi Trivedi, MPH, RAC – Trident Pharmaceuticals limited & Spinos Clinical Research Uk
Speaker: Stefanie Faßhauer, MBA – PharmaLex
Chair: Pallavi Trivedi, MPH, RAC – Trident Pharmaceuticals limited & Spinos Clinical Research Uk
Speaker: David Thompson, N/A – Clarity compliance solutions ltd
Speaker: Siegfried Schmitt, PhD CSci CChem FRSC – Parexel
Speaker: Irena Milobratovic, MPharm, RAC – Arriello
Speaker: Claudia Louati, MS – US Food and Drug Administration, Europe Office
Speaker: Gabriela Marton – Arriello s.r.o
Chair: Jennifer Neff, PhD – bess AG
Session Leader/Speaker: Charlie Mortazavi, PharmD – SANOFI
Speaker: Mark Louis Slisz, US & EU RAC – Pearl Pathways
Chair: Charlie Mortazavi, PharmD – SANOFI
Speaker: Robert Seevers, PhD – Pearl Pathways
Chair: Mark Di Cioccio – Team Consulting
Chair: Mark Di Cioccio – Team Consulting
Speaker: Philip M. Budashewitz, RPh MA – U.S. Food and Drug Administration
Co-Chair: Sabina Hoekstra-van den Bosch, PharmD, FRAPS – TUV SUD Product Service GmbH
Co-Chair: Gert Willem Bos, FRAPS – Qserve Group (Netherlands)
Panelist: Simon Richards, PhD – Abbott Rapid Diagnostics
Panelist: Natascha J. Cuper, PhD – DARE Medical Certifications
Panelist: Erica Conway, PhD – BSI (London)
Panelist: Waldo Weijers, PharmD – Medicines Evaluation Board (NL)
Panelist: Eric Klasen, MSc – Founder of Waypoint Consulting
Panelist: Armin Ritzhaupt, PhD, MPH – European Medicines Agency
Panelist: Micha Nuebling, PhD – Paul-Ehrlich-Institut
Panelist: Jayanth K. Katta, PhD – BSI
Panelist: Bassil Akra, PhD – QUNIQUE GmbH
Panelist: Elizabeth Gfoeller, MA – Med-El
Panelist: Erik Raadsheer, PhD – Align Technology, BV.
Panelist: Susana Waesch – Ypsomed
Panelist: Klaus-Dieter Ziel – MEDCERT GmbH, Notified Body Germany
Panelist: Erik Hansson – DG for Health and Food Safety (SANTE)
Poster Presenter: Shristi Shrestha, MSc – Lübeck University of Applied Sciences
Poster Presenter: Dragana Bundalo, MSc – PharmaSwiss
Poster Presenter: Dzeparoski Marjan, PhD – Bionika Pharmaceuticals
Moderator: Charlie Mortazavi, PharmD – SANOFI
Poster Presenter: Shristi Shrestha, MSc – Lübeck University of Applied Sciences
Poster Presenter: Dragana Bundalo, MSc – PharmaSwiss
Poster Presenter: Dzeparoski Marjan, PhD – Bionika Pharmaceuticals
Poster Presenter: Reeshav Pradhan, MSc. – Technical University of Applied Science Luebeck
Poster Presenter: Umesh Satyal, MSc – Lübeck University of Applied Science, Lübeck, Germany
Poster Presenter: Olivia McDermott, Ph.D – Olivia McDermott Hayes
Poster Presenter: Monica Hernandez, Bachelor in Biopharmaceutical Chemistry – Cardinal Health
Moderator: Charlie Mortazavi, PharmD – SANOFI
Poster Presenter: Olivia McDermott, Ph.D – Olivia McDermott Hayes
Poster Presenter: Monica Hernandez, Bachelor in Biopharmaceutical Chemistry – Cardinal Health
Workshop Leader: Lena Cordie-Bancroft – Qualitas Professional Services, LLC
Workshop Leader: Bassil Akra, PhD – QUNIQUE GmbH
Speaker: Martin Witte – TÜV SÜD Product Service GmbH
Speaker: Peter W. Bowness, PhD – British Standards Institution
Speaker: Dominik Herzog, Dr – TentaMedix GmbH
Speaker: Christoph D. Lindner, PhD, MSc – TUV Sud Product Service GmbH
Speaker: Christian Johner
Speaker: Andreas Purde, Dr – TÜV SÜD Product Service GmbH
Workshop Leader: Sabina Hoekstra-van den Bosch, PharmD, FRAPS – TUV SUD Product Service GmbH
Speaker: Wiebe Postma, PhD – Qserve Group B.V.
Speaker: Yvonne Ndefo, MD, MCh – NSAI
Session Leader/Speaker: Anja Wiersma, PhD – mi-CE consultancy
Speaker: Erica Conway, PhD – BSI (London)
Speaker: Simon Richards, PhD – Abbott Rapid Diagnostics
Speaker: Micha Nuebling, PhD – Paul-Ehrlich-Institut
Speaker: Philipp Hohenbrink, Dr rer nat – Medical Device Safety Service GmbH
Speaker: Claudia Dollins, PhD – Merck Healthcare KGaA
Workshop Leader: Koen Cobbaert, MA – Philips
Speaker: Leo Hovestadt – Elekta
Speaker: Martin de Bruin
Speaker: Katarina Kresankova – Schlafender Hase GmbH
Speaker: Marc Chaillou – Schlafender Hase GmbH