Full Schedule

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Wednesday, October 28, 2020
08:30 – 09:00 CET

Regulatory Landscape for Medial Device In China
Session Leader: Lena Cordie-Bancroft – Qualitas Professional Services, LLC
Speaker: Yingying Liu, M.Sc. – CSL Behring
Medical Devices

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Lena Cordie-Bancroft – Qualitas Professional Services, LLC ### 743793###Session Leader###President###Qualitas Professional Services, LLC###
Session Leader: Lena Cordie-Bancroft – Qualitas Professional Services, LLC
@@@ Yingying Liu, M.Sc. – CSL Behring ### 907090###Speaker###Associate Director###CSL Behring###
Speaker: Yingying Liu, M.Sc. – CSL Behring
08:30 – 09:30 CET

Creating and Implementing Effective Post-market Clinical Follow-up Under the EU Medical Devices Regulation
Session Leader/Speaker: Adrian Keene, BSc (Hons) – NAMSA
Speaker: Daniela Karrer – Donawa Lifescience
Medical Devices

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Adrian Keene, BSc (Hons) – NAMSA ### 535507###Session Leader/Speaker###Director EMEA, Consulting Services###NAMSA###
Session Leader/Speaker: Adrian Keene, BSc (Hons) – NAMSA
@@@ Daniela Karrer – Donawa Lifescience ### 716657###Speaker###VP Operations and Clinical Affairs###Donawa Lifescience###
Speaker: Daniela Karrer – Donawa Lifescience
08:30 – 09:30 CET

IVDR Regulatory Strategy Plan!: A Proper Regulatory Strategy is Key for IVD Manufacturers and Test-Labs with In-house Developed Tests/LDTs
Session Leader: Anja Wiersma, PhD – mi-CE consultancy
Speaker: Jacques J.M van Dongen, MD, PhD – Leiden University Medical Center (LUMC)
In Vitro Diagnostics

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Anja Wiersma, PhD – mi-CE consultancy ### 574723###Session Leader###Chair of Board of RAPS Netherlands Chapter, CEO of mi-CE consultancy###mi-CE consultancy###
Session Leader: Anja Wiersma, PhD – mi-CE consultancy
@@@ Jacques J.M van Dongen, MD, PhD – Leiden University Medical Center (LUMC) ### 955340###Speaker###Full professor of Medical Immunology###Leiden University Medical Center (LUMC)###
Speaker: Jacques J.M van Dongen, MD, PhD – Leiden University Medical Center (LUMC)
09:00 – 09:30 CET

International Regulatory Landscape Changes: Asia & ASEAN Effective Regulatory Strategy & Update in MedTech Product Registration Process
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)
Medical Devices

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Lena Cordie-Bancroft – Qualitas Professional Services, LLC ### 743793###Session Leader###President###Qualitas Professional Services, LLC###
Session Leader: Lena Cordie-Bancroft – Qualitas Professional Services, LLC
@@@ Joalin Lim, BSc, MSc, PhDc, CCRP, ISO13485:2016 Lead Auditor – Agape-Life Support System Pte Ltd (Agape-Life MedTech Group) ### 1055945###Speaker###CEO/Founder###Agape-Life Support System Pte Ltd (Agape-Life MedTech Group)###
Speaker: Joalin Lim, BSc, MSc, PhDc, CCRP, ISO13485:2016 Lead Auditor – Agape-Life Support System Pte Ltd (Agape-Life MedTech Group)
09:30 – 09:45 CET

Brain Break

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09:30 – 09:45 CET

Meet the Speakers: Creating and Implementing Effective Post-market Clinical Follow-up Under the EU Medical Devices Regulation
Networking & Entertainment

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09:30 – 09:45 CET

Meet the Speakers: International Regulatory Landscape Changes
Networking & Entertainment

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09:30 – 09:45 CET

Meet the Speakers: IVDR Regulatory Strategy Plan!: A Proper Regulatory Strategy is Key for IVD Manufacturers and Test-Labs with In-house Developed Tests/LDTs
Networking & Entertainment

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09:45 – 10:45 CET

European Union Reference Laboratory for IVD
Session Leader/Speaker: Anne Van Nerom, DVM, PhD – Sciensano
In Vitro Diagnostics

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Anne Van Nerom, DVM, PhD – Sciensano ### 907109###Session Leader/Speaker###Project leader###Sciensano###
Session Leader/Speaker: Anne Van Nerom, DVM, PhD – Sciensano
09:45 – 10:45 CET

Innovators and Regulators: Time to Collaborate
Session Leader/Speaker: Lena Cordie-Bancroft – Qualitas Professional Services, LLC
Speaker: Joyce Hansen – Johnson & Johnson
Medical Devices

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Lena Cordie-Bancroft – Qualitas Professional Services, LLC ### 743793###Session Leader/Speaker###President###Qualitas Professional Services, LLC###
Session Leader/Speaker: Lena Cordie-Bancroft – Qualitas Professional Services, LLC
@@@ Joyce Hansen – Johnson & Johnson ### 1139272###Speaker###Vice President, Microbiological Quality and Sterility Assurance###Johnson & Johnson###
Speaker: Joyce Hansen – Johnson & Johnson
09:45 – 10:45 CET

Sufficient Clinical Evidence: What is sufficient clinical evidence for legacy, new and software medical devices?
Session Leader/Speaker: Leo Hovestadt – Elekta
Speaker: Gert Willem Bos, FRAPS – Qserve Group (Netherlands)
Speaker: Giovanni Di Rienzo – Qserve Consultancy
Speaker: Julien Senac
Medical Devices

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Leo Hovestadt – Elekta ### 716677###Session Leader/Speaker###EU Director Governmental Affairs###Elekta###
Session Leader/Speaker: Leo Hovestadt – Elekta
@@@ Gert Willem Bos, FRAPS – Qserve Group (Netherlands) ### 535440###Speaker###CTO, Executive Director & Partner at Qserve Group###Qserve Group (Netherlands)###
Speaker: Gert Willem Bos, FRAPS – Qserve Group (Netherlands)
@@@ Giovanni Di Rienzo – Qserve Consultancy ### 907127###Speaker###Senior Consultant###Qserve Consultancy###
Speaker: Giovanni Di Rienzo – Qserve Consultancy
@@@ Julien Senac ### 1022552###Speaker###Director, IVD Global Focus Team######
Speaker: Julien Senac
10:45 – 11:00 CET

Meet the Speakers: European Union Reference Laboratory for IVD
Networking & Entertainment

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10:45 – 11:00 CET

Meet the Speakers: Innovators and Regulators: Time to Collaborate
Networking & Entertainment

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10:45 – 11:00 CET

Meet the Speakers: Sufficient Clinical Evidence: What is sufficient clinical evidence for legacy, new and software medical devices?
Networking & Entertainment

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10:45 – 11:15 CET

Engage with Solution Providers/Brain Break

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11:15 – 11:45 CET

Impact of Notified Body Representative Technical Documentation Sampling - It Affects Your MDR Compliance Workload
Session Leader/Speaker: Matt Royle, PhD – NAMSA
Medical Devices

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Matt Royle, PhD – NAMSA ### 907121###Session Leader/Speaker###Principal Regulatory Consultant###NAMSA###
Session Leader/Speaker: Matt Royle, PhD – NAMSA
11:15 – 12:15 CET

Clinical Investigation under MDR
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.
Medical Devices

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Sabina Hoekstra-van den Bosch, PharmD, FRAPS – TUV SUD Product Service GmbH ### 574720###Session Leader###Regulatory Strategy Principal###TUV SUD Product Service GmbH###
Session Leader: Sabina Hoekstra-van den Bosch, PharmD, FRAPS – TUV SUD Product Service GmbH
@@@ Steve Eglem, MSc – AFMPH (Competent Authority of Belgium) ### 716662###Speaker###Head of Unit Clinical Investigation & Unmet Medical needs###AFMPH (Competent Authority of Belgium)###
Speaker: Steve Eglem, MSc – AFMPH (Competent Authority of Belgium)
@@@ Wiebe Postma, PhD – Qserve Group B.V. ### 907094###Speaker###Medical Device CRO Lead###Qserve Group B.V.###
Speaker: Wiebe Postma, PhD – Qserve Group B.V.
11:15 – 12:15 CET

The WHO Prequalification (PQ) Program for IVD in the Light of the IVDR
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
In Vitro Diagnostics

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Michael Maier, MBA, RAC – Medidee Services SA ### 915009###Session Leader###Senior Partner###Medidee Services SA###
Session Leader: Michael Maier, MBA, RAC – Medidee Services SA
@@@ Robyn Meurant – NSF International ### 716649###Speaker###Executive Director, Regulatory Team, IVDs and Medical Devices###NSF International###
Speaker: Robyn Meurant – NSF International
@@@ Rima Padovani, PhD – Medidee Services SA ### 1022270###Speaker###Senior Associate###Medidee Services SA###
Speaker: Rima Padovani, PhD – Medidee Services SA
@@@ Mark Lanigan – World Health Organization ### 943227###Speaker###Technical Officer###World Health Organization###
Speaker: Mark Lanigan – World Health Organization
11:45 – 12:00 CET

Meet the Speakers: Impact of Notified Body Representative Technical Documentation Sampling - It Affects Your MDR Compliance Workload
Networking & Entertainment

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12:15 – 12:30 CET

Meet the Speakers: Clinical Investigation under MDR
Networking & Entertainment

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12:15 – 12:30 CET

Meet the Speakers: The WHO Prequalification (PQ) Program for IVD in the Light of the IVDR
Networking & Entertainment

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12:15 – 13:30 CET

Engage with Solution Providers/Lunch Break

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12:30 – 13:15 CET

Meet the Authors: European In Vitro Diagnostic Regulation Guidebook
Author: Rod Beuzeval – Meddev Solutions
Meet the Author

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Rod Beuzeval – Meddev Solutions ### 1142537###Author###Director###Meddev Solutions###
Author: Rod Beuzeval – Meddev Solutions
12:30 – 13:15 CET

The Leading Global Solution For All Your Proofreading Tasks (Sponsored by: Schlafender Hase GmbH)
Speaker: Katarina Kresankova – Schlafender Hase GmbH
Speaker: Marc Chaillou – Schlafender Hase GmbH
Sponsored Session

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Katarina Kresankova – Schlafender Hase GmbH ### 1154944###Speaker###Sales Manager###Schlafender Hase GmbH###
Speaker: Katarina Kresankova – Schlafender Hase GmbH
@@@ Marc Chaillou – Schlafender Hase GmbH ### 1154945###Speaker###Regional Sales Director###Schlafender Hase GmbH###
Speaker: Marc Chaillou – Schlafender Hase GmbH
13:30 – 14:30 CET

Clinical Evaluation Reports (CERs)
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
Medical Devices

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Diana Nogueira, MSc, PhD – Qserve Group Deutschland GmbH ### 1022276###Session Leader/Speaker###Senior Consultant###Qserve Group Deutschland GmbH###
Session Leader/Speaker: Diana Nogueira, MSc, PhD – Qserve Group Deutschland GmbH
@@@ Karen Bannick McQuoid, MA, FRAPS, RAC – Bannick LLC ### 907111###Speaker###CEO###Bannick LLC###
Speaker: Karen Bannick McQuoid, MA, FRAPS, RAC – Bannick LLC
@@@ Giovanni Di Rienzo – Qserve Consultancy ### 907127###Speaker###Senior Consultant###Qserve Consultancy###
Speaker: Giovanni Di Rienzo – Qserve Consultancy
13:30 – 14:30 CET

Software as a Medical Device: Comparison Between US and EU Approaches
Speaker: Pat Baird, MBA, MS – Philips
Medical Devices

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Pat Baird, MBA, MS – Philips ### 805710###Speaker###Senior Regulatory Specialist - Head of Global Software Standards###Philips###
Speaker: Pat Baird, MBA, MS – Philips
13:30 – 14:30 CET

What is Sufficient Clinical Evidence for IVDs in Preparation for the IVDR?
Session Leader/Speaker: Luc Van Hove, MD, PhD – MARACA International bvba
In Vitro Diagnostics

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Luc Van Hove, MD, PhD – MARACA International bvba ### 716641###Session Leader/Speaker###CEO###MARACA International bvba###
Session Leader/Speaker: Luc Van Hove, MD, PhD – MARACA International bvba
14:30 – 14:45 CET

Meet the Speakers: Clinical Evaluation Reports (CERs)
Networking & Entertainment

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14:30 – 14:45 CET

Meet the Speakers: Software as a Medical Device: Comparison Between US and EU Approaches
Networking & Entertainment

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14:30 – 14:45 CET

Meet the Speakers: What is Sufficient Clinical Evidence for IVDs in Preparation for the IVDR?
Networking & Entertainment

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14:30 – 15:00 CET

Brain Break

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15:00 – 16:00 CET

- SaMD/Cybersecurity - Regulatory Strategies for Machine Learning/AI and Software as a Medical Device (SaMD)
Speaker: Abtin Rad
Medical Devices

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Abtin Rad ### 1142780###Speaker#########
Speaker: Abtin Rad
15:00 – 16:00 CET

Navigating the Pre-Market Approval Process for FDA
Session Leader/Speaker: Hilary A. Baldwin – Caris Life Sciences
In Vitro Diagnostics

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Hilary A. Baldwin – Caris Life Sciences ### 716644###Session Leader/Speaker###Regulatory Director###Caris Life Sciences###
Session Leader/Speaker: Hilary A. Baldwin – Caris Life Sciences
15:00 – 16:00 CET

Risk Management - Focal Point for Regulatory and Legal Purposes
Session Leader/Speaker: Kimberly Ann Trautman, MS
Speaker: Richard Bassett, LLM, Msc, Bsc – NAMSA
Medical Devices

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Kimberly Ann Trautman, MS ### 535494###Session Leader/Speaker###EVP, Medical Device International Services######
Session Leader/Speaker: Kimberly Ann Trautman, MS
@@@ Richard Bassett, LLM, Msc, Bsc – NAMSA ### 907120###Speaker###Medical Writer###NAMSA###
Speaker: Richard Bassett, LLM, Msc, Bsc – NAMSA
16:00 – 16:10 CET

Brain Break

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16:00 – 16:15 CET

Meet the Speakers: Navigating the Pre-Market Approval Process for FDA
Networking & Entertainment

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16:00 – 16:15 CET

Meet the Speakers: Risk Management - Focal Point for Regulatory and Legal Purposes
Networking & Entertainment

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16:00 – 16:15 CET

Meet the Speakers: SaMD/Cybersecurity - Case Studies
Networking & Entertainment

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16:15 – 16:20 CET

Poster Presentation 1: Development of a Digital Tool for Risk Management, Post-Market Surveillance, Clinical Evaluation of Medical Devices
Poster Presenter: Shristi Shrestha, MSc – Lübeck University of Applied Sciences
Poster

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Shristi Shrestha, MSc – Lübeck University of Applied Sciences ### 907105###Poster Presenter###Student###Lübeck University of Applied Sciences###
Poster Presenter: Shristi Shrestha, MSc – Lübeck University of Applied Sciences
16:20 – 16:25 CET

Poster Presentation 2: Regulatory Challenges in the Non-EU Countries of the SEE Region
Poster Presenter: Dragana Bundalo, MSc – PharmaSwiss
Poster

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Dragana Bundalo, MSc – PharmaSwiss ### 907091###Poster Presenter###Regulatory Affairs Associate###PharmaSwiss###
Poster Presenter: Dragana Bundalo, MSc – PharmaSwiss
16:25 – 16:30 CET

Poster Presentation 3: eSubmissions: Regional Moving Towards Global Aspects
Poster Presenter: Dzeparoski Marjan, PhD – Bionika Pharmaceuticals
Poster

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Dzeparoski Marjan, PhD – Bionika Pharmaceuticals ### 907084###Poster Presenter###RA&PV Manager###Bionika Pharmaceuticals###
Poster Presenter: Dzeparoski Marjan, PhD – Bionika Pharmaceuticals
16:30 – 16:45 CET

Live Q&A: poster presentations 1 - 3
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

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Charlie Mortazavi, PharmD – SANOFI ### 907082###Moderator###SENIOR MANAGER###SANOFI###
Moderator: Charlie Mortazavi, PharmD – SANOFI
@@@ Shristi Shrestha, MSc – Lübeck University of Applied Sciences ### 907105###Poster Presenter###Student###Lübeck University of Applied Sciences###
Poster Presenter: Shristi Shrestha, MSc – Lübeck University of Applied Sciences
@@@ Dragana Bundalo, MSc – PharmaSwiss ### 907091###Poster Presenter###Regulatory Affairs Associate###PharmaSwiss###
Poster Presenter: Dragana Bundalo, MSc – PharmaSwiss
@@@ Dzeparoski Marjan, PhD – Bionika Pharmaceuticals ### 907084###Poster Presenter###RA&PV Manager###Bionika Pharmaceuticals###
Poster Presenter: Dzeparoski Marjan, PhD – Bionika Pharmaceuticals
@@@ Reeshav Pradhan, MSc. – Technical University of Applied Science Luebeck ### 1145306###Poster Presenter######Technical University of Applied Science Luebeck###
Poster Presenter: Reeshav Pradhan, MSc. – Technical University of Applied Science Luebeck
@@@ Umesh Satyal, MSc – Lübeck University of Applied Science, Lübeck, Germany ### 1145308###Poster Presenter###Student###Lübeck University of Applied Science, Lübeck, Germany###
Poster Presenter: Umesh Satyal, MSc – Lübeck University of Applied Science, Lübeck, Germany
16:45 – 16:50 CET

Poster Presentation 4: The Importance of a Regulatory Qualification and Continuous Professional Development in Career Progression and Advancement
Poster Presenter: Olivia McDermott, Ph.D – Olivia McDermott Hayes
Poster

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Olivia McDermott, Ph.D – Olivia McDermott Hayes ### 907092###Poster Presenter###Lecturer in Healthcare Regulatory Affairs###Olivia McDermott Hayes###
Poster Presenter: Olivia McDermott, Ph.D – Olivia McDermott Hayes
16:50 – 16:55 CET

Poster Presentation 5: Can Legislation Evolve Along with Technology? Case Study: Software as Medical Device in Emerging Markets
Poster Presenter: Monica Hernandez, Bachelor in Biopharmaceutical Chemistry – Cardinal Health
Poster

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Monica Hernandez, Bachelor in Biopharmaceutical Chemistry – Cardinal Health ### 907102###Poster Presenter###Regulatory Affairs Specialist in Central America###Cardinal Health###
Poster Presenter: Monica Hernandez, Bachelor in Biopharmaceutical Chemistry – Cardinal Health
17:00 – 17:15 CET

Live Q&A: poster presentations 4 - 5
Moderator: Charlie Mortazavi, PharmD – SANOFI
Poster Presenter: Olivia McDermott, Ph.D – Olivia McDermott Hayes
Poster Presenter: Monica Hernandez, Bachelor in Biopharmaceutical Chemistry – Cardinal Health
Poster

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Charlie Mortazavi, PharmD – SANOFI ### 907082###Moderator###SENIOR MANAGER###SANOFI###
Moderator: Charlie Mortazavi, PharmD – SANOFI
@@@ Olivia McDermott, Ph.D – Olivia McDermott Hayes ### 907092###Poster Presenter###Lecturer in Healthcare Regulatory Affairs###Olivia McDermott Hayes###
Poster Presenter: Olivia McDermott, Ph.D – Olivia McDermott Hayes
@@@ Monica Hernandez, Bachelor in Biopharmaceutical Chemistry – Cardinal Health ### 907102###Poster Presenter###Regulatory Affairs Specialist in Central America###Cardinal Health###
Poster Presenter: Monica Hernandez, Bachelor in Biopharmaceutical Chemistry – Cardinal Health
17:25 – 19:00 CET

Virtual Culinary Experience
Networking & Entertainment

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