Full Schedule

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Thursday, October 29, 2020
09:15 – 09:45 CET

From Product Information to Promotional Material - Electronic Product Information: Creating a Meaningful Future for Patient Information in Europe
Speaker: Aimad Torqui – MSD
Chair: Colette Shortt, MSc,PhD, MBA
Speaker: Elizabeth Scanlan, MSc, PhD – European Medicines Agency
Pharmaceuticals

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Aimad Torqui – MSD ### 907075###Speaker###Director Global Regulatory Policy###MSD###
Speaker: Aimad Torqui – MSD
@@@ Colette Shortt, MSc,PhD, MBA ### 973109###Chair###Regulatory Director######
Chair: Colette Shortt, MSc,PhD, MBA
@@@ Elizabeth Scanlan, MSc, PhD – European Medicines Agency ### 1096900###Speaker###Scientific Communication Officer###European Medicines Agency###
Speaker: Elizabeth Scanlan, MSc, PhD – European Medicines Agency
09:45 – 10:15 CET

From Product Information to Promotional Material - Promotional Material and National Regulations in EU: How to Successfully Launch Your Product in Different Markets?
Chair: Colette Shortt, MSc,PhD, MBA
Speaker: Camille Piriou, PharmD – BlueReg
Pharmaceuticals

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Colette Shortt, MSc,PhD, MBA ### 973109###Chair###Regulatory Director######
Chair: Colette Shortt, MSc,PhD, MBA
@@@ Camille Piriou, PharmD – BlueReg ### 1079441###Speaker###Senior Consultant Regulatory Affairs###BlueReg###
Speaker: Camille Piriou, PharmD – BlueReg
10:15 – 10:30 CET

Brain Break

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10:15 – 10:30 CET

Meet the Speakers: From Product Information to Promotional Material
Networking & Entertainment

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10:30 – 11:00 CET

Orphan Drugs: Challenges and Differences for its Designation in the European Union and the United States of America
Speaker: Maria Mercedes Bertoli, PhD – Self-employee
Chair: Jennifer Neff, PhD – bess AG
Pharmaceuticals

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Maria Mercedes Bertoli, PhD – Self-employee ### 907133###Speaker###Regulatory Affairs Consultant###Self-employee###
Speaker: Maria Mercedes Bertoli, PhD – Self-employee
@@@ Jennifer Neff, PhD – bess AG ### 958555###Chair###Director QM/RA & Medical Affairs###bess AG###
Chair: Jennifer Neff, PhD – bess AG
11:00 – 11:30 CET

Orphan Drugs: Global Regulatory Landscape and Strategy for Orphan Drugs
Speaker: Mridula Shukla, Masters in Biotechnology – Arcutis Biotherapeutics Inc.
Chair: Jennifer Neff, PhD – bess AG
Speaker: Kristina Larsson, MSc – European Medicines Agency
Pharmaceuticals

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Mridula Shukla, Masters in Biotechnology – Arcutis Biotherapeutics Inc. ### 907124###Speaker###Director, Global Regulatory Affairs###Arcutis Biotherapeutics Inc.###
Speaker: Mridula Shukla, Masters in Biotechnology – Arcutis Biotherapeutics Inc.
@@@ Jennifer Neff, PhD – bess AG ### 958555###Chair###Director QM/RA & Medical Affairs###bess AG###
Chair: Jennifer Neff, PhD – bess AG
@@@ Kristina Larsson, MSc – European Medicines Agency ### 1061459###Speaker###Head of Orphan Drugs###European Medicines Agency###
Speaker: Kristina Larsson, MSc – European Medicines Agency
11:30 – 11:45 CET

Meet the Speakers: Orphan Drugs
Networking & Entertainment

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11:30 – 12:00 CET

Brain Break

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12:00 – 13:00 CET

Supporting Innovation
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
Pharmaceuticals

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Siegfried Schmitt, PhD CSci CChem FRSC – Parexel ### 907098###Session Leader###Vice President Technical###Parexel###
Session Leader: Siegfried Schmitt, PhD CSci CChem FRSC – Parexel
@@@ Stephanie O. Omokaro, MD – U.S. Food & Drug Administration ### 858252###Speaker###Division Deputy Director###U.S. Food & Drug Administration###
Speaker: Stephanie O. Omokaro, MD – U.S. Food & Drug Administration
@@@ Anthony Humphreys – European Medicines Agency ### 978348###Speaker###Head Regulatory Science and Innovation Taskforce###European Medicines Agency###
Speaker: Anthony Humphreys – European Medicines Agency
13:00 – 13:15 CET

Meet the Speakers: Supporting Innovation
Networking & Entertainment

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13:00 – 13:30 CET

Brain Break

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13:30 – 14:30 CET

Regulatory Strategy for Gene Therapy: Challenges and Opportunities
Session Leader/Speaker: Mridula Shukla, Masters in Biotechnology – Arcutis Biotherapeutics Inc.
Speaker: Patrick Celis, PhD – European Medicines Agency
Pharmaceuticals

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Mridula Shukla, Masters in Biotechnology – Arcutis Biotherapeutics Inc. ### 907124###Session Leader/Speaker###Director, Global Regulatory Affairs###Arcutis Biotherapeutics Inc.###
Session Leader/Speaker: Mridula Shukla, Masters in Biotechnology – Arcutis Biotherapeutics Inc.
@@@ Patrick Celis, PhD – European Medicines Agency ### 1096893###Speaker###Scientific Officer###European Medicines Agency###
Speaker: Patrick Celis, PhD – European Medicines Agency
14:30 – 14:45 CET

Brain Break

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14:30 – 14:45 CET

Meet the Speakers: Regulatory Strategy for Gene Therapy: Challenges and Opportunities
Networking & Entertainment

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14:45 – 15:15 CET

Navigating the Future of Regulatory Affairs - The Future of the Regulatory Affairs Profession
Session Leader/Speaker: Peter Lassoff, PharmD – Syneos Health
Speaker: John S. Klein, MS MBA – NorthCoast Clinical Consulting, LLC
Pharmaceuticals

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Peter Lassoff, PharmD – Syneos Health ### 907103###Session Leader/Speaker###Senior Vice President, Regulatory Affairs###Syneos Health###
Session Leader/Speaker: Peter Lassoff, PharmD – Syneos Health
@@@ John S. Klein, MS MBA – NorthCoast Clinical Consulting, LLC ### 907104###Speaker###Principal###NorthCoast Clinical Consulting, LLC###
Speaker: John S. Klein, MS MBA – NorthCoast Clinical Consulting, LLC
15:15 – 16:15 CET

Navigating the Future of Regulatory Affairs - Getting Out More - How Regulatory Affairs Professionals Can Connect with the Shop Floor
Speaker: Siegfried Schmitt, PhD CSci CChem FRSC – Parexel
Session Leader: Peter Lassoff, PharmD – Syneos Health
Pharmaceuticals

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Siegfried Schmitt, PhD CSci CChem FRSC – Parexel ### 907098###Speaker###Vice President Technical###Parexel###
Speaker: Siegfried Schmitt, PhD CSci CChem FRSC – Parexel
@@@ Peter Lassoff, PharmD – Syneos Health ### 907103###Session Leader###Senior Vice President, Regulatory Affairs###Syneos Health###
Session Leader: Peter Lassoff, PharmD – Syneos Health
16:15 – 16:30 CET

Brain Break

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16:15 – 16:30 CET

Meet the Speakers: Navigating the Future of Regulatory Affairs
Networking & Entertainment

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16:30 – 17:30 CET

RNA-Based Therapeutics: Opportunities and Challenges
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
Pharmaceuticals

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Tracy Meffen, MS, CQA, RAC – Genevant Sciences ### 720627###Session Leader/Speaker###Vice President, Quality & Regulatory Affairs###Genevant Sciences###
Session Leader/Speaker: Tracy Meffen, MS, CQA, RAC – Genevant Sciences
@@@ Andreas N. Kuhn, Dr – BioNTech RNA Pharmaceuticals GmbH ### 907113###Speaker###Senior Vice President RNA Biochemistry & Manufacturing###BioNTech RNA Pharmaceuticals GmbH###
Speaker: Andreas N. Kuhn, Dr – BioNTech RNA Pharmaceuticals GmbH
@@@ Ana Hidalgo-Simon, MD, PhD – European Medicines Agency ### 1061460###Speaker######European Medicines Agency###
Speaker: Ana Hidalgo-Simon, MD, PhD – European Medicines Agency
17:30 – 17:45 CET

Meet the Speakers: RNA-Based Therapeutics: Opportunities and Challenges
Networking & Entertainment

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