Grace Fu Palma, MBA – China Med Device, LLC ### 1000101###Moderator###CEO###China Med Device, LLC###
Moderator: Grace Fu Palma, MBA – China Med Device, LLC
@@@ Jason Liang – China Med Device, LLC ### 1000111###Speaker###QA Director###China Med Device, LLC###
Speaker: Jason Liang – China Med Device, LLC
@@@ Xin Sun – West China Hospital, Sichuan University in Chengdu, China ### 1061434###Speaker###Professor and Director of Clinical Epidemiology and Evidence-based Medicine Research Center###West China Hospital, Sichuan University in Chengdu, China###
Speaker: Xin Sun – West China Hospital, Sichuan University in Chengdu, China
@@@ Jane Lin – Johnson and Johnson Medical ### 1061435###Speaker###Head of Regulatory Affairs, Asia Pacific###Johnson and Johnson Medical###
Speaker: Jane Lin – Johnson and Johnson Medical
@@@ Wei Shang, RAC, CQA ### 1072904###Speaker###Senior RA Manager######
Speaker: Wei Shang, RAC, CQA
@@@ Lindsay Tao, MD – J&J Worldwide GA & Policy ### 1089154###Speaker###Corporate Director, Global Health Policy###J&J Worldwide GA & Policy###
Speaker: Lindsay Tao, MD – J&J Worldwide GA & Policy
Panelist: Falk Ehmann, MD, PhD, MSc, – European Medicines Agency
@@@ Ana Hidalgo-Simon, MD, PhD – European Medicines Agency ### 1061460###Panelist######European Medicines Agency###
Panelist: Ana Hidalgo-Simon, MD, PhD – European Medicines Agency
@@@ Jan Mueller-Berghaus, MD ### 790291###Panelist#########
Panelist: Jan Mueller-Berghaus, MD
@@@ Karl-Heinz Huemer, MD, PhD – AGES (Austrian Agency for Health & Food Safety) ### 573393###Panelist###Medical Assessor###AGES (Austrian Agency for Health & Food Safety)###
Panelist: Karl-Heinz Huemer, MD, PhD – AGES (Austrian Agency for Health & Food Safety)
@@@ Maria Concepción Prieto Yerro, MD, PhD – Spanish Agency for Medicines and Medical Devices ### 790292###Panelist###CHMP member from Spain###Spanish Agency for Medicines and Medical Devices###
Panelist: Maria Concepción Prieto Yerro, MD, PhD – Spanish Agency for Medicines and Medical Devices
@@@ 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
@@@ Philippe Auclair, Pharma Dr, PhD , FRAPS – Abbott ### 535445###Panelist###Senior Director Regulatory Strategy EMEA###Abbott###
Panelist: Philippe Auclair, Pharma Dr, PhD , FRAPS – Abbott
@@@ Oliver Bisazza – MedTech Europe ### 535442###Panelist######MedTech Europe###
Panelist: Oliver Bisazza – MedTech Europe
@@@ Erica Conway, PhD – BSI (London) ### 535513###Panelist###Global Head - In Vitro Diagnostic Medical Devices###BSI (London)###
Panelist: Erica Conway, PhD – BSI (London)
@@@ Laura de Vries, PhD – Dutch Health and Youth Care Inspectorate ### 1089150###Panelist###Coordinating/Specialist Inspector###Dutch Health and Youth Care Inspectorate###
Panelist: Laura de Vries, PhD – Dutch Health and Youth Care Inspectorate
@@@ Sabina Hoekstra-van den Bosch, PharmD, FRAPS – TUV SUD Product Service GmbH ### 574720###Panelist###Regulatory Strategy Principal###TUV SUD Product Service GmbH###
Panelist: Sabina Hoekstra-van den Bosch, PharmD, FRAPS – TUV SUD Product Service GmbH
Panelist: Armin Ritzhaupt, PhD, MPH – European Medicines Agency
@@@ Sue Spencer – Qserve Group (United Kingdom) ### 535447###Panelist###IVD Lead/ Principal Consultant###Qserve Group (United Kingdom)###
Panelist: Sue Spencer – Qserve Group (United Kingdom)
@@@ John Wilkinson, MBA – Global Medical Devices Nomenclature ### 574719###Panelist###Chair of the Board of Trustees###Global Medical Devices Nomenclature###
Panelist: John Wilkinson, MBA – Global Medical Devices Nomenclature
10:00 AM – 11:30 AM EDT
Orphan Precedent and the Continued Evolution of the Orphan Drug Framework
@@@ Kristina Larsson, MSc – European Medicines Agency ### 1061459###Speaker###Head of Orphan Drugs###European Medicines Agency###
Speaker: Kristina Larsson, MSc – European Medicines Agency
@@@ Janet Maynard, MD, MHS – US Food and Drug Administration ### 1061475###Speaker###Director of Office of Orphan Products Development###US Food and Drug Administration###
Speaker: Janet Maynard, MD, MHS – US Food and Drug Administration
@@@ Martine Zimmermann, PharmD – Alexion Pharmaceuticals ### 740303###Speaker###SVP, Head of Global Regulatory Affairs###Alexion Pharmaceuticals###
Speaker: Michael Shum – Therapeutic Goods Administration - ENTERPRISE
@@@ Dianne Spillman – US Food and Drug Administration ### 1049039###Speaker###Associate Director, Global Regulatory Outreach, OCE###US Food and Drug Administration###
Speaker: Dianne Spillman – US Food and Drug Administration
@@@ Melissa Hunt, MSc – Health Canada ### 1049040###Speaker###Director of the Bureau of Metabolism, Oncology and Reproductive Sciences, Therapeutic Products Directorate###Health Canada###
Lisa M. Casavant, MME – Regulatory and Quality Solutions LLC - Enterprise ### 765192###Moderator###Cofounder and Chief Strategy Officer###Regulatory and Quality Solutions LLC - Enterprise###
Moderator: Lisa M. Casavant, MME – Regulatory and Quality Solutions LLC - Enterprise
@@@ Jonathan Gimbel, PhD – Regulatory and Quality Solutions LLC - Enterprise ### 1071091###Panelist######Regulatory and Quality Solutions LLC - Enterprise###
Panelist: Jonathan Gimbel, PhD – Regulatory and Quality Solutions LLC - Enterprise
Speaker: Ryan McGowan, BS Eng, MEng – AstraZeneca/MedImmune - ENTERPRISE
@@@ John Barr Weiner, JD – US Food and Drug Administration ### 1083189###Speaker###Associate Director for Policy and Product Classification Officer, Office of Combination Products###US Food and Drug Administration###
Speaker: John Barr Weiner, JD – US Food and Drug Administration
Speaker: Nathalie Bere, MPH – European Medicines Agency
@@@ Andrea Furia-Helms, MPH – US Food and Drug Administration ### 1083216###Speaker###Director, Patient Affairs Staff, Office of Clinical Policy and Programs, Office of the Commissioner###US Food and Drug Administration###
Speaker: Andrea Furia-Helms, MPH – US Food and Drug Administration
Lawrence Liberti, MSc, PhD – CIRS- Centre for Innovation in Regulatory Science ### 1046359###Moderator###Head, Regulatory Collaborations###CIRS- Centre for Innovation in Regulatory Science###
Moderator: Lawrence Liberti, MSc, PhD – CIRS- Centre for Innovation in Regulatory Science
@@@ Agnes Saint-Raymond, MD – European Medicines Agency ### 1070853###Speaker###Head of International Affairs Division###European Medicines Agency###
Speaker: Agnes Saint-Raymond, MD – European Medicines Agency
@@@ Fergus Sweeney – European Medicines Agency ### 1070852###Speaker###Head of Inspections and Human Medicines Pharmacovigilance Division###European Medicines Agency###
Speaker: Fergus Sweeney – European Medicines Agency
@@@ Celia Lourenco, PhD – Health Canada ### 1083173###Panelist###Director General of the Biologic and Radiopharmaceutical Drugs Directorate (BRDD), Health Products and Food Branch###Health Canada###
Panelist: Celia Lourenco, PhD – Health Canada
12:00 PM – 1:30 PM EDT
Implementing Effective EU MDR Postmarket Surveillance (PMS) Processes to Deliver Your Periodic Safety Update Report (PSUR): Challenges and Practical Approaches
@@@ Suzanne Schwartz, MD, MBA – US Food and Drug Administration ### 593621###Speaker###Director, Office of Strategic Partnerships and Technology Innovation, CDRH###US Food and Drug Administration###
Speaker: Suzanne Schwartz, MD, MBA – US Food and Drug Administration
12:00 PM – 1:30 PM EDT
The Future of the Regulatory Professional in the digital world
Maria Vrabie – Abbott ### 1083895###Moderator######Abbott###
Moderator: Maria Vrabie – Abbott
@@@ Mindy McCann – Qserve Group Inc. - ENTERPRISE ### 720640###Session Leader###Vice President Regulatory Compliance###Qserve Group Inc. - ENTERPRISE###
Session Leader: Mindy McCann – Qserve Group Inc. - ENTERPRISE
@@@ Jane Arnold-Round, B.Eng Msc. ### 907114###Speaker#########
Speaker: Jane Arnold-Round, B.Eng Msc.
@@@ Lena Cordie-Bancroft – Qualitas Professional Services, LLC ### 743793###Speaker###President###Qualitas Professional Services, LLC###
Speaker: Lena Cordie-Bancroft – Qualitas Professional Services, LLC
Moderator: Mac McKeen, RAC, FRAPS, MBA, RAC FRAPS MBA – Boston Scientific - ENTERPRISE
Speaker: Marjorie Shulman – US Food and Drug Administration
Speaker: Peter Yang, PhD – Division of Submission Support, Office of Regulatory Programs, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration
Mac McKeen, RAC, FRAPS, MBA, RAC FRAPS MBA – Boston Scientific - ENTERPRISE ### 772303###Moderator###Fellow, Regulatory Science###Boston Scientific - ENTERPRISE###
Moderator: Mac McKeen, RAC, FRAPS, MBA, RAC FRAPS MBA – Boston Scientific - ENTERPRISE
@@@ Marjorie Shulman – US Food and Drug Administration ### 772335###Speaker###Assistant Director 510(k), DeNovo, 513(g), Device Determinations and Custom Devices Lifecycle Team, Division of Regulatory Programs 1 (Submission Support), OPEQ, CDRH###US Food and Drug Administration###
Speaker: Marjorie Shulman – US Food and Drug Administration
@@@ Peter Yang, PhD – Division of Submission Support, Office of Regulatory Programs, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration ### 1083214###Speaker###De Novo Program Lead###Division of Submission Support, Office of Regulatory Programs, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration###
Speaker: Peter Yang, PhD – Division of Submission Support, Office of Regulatory Programs, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration
2:05 PM – 3:00 PM EDT
How to Apply Risk to Your Total Product Life Cycle Using ISO 14971:2019
@@@ Junichi Ohishi, PhD – Pharmaceuticals and Medical Devices Agency (PMDA) ### 1052817###Speaker######Pharmaceuticals and Medical Devices Agency (PMDA)###
Speaker: Junichi Ohishi, PhD – Pharmaceuticals and Medical Devices Agency (PMDA)
Don E. Boyer, HBSc., RAC, FRAP ### 535533###Session Leader###President, BOYER@RegulatorySolns######
Session Leader: Don E. Boyer, HBSc., RAC, FRAP
@@@ Elizabeth Toller – Health Canada ### 1089146###Speaker###Executive Director for Regulatory Innovation, Health Products and Food Branch###Health Canada###
Speaker: Elizabeth Toller – Health Canada
@@@ Tanya Ramsamy, PhD – Health Canada ### 1089147###Speaker###Associate Director, Office of Clinical Trials###Health Canada###
Speaker: Tanya Ramsamy, PhD – Health Canada
@@@ Celia Lourenco, PhD – Health Canada ### 1083173###Speaker###Director General of the Biologic and Radiopharmaceutical Drugs Directorate (BRDD), Health Products and Food Branch###Health Canada###
Speaker: Celia Lourenco, PhD – Health Canada
@@@ David Boudreau, ing – Health Canada ### 570151###Speaker###Executive Director, Medical Devices Bureau###Health Canada###
Speaker: David Boudreau, ing – Health Canada
@@@ Catherine Hudon – Health Canada ### 1089148###Speaker###Director, Compliance Policy and Regulatory Affairs###Health Canada###
Speaker: Catherine Hudon – Health Canada
2:05 PM – 3:00 PM EDT
Rx to OTC Switch – Expanding Self-Care by Enabling Consumer Decision-Making
Ken Skodacek – FDA ### 1005446###Facilitator###FDA/CDRH Deputy Ombudsman###FDA###
Facilitator: Ken Skodacek – FDA
9:35 AM – 10:20 AM EDT
Evolving From Compliance Enablement to Strategic Value: Driving Further Adoption of Digital Tools in Regulatory Affairs and Lessons Learned From Global RIM Implementations (Sponsored by KPMG)
@@@ Lawrence Liberti, MSc, PhD – CIRS- Centre for Innovation in Regulatory Science ### 1046359###Speaker###Head, Regulatory Collaborations###CIRS- Centre for Innovation in Regulatory Science###
Speaker: Lawrence Liberti, MSc, PhD – CIRS- Centre for Innovation in Regulatory Science
@@@ Mario Alanis, PhD – CIRS- Centre for Innovation in Regulatory Science ### 1046358###Speaker###Senior Advisor###CIRS- Centre for Innovation in Regulatory Science###
Speaker: Mario Alanis, PhD – CIRS- Centre for Innovation in Regulatory Science
@@@ Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency ### 573431###Speaker###Head of Scientific Office###Austrian Medicines and Medical Devices Agency###
Speaker: Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency
@@@ Cesar Hernández – AEMPS ### 1061431###Speaker###Head of Department of Medicines for Human Use###AEMPS###
Speaker: Cesar Hernández – AEMPS
9:35 AM – 10:30 AM EDT
Lessons Learned From First MDR/IVDR Certifications
Suzanne Elizabeth Halliday, MSc. D.Phil. – BSI - ENTERPRISE ### 535446###Moderator###Head of Notified Body###BSI - ENTERPRISE###
Moderator: Suzanne Elizabeth Halliday, MSc. D.Phil. – BSI - ENTERPRISE
@@@ Johnathon William Bis – BSI (London) ### 1000127###Speaker###Vice President Sales###BSI (London)###
Speaker: Johnathon William Bis – BSI (London)
@@@ Erica Conway, PhD – BSI (London) ### 535513###Speaker###Global Head - In Vitro Diagnostic Medical Devices###BSI (London)###
Speaker: Erica Conway, PhD – BSI (London)
@@@ Royth Philippp von Hahn, PhD – TUV SUD Product Services ### 1027488###Speaker###Senior Vice President of Medical Health Services (global)###TUV SUD Product Services###
Speaker: Royth Philippp von Hahn, PhD – TUV SUD Product Services
9:35 AM – 10:30 AM EDT
Manufacturing Quality: Lessons Learned from dealing with the Nitrosamine Impurities Case and Covid-19
Young Kim – Synex Consulting Ltd. ### 1000089###Moderator###CEO & Principal Consultant###Synex Consulting Ltd.###
Moderator: Young Kim – Synex Consulting Ltd.
@@@ Young Kyu Kang – Ministry of Food and Drug Safety, Korea ### 1049100###Speaker###Deputy Director, Division of High-Tech Medical Devices###Ministry of Food and Drug Safety, Korea###
Speaker: Young Kyu Kang – Ministry of Food and Drug Safety, Korea
@@@ Seung Hwan Jung – Ministry of Food and Drug Safety, Korea ### 1049101###Speaker###Deputy Director, Division of High-Tech Medical Devices###Ministry of Food and Drug Safety, Korea###
Speaker: Seung Hwan Jung – Ministry of Food and Drug Safety, Korea
@@@ Young Wook Ahn – Ministry of Food and Drug Safety, Korea ### 1049102###Speaker###Deputy Director, Division of In Vitro Diagnostics Devices###Ministry of Food and Drug Safety, Korea###
Speaker: Young Wook Ahn – Ministry of Food and Drug Safety, Korea
Cara Vivarelli-O’Neill, MPH – 3D Communications ### 1092281###Facilitator###Senior Communications Specialist and Executive Communications Coach###3D Communications###
Facilitator: Cara Vivarelli-O’Neill, MPH – 3D Communications
Margaret Mucha (FRAPS), MJ, RAC, FRAP, CQA – Merge IBM ### 579833###Moderator###RAQA Executive, Quality Management System Medical Devices###Merge IBM###
Moderator: Margaret Mucha (FRAPS), MJ, RAC, FRAP, CQA – Merge IBM
@@@ Heather Agler, PhD – US Food and Drug Administration ### 1083192###Panelist###Senior Program Manager, All Hazards Readiness and Cybersecurity Program, Office of Strategic Partnerships and Technology Innovation, CDRH###US Food and Drug Administration###
Panelist: Heather Agler, PhD – US Food and Drug Administration
@@@ Binita Ashar, MD, MBA, FACS – US Food and Drug Administration ### 1083193###Panelist###Director, OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality, CDRH###US Food and Drug Administration###
Panelist: Binita Ashar, MD, MBA, FACS – US Food and Drug Administration
@@@ Daniel Caños, PhD, MPH – US Food and Drug Administration ### 1083194###Panelist###Director, Office of Clinical Evidence and Analysis, Office of Product Evaluation and Quality, CDRH###US Food and Drug Administration###
Panelist: Daniel Caños, PhD, MPH – US Food and Drug Administration
@@@ William Maisel, MD, MPH – US Food and Drug Administration ### 1083195###Panelist###Director, Office of Product Evaluation and Quality, CDRH Chief Medical Officer###US Food and Drug Administration###
Panelist: William Maisel, MD, MPH – US Food and Drug Administration
@@@ Timothy T. Stenzel, MD, PhD – US Food and Drug Administration ### 772342###Panelist###Director, OHT7, Office of In Vitro Diagnostics and Radiological Health, CDRH###US Food and Drug Administration###
Panelist: Timothy T. Stenzel, MD, PhD – US Food and Drug Administration
@@@ Michelle Tarver, MD, PhD – US Food and Drug Administration ### 1052823###Panelist###Director, Patient Science & Engagement Program, Office of Strategic Partnerships and Technology Innovation, CDRH###US Food and Drug Administration###
Panelist: Michelle Tarver, MD, PhD – US Food and Drug Administration
@@@ Eli Tomar, JD, MPH – US Food and Drug Administration ### 1083197###Panelist###Associate Director for Guidance, Legislation and Special Projects, Office of Policy, CDRH###US Food and Drug Administration###
Panelist: Eli Tomar, JD, MPH – US Food and Drug Administration
Speaker: Susan Hibbeln, MS, RAC – Lumos Diagnostics
@@@ Ludger Johannes Moeller – Medical Device Safety Service GmbH ### 907125###Speaker###President, MDSS GmbH###Medical Device Safety Service GmbH###
Speaker: Ludger Johannes Moeller – Medical Device Safety Service GmbH
@@@ Erik Vollebregt ### 535481###Speaker###Partner######
Speaker: Erik Vollebregt
@@@ Suzanne Elizabeth Halliday, MSc. D.Phil. – BSI - ENTERPRISE ### 535446###Panelist###Head of Notified Body###BSI - ENTERPRISE###
Panelist: Suzanne Elizabeth Halliday, MSc. D.Phil. – BSI - ENTERPRISE
@@@ Royth Philippp von Hahn, PhD – TUV SUD Product Services ### 1027488###Panelist###Senior Vice President of Medical Health Services (global)###TUV SUD Product Services###
Panelist: Royth Philippp von Hahn, PhD – TUV SUD Product Services
11:00 AM – 12:30 PM EDT
FDA Emergency Use Authorization (EUA) program in response to COVID-19
Glenn N. Byrd, MBA – GByrd Ad-Promo Solutions, LLC ### 535430###Moderator###President###GByrd Ad-Promo Solutions, LLC###
Moderator: Glenn N. Byrd, MBA – GByrd Ad-Promo Solutions, LLC
@@@ Jennifer L. Kelley, MS, RAC – Sanofi ### 1000121###Speaker###Director, Global Regulatory Affairs###Sanofi###
Speaker: Jennifer L. Kelley, MS, RAC – Sanofi
@@@ Alan G. Minsk, Esq. – Arnall Golden Gregory, LLP ### 1061422###Speaker###Partner & Leader, Food & Drug Practice Group###Arnall Golden Gregory, LLP###
Speaker: Alan G. Minsk, Esq. – Arnall Golden Gregory, LLP
@@@ Olaf Hedrich, MD, F.A.C.C., F.H.R.S. – Boston Scientific (Marlborough) ### 1000155###Speaker######Boston Scientific (Marlborough)###
Speaker: Olaf Hedrich, MD, F.A.C.C., F.H.R.S. – Boston Scientific (Marlborough)
@@@ Stephanie Christopher, MA, CCRC, FACRP – Providence St. Joseph Health ### 535495###Speaker###Senior Program Manager, Health Insights###Providence St. Joseph Health###
Speaker: Stephanie Christopher, MA, CCRC, FACRP – Providence St. Joseph Health
@@@ Carrie M. Kuehn, MA, MPH, LPD, RAC – Evidation Health ### 720643###Speaker###Senior Manager, Regulatory and Clinical###Evidation Health###
Speaker: Carrie M. Kuehn, MA, MPH, LPD, RAC – Evidation Health
Dan Stephens, PhD – Boston Scientific - ENTERPRISE ### 1000118###Moderator######Boston Scientific - ENTERPRISE###
Moderator: Dan Stephens, PhD – Boston Scientific - ENTERPRISE
@@@ Misti Malone, PhD – US Food and Drug Administration ### 1000156###Speaker###PhD, Assistant Director, Peripheral Interventional Devices, CDRH###US Food and Drug Administration###
Speaker: Misti Malone, PhD – US Food and Drug Administration
@@@ Robert Shipley, PhD – Boston Scientific - ENTERPRISE ### 1000120###Speaker###Fellow, Clinical Science###Boston Scientific - ENTERPRISE###
Speaker: Robert Shipley, PhD – Boston Scientific - ENTERPRISE
@@@ Heather Colvin – Johnson & Johnson ### 1083203###Speaker###Director, Evidence & Outcomes Policy, MD Regulatory Affairs###Johnson & Johnson###
Moderator: Marissa Braff, PhD, RAC – Seattle Genetics, Inc.
@@@ Tamy Kim, PharmD – US Food and Drug Administration ### 838301###Speaker###Director for Regulatory Affairs and Policy, Oncology Center of Excellence (OCE) and Supervisory Associate Director for Regulatory Affairs (Acting), Office of Oncologic Diseases (OOD)###US Food and Drug Administration###
Speaker: Tamy Kim, PharmD – US Food and Drug Administration
@@@ Elleni Alebachew, MS – US Food and Drug Administration ### 1094838###Speaker###Senior Regulatory Project Manager, Oncology Center of Excellence (OCE)###US Food and Drug Administration###
Speaker: Elleni Alebachew, MS – US Food and Drug Administration
@@@ Dianne Spillman – US Food and Drug Administration ### 1049039###Speaker###Associate Director, Global Regulatory Outreach, OCE###US Food and Drug Administration###
Speaker: Dianne Spillman – US Food and Drug Administration
@@@ Pamela Balcazar, MS – US Food and Drug Administration ### 1094839###Speaker###Health Scientist, Oncology Center of Excellence (OCE)###US Food and Drug Administration###
Speaker: Pamela Balcazar, MS – US Food and Drug Administration
@@@ Jessica Boehmer, MBA – US Food and Drug Administration ### 1094840###Speaker###Regulatory Scientist, Office of Oncologic Diseases###US Food and Drug Administration###
Speaker: Jessica Boehmer, MBA – US Food and Drug Administration
1:00 PM – 2:30 PM EDT
Software as Medical Device - Has AI Learned Too Much?
Bradley M. Thompson, MBA, JD, RAC – Epstein, Becker & Green ### 1005443###Session Leader###Attorney###Epstein, Becker & Green###
Session Leader: Bradley M. Thompson, MBA, JD, RAC – Epstein, Becker & Green
@@@ James Warren Monroe, MS, RAC, CQA – American Society for Quality ### 907126###Speaker###President and CEO###American Society for Quality###
Speaker: James Warren Monroe, MS, RAC, CQA – American Society for Quality
@@@ Jennifer Segui, MS ### 1052819###Speaker#########
Speaker: Jennifer Segui, MS
@@@ Lisa M. Baumhardt, MT (ASCP), MS, MJ, RAC, FRAP – IBM Watson Health Imaging ### 535449###Panelist###Sr. Regulatory Affairs Manager of AI Strategy###IBM Watson Health Imaging###
Panelist: Lisa M. Baumhardt, MT (ASCP), MS, MJ, RAC, FRAP – IBM Watson Health Imaging
2:30 PM – 3:00 PM EDT
Tuesday Wrap-Up Experience (Sponsored by: China Medical Device)
@@@ Linda Bowen, MS, RAC, FRAPS – Seattle Genetics, Inc. ### 551690###Panelist###Head of Regulatory Policy and Intelligence###Seattle Genetics, Inc.###
Panelist: Linda Bowen, MS, RAC, FRAPS – Seattle Genetics, Inc.
@@@ John Wilkinson, MBA – Global Medical Devices Nomenclature ### 574719###Panelist###Chair of the Board of Trustees###Global Medical Devices Nomenclature###
Panelist: John Wilkinson, MBA – Global Medical Devices Nomenclature
@@@ Robert E. Yocher, MHSc, FRAPS – HeartWare, Inc. ### 1083164###Panelist######HeartWare, Inc.###
Panelist: Robert E. Yocher, MHSc, FRAPS – HeartWare, Inc.
10:35 AM – 11:30 AM EDT
An Insight into LATAM and Eurasian Economic Union Regional Regulatory Frameworks
Margaret Mucha (FRAPS), MJ, RAC, FRAP, CQA – Merge IBM ### 579833###Moderator###RAQA Executive, Quality Management System Medical Devices###Merge IBM###
Moderator: Margaret Mucha (FRAPS), MJ, RAC, FRAP, CQA – Merge IBM
Don E. Boyer, HBSc., RAC, FRAP ### 535533###Facilitator###President, BOYER@RegulatorySolns######
Facilitator: Don E. Boyer, HBSc., RAC, FRAP
@@@ Susan B. Stewart, JD, RAC, FRAPS – Kaleido Biosciences ### 549202###Facilitator###Chief Regulatory Officer###Kaleido Biosciences###
Facilitator: Susan B. Stewart, JD, RAC, FRAPS – Kaleido Biosciences
@@@ John Barr Weiner, JD – US Food and Drug Administration ### 1083189###Panelist###Associate Director for Policy and Product Classification Officer, Office of Combination Products###US Food and Drug Administration###
Panelist: John Barr Weiner, JD – US Food and Drug Administration
Speaker: Caroline Byrd – Leica Biosystems Richmond, Inc.
@@@ Ibim Tariah, Former Notified Body Employee – Regulatory & Quality Solutions LLC ### 757431###Speaker###Vice President of EU MDR and IVDR Consulting Services###Regulatory & Quality Solutions LLC###
Speaker: Ibim Tariah, Former Notified Body Employee – Regulatory & Quality Solutions LLC
Paul B. Cook, PhD, PMP ### 1050491###Moderator###Director, Business Development Life Sciences######
Moderator: Paul B. Cook, PhD, PMP
@@@ Tina M. Purcell, PharmD, BCPS, PMP – Astellas Pharma Global Development, Inc. ### 1050492###Speaker###Associate Director, Medical Affairs###Astellas Pharma Global Development, Inc.###
Speaker: Tina M. Purcell, PharmD, BCPS, PMP – Astellas Pharma Global Development, Inc.
@@@ Janaki M. Subramanyam, MS, RAC – Allena Pharmaceuticals Inc. ### 1050493###Speaker###Executive Director, Head of Regulatory Affairs###Allena Pharmaceuticals Inc.###
Speaker: Janaki M. Subramanyam, MS, RAC – Allena Pharmaceuticals Inc.
Daniel Paul Keravich, MSc, MBA , RAC – GlaxoSmithKline ### 1004188###Moderator###Director, Regulatory Policy & External Relations###GlaxoSmithKline###
Moderator: Daniel Paul Keravich, MSc, MBA , RAC – GlaxoSmithKline
@@@ Theresa Michele, MD – US Food and Drug Administration ### 1052818###Speaker###Director, Office of Nonprescription Drugs, Office of New Drugs, CDER###US Food and Drug Administration###
Speaker: Theresa Michele, MD – US Food and Drug Administration
@@@ Barbara Kochanowski, PhD – CHPA consumer healthcare products association ### 1027480###Speaker###Sr. Vice President###CHPA consumer healthcare products association###
Speaker: Barbara Kochanowski, PhD – CHPA consumer healthcare products association
12:05 PM – 1:00 PM EDT
MDSAP Integration Across Medical Device Schemes Including MDR/IVDR
@@@ Susan Carino, MBA, MS, PMP, RAC – Integrated Project Management Company, Inc. ### 1000086###Speaker###Principal Consultant###Integrated Project Management Company, Inc.###
Speaker: Susan Carino, MBA, MS, PMP, RAC – Integrated Project Management Company, Inc.
@@@ Fortunato Senatore, MD, PhD, FACC – US Food and Drug Administration ### 1050490###Speaker###Medical Officer, CDER###US Food and Drug Administration###
Speaker: Fortunato Senatore, MD, PhD, FACC – US Food and Drug Administration
