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)
