Facilitator: Sarah Michel, CSP – Velvet Chainsaw Consulting
Facilitator: Kimberly Belsky, MS
Panelist: Megha Deviprasad Iyer, RAC – Thermo Fisher Scientific
Panelist: Rabia Khan, PhD, MBA – Sensyne Health
Panelist: David Fischel – Stereotaxis
Panelist: Noël Wathion – European Medicines Agency (EMA)
Plenary
Facilitator: Sarah Michel, CSP – Velvet Chainsaw Consulting
@@@ Kimberly Belsky, MS ### 535468###Facilitator###Head of Regulatory Policy and Intelligence######Facilitator: Kimberly Belsky, MS
@@@ Megha Deviprasad Iyer, RAC – Thermo Fisher Scientific ### 1083158###Panelist###Global Director, Regulatory Affairs###Thermo Fisher Scientific###Panelist: Megha Deviprasad Iyer, RAC – Thermo Fisher Scientific
@@@ Rabia Khan, PhD, MBA – Sensyne Health ### 1083157###Panelist###Managing Director - Discovery Science###Sensyne Health###Panelist: Rabia Khan, PhD, MBA – Sensyne Health
@@@ David Fischel – Stereotaxis ### 1083156###Panelist###CEO and Chairman###Stereotaxis###Panelist: David Fischel – Stereotaxis
@@@ Noël Wathion – European Medicines Agency (EMA) ### 1083160###Panelist###Deputy Executive Director###European Medicines Agency (EMA)###Panelist: Noël Wathion – European Medicines Agency (EMA)
Moderator: Stefan Burde, PhD – BSI
Moderator: Grace Fu Palma, MBA – China Med Device, LLC
Speaker: Jason Liang – China Med Device, LLC
Speaker: Xin Sun – West China Hospital, Sichuan University in Chengdu, China
Speaker: Jane Lin – Johnson and Johnson Medical
Speaker: Wei Shang, RAC, CQA
Speaker: Lindsay Tao, MD – J&J Worldwide GA & Policy
Medical Devices (includes IVDs)
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
Moderator: Robert Stringer – Brandwood CKC
Moderator: Tina Kim-Hafken, MS
Speaker: Michael Shum – Therapeutic Goods Administration - ENTERPRISE
Speaker: Dianne Spillman – US Food and Drug Administration
Speaker: Melissa Hunt, MSc – Health Canada
Biopharma (includes Biologics)
Moderator: Robert Stringer – Brandwood CKC
@@@ Tina Kim-Hafken, MS ### 1027493###Moderator#########Moderator: Tina Kim-Hafken, MS
@@@ Michael Shum – Therapeutic Goods Administration - ENTERPRISE ### 1049041###Speaker######Therapeutic Goods Administration - ENTERPRISE ###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###Speaker: Melissa Hunt, MSc – Health Canada
Moderator: Lisa M. Casavant, MME – Regulatory and Quality Solutions LLC - Enterprise
Panelist: Jonathan Gimbel, PhD – Regulatory and Quality Solutions LLC - Enterprise
Panelist: Celeste Maksim, PhD – Regulatory & Quality Solutions (R&Q)
Panelist: Nancy J. Morrison, RAC – Regulatory and Quality Solutions LLC - Enterprise
Panelist: Ron Sills – Regulatory & Quality Solutions (R&Q)
Panelist: Amie Smirthwaite, PhD – MAETRICS
Sponsored Session
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
@@@ Celeste Maksim, PhD – Regulatory & Quality Solutions (R&Q) ### 1092278###Panelist###Principal Consultant###Regulatory & Quality Solutions (R&Q)###Panelist: Celeste Maksim, PhD – Regulatory & Quality Solutions (R&Q)
@@@ Nancy J. Morrison, RAC – Regulatory and Quality Solutions LLC - Enterprise ### 757434###Panelist###Executive Director Regulatory and Quality Consulting Services###Regulatory and Quality Solutions LLC - Enterprise###Panelist: Nancy J. Morrison, RAC – Regulatory and Quality Solutions LLC - Enterprise
@@@ Ron Sills – Regulatory & Quality Solutions (R&Q) ### 1092279###Panelist###Senior Principal Specialist###Regulatory & Quality Solutions (R&Q)###Panelist: Ron Sills – Regulatory & Quality Solutions (R&Q)
@@@ Amie Smirthwaite, PhD – MAETRICS ### 1071119###Panelist###Senior Director, Global Clinical Practise###MAETRICS###Panelist: Amie Smirthwaite, PhD – MAETRICS
Moderator: Alexis Reisin Miller, JD
Speaker: Joao Duarte, MSc MPharm – Alexion Pharmaceuticals
Speaker: Nathalie Bere, MPH – European Medicines Agency
Speaker: Andrea Furia-Helms, MPH – US Food and Drug Administration
Speaker: Danielle Boyce, MPH
Biopharma (includes Biologics)
Moderator: Alexis Reisin Miller, JD
@@@ Joao Duarte, MSc MPharm – Alexion Pharmaceuticals ### 720625###Speaker###Director, Chief of Staff & Regulatory Science###Alexion Pharmaceuticals###Speaker: Joao Duarte, MSc MPharm – Alexion Pharmaceuticals
@@@ Nathalie Bere, MPH – European Medicines Agency ### 1061461###Speaker###Patient Engagement###European Medicines Agency###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
@@@ Danielle Boyce, MPH ### 1061420###Speaker#########Speaker: Danielle Boyce, MPH
Moderator: Michelle Lynn Jump, RAC – Stryker - ENTERPRISE
Speaker: Suzanne Schwartz, MD, MBA – US Food and Drug Administration
Medical Devices (includes IVDs)
Moderator: Michelle Lynn Jump, RAC – Stryker - ENTERPRISE
@@@ 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
Author: Peter Takes, PhD, RAC, FRAPS – Regulatory Intelligence Associates, LLC
Author: Susumu Nozawa, RAC, FRAPS – Siemens Healthineers
Author: Peter Takes, PhD, RAC, FRAPS – Regulatory Intelligence Associates, LLC
@@@ Susumu Nozawa, RAC, FRAPS – Siemens Healthineers ### 625151###Author###Head of Regulatory Policy - North America###Siemens Healthineers###Author: Susumu Nozawa, RAC, FRAPS – Siemens Healthineers
Session Leader: Tom Rish
Medical Devices (includes IVDs)
Session Leader: Tom Rish
Moderator: Richard Jahn, JD, MS – Pfizer
Speaker: Linda Bowen, MS, RAC, FRAPS – Seattle Genetics, Inc.
Speaker: Heidi Christl Marchand, PharmD – Gilead Sciences Inc. - ENTERPRISE
Biopharma (includes Biologics)
Moderator: Richard Jahn, JD, MS – Pfizer
@@@ Linda Bowen, MS, RAC, FRAPS – Seattle Genetics, Inc. ### 551690###Speaker###Head of Regulatory Policy and Intelligence###Seattle Genetics, Inc.###Speaker: Linda Bowen, MS, RAC, FRAPS – Seattle Genetics, Inc.
@@@ Heidi Christl Marchand, PharmD – Gilead Sciences Inc. - ENTERPRISE ### 1042127###Speaker###Executive Director###Gilead Sciences Inc. - ENTERPRISE###Speaker: Heidi Christl Marchand, PharmD – Gilead Sciences Inc. - ENTERPRISE
Facilitator: Sarah Michel, CSP – Velvet Chainsaw Consulting
Facilitator: Elena Kyria – Elemed
Plenary
Facilitator: Sarah Michel, CSP – Velvet Chainsaw Consulting
@@@ Elena Kyria – Elemed ### 1083155###Facilitator###Founder and CEO###Elemed###Facilitator: Elena Kyria – Elemed
Speaker: Rebecca James, RAC, MBA – KPMG
Speaker: Brian Williams – KPMG
Sponsored Session
Speaker: Rebecca James, RAC, MBA – KPMG
@@@ Brian Williams – KPMG ### 1083899###Speaker###Director, Advisory Services###KPMG###Speaker: Brian Williams – KPMG
Moderator: Kirsten Messmer, PhD, RAC – PPD
Speaker: Stephen Westover, RAC – Cook MyoSite Incorporated
Speaker: Mary A. Lokuta, PhD – Mallinckrodt
Biopharma (includes Biologics)
Moderator: Kirsten Messmer, PhD, RAC – PPD
@@@ Stephen Westover, RAC – Cook MyoSite Incorporated ### 1000109###Speaker###Director of Regualtory Affairs###Cook MyoSite Incorporated###Speaker: Stephen Westover, RAC – Cook MyoSite Incorporated
@@@ Mary A. Lokuta, PhD – Mallinckrodt ### 1027484###Speaker######Mallinckrodt###Speaker: Mary A. Lokuta, PhD – Mallinckrodt
Moderator: Suzanne Elizabeth Halliday, MSc. D.Phil. – BSI - ENTERPRISE
Speaker: Johnathon William Bis – BSI (London)
Speaker: Erica Conway, PhD – BSI (London)
Speaker: Royth Philippp von Hahn, PhD – TUV SUD Product Services
Medical Devices (includes IVDs)
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
Moderator: Seth Goldenberg, PhD – Veeva Systems Inc.
Speaker: Lori K. Holder, RAC – Alcon Laboratories Inc
Speaker: Patrick Axtell, PhD – FDA
Speaker: Bassil Akra, PhD – QUNIQUE GmbH
Medical Devices (includes IVDs)
Moderator: Seth Goldenberg, PhD – Veeva Systems Inc.
@@@ Lori K. Holder, RAC – Alcon Laboratories Inc ### 1000136###Speaker###Senior Director, Global Regulatory Operations###Alcon Laboratories Inc###Speaker: Lori K. Holder, RAC – Alcon Laboratories Inc
@@@ Patrick Axtell, PhD – FDA ### 1000137###Speaker###Senior Tools and Template Engineer###FDA###Speaker: Patrick Axtell, PhD – FDA
@@@ Bassil Akra, PhD – QUNIQUE GmbH ### 535482###Speaker###CEO###QUNIQUE GmbH###Speaker: Bassil Akra, PhD – QUNIQUE GmbH
Moderator: Ilker Oztop, PhD – Janssen Pharmaceuticals
Speaker: Dharmi Shah, PharmD – Sanofi - ENTERPRISE
Speaker: Eric Faulkner, MPH – Evidera
Speaker: Xavier Kurz, MD, MSc, PhD – European Medicines Agency
Biopharma (includes Biologics)
Moderator: Ilker Oztop, PhD – Janssen Pharmaceuticals
@@@ Dharmi Shah, PharmD – Sanofi - ENTERPRISE ### 1000099###Speaker######Sanofi - ENTERPRISE###Speaker: Dharmi Shah, PharmD – Sanofi - ENTERPRISE
@@@ Eric Faulkner, MPH – Evidera ### 1027489###Speaker###Vice President, Precision and Transformative Medicine###Evidera###Speaker: Eric Faulkner, MPH – Evidera
@@@ Xavier Kurz, MD, MSc, PhD – European Medicines Agency ### 1070851###Speaker###Head of Surveillance & Epidemiology###European Medicines Agency###Speaker: Xavier Kurz, MD, MSc, PhD – European Medicines Agency
Author: William Sietsema, PhD – Caladrius Biosciences Inc.
Author: Monica Meacham, PhD – NantBio
Author: William Sietsema, PhD – Caladrius Biosciences Inc.
@@@ Monica Meacham, PhD – NantBio ### 593806###Author###Senior Manager Regulatory Affairs###NantBio###Author: Monica Meacham, PhD – NantBio
Moderator: Anne Marie Finley, MS, RAC – Biotech Policy Group LLC
Speaker: Richardae Araojo, PharmD, MS – FDA
Speaker: Anne Marie Inglis, PhD
Speaker: Neena Nizar – The Jansens Foundation
Biopharma (includes Biologics)
Moderator: Anne Marie Finley, MS, RAC – Biotech Policy Group LLC
@@@ Richardae Araojo, PharmD, MS – FDA ### 1083168###Speaker###Associate Commissioner for Minority Health###FDA###Speaker: Richardae Araojo, PharmD, MS – FDA
@@@ Anne Marie Inglis, PhD ### 1061476###Speaker#########Speaker: Anne Marie Inglis, PhD
@@@ Neena Nizar – The Jansens Foundation ### 1083169###Speaker######The Jansens Foundation###Speaker: Neena Nizar – The Jansens Foundation
Session Leader: Bradley M. Thompson, MBA, JD, RAC – Epstein, Becker & Green
Speaker: James Warren Monroe, MS, RAC, CQA – American Society for Quality
Speaker: Jennifer Segui, MS
Panelist: Lisa M. Baumhardt, MT (ASCP), MS, MJ, RAC, FRAP – IBM Watson Health Imaging
Medical Devices (includes IVDs)
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
Facilitator: Sarah Michel, CSP – Velvet Chainsaw Consulting
Speaker: Bill McMoil – RAPS
Moderator: Denise Fulton – RAPS
Panelist: Linda Bowen, MS, RAC, FRAPS – Seattle Genetics, Inc.
Panelist: David Jefferys, MD, FRAPS – Eisai
Panelist: John Wilkinson, MBA – Global Medical Devices Nomenclature
Panelist: Robert E. Yocher, MHSc, FRAPS – HeartWare, Inc.
Plenary
Facilitator: Sarah Michel, CSP – Velvet Chainsaw Consulting
@@@ Bill McMoil – RAPS ### 1083161###Speaker###Interim Executive Director###RAPS###Speaker: Bill McMoil – RAPS
@@@ Denise Fulton – RAPS ### 1083162###Moderator###Vice President, Research & Content Strategy###RAPS###Moderator: Denise Fulton – RAPS
@@@ 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.
@@@ David Jefferys, MD, FRAPS – Eisai ### 1083165###Panelist###Senior Vice President###Eisai###Panelist: David Jefferys, MD, FRAPS – Eisai
@@@ 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.
Moderator: Margaret Mucha (FRAPS), MJ, RAC, FRAP, CQA – Merge IBM
Speaker: Monica Guaita, MSc(Eng) – MMGC SRL
Speaker: Magdalena Ferrari del Sel, Msc (Eng) – MMGC SRL
Speaker: Ruslan Kalachev, MA
Speaker: Tatiana Nosova
Medical Devices (includes IVDs)
Moderator: Margaret Mucha (FRAPS), MJ, RAC, FRAP, CQA – Merge IBM
@@@ Monica Guaita, MSc(Eng) – MMGC SRL ### 907095###Speaker###Director###MMGC SRL###Speaker: Monica Guaita, MSc(Eng) – MMGC SRL
@@@ Magdalena Ferrari del Sel, Msc (Eng) – MMGC SRL ### 907096###Speaker###Biomedical Engineer- Regulatory Affairs Senior Consultant-Medical Devices Specialist###MMGC SRL###Speaker: Magdalena Ferrari del Sel, Msc (Eng) – MMGC SRL
@@@ Ruslan Kalachev, MA ### 1000107###Speaker###Development Director######Speaker: Ruslan Kalachev, MA
@@@ Tatiana Nosova ### 1000140###Speaker###CEO######Speaker: Tatiana Nosova
Moderator: Anne Marie Finley, MS, RAC – Biotech Policy Group LLC
Speaker: Roxanne Tavakkol, MS, RAC – Mallinckrodt Pharmaceuticals (Specialty Brands Principal Office)
Speaker: Philippe MOTTE, PhD, MBA – GENFIT
Biopharma (includes Biologics)
Moderator: Anne Marie Finley, MS, RAC – Biotech Policy Group LLC
@@@ Roxanne Tavakkol, MS, RAC – Mallinckrodt Pharmaceuticals (Specialty Brands Principal Office) ### 535490###Speaker###Vice President, Regulatory Affairs - ARD###Mallinckrodt Pharmaceuticals (Specialty Brands Principal Office)###Speaker: Roxanne Tavakkol, MS, RAC – Mallinckrodt Pharmaceuticals (Specialty Brands Principal Office)
@@@ Philippe MOTTE, PhD, MBA – GENFIT ### 1000104###Speaker###SVP Global Regulatory Affairs###GENFIT###Speaker: Philippe MOTTE, PhD, MBA – GENFIT
Moderator: Rania Gerges – Qserve Group Inc. - ENTERPRISE
Speaker: Jasmin Hunter – Qserve Group Inc. - ENTERPRISE
Speaker: Jasmin Lindner, Dr. – Dr. Ebeling & Assoc. GmbH
Medical Devices (includes IVDs)
Moderator: Rania Gerges – Qserve Group Inc. - ENTERPRISE
@@@ Jasmin Hunter – Qserve Group Inc. - ENTERPRISE ### 757436###Speaker###Consultant###Qserve Group Inc. - ENTERPRISE###Speaker: Jasmin Hunter – Qserve Group Inc. - ENTERPRISE
@@@ Jasmin Lindner, Dr. – Dr. Ebeling & Assoc. GmbH ### 1000106###Speaker###Medical Science, Medical Affairs & Pharmacovigilance###Dr. Ebeling & Assoc. GmbH###Speaker: Jasmin Lindner, Dr. – Dr. Ebeling & Assoc. GmbH
Moderator: Daniela Drago, PhD, RAC – Biogen - ENTERPRISE
Speaker: Susan Carino, MBA, MS, PMP, RAC – Integrated Project Management Company, Inc.
Speaker: Fortunato Senatore, MD, PhD, FACC – US Food and Drug Administration
Biopharma (includes Biologics)
Moderator: Daniela Drago, PhD, RAC – Biogen - ENTERPRISE
@@@ 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