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
Facilitator: Julia Frese
Solution Circles
Facilitator: Julia Frese
Facilitator: Ken Skodacek – FDA
Solution Circles
Facilitator: Ken Skodacek – FDA
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: Megha Sinha, RAC
Speaker: Brian Riewerts – PwC
Business Acumen
Moderator: Megha Sinha, RAC
@@@ Brian Riewerts – PwC ### 1089149###Speaker######PwC###Speaker: Brian Riewerts – PwC
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: Kimberly Belsky, MS – Mallinckrodt Pharmaceuticals
Speaker: Michael Craig, BSc Pharm – PAREXEL International
Speaker: Liam Keary – Mallinckrodt Pharmaceuticals (Specialty Brands Principal Office)
Speaker: Keith McDonald, FRPharmS, FFPM(hon) – Medicines & Healthcare Products Regulatory Agency (MHRA)
Biopharma (includes Biologics)
Moderator: Kimberly Belsky, MS – Mallinckrodt Pharmaceuticals
@@@ Michael Craig, BSc Pharm – PAREXEL International ### 535462###Speaker###Principal Consultant###PAREXEL International###Speaker: Michael Craig, BSc Pharm – PAREXEL International
@@@ Liam Keary – Mallinckrodt Pharmaceuticals (Specialty Brands Principal Office) ### 1049042###Speaker######Mallinckrodt Pharmaceuticals (Specialty Brands Principal Office)###Speaker: Liam Keary – Mallinckrodt Pharmaceuticals (Specialty Brands Principal Office)
@@@ Keith McDonald, FRPharmS, FFPM(hon) – Medicines & Healthcare Products Regulatory Agency (MHRA) ### 1049036###Speaker###Deputy Director, Licensing Division###Medicines & Healthcare Products Regulatory Agency (MHRA)###Speaker: Keith McDonald, FRPharmS, FFPM(hon) – Medicines & Healthcare Products Regulatory Agency (MHRA)
Session Leader: Don E. Boyer, HBSc., RAC, FRAP
Session Leader: Susan B. Stewart, JD, RAC, FRAPS – Kaleido Biosciences
Panelist: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
Panelist: Anabela Marcal – European Medicines Agency
Solution Circles
Session Leader: Don E. Boyer, HBSc., RAC, FRAP
@@@ Susan B. Stewart, JD, RAC, FRAPS – Kaleido Biosciences ### 549202###Session Leader###Chief Regulatory Officer###Kaleido Biosciences###Session Leader: Susan B. Stewart, JD, RAC, FRAPS – Kaleido Biosciences
@@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Panelist###Principal Scientific Administrator###European Medicines Agency###Panelist: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
@@@ Anabela Marcal – European Medicines Agency ### 1061464###Panelist###Head of Compliance and Inspection Department###European Medicines Agency###Panelist: Anabela Marcal – European Medicines Agency
Moderator: Maurizio Suppo, PhD – Qarad
Speaker: Hilary A. Baldwin – Caris Life Sciences
Medical Devices (includes IVDs)
Moderator: Maurizio Suppo, PhD – Qarad
@@@ Hilary A. Baldwin – Caris Life Sciences ### 716644###Speaker###Regulatory Director###Caris Life Sciences###Speaker: Hilary A. Baldwin – Caris Life Sciences
Moderator: Silvia B. Bendiner, BA – BENDINER NL
Speaker: Yaquelin Rodríguez Valdés – Cuban Regulatory Authority (CECMED)
Speaker: Lawrence Liberti, MSc, PhD – CIRS- Centre for Innovation in Regulatory Science
Speaker: Mario Alanis, PhD – CIRS- Centre for Innovation in Regulatory Science
Speaker: Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency
Speaker: Cesar Hernández – AEMPS
Health Authority Forum
Moderator: Silvia B. Bendiner, BA – BENDINER NL
@@@ Yaquelin Rodríguez Valdés – Cuban Regulatory Authority (CECMED) ### 1089145###Speaker###Deputy Director###Cuban Regulatory Authority (CECMED)###Speaker: Yaquelin Rodríguez Valdés – Cuban Regulatory Authority (CECMED)
@@@ 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
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: Shereen Marie Nennig, BS
Speaker: Tom Cosgrove – Covington & Burling LLP
Speaker: Andrei Spinei, MPharm, MSc – European Medicines Agency
Biopharma (includes Biologics)
Moderator: Shereen Marie Nennig, BS
@@@ Tom Cosgrove – Covington & Burling LLP ### 1071006###Speaker###Partner in Food, Drug and Device Group###Covington & Burling LLP###Speaker: Tom Cosgrove – Covington & Burling LLP
@@@ Andrei Spinei, MPharm, MSc – European Medicines Agency ### 1061465###Speaker###Scientific Administrator###European Medicines Agency###Speaker: Andrei Spinei, MPharm, MSc – European Medicines Agency
Moderator: Young Kim – Synex Consulting Ltd.
Speaker: Young Kyu Kang – Ministry of Food and Drug Safety, Korea
Speaker: Seung Hwan Jung – Ministry of Food and Drug Safety, Korea
Speaker: Young Wook Ahn – Ministry of Food and Drug Safety, Korea
Speaker: Rachel Chung – Synex Consulting Ltd.
Medical Devices (includes IVDs)
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
@@@ Rachel Chung – Synex Consulting Ltd. ### 535500###Speaker###Managing Director###Synex Consulting Ltd.###Speaker: Rachel Chung – Synex Consulting Ltd.
Facilitator: Elena Kyria – Elemed
Facilitator: Sarah Michel, CSP – Velvet Chainsaw Consulting
Solution Circles
Facilitator: Elena Kyria – Elemed
@@@ Sarah Michel, CSP – Velvet Chainsaw Consulting ### 542411###Facilitator###Vice President, Professional Connexity###Velvet Chainsaw Consulting###Facilitator: Sarah Michel, CSP – Velvet Chainsaw Consulting
Facilitator: Kristian Worziger Nielsen, MPhys
Solution Circles
Facilitator: Kristian Worziger Nielsen, MPhys
Facilitator: Cara Vivarelli-O’Neill, MPH – 3D Communications
Solution Circles
Facilitator: Cara Vivarelli-O’Neill, MPH – 3D Communications
Facilitator: Elena Kyria – Elemed
Facilitator: Sarah Michel, CSP – Velvet Chainsaw Consulting
Solution Circles
Facilitator: Elena Kyria – Elemed
@@@ Sarah Michel, CSP – Velvet Chainsaw Consulting ### 542411###Facilitator###Vice President, Professional Connexity###Velvet Chainsaw Consulting###Facilitator: Sarah Michel, CSP – Velvet Chainsaw Consulting
Moderator: Margaret Mucha (FRAPS), MJ, RAC, FRAP, CQA – Merge IBM
Panelist: Heather Agler, PhD – US Food and Drug Administration
Panelist: Binita Ashar, MD, MBA, FACS – US Food and Drug Administration
Panelist: Daniel Caños, PhD, MPH – US Food and Drug Administration
Panelist: William Maisel, MD, MPH – US Food and Drug Administration
Panelist: Jeffrey Shuren, MD, JD – CDRH
Panelist: Timothy T. Stenzel, MD, PhD – US Food and Drug Administration
Panelist: Michelle Tarver, MD, PhD – US Food and Drug Administration
Panelist: Eli Tomar, JD, MPH – US Food and Drug Administration
Health Authority Forum
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
@@@ Jeffrey Shuren, MD, JD – CDRH ### 1083196###Panelist###Director###CDRH###Panelist: Jeffrey Shuren, MD, JD – CDRH
@@@ 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
Moderator: Keith Morel, PhD – Qserve Group Inc. - ENTERPRISE
Speaker: Susan Hibbeln, MS, RAC – Lumos Diagnostics
Speaker: Ludger Johannes Moeller – Medical Device Safety Service GmbH
Speaker: Erik Vollebregt
Panelist: Suzanne Elizabeth Halliday, MSc. D.Phil. – BSI - ENTERPRISE
Panelist: Royth Philippp von Hahn, PhD – TUV SUD Product Services
Medical Devices (includes IVDs)
Moderator: Keith Morel, PhD – Qserve Group Inc. - ENTERPRISE
@@@ Susan Hibbeln, MS, RAC – Lumos Diagnostics ### 716672###Speaker###Sr. Director, Regulatory Affairs###Lumos Diagnostics###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
Moderator: Mac McKeen, RAC, FRAPS, MBA, RAC FRAPS MBA – Boston Scientific - ENTERPRISE
Speaker: Angela Krueger – US Food and Drug Adminstration
Speaker: Annabel Tsai, PhD – InBios
Medical Devices (includes IVDs)
Moderator: Mac McKeen, RAC, FRAPS, MBA, RAC FRAPS MBA – Boston Scientific - ENTERPRISE
@@@ Angela Krueger – US Food and Drug Adminstration ### 1083202###Speaker######US Food and Drug Adminstration###Speaker: Angela Krueger – US Food and Drug Adminstration
@@@ Annabel Tsai, PhD – InBios ### 1000082###Speaker###Sr. manager, RA/QA###InBios###Speaker: Annabel Tsai, PhD – InBios
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: William J. Timmons, n/a – Deloitte
Speaker: Darin Seth Oppenheimer, FRAPS, RAC, DRsc – Merck
Speaker: Oliver Steck – Deloitte & Touche LLP
Biopharma (includes Biologics)
Moderator: William J. Timmons, n/a – Deloitte
@@@ Darin Seth Oppenheimer, FRAPS, RAC, DRsc – Merck ### 1000096###Speaker###Executive Director, Global Regulatory Affairs and Clinical Safety###Merck###Speaker: Darin Seth Oppenheimer, FRAPS, RAC, DRsc – Merck
@@@ Oliver Steck – Deloitte & Touche LLP ### 593741###Speaker###Principal###Deloitte & Touche LLP###Speaker: Oliver Steck – Deloitte & Touche LLP
Moderator: Ruba Hadidi, M.Eng, PMP – Integrated Project Management Inc.
Business Acumen
Moderator: Ruba Hadidi, M.Eng, PMP – Integrated Project Management Inc.
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
Moderator: Anne Marie Finley, MS, RAC – Biotech Policy Group LLC
Speaker: Marco Cavaleri, PhD
Speaker: Sascha Haverfield, PhD – Takeda Pharmaceuticals
Speaker: Alan Liss, PhD
Biopharma (includes Biologics)
Moderator: Anne Marie Finley, MS, RAC – Biotech Policy Group LLC
@@@ Marco Cavaleri, PhD ### 1061462###Speaker#########Speaker: Marco Cavaleri, PhD
@@@ Sascha Haverfield, PhD – Takeda Pharmaceuticals ### 1083167###Speaker###Head of Regulatory Affairs, PTD BU###Takeda Pharmaceuticals###Speaker: Sascha Haverfield, PhD – Takeda Pharmaceuticals
@@@ Alan Liss, PhD ### 1061421###Speaker###CEO######Speaker: Alan Liss, PhD
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
Facilitator: Alexander Lee Friedman, PhD, RAC – Philips Healthcare - ENTERPRISE
Solution Circles
Facilitator: Alexander Lee Friedman, PhD, RAC – Philips Healthcare - ENTERPRISE
Facilitator: Vasum Peiris, MD, MPH, FAAP, FACC, FASE
Facilitator: Amra Racic, MBA – Medtronic
Solution Circles
Facilitator: Vasum Peiris, MD, MPH, FAAP, FACC, FASE
@@@ Amra Racic, MBA – Medtronic ### 535477###Facilitator###Sr. Regulatory Affairs Program Manager ###Medtronic###Facilitator: Amra Racic, MBA – Medtronic
Moderator: Glenn N. Byrd, MBA – GByrd Ad-Promo Solutions, LLC
Speaker: Jennifer L. Kelley, MS, RAC – Sanofi
Speaker: Alan G. Minsk, Esq. – Arnall Golden Gregory, LLP
Biopharma (includes Biologics)
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
Session Leader: Eric Hill, MS, PMP – Integrated Project Management Company, Inc.
Session Leader: Patricia Reardon, PhD, PMP – Integrated Project Management Company, Inc.
Business Acumen
Session Leader: Eric Hill, MS, PMP – Integrated Project Management Company, Inc.
@@@ Patricia Reardon, PhD, PMP – Integrated Project Management Company, Inc. ### 1000098###Session Leader###Sr. Project Management Consultant###Integrated Project Management Company, Inc.###Session Leader: Patricia Reardon, PhD, PMP – Integrated Project Management Company, Inc.
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
Moderator: Kirsten Messmer, PhD, RAC – PPD
Speaker: Daniel O'Connell – Intellia Therapeutics, Inc.
Speaker: Aron Stein, PhD – Sangamo Therapeutics, Inc.
Speaker: James Valentine – Hyman, Phelps & McNamara PC
Biopharma (includes Biologics)
Moderator: Kirsten Messmer, PhD, RAC – PPD
@@@ Daniel O'Connell – Intellia Therapeutics, Inc. ### 1092321###Speaker###Associate Director###Intellia Therapeutics, Inc.###Speaker: Daniel O'Connell – Intellia Therapeutics, Inc.
@@@ Aron Stein, PhD – Sangamo Therapeutics, Inc. ### 1061477###Speaker###Vice President, Global Regulatory Affairs###Sangamo Therapeutics, Inc.###Speaker: Aron Stein, PhD – Sangamo Therapeutics, Inc.
@@@ James Valentine – Hyman, Phelps & McNamara PC ### 1081717###Speaker###Associate###Hyman, Phelps & McNamara PC###Speaker: James Valentine – Hyman, Phelps & McNamara PC
Moderator: Dan Stephens, PhD – Boston Scientific - ENTERPRISE
Speaker: Michelle Tarver, MD, PhD
Speaker: Olaf Hedrich, MD, F.A.C.C., F.H.R.S. – Boston Scientific (Marlborough)
Speaker: Stephanie Christopher, MA, CCRC, FACRP – Providence St. Joseph Health
Speaker: Carrie M. Kuehn, MA, MPH, LPD, RAC – Evidation Health
Speaker: Renee Marie Mitchell, MT (ASCP), CLS (NCA) – Boston Scientific - ENTERPRISE
Medical Devices (includes IVDs)
Moderator: Dan Stephens, PhD – Boston Scientific - ENTERPRISE
@@@ Michelle Tarver, MD, PhD ### 1052823###Speaker###Director, CDRH Patient Science & Engagement Program######Speaker: Michelle Tarver, MD, PhD
@@@ 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
@@@ Renee Marie Mitchell, MT (ASCP), CLS (NCA) – Boston Scientific - ENTERPRISE ### 1000154###Speaker###Manager, Regulatory Affairs ###Boston Scientific - ENTERPRISE###Speaker: Renee Marie Mitchell, MT (ASCP), CLS (NCA) – Boston Scientific - ENTERPRISE
Moderator: Dan Stephens, PhD – Boston Scientific - ENTERPRISE
Speaker: Misti Malone, PhD – US Food and Drug Administration
Speaker: Robert Shipley, PhD – Boston Scientific - ENTERPRISE
Speaker: Heather Colvin – Johnson & Johnson
Medical Devices (includes IVDs)
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###Speaker: Heather Colvin – Johnson & Johnson
Moderator: Marissa Braff, PhD, RAC – Seattle Genetics, Inc.
Speaker: Tamy Kim, PharmD – US Food and Drug Administration
Speaker: Elleni Alebachew, MS – US Food and Drug Administration
Speaker: Dianne Spillman – US Food and Drug Administration
Speaker: Pamela Balcazar, MS – US Food and Drug Administration
Speaker: Jessica Boehmer, MBA – US Food and Drug Administration
Health Authority Forum
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
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
Performer: Ben Corey – The Meeting Illusionist
Performer: Ben Corey – The Meeting Illusionist