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