- Tuesday, September 13, 2022
6:00 AM – 6:30 AM MST
Wellness at RAPS Convergence: Check In
6:00 AM – 6:30 AM MST
Wellness at RAPS Convergence: Check InLocation/Room:Hyatt Regency Phoenix, Offsite: Hyatt Regency Phoenix Ballroom
6:00 AM – 6:30 PM MST
First Aid Services
6:00 AM – 6:30 PM MST
First Aid Services
Location/Room:Exhibit Hall 1: Back of Hall
6:30 AM – 7:30 AM MST
Wellness at RAPS Convergence: Yoga for Good Posture & Guided Meditation
6:30 AM – 7:30 AM MST
Wellness at RAPS Convergence: Yoga for Good Posture & Guided MeditationLocation/Room:Offsite: Hyatt Regency Phoenix Ballroom
6:30 AM – 3:00 PM MST
Registration Open
6:30 AM – 3:00 PM MST
Registration Open
Location/Room:West Hall 1-3 Lobby, Lower Level
7:00 AM – 3:30 PM MST
Mobile App Support Desk
7:00 AM – 3:30 PM MST
Mobile App Support DeskLocation/Room:West Hall 1-3 Lobby, Lower Level
7:30 AM – 8:45 AM MST
Community Gathering & Continental Breakfast
7:30 AM – 8:45 AM MST
Community Gathering & Continental BreakfastLocation/Room:W301 A-D Lobbies
7:30 AM – 5:00 PM MST
RAPS Store
7:30 AM – 5:00 PM MST
RAPS Store
Location/Room:West Hall 1-3 Lobby, Lower Level
7:30 AM – 6:00 PM MST
Press Room
7:30 AM – 6:00 PM MST
Press Room
Location/Room:W203
8:00 AM – 4:00 PM MST
Speaker Ready Room Open
8:00 AM – 4:00 PM MST
Speaker Ready Room Open
Location/Room:W202
8:15 AM – 9:30 AM MST
Plenary Session: Advancing Science Through Collaboration: Celebrating Friends of Cancer Research, Recipient of the 2022 Patient-Centered Health Award
8:15 AM – 9:30 AM MST
Plenary Session: Advancing Science Through Collaboration: Celebrating Friends of Cancer Research, Recipient of the 2022 Patient-Centered Health AwardLocation/Room:W301 A-DSpeaker: – Friends of Cancer Research
Moderator: – Velvet Chainsaw Consulting
Jeff Allen – Friends of Cancer Research ### 1759672###Speaker###President and CEO###Friends of Cancer Research###Speaker: – Friends of Cancer Research
### @@@ Sarah Michel, CSP – Velvet Chainsaw Consulting ### 542411###Moderator###Vice President, Professional Connexity###Velvet Chainsaw Consulting###Moderator: – Velvet Chainsaw Consulting
### 9:45 AM – 11:00 AM MST
Clinical Trial Design and Alternative Data Sources
9:45 AM – 11:00 AM MST
Enhancing Diversity in Clinical Trial Populations – The Evolving Regulatory Landscape, Perspectives, and Practical Strategies to Lead ChangeLocation/Room:W104 A-BModerator: – Office of Medical Policy, FDA
Session Leader/Speaker: – Pfizer
Speaker: – Pfizer
Speaker (Remote): – Health Canada
Speaker (Remote): – Food and Drug Administration
Biopharmaceuticals
Session Room Sponsored By
Mathilda Fienkeng, PharmD, MS, RAC, CDR USPHS – Office of Medical Policy, FDA ### 1615715###Moderator###Division Director###Office of Medical Policy, FDA###Moderator: – Office of Medical Policy, FDA
### @@@ Monique Carter, MS,RAC – Pfizer ### 720633###Session Leader/Speaker###Senior Director, Pfizer Global Regulatory Affairs - Internal Medicine###Pfizer###Session Leader/Speaker: – Pfizer
### @@@ Zaida Recinos-Vasquez, MS, MS – Pfizer ### 1615708###Speaker###Global CMC Manager###Pfizer###Speaker: – Pfizer
### @@@ Alysha Croker, PhD – Health Canada ### 1728926###Speaker (Remote)###Director, Centre for Policy, Pediatrics and International Collaboration###Health Canada###Speaker (Remote): – Health Canada
### @@@ Lola Fashoyin-Aje, MD, MPH – Food and Drug Administration ### 1728927###Speaker (Remote)###Deputy Division Director, OND/CDER
Associate Directory, Oncology Center of Excellence###Food and Drug Administration###Speaker (Remote): – Food and Drug Administration
###
9:45 AM – 11:00 AM MST
Combined Session Topic: Accelerated Drug Development and Approval Through Pilot Programs and Initiatives
9:45 AM – 11:00 AM MST
FDA and Industry Perspectives on the OCE Initiatives to Optimize Oncology Drug Development and ReviewLocation/Room:W101 CSession Leader/Speaker: – Asher Biotherapeutics, Inc.
Speaker: – Hoffmann-La Roche Limited
Speaker (Remote): – US Food and Drug Administration
Speaker (Remote): – Genentech
Biopharmaceuticals
James Cross, PhD – Asher Biotherapeutics, Inc. ### 1615712###Session Leader/Speaker###Vice-President, Regulatory Affairs###Asher Biotherapeutics, Inc.###Session Leader/Speaker: – Asher Biotherapeutics, Inc.
### @@@ Grace Gao, PharmD – Hoffmann-La Roche Limited ### 1615706###Speaker###Program Manager, Regulatory Affairs###Hoffmann-La Roche Limited###Speaker: – Hoffmann-La Roche Limited
### @@@ Tamy Kim, PharmD – US Food and Drug Administration ### 838301###Speaker (Remote)###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 (Remote): – US Food and Drug Administration
### @@@ Sarah Bentouati, MA, PharmD – Genentech ### 1766669###Speaker (Remote)###Regulatory Group Director###Genentech###Speaker (Remote): – Genentech
###
9:45 AM – 11:00 AM MST
Companion Diagnostics and Personalized Medicine
9:45 AM – 11:00 AM MST
Strategic Considerations for Navigating the Global Landscape of Companion DiagnosticsLocation/Room:W101 A-BSession Leader/Speaker: – Seagen Inc.
Speaker: – PharmaLex
Speaker: – Merck Sharp & Dohme LLC
Speaker: – Seagen Inc.
Bothell, Washington, United States
Speaker (Remote): – European Medicines Agency
In Vitro Diagnostics
Session Room Sponsored By
Linda Bowen, MSc, RAC, FRAPS – Seagen Inc. ### 1615689###Session Leader/Speaker###Head of Global Regulatory Policy and Intelligence###Seagen Inc.###Session Leader/Speaker: – Seagen Inc.
### @@@ TJ Thiel, RAC – PharmaLex ### 1614540###Speaker###Senior Director, Medical Devices / IVD Services###PharmaLex###Speaker: – PharmaLex
### @@@ Erin K. Grath, BS, MS – Merck Sharp & Dohme LLC ### 1698213###Speaker###Senior Director###Merck Sharp & Dohme LLC###Speaker: – Merck Sharp & Dohme LLC
### @@@ Adriana Racolta, PhD, RAC – Seagen Inc.
Bothell, Washington, United States ### 1728971###Speaker###Associate Director Regulatory Affairs Companion Diagnostics###Seagen Inc.
Bothell, Washington, United States###Speaker: – Seagen Inc.
Bothell, Washington, United States
### @@@ Miguel Antunes, PharmD, MPH – European Medicines Agency ### 1778452###Speaker (Remote)###Medical Device Specialist###European Medicines Agency###Speaker (Remote): – European Medicines Agency
###
9:45 AM – 11:00 AM MST
Health Authority Forum - CBER/CDER
9:45 AM – 11:00 AM MST
Health Authority Forum - CBER/CDERLocation/Room:W105 A-CSpeaker (Remote): – United States Food and Drug Administration
Speaker (Remote): – US FDA
Moderator: – Regulatory Project Management Staff / Office of Blood Research and Review / Center for Biologics Evaluation and Research / Food and Drug Administration
Speaker (Remote): – Office of New Drugs, CDER, FDA
Health Authority Forum
Peter W. Marks, MD, PhD – United States Food and Drug Administration ### 574711###Speaker (Remote)###Director, Center for Biologics Evaluation and Research###United States Food and Drug Administration###Speaker (Remote): – United States Food and Drug Administration
### @@@ Christopher Joneckis, PhD – US FDA ### 601550###Speaker (Remote)###Associate Director For Review Management, CBER###US FDA###Speaker (Remote): – US FDA
### @@@ Sonday L. Kelly, MS, RAC, PMP – Regulatory Project Management Staff / Office of Blood Research and Review / Center for Biologics Evaluation and Research / Food and Drug Administration ### 1679212###Moderator###Staff Director###Regulatory Project Management Staff / Office of Blood Research and Review / Center for Biologics Evaluation and Research / Food and Drug Administration###Moderator: – Regulatory Project Management Staff / Office of Blood Research and Review / Center for Biologics Evaluation and Research / Food and Drug Administration
### @@@ Peter P. Stein, MD – Office of New Drugs, CDER, FDA ### 1379324###Speaker (Remote)###Director###Office of New Drugs, CDER, FDA###Speaker (Remote): – Office of New Drugs, CDER, FDA
###
9:45 AM – 11:00 AM MST
Improve Your Public Speaking Skills
9:45 AM – 11:00 AM MST
Improve Your Public Speaking SkillsLocation/Room:W103 A-BSpeaker: – Integrated Project Management Company, Inc.
Skill Building
Susan E. Carino, MBA, MS, PMP, RAC – Integrated Project Management Company, Inc. ### 1000086###Speaker###Principal Consultant###Integrated Project Management Company, Inc.###Speaker: – Integrated Project Management Company, Inc.
###
9:45 AM – 11:00 AM MST
Practical Implications and Changes Post Order 739 for Medical Devices and IVD in China
9:45 AM – 11:00 AM MST
Practical Implications and Changes Post Order 739 for Medical Devices and IVD in ChinaLocation/Room:W102 A-CSession Leader/Speaker: – BradyKnows Medical, LLC
Speaker: – Immucor, Inc.
Speaker: – China Med Device
Medical Devices
Session Room Sponsored By
Tracy Yu, MSc – BradyKnows Medical, LLC ### 1614534###Session Leader/Speaker###Senior Regulatory Affairs Manager###BradyKnows Medical, LLC###Session Leader/Speaker: – BradyKnows Medical, LLC
### @@@ Qianqian Zhu, MBA, LLM, RAC Global – Immucor, Inc. ### 1614529###Speaker###Director of International Regulatory Affairs###Immucor, Inc.###Speaker: – Immucor, Inc.
### @@@ Grace Palma, MBA – China Med Device ### 720651###Speaker###CEO###China Med Device###Speaker: – China Med Device
###
9:45 AM – 11:00 AM MST
Recent Developments in EU Regulations & Clinical Evaluation
9:45 AM – 11:00 AM MST
Recent Developments in EU Regulations & Clinical EvaluationLocation/Room:W106 A-BSpeaker (Remote): – Akra Team GmbH
Speaker: – (British Standards Institute) BSI
Speaker (Remote): – NAMSA
Medical Devices
Session Room Sponsored By
Markus Balkenhol – Akra Team GmbH ### 1614527###Speaker (Remote)###Senior Clinical Consultant###Akra Team GmbH###Speaker (Remote): – Akra Team GmbH
### @@@ Richard G. Holborow, Medical/Professional – (British Standards Institute) BSI ### 1054191###Speaker###Global Head of Clinical Compliance/Clinical Physiologist###(British Standards Institute) BSI###Speaker: – (British Standards Institute) BSI
### @@@ Rachel K. Gibbs, PhD – NAMSA ### 1523468###Speaker (Remote)###Principal Regulatory Consultant###NAMSA###Speaker (Remote): – NAMSA
###
9:45 AM – 11:00 AM MST
Uncertainty and Strategies to Increase Confidence in R&D and Regulatory Decision-Making
9:45 AM – 11:00 AM MST
Uncertainty and Strategies to Increase Confidence in R&D and Regulatory Decision-makingLocation/Room:W106 CSession Leader/Speaker: – Alexion Pharmaceuticals Inc.
Speaker: – Merck & Co., Inc
Speaker (Remote):
Biopharmaceuticals
Martine Zimmermann, PharmD – Alexion Pharmaceuticals Inc. ### 1452236###Session Leader/Speaker###SVP, Head of Regulatory and R&D and Commercial Quality###Alexion Pharmaceuticals Inc.###Session Leader/Speaker: – Alexion Pharmaceuticals Inc.
### @@@ Seema S. Betigeri, PhD – Merck & Co., Inc ### 828929###Speaker###Executive Director, Global Regulatory Affairs###Merck & Co., Inc###Speaker: – Merck & Co., Inc
### @@@ Huong Huynh ### 1779249###Speaker (Remote)#########Speaker (Remote):
###
11:00 AM – 11:30 AM MST
Writing for RAPS: A Guide to Contributing to RAPS' Publications
11:00 AM – 11:30 AM MST
Writing for RAPS: A Guide to Contributing to RAPS' PublicationsLocation/Room:RAPS Store (Registration Foyer)Presenter: – Regulatory Affairs Professionals Society
Presenter: – Regulatory Affairs Professionals Society
Gloria Hall – Regulatory Affairs Professionals Society ### 1451670###Presenter###Senior Editor, Publications###Regulatory Affairs Professionals Society###Presenter: – Regulatory Affairs Professionals Society
### @@@ Renee Matthews – Regulatory Affairs Professionals Society ### 1768455###Presenter###Senior Editor, Features###Regulatory Affairs Professionals Society###Presenter: – Regulatory Affairs Professionals Society
###
11:00 AM – 4:30 PM MST
Exhibit Hall Open
11:00 AM – 4:30 PM MST
Exhibit Hall OpenLocation/Room:Exhibit Hall
11:00 AM – 4:30 PM MST
Headshot Lounge
11:00 AM – 4:30 PM MST
Headshot Lounge
Location/Room:Exhibit Hall: Booth 939
11:15 AM – 11:40 AM MST
Accelerate Trust in Healthcare Patient Verification
11:15 AM – 11:40 AM MST
Accelerate Trust in Healthcare Patient VerificationLocation/Room:Exhibit Hall: Ignite! Stage - Booth 337Speaker: – Shufti Pro Limited
Patrick Kelly – Shufti Pro Limited ### 1756308###Speaker###Head of Americas Sales###Shufti Pro Limited###Speaker: – Shufti Pro Limited
###
11:15 AM – 11:40 AM MST
Benefits of Implementing an End-to-End Regulatory Information Management Platform
11:15 AM – 11:40 AM MST
Benefits of Implementing an End-to-End Regulatory Information Management PlatformLocation/Room:Exhibit Hall: Spark! Stage - Booth 215
Kathie Clark – Ennov ### 1756307###Speaker###Director, Product Management###Ennov###Speaker: – Ennov
###
11:15 AM – 11:45 AM MST
Solutions Circle: An insight into MDR Technical Documentation auditing - Improving submissions to your Notified Body
11:15 AM – 11:45 AM MST
Solutions Circle: Improving MDR Technical Documentation Submissions to Your Notified BodyLocation/Room:Exhibit Hall: Booth 104Solutions Circle
Paul John Risborough, BEng Hons – NAMSA ### 1441663###Speaker###Principal Regulatory Consultant ###NAMSA###Speaker: – NAMSA
### 11:15 AM – 11:45 AM MST
Solutions Circle: Global Label Management and Automation
11:15 AM – 11:45 AM MST
Solutions Circle: Global Label Management and AutomationLocation/Room:Exhibit Hall: Booth 104Speaker: – PwC
Speaker: – PwC
Speaker: – PwC
Solutions Circle
Megha Sinha, MS, RAC – PwC ### 1615742###Speaker###Director###PwC###Speaker: – PwC
### @@@ Zhi Chai, MBA – PwC ### 1615686###Speaker###Senior Associate###PwC###Speaker: – PwC
### @@@ Nidhi Singh – PwC ### 1753092###Speaker###Sr Associate###PwC###Speaker: – PwC
###
11:15 AM – 11:45 AM MST
Solutions Circle: Regulatory Challenges of Augmented Reality
11:15 AM – 11:45 AM MST
Solutions Circle: Regulatory Challenges of Novel Technology Location/Room:Exhibit Hall: Booth 104Speaker: – MediView XR
Speaker: – MediView XR, Inc.
Solutions Circle
Adam S. Cargill, MS, RAC-US – MediView XR ### 1614398###Speaker###Director, QA/RA/CA###MediView XR###Speaker: – MediView XR
### @@@ Crew J. Weunski, M.S. – MediView XR, Inc. ### 1632165###Speaker###Quality & Regulatory Specialist###MediView XR, Inc.###Speaker: – MediView XR, Inc.
###
11:15 AM – 11:45 AM MST
Solutions Circle: The Top 10 483s: A Trip Through History
11:15 AM – 11:45 AM MST
Solutions Circle: The Top 10 483s: a Trip Through HistoryLocation/Room:Exhibit Hall: Booth 104Speaker: – Compliance Team, LLC
Solutions Circle
Regina M. Fullin, Compliance Team, LLC – Compliance Team, LLC ### 1615664###Speaker###V.P. of RA/QA###Compliance Team, LLC###Speaker: – Compliance Team, LLC
### 11:30 AM – 12:30 PM MST
Chapter Meet and Greets
11:30 AM – 12:30 PM MST
Chapter Meet and GreetsLocation/Room:Exhibit Hall: Booth 728
11:30 AM – 1:30 PM MST
Networking Lunch in Exhibit Hall
11:30 AM – 1:30 PM MST
Networking Lunch in Exhibit HallLocation/Room:Exhibit Hall
11:45 AM – 12:10 PM MST
Your Next Career Path...Regulatory Affairs Consulting
11:45 AM – 12:10 PM MST
Your Next Career Path...Regulatory Affairs ConsultingLocation/Room:Exhibit Hall: Spark! Stage - Booth 215Speaker: – Lindsey Regulatory Affairs Consulting, LLC
Sequita Lindsey, RAC – Lindsey Regulatory Affairs Consulting, LLC ### 1756313###Speaker###President and CEO###Lindsey Regulatory Affairs Consulting, LLC###Speaker: – Lindsey Regulatory Affairs Consulting, LLC
###
11:45 AM – 12:15 PM MST
Student Capstone Showcase Presentation: Critical CMC Requirements in the Approval of CAR T Cell Products
11:45 AM – 12:15 PM MST
Student Capstone Showcase Presentation: Critical CMC Requirements in the Approval of CAR T Cell ProductsLocation/Room:Exhibit Hall: Career Central, Booth 728Speaker: – University of Southern California
Alberto Fernandez – University of Southern California ### 1764974###Speaker###Student###University of Southern California###Speaker: – University of Southern California
###
11:45 AM – 12:30 PM MST
Board of Directors Meet and Greets
11:45 AM – 12:30 PM MST
Board of Directors Meet and GreetsLocation/Room:Exhibit Hall: Booth 413
12:00 PM – 12:30 PM MST
Solutions Circle: Ethylene Oxide Sterilization: FDA/EPA order to Reduce EtO Use and Protect the Supply Chain
12:00 PM – 12:30 PM MST
Solutions Circle: Ethylene Oxide Sterilization: FDA/EPA Order to Reduce Eto Use and Protect the Supply ChainLocation/Room:Exhibit Hall: Booth 104Speaker: – Boston Scientific - ENTERPRISE
Solutions Circle
Mac McKeen, RAC FRAPS MBA – Boston Scientific - ENTERPRISE ### 772303###Speaker###Fellow, Regulatory Science###Boston Scientific - ENTERPRISE###Speaker: – Boston Scientific - ENTERPRISE
### 12:00 PM – 12:30 PM MST
Solutions Circle: Maximizing the potential of the FDA assessment aid
12:00 PM – 12:30 PM MST
Solutions Circle: Maximizing the Potential of the FDA Assessment AidLocation/Room:Exhibit Hall: Booth 104Speaker: – Hoffman-La Roche Limited
Solutions Circle
Lawrence Giraudi, MSc. – Hoffman-La Roche Limited ### 1615684###Speaker###Senior Director, Regulatory Documentation###Hoffman-La Roche Limited###Speaker: – Hoffman-La Roche Limited
### 12:00 PM – 12:30 PM MST
Solutions Circle: Overview of Global E-labeling
12:00 PM – 12:30 PM MST
Solutions Circle: Overview of Global E-labelingLocation/Room:Exhibit Hall: Booth 104Speaker: – PwC
Speaker: – PwC
Speaker: – PwC
Solutions Circle
Zhi Chai, MBA – PwC ### 1615686###Speaker###Senior Associate###PwC###Speaker: – PwC
### @@@ Daniel Lozano – PwC ### 1615743###Speaker###Manager###PwC###Speaker: – PwC
### @@@ Steven Spencer – PwC ### 1753093###Speaker###Experienced Associate###PwC###Speaker: – PwC
### 12:00 PM – 12:30 PM MST
Solutions Circle: Types of Types and Types .. er, is that a Typo?
12:00 PM – 12:30 PM MST
Solutions Circle: Types of Types and Types .. Er, Is That a Typo?Location/Room:Exhibit Hall: Booth 104Solutions Circle
Keith Morel, PhD – Qserve ### 535522###Speaker###VP Regulatory Compliance###Qserve###Speaker: – Qserve
###
12:20 PM – 12:45 PM MST
Comparative Analysis of Approvals in Oncology, With and Without Project Orbis
12:20 PM – 12:45 PM MST
Comparative Analysis of Approvals in Oncology, With and Without Project OrbisLocation/Room:Exhibit Hall: Spark! Stage - Booth 215
Sheila Galan – Cedience ### 1761481###Speaker###Head of Quality & Regulatory Sciences###Cedience###Speaker: – Cedience
###
12:20 PM – 12:45 PM MST
EU MDR Class I … not so simple.
12:20 PM – 12:45 PM MST
EU MDR Class I … not so simple.Location/Room:Exhibit Hall: Ignite! Stage - Booth 337Presenter: – Fang Consulting
Heather Kurtz – Fang Consulting ### 1771194###Presenter###Senior Regulatory Affairs Consultant###Fang Consulting###Presenter: – Fang Consulting
###
12:30 PM – 1:00 PM MST
Career Central Presentation: Insights from the RAPS 2022 Global Compensation and Scope of Practice Report
12:30 PM – 1:00 PM MST
Career Central Presentation: Insights from the RAPS 2022 Global Compensation and Scope of Practice Report Location/Room:Exhibit Hall: Booth 728
Denise Fulton – RAPS ### 1083162###Presenter###Vice President, Research & Content Strategy###RAPS###Presenter: – RAPS
###
12:45 PM – 1:15 PM MST
Regulatory Focus Meet Up
12:45 PM – 1:15 PM MST
Regulatory Focus Meet UpLocation/Room:Exhibit Hall: Booth 413
12:45 PM – 1:15 PM MST
Meet the Authors: Fundamentals of Medical Device Regulations, Fifth Edition by Gert Bos and Jocelyn Jennings
12:45 PM – 1:15 PM MST
Meet the Authors: Fundamentals of Medical Device Regulations, Fifth Edition by Gert Bos and Jocelyn JenningsLocation/Room:RAPS Store (Registration Foyer)
12:45 PM – 1:15 PM MST
Solutions Circle: Developing IVDR Compliant Intended Purpose Statements That Serve the Business and Meet Notified Body Expectations
12:45 PM – 1:15 PM MST
Solutions Circle: Developing IVDR Compliant Intended Purpose Statements That Serve the Business and Meet Notified Body ExpectationsLocation/Room:Exhibit Hall: Booth 104Speaker: – RQM+
Speaker: – RQM+
Solutions Circle
Carlos Galamba – RQM+ ### 1523600###Speaker###Vice President IVD, Intelligence & Innovation###RQM+###Speaker: – RQM+
### @@@ Celeste Ann Maksim, PhD – RQM+ ### 1092278###Speaker###Chief of Staff, Clinical & Post-Market Practice###RQM+###Speaker: – RQM+
###
12:45 PM – 1:15 PM MST
Solutions Circle: Kits & Procedure Packs - Ranging from Easy to Impossible
12:45 PM – 1:15 PM MST
Solutions Circle: Kits & Procedure Packs - Ranging from Easy to ImpossibleLocation/Room:Exhibit Hall: Booth 104Speaker: – Qserve Group
Speaker: – Qserve Group
Solutions Circle
Mindy McCann – Qserve Group ### 720640###Speaker###VP Regulatory Compliance###Qserve Group###Speaker: – Qserve Group
### @@@ Christie Hughes, MPH, MLS(ASCP) – Qserve Group ### 1389439###Speaker###Principal Consultant, QA/RA and IVD Expert###Qserve Group###Speaker: – Qserve Group
### 12:45 PM – 1:15 PM MST
Solutions Circle: Role of Prescription Drug Labeling in Minimizing Medication Errors
12:45 PM – 1:15 PM MST
Solutions Circle: Role of Prescription Drug Labeling in Minimizing Medication ErrorsLocation/Room:Exhibit Hall: Booth 104Speaker: – Opus Regulatory
Solutions Circle
Kamana Singh, BVSc, MVSc, PSM-MMB, MBA, RAC(US) – Opus Regulatory ### 1615685###Speaker###Principal Regulatory Consultant###Opus Regulatory###Speaker: – Opus Regulatory
###
12:45 PM – 1:15 PM MST
Solutions Circle: Strategic Down Classification of a PMA Accessory
12:45 PM – 1:15 PM MST
Solutions Circle: Strategic Down Classification of a PMA AccessoryLocation/Room:Exhibit Hall: Booth 104Solutions Circle
Brian Godwin, RAC – Ethicon ### 1614393###Speaker###Associater Director, Regulatory Affairs###Ethicon###Speaker: – Ethicon
### 12:45 PM – 1:45 PM MST
RAPS Fellows "Speed Mentoring"
12:45 PM – 1:45 PM MST
RAPS Fellows "Speed Mentoring"
Location/Room:Exhibit Hall: Booth 728
12:55 PM – 1:20 PM MST
2023 Outlook for the European Market
12:55 PM – 1:20 PM MST
2023 Outlook for the European MarketLocation/Room:Exhibit Hall: Ignite! Stage - Booth 337
Evangeline Loh, Ph.D., RAC (US, EU) – Emergo by UL ### 1773497###Speaker###Manager, Quality & Regulatory Affairs###Emergo by UL###Speaker: – Emergo by UL
###
12:55 PM – 1:20 PM MST
7 Deadly Sins of Product Compliance
12:55 PM – 1:20 PM MST
7 Deadly Sins of Product ComplianceLocation/Room:Exhibit Hall: Spark! Stage - Booth 215
Travis Miller – Assent ### 1773541###Speaker###General Counsel###Assent###Speaker: – Assent
###
1:15 PM – 1:45 PM MST
Career Central Presentation: RAPS Code of Ethics for the Regulatory Profession
1:15 PM – 1:45 PM MST
Career Central Presentation: RAPS Code of Ethics for the Regulatory ProfessionLocation/Room:Exhibit Hall: Booth 728Presenter: – CM Cooper & Associates
Carol M. Cooper, MS, RAC, IM(ASCP), RM(AAM) – CM Cooper & Associates ### 1630469###Presenter###Principal###CM Cooper & Associates###Presenter: – CM Cooper & Associates
###
1:30 PM – 1:55 PM MST
Can AI be Safe in Medical Devices?: Shaping the Future with the Cloud and Open Source Software
1:30 PM – 1:55 PM MST
Can AI be Safe in Medical Devices?: Shaping the Future with the Cloud and Open Source SoftwareLocation/Room:Exhibit Hall: Spark! Stage - Booth 215Speaker: – Ketryx Corporation
Erez Kaminski, MS, MBA – Ketryx Corporation ### 1764635###Speaker###Founder and CEO###Ketryx Corporation###Speaker: – Ketryx Corporation
###
1:30 PM – 1:55 PM MST
The Role of RA in the Clinical and Performance Evaluation Process: Key Strategies to Support Project Success
1:30 PM – 1:55 PM MST
The Role of RA in the Clinical and Performance Evaluation Process: Key Strategies to Support Project SuccessLocation/Room:Exhibit Hall: Ignite! Stage - Booth 337Speaker: – Criterion Edge
Laurie Mitchell – Criterion Edge ### 1634261###Speaker###President###Criterion Edge###Speaker: – Criterion Edge
###
1:30 PM – 2:00 PM MST
Solutions Circle: Clinical Investigations Using FDA Consensus EU Harmonised ISO 14155:2020 - Changes from 2011
1:30 PM – 2:00 PM MST
Solutions Circle: Clinical Investigations Using FDA Consensus EU Harmonised ISO 14155:2020 - Changes from 2011Location/Room:Exhibit Hall: Booth 104Speaker: – SG Consulting-Pro Ltd.
Solutions Circle
Sharon Goldfarb – SG Consulting-Pro Ltd. ### 1614382###Speaker###Ceo/Consultant###SG Consulting-Pro Ltd.###Speaker: – SG Consulting-Pro Ltd.
### 1:30 PM – 2:00 PM MST
Solutions Circle: How to Efficiently Prepare Your eSTAR Submission
1:30 PM – 2:00 PM MST
Solutions Circle: How to Efficiently Prepare Your Estar SubmissionLocation/Room:Exhibit Hall: Booth 104Solutions Circle
Anike Freeman, M.Eng. – RQM+ ### 1614396###Speaker###Principal Consultant###RQM+###Speaker: – RQM+
### 1:30 PM – 2:00 PM MST
Solutions Circle: Partnering with the FDA: The Q-Submission Solution
1:30 PM – 2:00 PM MST
Solutions Circle: Partnering with the FDA: The Q-submission SolutionLocation/Room:Exhibit Hall: Booth 104Speaker: – Network Partners
Solutions Circle
Amy Winegarden – Network Partners ### 1636771###Speaker###Associate Director, Regulatory Affairs###Network Partners###Speaker: – Network Partners
### 1:30 PM – 2:00 PM MST
Solutions Circle: Potential Pitfalls of Orphan Drug Designation Requests
1:30 PM – 2:00 PM MST
Solutions Circle: Potential Pitfalls of Orphan Drug Designation RequestsLocation/Room:Exhibit Hall: Booth 104Speaker: – Premier Consulting
Solutions Circle
Jennifer L. Fielder – Premier Consulting ### 1615687###Speaker###Regulatory Compliance Manager###Premier Consulting###Speaker: – Premier Consulting
### 2:00 PM – 3:00 PM MST
Accelerated Drug Development & Approval through Pilot Programs and Initiatives
2:00 PM – 3:00 PM MST
When Everyday Counts: Global Expedited Approval Pathways for Novel TherapeuticsLocation/Room:W103 A-BSession Leader/Speaker: – Seagen Inc.
Speaker: – PharmaLex
Speaker: – Genentech, a member of the Roche Group
Speaker: – European Medicines Agency
Biopharmaceuticals
Linda Bowen, MSc, RAC, FRAPS – Seagen Inc. ### 1615689###Session Leader/Speaker###Head of Global Regulatory Policy and Intelligence###Seagen Inc.###Session Leader/Speaker: – Seagen Inc.
### @@@ Mark Lane, MS, PhD – PharmaLex ### 1615688###Speaker###VP Development and Scientific Affairs###PharmaLex###Speaker: – PharmaLex
### @@@ Jamie L. Robinson, MBA, RAC – Genentech, a member of the Roche Group ### 535434###Speaker###Program Director, Pharma Technical Regulatory###Genentech, a member of the Roche Group###Speaker: – Genentech, a member of the Roche Group
### @@@ Anabela Marcal – European Medicines Agency ### 1061464###Speaker###EMA Liaison Official to FDA###European Medicines Agency###Speaker: – European Medicines Agency
###
2:00 PM – 3:00 PM MST
Breaking Through New FDA Pathways: EUA and Novel Device Programs
2:00 PM – 3:00 PM MST
Breaking Through New FDA Pathways: EUA and Novel Device ProgramsLocation/Room:W101 A-BSession Leader/Speaker: – DuVal & Associates, P.A.
Speaker: – Veeva Systems
Speaker: – DuVal & Associates, P.A.
Medical Devices
Session Room Sponsored By
Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A. ### 1614391###Session Leader/Speaker###VP, Regulatory, Quality, Clinical & Engineering###DuVal & Associates, P.A.###Session Leader/Speaker: – DuVal & Associates, P.A.
### @@@ Brian Scogland, MBA, MS – Veeva Systems ### 1614542###Speaker###Senior Director of Regulatory Strategy, MedTech###Veeva Systems###Speaker: – Veeva Systems
### @@@ Kathy Herzog, BSME – DuVal & Associates, P.A. ### 1614392###Speaker###Regulatory Consultant###DuVal & Associates, P.A.###Speaker: – DuVal & Associates, P.A.
###
2:00 PM – 3:00 PM MST
Conversations that Matter (Devices)
2:00 PM – 3:00 PM MST
Conversations That Matter (Devices)Location/Room:W105 A-BModerator:
Moderator:
Speaker: – Health Canada
Speaker: – European Medicines Agency
Speaker: – Regulatory Project Management Staff / Office of Blood Research and Review / Center for Biologics Evaluation and Research / Food and Drug Administration
Speaker: – US Food & Drug Administration / CBER
Speaker: – TÜV SÜD Medical Health Services
Speaker (Remote): – FDA/CDRH
Speaker (Remote): – US Food and Drug Administration
Conversations That Matter
Susan Stewart ### 1698805###Moderator#########Moderator:
### @@@ Jethro Ekuta ### 1698806###Moderator#########Moderator:
### @@@ David Boudreau, ing – Health Canada ### 570151###Speaker###Director General###Health Canada###Speaker: – Health Canada
### @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Speaker###Principal Scientific Administrator###European Medicines Agency###Speaker: – European Medicines Agency
### @@@ Sonday L. Kelly, MS, RAC, PMP – Regulatory Project Management Staff / Office of Blood Research and Review / Center for Biologics Evaluation and Research / Food and Drug Administration ### 1679212###Speaker###Staff Director###Regulatory Project Management Staff / Office of Blood Research and Review / Center for Biologics Evaluation and Research / Food and Drug Administration###Speaker: – Regulatory Project Management Staff / Office of Blood Research and Review / Center for Biologics Evaluation and Research / Food and Drug Administration
### @@@ Katherine Kim, MPH, RAC, CQA – US Food & Drug Administration / CBER ### 1728974###Speaker###Acting Senior Advisor for Medical Device###US Food & Drug Administration / CBER###Speaker: – US Food & Drug Administration / CBER
### @@@ Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Services ### 1187581###Speaker###Regulatory Strategy Principal###TÜV SÜD Medical Health Services###Speaker: – TÜV SÜD Medical Health Services
### @@@ Ken Skodacek – FDA/CDRH ### 1005446###Speaker (Remote)###FDA/CDRH Deputy Ombudsman###FDA/CDRH###Speaker (Remote): – FDA/CDRH
### @@@ Eli Tomar, JD, MPH – US Food and Drug Administration ### 1083197###Speaker (Remote)###Associate Director for Guidance, Legislation and Special Projects, Office of Policy, CDRH###US Food and Drug Administration###Speaker (Remote): – US Food and Drug Administration
### 2:00 PM – 3:00 PM MST
Decentralized Clinical Trials: What Are Clinical Trials Like Today?
2:00 PM – 3:00 PM MST
Decentralized Clinical Trials: What Are Clinical Trials Like Today?Location/Room:W106 CSession Leader/Speaker: – Biotechnology innovation organization
Speaker: – Bayer Pharma
Speaker: – Janssen
Biopharmaceuticals
Leslie Harden, PharmD – Biotechnology innovation organization ### 1615668###Session Leader/Speaker###Director###Biotechnology innovation organization###Session Leader/Speaker: – Biotechnology innovation organization
### @@@ Sumana Biswas, PhD – Bayer Pharma ### 1698209###Speaker###US Head, RA Strategy, Cardio-Renal###Bayer Pharma###Speaker: – Bayer Pharma
### @@@ Danielle Friend – Janssen ### 1698210###Speaker###Director, Regulatory Policy and Intelligence###Janssen###Speaker: – Janssen
###
2:00 PM – 3:00 PM MST
ICH a Unique Platform for Convergence & Collaboration
2:00 PM – 3:00 PM MST
ICH a Unique Platform for Convergence & CollaborationLocation/Room:W104 A-BSession Leader/Speaker: – Merck (EMD Serono in the US)
Speaker (Remote): – FDA/Center for Drug Evaluation and Research
Speaker (Remote): – Health Canada
Biopharmaceuticals
Session Room Sponsored By
Isabelle Colmagne-Poulard, PhD Pharmacy, MBA – Merck (EMD Serono in the US) ### 1321690###Session Leader/Speaker###Director, International Global Regulatory Affairs & Scientific Policy (GRASP)###Merck (EMD Serono in the US)###Session Leader/Speaker: – Merck (EMD Serono in the US)
### @@@ Ashley Boam, BSE, MSBE – FDA/Center for Drug Evaluation and Research ### 1728952###Speaker (Remote)###Director, Office of Policy for Pharmaceutical Quality###FDA/Center for Drug Evaluation and Research###Speaker (Remote): – FDA/Center for Drug Evaluation and Research
### @@@ Bruce Randall, B. Sc – Health Canada ### 1402493###Speaker (Remote)###Senior Executive Director###Health Canada###Speaker (Remote): – Health Canada
###
2:00 PM – 3:00 PM MST
Plain Language and Lay Language Summaries: Overview and Writing
2:00 PM – 3:00 PM MST
Plain Language and Lay Language Summaries: Overview and WritingLocation/Room:W101 CSession Leader/Speaker: – Certara
Broad Interest
Laura Sheppard, MBA, MA – Certara ### 1615669###Session Leader/Speaker###Senior Director, Global Submissions and Plain Language Summary Lead###Certara###Session Leader/Speaker: – Certara
###
2:00 PM – 3:00 PM MST
Regulatory challenges and Implications of UK and Switzerland leaving the EU
2:00 PM – 3:00 PM MST
Regulatory Challenges and Implications of UK and Switzerland Leaving the EULocation/Room:W106 A-BSession Leader/Speaker: – Abbott
Speaker: – BSI Group
Speaker (Remote): – Swissmedic, Division Medical Devices Surveillance
Medical Devices
Session Room Sponsored By
Amra Racic – Abbott ### 1614546###Session Leader/Speaker###Director RIS###Abbott###Session Leader/Speaker: – Abbott
### @@@ Vishal Thakker, MEng – BSI Group ### 1614543###Speaker###Head of UK Approved Body & Senior Regulatory Lead###BSI Group###Speaker: – BSI Group
### @@@ Michael Köhli, PhD – Swissmedic, Division Medical Devices Surveillance ### 1671525###Speaker (Remote)###Head of section MDS1###Swissmedic, Division Medical Devices Surveillance ###Speaker (Remote): – Swissmedic, Division Medical Devices Surveillance
###
2:00 PM – 3:00 PM MST
Safety in EU Medical Device Clinical Trials: Best Practices for Compliance and Inspection Readiness
2:00 PM – 3:00 PM MST
Safety in EU Medical Device Clinical Trials: Best Practices for Compliance and Inspection ReadinessLocation/Room:W102 A-CSpeaker: – Meditrial USA Inc.
Speaker: – AGES (Austrian Agency for Health & Food Safety)
Speaker: – Meditrial
Moderator: – Self Employed
Speaker: – Meditrial GmbH
Medical Devices
Session Room Sponsored By
Monica Tocchi, MD – Meditrial USA Inc. ### 1614387###Speaker###Chief Medical Officer###Meditrial USA Inc.###Speaker: – Meditrial USA Inc.
### @@@ Karl-Heinz Huemer, MD, PhD – AGES (Austrian Agency for Health & Food Safety) ### 573393###Speaker###Medical Assessor###AGES (Austrian Agency for Health & Food Safety)###Speaker: – AGES (Austrian Agency for Health & Food Safety)
### @@@ Debra Kridner, MA – Meditrial ### 1776778###Speaker###Executive in Regulatory, Quality and Clinical###Meditrial ###Speaker: – Meditrial
### @@@ Vicki Bebeau, BSN – Self Employed ### 1614390###Moderator###Clinical Advisor###Self Employed###Moderator: – Self Employed
### @@@ Kristin Forßmann, MD – Meditrial GmbH ### 1670172###Speaker###Director Clinical Development###Meditrial GmbH###Speaker: – Meditrial GmbH
###
2:00 PM – 4:00 PM MST
Resume Reviews and Career Coaching
2:00 PM – 4:00 PM MST
Resume Reviews and Career CoachingLocation/Room:Exhibit Hall: Booth 728
3:00 PM – 3:30 PM MST
Coffee & Refreshment Break
3:00 PM – 3:30 PM MST
Coffee & Refreshment BreakLocation/Room:Session Rooms: W101-106 Foyers
3:30 PM – 4:30 PM MST
Adapting a Regulatory Framework for Personalized Devices
3:30 PM – 4:30 PM MST
Adapting a Regulatory Framework for Personalized DevicesLocation/Room:W102 A-CSession Leader/Speaker: – Philips Healthcare
Speaker: – Ricoh USA
Speaker: – Optum
Medical Devices
Session Room Sponsored By
Meg Mucha, RAC, FRAP – Philips Healthcare ### 1614524###Session Leader/Speaker###Director###Philips Healthcare###Session Leader/Speaker: – Philips Healthcare
### @@@ Scott Brewer – Ricoh USA ### 1614525###Speaker###Senior Manager, Regulatory Compliance - Additive Manufacturing###Ricoh USA###Speaker: – Ricoh USA
### @@@ Tracey Fox, MS, RAC – Optum ### 535448###Speaker###Sr. Director, Regulatory Affairs###Optum###Speaker: – Optum
###
3:30 PM – 4:30 PM MST
Combination Products: Perspectives from Drug/biologics and Device Industries
3:30 PM – 4:30 PM MST
Combination Products: Perspectives from Drug/biologics and Device IndustriesLocation/Room:W106 CSession Leader/Speaker: – NSF International, Health Sciences Division
Speaker: – Hyman, Phelps & McNamara, P.C.
Moderator: – Quidel
Biopharmaceuticals
Andy Papas, PhD, MBA – NSF International, Health Sciences Division ### 1615716###Session Leader/Speaker###Vice President of Regulatory Affairs###NSF International, Health Sciences Division###Session Leader/Speaker: – NSF International, Health Sciences Division
### @@@ Adrienne Lenz, MS, RAC – Hyman, Phelps & McNamara, P.C. ### 535486###Speaker###Principal Medical Device Regulatory Expert###Hyman, Phelps & McNamara, P.C.###Speaker: – Hyman, Phelps & McNamara, P.C.
### @@@ Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – Quidel ### 1642067###Moderator###Sr. Director, Reg. Affairs###Quidel###Moderator: – Quidel
###
3:30 PM – 4:30 PM MST
eCTD 4.0 - No Need to be afraid
3:30 PM – 4:30 PM MST
Ectd 4.0 - No Need to Be AfraidLocation/Room:W101 A-BSession Leader/Speaker: – EXTEDO GmbH
Skill Building
Session Room Sponsored By
Frank Dickert – EXTEDO GmbH ### 1321687###Session Leader/Speaker###Senior Business Consultant###EXTEDO GmbH###Session Leader/Speaker: – EXTEDO GmbH
###
3:30 PM – 4:30 PM MST
Health Authority Forum
3:30 PM – 4:30 PM MST
Health Authority Forum - JapanLocation/Room:W105 A-CModerator: – Cook Medical
Speaker: – PMDA
Speaker: – Pharmaceuticals and Medical Devices Agency
Health Authority Forum
David Chadwick, PhD, RAC, FRAPS – Cook Medical ### 549204###Moderator###Director, Regulatory Affairs / Regulatory Science###Cook Medical###Moderator: – Cook Medical
### @@@ Kuniki Imagawa, MSc – PMDA ### 1614535###Speaker###Principal Officer, Office of Standards and Compliance for Medical Devices###PMDA###Speaker: – PMDA
### @@@ Haruko Yamamoto, MD, PhD – Pharmaceuticals and Medical Devices Agency ### 1688377###Speaker###Associate Executive Director###Pharmaceuticals and Medical Devices Agency###Speaker: – Pharmaceuticals and Medical Devices Agency
###
3:30 PM – 4:30 PM MST
Real-World Evidence: Current Global Landscape and utility in Regulatory Decision-Making
3:30 PM – 4:30 PM MST
Real-World Evidence: Current Global Landscape and Utility in Regulatory Decision-makingLocation/Room:W103 A-BSession Leader/Speaker: – Merck & Co., Inc
Speaker: – Bristol Myers Squibb
Speaker: – European Medicines Agency
Biopharmaceuticals
Seema S. Betigeri, PhD – Merck & Co., Inc ### 828929###Session Leader/Speaker###Executive Director, Global Regulatory Affairs###Merck & Co., Inc###Session Leader/Speaker: – Merck & Co., Inc
### @@@ Rob Kalesnik-Orszulak, PharmD – Bristol Myers Squibb ### 1321696###Speaker###Director, Regulatory Innovation Lead for RWE and Data Science###Bristol Myers Squibb###Speaker: – Bristol Myers Squibb
### @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Speaker###Principal Scientific Administrator###European Medicines Agency###Speaker: – European Medicines Agency
###
3:30 PM – 4:30 PM MST
Risk Management & Clinical Evaluation
3:30 PM – 4:30 PM MST
Meaningful Conversations about Benefit Risk Analysis – A Panel DiscussionLocation/Room:W101 CSession Leader/Speaker: – Qserve Group
Speaker (Remote): – AKRA Team GmbH
Speaker: – NAMSA
Speaker: – (British Standards Institute) BSI
Medical Devices
Mindy McCann – Qserve Group ### 720640###Session Leader/Speaker###VP Regulatory Compliance###Qserve Group###Session Leader/Speaker: – Qserve Group
### @@@ Fabienne Neibecker, PhD – AKRA Team GmbH ### 1614528###Speaker (Remote)###Senior Consultant###AKRA Team GmbH###Speaker (Remote): – AKRA Team GmbH
### @@@ Matt Royle, PhD – NAMSA ### 907121###Speaker###Principal Regulatory Consultant###NAMSA###Speaker: – NAMSA
### @@@ Richard G. Holborow, Medical/Professional – (British Standards Institute) BSI ### 1054191###Speaker###Global Head of Clinical Compliance/Clinical Physiologist###(British Standards Institute) BSI###Speaker: – (British Standards Institute) BSI
###
3:30 PM – 4:30 PM MST
The Future of Patient Experience Data in Global Drug Development: EMA, FDA, and Industry Views
3:30 PM – 4:30 PM MST
The Future of Patient Experience Data in Global Drug Development: EMA, FDA, and Industry ViewsLocation/Room:W104 A-BSpeaker (Remote): – FDA
Moderator: – Bayer
Speaker: – Biotechnology innovation organization
Speaker (Remote): – European Medicines Agency
Speaker: – European Medicines Agency
Speaker (Remote): – TSC Alliance
Biopharmaceuticals
Session Room Sponsored By
Robyn Bent – FDA ### 1724460###Speaker (Remote)###FDA/CDER/OCD, Supervisory General Health Scientist###FDA###Speaker (Remote): – FDA
### @@@ Kim Quaintance-Lunn – Bayer ### 1698208###Moderator###VP, US Regulatory Lead###Bayer###Moderator: – Bayer
### @@@ Leslie Harden, PharmD – Biotechnology innovation organization ### 1615668###Speaker###Director###Biotechnology innovation organization###Speaker: – Biotechnology innovation organization
### @@@ Juan Garcia Burgos, MD – European Medicines Agency ### 1551387###Speaker (Remote)###Head of Public and Stakeholders Engagement Department###European Medicines Agency###Speaker (Remote): – European Medicines Agency
### @@@ Anabela Marcal – European Medicines Agency ### 1061464###Speaker###EMA Liaison Official to FDA###European Medicines Agency###Speaker: – European Medicines Agency
### @@@ Gabrielle Rushing, PhD – TSC Alliance ### 1778869###Speaker (Remote)###Director, Research###TSC Alliance###Speaker (Remote): – TSC Alliance
###
3:30 PM – 4:30 PM MST
With All Due Respect, We Disagree with FDA’s Assessment – Resolving Differences During Pre-Market Review
3:30 PM – 4:30 PM MST
With All Due Respect, We Disagree with FDA’s Assessment – Resolving Disagreements During Pre-market Review – Insights from Fda's Ombudsman ProgramsLocation/Room:W106 A-BSpeaker (Remote): – FDA/CDRH
Speaker (Remote): – Center for Biologics Evaluation and Research, US FDA
Speaker (Remote): – Food and Drug Administration, Center for Drug Evaluation and Research
Speaker (Remote): – USFDA Office of Regulatory Affairs (ORA)
Moderator: – Thermo Fisher Scientific
Devices & Pharmaceuticals
Session Room Sponsored By
Ken Skodacek – FDA/CDRH ### 1005446###Speaker (Remote)###FDA/CDRH Deputy Ombudsman###FDA/CDRH###Speaker (Remote): – FDA/CDRH
### @@@ Sheryl Lard-Whiteford, PhD – Center for Biologics Evaluation and Research, US FDA ### 1679217###Speaker (Remote)###Associate Director for Product Management###Center for Biologics Evaluation and Research, US FDA###Speaker (Remote): – Center for Biologics Evaluation and Research, US FDA
### @@@ Virginia Behr – Food and Drug Administration, Center for Drug Evaluation and Research ### 1728964###Speaker (Remote)###Ombuds###Food and Drug Administration, Center for Drug Evaluation and Research###Speaker (Remote): – Food and Drug Administration, Center for Drug Evaluation and Research
### @@@ Erica Katherine, MS – USFDA Office of Regulatory Affairs (ORA) ### 1768449###Speaker (Remote)###ORA Ombudsman###USFDA Office of Regulatory Affairs (ORA)###Speaker (Remote): – USFDA Office of Regulatory Affairs (ORA)
### @@@ Megha Deviprasad Iyer, MS, RAC – Thermo Fisher Scientific ### 1083158###Moderator###Global Director, Regulatory Affairs###Thermo Fisher Scientific###Moderator: – Thermo Fisher Scientific
### 4:35 PM – 5:30 PM MST
Advanced/Innovative Manufacturing: A Panel Discussion about Benefits, Challenges, and the Current Regulatory Landscape
4:35 PM – 5:30 PM MST
Advanced/innovative Manufacturing: A Panel Discussion About Benefits, Challenges, and the Current Regulatory LandscapeLocation/Room:W104 A-BSession Leader/Speaker: – Biotechnology Innovation Organization
Speaker: – Biogen
Speaker: – GSK
Speaker (Remote): – OBP/OPQ/CDER/FDA
Biopharmaceuticals
Session Room Sponsored By
Alex May, M.S. – Biotechnology Innovation Organization ### 1615691###Session Leader/Speaker###Director, Science & Regulatory ###Biotechnology Innovation Organization###Session Leader/Speaker: – Biotechnology Innovation Organization
### @@@ Kim Wolfram, MS – Biogen ### 1666112###Speaker###Head of Regulatory CMC Biologics and Gene Therapy ###Biogen ###Speaker: – Biogen
### @@@ Ben Stevens, PhD, MPH – GSK ### 1666113###Speaker###Director CMC Policy and Advocacy###GSK###Speaker: – GSK
### @@@ Joel Welch, PhD – OBP/OPQ/CDER/FDA ### 1724454###Speaker (Remote)###Associate Director for Science&Biosimilar Strategy###OBP/OPQ/CDER/FDA###Speaker (Remote): – OBP/OPQ/CDER/FDA
###
4:35 PM – 5:30 PM MST
Beyond the MDR/IVDR: Medical Device Regulatory Compliance Challenges outside of the MDR and IVDR
4:35 PM – 5:30 PM MST
Beyond the MDR/IVDR: Medical Device Regulatory Compliance Challenges Outside of the MDR and IVDRLocation/Room:W106 CSession Leader/Speaker: – Qserve Group
Speaker: – Axon Lawyers
In Vitro Diagnostics
Mindy McCann – Qserve Group ### 720640###Session Leader/Speaker###VP Regulatory Compliance###Qserve Group###Session Leader/Speaker: – Qserve Group
### @@@ Erik R. Vollebregt, LLM – Axon Lawyers ### 535481###Speaker###Partner###Axon Lawyers###Speaker: – Axon Lawyers
###
4:35 PM – 5:30 PM MST
Developing Your Label for Impact while Keeping AdPromo in Mind
4:35 PM – 5:30 PM MST
Labeling Creation: Impact on Adpromo and the Importance of Cross-Functional CollaborationLocation/Room:W103 A-BSession Leader/Speaker: – Turning Point Therapeutics, Inc.
Speaker: – Genentech, Inc.
Biopharmaceuticals
Micheline Awad, MBA – Turning Point Therapeutics, Inc. ### 535432###Session Leader/Speaker###Sr. Director, Regulatory Affairs – Advertising, Promotion, and Labeling###Turning Point Therapeutics, Inc.###Session Leader/Speaker: – Turning Point Therapeutics, Inc.
### @@@ Lisa M. Kelsey, MA LMFT – Genentech, Inc. ### 1663948###Speaker###Group Director, Head of Commercial Labeling###Genentech, Inc.###Speaker: – Genentech, Inc.
###
4:35 PM – 5:30 PM MST
EUDAMED & UDI – Evolution of the EU Regulatory Landscape
4:35 PM – 5:30 PM MST
EUDAMED & UDI – Evolution of the EU Regulatory LandscapeLocation/Room:W101 A-BSession Leader/Speaker: – Boston Scientific
Speaker: – Qserve Group
Speaker: – TÜV SÜD Medical Health Services
Speaker: – Arizona State University/Center for Healthcare Delivery and Policy
Medical Devices
Session Room Sponsored By
Olga van Grol-Lawlor, MPhil – Boston Scientific ### 1534231###Session Leader/Speaker###Manager Global Regulatory Intelligence & Advocacy###Boston Scientific###Session Leader/Speaker: – Boston Scientific
### @@@ Gert W. Bos, MSc, PhD, FRAPS – Qserve Group ### 535440###Speaker###CSO - CEO###Qserve Group###Speaker: – Qserve Group
### @@@ Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Services ### 1187581###Speaker###Regulatory Strategy Principal###TÜV SÜD Medical Health Services###Speaker: – TÜV SÜD Medical Health Services
### @@@ Natalia Wilson, MD MPH – Arizona State University/Center for Healthcare Delivery and Policy ### 1773705###Speaker###Executive Director###Arizona State University/Center for Healthcare Delivery and Policy###Speaker: – Arizona State University/Center for Healthcare Delivery and Policy
###
4:35 PM – 5:30 PM MST
How to define the expected lifetime of a medical device & its consequences
4:35 PM – 5:30 PM MST
How to Define the Expected Lifetime of a Medical Device & Its ConsequencesLocation/Room:W102 A-CSession Leader/Speaker: – Qserve Group
Speaker: – Haemonetics
Speaker: – Teleflex Interventional Urology
Medical Devices
Session Room Sponsored By
Keith Morel, PhD (he/him/his) – Qserve Group ### 535522###Session Leader/Speaker###VP Regulatory Compliance###Qserve Group###Session Leader/Speaker: – Qserve Group
### he/him/his @@@ Eva Hellman – Haemonetics ### 1764625###Speaker###RA/CA Manager###Haemonetics###Speaker: – Haemonetics
### @@@ Louis Marcoux – Teleflex Interventional Urology ### 1764626###Speaker###Sr. Director, Regulatory Affairs###Teleflex Interventional Urology###Speaker: – Teleflex Interventional Urology
###
4:35 PM – 5:30 PM MST
OTC Monograph Modernization – Facilitating FDA & Industry Engagement
4:35 PM – 5:30 PM MST
OTC Monograph Modernization – Facilitating FDA & Industry EngagementLocation/Room:W106 A-BSession Leader/Speaker: – Haleon
Speaker (Remote): – FDA
Speaker: – Haleon
Biopharmaceuticals
Session Room Sponsored By
Erin Oliver, MS, MBA, FRAPS – Haleon ### 1007343###Session Leader/Speaker###Senior Director, Regulatory Affairs###Haleon###Session Leader/Speaker: – Haleon
### @@@ Theresa Michele, MD – FDA ### 1052818###Speaker (Remote)###Director, Office of Nonprescription Drugs###FDA###Speaker (Remote): – FDA
### @@@ Lauren Quinn, JD – Haleon ### 1729166###Speaker###Vice President US Regulatory Affairs###Haleon###Speaker: – Haleon
###
4:35 PM – 5:30 PM MST
Regulatory Intelligence SUPER Jam Session: tips and tricks and best practices too!
4:35 PM – 5:30 PM MST
Regulatory Intelligence SUPER Jam Session: Tips and Tricks and Best Practices Too!Location/Room:W101 CSpeaker: – LifeScan
Speaker: – LifeScan
Skill Building
Rosanne Middleton – LifeScan ### 1376586###Speaker###Senior Program Lead, Regulatory Policy & Intelligence###LifeScan###Speaker: – LifeScan
### @@@ Dinar Suleman, RAC – LifeScan ### 1374645###Speaker###Manager, Regulatory Policy & Intelligence###LifeScan###Speaker: – LifeScan
###
6:00 PM – 9:00 PM MST
Closing Party: Arizona Science Center
6:00 PM – 9:00 PM MST
Closing Party: Arizona Science Center Location/Room:Offsite: Arizona Science Center
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