- Saturday, September 10, 2022
6:30 AM – 10:00 AM MST
Speaker Ready Room Open
6:30 AM – 10:00 AM MST
Speaker Ready Room Open
Location/Room:W202
6:30 AM – 1:00 PM MST
Registration Open
6:30 AM – 1:00 PM MST
Registration Open
Location/Room:West Hall 1-3 Lobby, Lower Level
7:00 AM – 8:00 AM MST
Preconference Workshops: Breakfast
7:00 AM – 8:00 AM MST
Preconference Workshops: Breakfast
Location/Room:Session Rooms: W101-106 Foyers
7:00 AM – 5:00 PM MST
First Aid Services
7:00 AM – 5:00 PM MST
First Aid Services
Location/Room:Exhibit Hall 1: Back of Hall
8:00 AM – 8:30 AM MST
Preconference Workshops: Welcome
8:00 AM – 8:30 AM MST
Preconference Workshops: WelcomeLocation/Room:Session Rooms: W101-106 FoyersPresenter: – Velvet Chainsaw Consulting
Sarah Michel, CSP – Velvet Chainsaw Consulting ### 542411###Presenter###Vice President, Professional Connexity###Velvet Chainsaw Consulting###Presenter: – Velvet Chainsaw Consulting
### 8:30 AM – 4:00 PM MST
Preconference Workshop: Advanced Leadership (Day 1 of 2)
8:30 AM – 4:00 PM MST
Preconference Workshop: Advanced Leadership (Day 1 of 2)Location/Room:W102 A-CWorkshop Leader: – COPIA Coaching and Consulting
Carol Robert, MA, PCC, PMP, CDTLF – COPIA Coaching and Consulting ### 1699441###Workshop Leader###Associate###COPIA Coaching and Consulting###Workshop Leader: – COPIA Coaching and Consulting
###
8:30 AM – 4:00 PM MST
Preconference Workshop: Bootstrapping Your Regulatory Intelligence: Start and Grow a Successful RI program from Scratch
8:30 AM – 4:00 PM MST
Preconference Workshop: Bootstrapping Your Regulatory Intelligence: Start and Grow a Successful RI Program from ScratchLocation/Room:W103 A-BWorkshop Leader: – Seagen Inc.
Biopharmaceuticals
Chris Whalley – Seagen Inc. ### 1000102###Workshop Leader###Associate Director, Regulatory Policy & Intelligence###Seagen Inc.###Workshop Leader: – Seagen Inc.
###
8:30 AM – 4:00 PM MST
Preconference Workshop: Clinical Evaluation
8:30 AM – 4:00 PM MST
Preconference Workshop: Clinical EvaluationLocation/Room:W101 A-BWorkshop Leader: – Qserve Group
Speaker: – Qserve Group
Medical Devices
Mindy McCann – Qserve Group ### 720640###Workshop Leader###VP Regulatory Compliance###Qserve Group###Workshop Leader: – Qserve Group
### @@@ Patrícia da Silva Peres, PhD – Qserve Group ### 1755603###Speaker###Consultant###Qserve Group###Speaker: – Qserve Group
###
8:30 AM – 4:00 PM MST
Preconference Workshop: Drug Development in EU: Regulatory Standards, Support and New Approaches
8:30 AM – 4:00 PM MST
Preconference Workshop: Drug Development in EU: Regulatory Standards, Support and New ApproachesLocation/Room:W104 A-BSpeaker: – Austrian Medicines and Medical Devices Agency
Speaker: – AGES (Austrian Agency for Health & Food Safety)
Speaker (Remote): – Spanish Agency for Medicines and Medical Devices
Speaker: – European Medicines Agency
Speaker: – MDC RegAffairs GmbH
Speaker: – Malta Medicines Authority
Speaker (Remote): – Norwegian Medicines Agency
Biopharmaceuticals
Andrea Laslop, Prof, MD – Austrian Medicines and Medical Devices Agency ### 573431###Speaker###Head of Scientific Office, Federal Office for Safety in Health Care###Austrian Medicines and Medical Devices Agency###Speaker: – Austrian Medicines and Medical Devices Agency
### @@@ 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)
### @@@ Maria Concepción Prieto Yerro, MD, PhD – Spanish Agency for Medicines and Medical Devices ### 790292###Speaker (Remote)###Representative from Spain at the CHMP (EMA)###Spanish Agency for Medicines and Medical Devices###Speaker (Remote): – Spanish Agency for Medicines and Medical Devices
### @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Speaker###Principal Scientific Administrator###European Medicines Agency###Speaker: – European Medicines Agency
### @@@ Matthias Dormeyer, MD – MDC RegAffairs GmbH ### 573390###Speaker###Managing Director###MDC RegAffairs GmbH###Speaker: – MDC RegAffairs GmbH
### @@@ John Borg, Prof, PhD, Technical Director, Medicines Authority Malta – Malta Medicines Authority ### 1757708###Speaker###Post-Licensing Director###Malta Medicines Authority###Speaker: – Malta Medicines Authority
### @@@ Anja E. Schiel, PhD, Senior Advisor – Norwegian Medicines Agency ### 1773211###Speaker (Remote)###Lead Methodologist in Regulatory and Pharmacoeconomic Statistics###Norwegian Medicines Agency###Speaker (Remote): – Norwegian Medicines Agency
###
8:30 AM – 4:00 PM MST
Preconference Workshop: Strategic and Innovative Thinking for Regulatory Professionals - Principles and Practical Guidance
8:30 AM – 4:00 PM MST
Preconference Workshop: Strategic and Innovative Thinking for Regulatory Professionals - Principles and Practical GuidanceLocation/Room:W101 CWorkshop Leader: – Pearl Meyer Consulting
Broad Interest
Elise Walton, MA, PhD – Pearl Meyer Consulting ### 1718918###Workshop Leader###Principal of Veritas Partners###Pearl Meyer Consulting###Workshop Leader: – Pearl Meyer Consulting
###
8:30 AM – 4:00 PM MST
Preconference Workshop: US Regulatory Essentials - Medical Devices and IVDs
8:30 AM – 4:00 PM MST
Preconference Workshop: US Regulatory Essentials - Medical Devices and IVDsLocation/Room:W106 A-BWorkshop Leader: – Cook Medical
Speaker: – Cook Medical
Speaker: – Cook Incorporated
Speaker: – DuVal & Associates, P.A.
Speaker (Remote): – AtriCure, Inc.
Speaker: – Greenlight Guru
Speaker: – Greenlight Guru
Session Leader/Speaker (Remote): – Qserve Group
David Chadwick, PhD, RAC, FRAPS – Cook Medical ### 549204###Workshop Leader###Director, Regulatory Affairs / Regulatory Science###Cook Medical###Workshop Leader: – Cook Medical
### @@@ Andrea Gadsby – Cook Medical ### 1397976###Speaker###Quality Director, Cook Incorporated###Cook Medical###Speaker: – Cook Medical
### @@@ Larry Pool – Cook Incorporated ### 1397977###Speaker###Dir, Post Market###Cook Incorporated###Speaker: – Cook Incorporated
### @@@ Mark DuVal, J.D., FRAPS – DuVal & Associates, P.A. ### 535473###Speaker###President & CEO,###DuVal & Associates, P.A.###Speaker: – DuVal & Associates, P.A.
### @@@ Tony Blank – AtriCure, Inc. ### 1036809###Speaker (Remote)###Senior Director, Regulatory Affairs###AtriCure, Inc.###Speaker (Remote): – AtriCure, Inc.
### @@@ Etienne Nichols, PMP, CSM – Greenlight Guru ### 1397975###Speaker###Medical Device Guru###Greenlight Guru###Speaker: – Greenlight Guru
### @@@ Laura Court – Greenlight Guru ### 1605904###Speaker###Medical Device Guru###Greenlight Guru###Speaker: – Greenlight Guru
### @@@ Christie Hughes, MPH, MLS(ASCP) – Qserve Group ### 1389439###Session Leader/Speaker (Remote)###Principal Consultant, QA/RA and IVD Expert###Qserve Group###Session Leader/Speaker (Remote): – Qserve Group
###
8:30 AM – 5:00 PM MST
Press Room
8:30 AM – 5:00 PM MST
Press Room
Location/Room:W203
10:30 AM – 11:00 AM MST
Preconference Workshops: Refreshment Break
10:30 AM – 11:00 AM MST
Preconference Workshops: Refreshment Break
Location/Room:Session Rooms: W101-106 Foyers
12:30 PM – 1:30 PM MST
Preconference Workshops: Lunch
12:30 PM – 1:30 PM MST
Preconference Workshops: Lunch
Location/Room:Session Rooms: W101-106 Foyers
