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Monday, October 1, 2018
8:00 AM - 9:00 AM

Workshop Continental Breakfast
8:00 AM - 9:00 AM

Workshop Continental Breakfast
Location: Ballroom D

Favorite
8:00 AM - 10:00 AM

Workshop Registration
8:00 AM - 10:00 AM

Workshop Registration
Location: Ballroom Lobby (outside 105-106)

Favorite
8:00 AM - 5:00 PM

Speaker Ready Open
8:00 AM - 5:00 PM

Speaker Ready Open
Location: 111-112

Favorite
9:00 AM - 5:00 PM

Advanced Leadership Workshop
9:00 AM - 5:00 PM

Advanced Leadership Workshop
Location: 116-117
Trista Schoonmaker, PCC – COPIA Coaching and Consulting; Virginia Swassing, RAC – Device and Diagnostic Regulatory LLC
Workshops

Favorite

Trista Schoonmaker, PCC – COPIA Coaching and Consulting ### 593803###Workshop Leader @@@ Virginia Swassing, RAC – Device and Diagnostic Regulatory LLC ### 593804###Workshop Leader
9:00 AM - 5:00 PM

Developing Your Global Medical Device Regulatory Strategy
9:00 AM - 5:00 PM

Developing Your Global Medical Device Regulatory Strategy
Location: 212-214
Nicole Landreville, Eng, RAC, FRAPS – GE Healthcare; bradley Hossack, Bsc – Stryker Corporation; Patrick S. Lee, MS, MBA – Vascular Dynamics Inc.; Megha D. Iyer, MS, RAC – Thermo Fisher Scientific
Workshops

Favorite

Nicole Landreville, Eng, RAC, FRAPS – GE Healthcare ### 549200###Workshop Leader @@@ bradley Hossack, Bsc – Stryker Corporation ### 549201###Speaker @@@ Patrick S. Lee, MS, MBA – Vascular Dynamics Inc. ### 549205###Speaker @@@ Megha D. Iyer, MS, RAC – Thermo Fisher Scientific ### 549206###Speaker
9:00 AM - 5:00 PM

EU Regulatory Essentials, Pharmaceuticals and Biologics
9:00 AM - 5:00 PM

EU Regulatory Essentials, Pharmaceuticals and Biologics
Location: 202-204
Patricia Anderson, MSc, RAC, FRAPS – RedHill Biopharma Ltd.; Andrea Laslop, MD – Austrian Federal Agency for Safety in Health Care; Matthias Dormeyer, PhD – MDC RegAffairs GmbH; Karl-Heinz Huemer, MD, PhD – Austrian Medicines Agency; Isabelle Lefebvre, MSc. RA – Valeant; Beate R. Schmidt, MSc, MDRA, RAC – Benefits Regulatory Consulting; Piet A. Vervaet, MD – Exelixis; Bettina Ziegele, MA – Paul-Ehrlic- Institut (Germany)
Workshops

Favorite

Patricia Anderson, MSc, RAC, FRAPS – RedHill Biopharma Ltd. ### 573388###Workshop Leader @@@ Andrea Laslop, MD – Austrian Federal Agency for Safety in Health Care ### 573431###Workshop Leader @@@ Matthias Dormeyer, PhD – MDC RegAffairs GmbH ### 573390###Speaker @@@ Karl-Heinz Huemer, MD, PhD – Austrian Medicines Agency ### 573393###Speaker @@@ Isabelle Lefebvre, MSc. RA – Valeant ### 573389###Speaker @@@ Beate R. Schmidt, MSc, MDRA, RAC – Benefits Regulatory Consulting ### 573538###Speaker @@@ Piet A. Vervaet, MD – Exelixis ### 573549###Speaker @@@ Bettina Ziegele, MA – Paul-Ehrlic- Institut (Germany) ### 573550###Speaker
9:00 AM - 5:00 PM

Regulatory Strategy for the Biologics Regulatory Professional
9:00 AM - 5:00 PM

Regulatory Strategy for the Biologics Regulatory Professional
Location: 208-209
William Sietsema, PhD – Caladrius Biosciences Inc.; Linda F. Bowen, MS, RAC, FRAPS – Temple University; Kamali Gill Chance, MPH, PhD, RAC – Biosciences Corporation LLC; Jean Dehdashti, MSc, RAC – US FDA; Vanessa D'Souza, PhD – Pfizer Inc.; Ning F. Go, MA, MD – Amgen; Monica Meacham, PhD – NantBio; Lei Xu, MD, PhD – US FDA
Workshops

Favorite

William Sietsema, PhD – Caladrius Biosciences Inc. ### 573564###Workshop Leader @@@ Linda F. Bowen, MS, RAC, FRAPS – Temple University ### 551690###Speaker @@@ Kamali Gill Chance, MPH, PhD, RAC – Biosciences Corporation LLC ### 535467###Speaker @@@ Jean Dehdashti, MSc, RAC – US FDA ### 602170###Speaker @@@ Vanessa D'Souza, PhD – Pfizer Inc. ### 573561###Speaker @@@ Ning F. Go, MA, MD – Amgen ### 573562###Speaker @@@ Monica Meacham, PhD – NantBio ### 593806###Speaker @@@ Lei Xu, MD, PhD – US FDA ### 602169###Speaker
9:00 AM - 5:00 PM

Toolkit for the Emerging Regulatory Leader
9:00 AM - 5:00 PM

Toolkit for the Emerging Regulatory Leader
Location: 109
Minnie Baylor-Henry – B-Henry & Associates; Jennifer Owen-O’Quill, MDiv – Voltage Leadership Consulting

Favorite

Minnie Baylor-Henry – B-Henry & Associates ### 593801###Workshop Leader @@@ Jennifer Owen-O’Quill, MDiv – Voltage Leadership Consulting ### 593800###Workshop Leader
9:00 AM - 5:00 PM

US Regulatory Essentials, Medical Devices and IVDs
9:00 AM - 5:00 PM

US Regulatory Essentials, Medical Devices and IVDs
Location: 118-120 (IVD Breakout 121-122)
David Chadwick, PhD, RAC, FRAPS – Cook Medical; Tony Blank – Infinity Biomedical Group; Mark DuVal, J.D., FRAPS – DuVal & Associates, P.A.; Rita Hoffman, RAC – The FDA Group; Lorry Weaver Huffman, MT (ASCP), CLS – Qserve Group US, Inc.; Tom Rish, BS – Greenlight Guru
Workshops

Favorite

David Chadwick, PhD, RAC, FRAPS – Cook Medical ### 549204###Workshop Leader @@@ Tony Blank – Infinity Biomedical Group ### 573383###Speaker @@@ Mark DuVal, J.D., FRAPS – DuVal & Associates, P.A. ### 535473###Speaker @@@ Rita Hoffman, RAC – The FDA Group ### 535451###Speaker @@@ Lorry Weaver Huffman, MT (ASCP), CLS – Qserve Group US, Inc. ### 573387###Speaker @@@ Tom Rish, BS – Greenlight Guru ### 593903###Speaker
9:00 AM - 5:00 PM

Demystifying the EU MDR and IVDR: From Transition to Implementation (Basic to Intermediate)
9:00 AM - 5:00 PM

Demystifying the EU MDR and IVDR: From Transition to Implementation (Basic to Intermediate)
Location: 211 (Breakout 215-216)
Bassil Akra, PhD – TÜV SÜD Product Service GmbH; Connie Del Buono, BA Biology,Microbiology – Synoptyx Inc.; Sabina Hoekstra-van den Bosch, PharmD, FRAPS – Central Committee on Research Involving Human Subjects (CCMO); Sue Spencer, Director – UL - Notified Body; Philippe Auclair, Pharma Dr, PhD , FRAPS – Abbott; Gert W. Bos, FRAPS – Qserve; Mindy McCann – Qserve Group; Julien S. Senac, PhD – GMED North America; Andreas F. Stange, PhD – TÜV SÜD; Erik Vollebregt, LLM – Axon Lawyers; Joachim Wilke, PhD MSc – Medtronic GmbH; John Wilkinson, OBE – MHRA
Workshops

Favorite

Bassil Akra, PhD – TÜV SÜD Product Service GmbH ### 535482###Workshop Leader @@@ Connie Del Buono, BA Biology,Microbiology – Synoptyx Inc. ### 574722###Workshop Leader @@@ Sabina Hoekstra-van den Bosch, PharmD, FRAPS – Central Committee on Research Involving Human Subjects (CCMO) ### 574720###Workshop Leader @@@ Sue Spencer, Director – UL - Notified Body ### 535447###Workshop Leader @@@ Philippe Auclair, Pharma Dr, PhD , FRAPS – Abbott ### 535445###Speaker @@@ Gert W. Bos, FRAPS – Qserve ### 535440###Speaker @@@ Mindy McCann – Qserve Group ### 574721###Speaker @@@ Julien S. Senac, PhD – GMED North America ### 535509###Speaker @@@ Andreas F. Stange, PhD – TÜV SÜD ### 585266###Speaker @@@ Erik Vollebregt, LLM – Axon Lawyers ### 535481###Speaker @@@ Joachim Wilke, PhD MSc – Medtronic GmbH ### 573373###Speaker @@@ John Wilkinson, OBE – MHRA ### 574719###Speaker
9:00 AM - 5:00 PM

Optimizing Your Strategy: Expedited Pathways and More!
9:00 AM - 5:00 PM

Optimizing Your Strategy: Expedited Pathways and More!
Location: 205-207
Linda F. Bowen, MS, RAC, FRAPS – Temple University; Ayse Baker, PhD, MBA, FRAPS – Chugai Pharma USA; Meredith Brown-Tuttle, RAC, US, EU – Regulatorium; Ruth Turner – Shire
Workshops

Favorite

Linda F. Bowen, MS, RAC, FRAPS – Temple University ### 551690###Workshop Leader @@@ Ayse Baker, PhD, MBA, FRAPS – Chugai Pharma USA ### 576300###Speaker @@@ Meredith Brown-Tuttle, RAC, US, EU – Regulatorium ### 535518###Speaker @@@ Ruth Turner – Shire ### 555674###Speaker
10:30 AM - 11:00 AM

Beverage Break
10:30 AM - 11:00 AM

Beverage Break
Location: Level 1 & 2 Burrard Foyer

Favorite
12:30 PM - 1:30 PM

Lunch
12:30 PM - 1:30 PM

Lunch

Favorite
3:00 PM - 3:30 PM

Beverage Break
3:00 PM - 3:30 PM

Beverage Break
Location: Level 1 &2 Burrard Foyer

Favorite
Tuesday, October 2, 2018
7:00 AM - 8:00 AM

Workshop Continental Breakfast
7:00 AM - 8:00 AM

Workshop Continental Breakfast
Location: Ballroom D

Favorite
7:00 AM - 6:00 PM

Registration Open
7:00 AM - 6:00 PM

Registration Open
Location: Exhibit Hall Lobby (outside B1)

Favorite
7:00 AM - 6:00 PM

Speaker Ready Open
7:00 AM - 6:00 PM

Speaker Ready Open
Location: 111-112

Favorite
8:00 AM - 4:00 PM

Advanced Leadership Workshop
8:00 AM - 4:00 PM

Advanced Leadership Workshop
Location: 116-117
Trista Schoonmaker, PCC – COPIA Coaching and Consulting; Virginia Swassing, RAC – Device and Diagnostic Regulatory LLC
Workshops

Favorite

Trista Schoonmaker, PCC – COPIA Coaching and Consulting ### 593803###Workshop Leader @@@ Virginia Swassing, RAC – Device and Diagnostic Regulatory LLC ### 593804###Workshop Leader
8:00 AM - 4:00 PM

Developing Your Global Medical Device Regulatory Strategy
8:00 AM - 4:00 PM

Developing Your Global Medical Device Regulatory Strategy
Location: 212-214
Nicole Landreville, Eng, RAC, FRAPS – GE Healthcare; bradley Hossack, Bsc – Stryker Corporation; Patrick S. Lee, MS, MBA – Vascular Dynamics Inc.; Megha D. Iyer, MS, RAC – Thermo Fisher Scientific
Workshops

Favorite

Nicole Landreville, Eng, RAC, FRAPS – GE Healthcare ### 549200###Workshop Leader @@@ bradley Hossack, Bsc – Stryker Corporation ### 549201###Speaker @@@ Patrick S. Lee, MS, MBA – Vascular Dynamics Inc. ### 549205###Speaker @@@ Megha D. Iyer, MS, RAC – Thermo Fisher Scientific ### 549206###Speaker
8:00 AM - 4:00 PM

Regulatory Intelligence as a Strategic Imperative
8:00 AM - 4:00 PM

Regulatory Intelligence as a Strategic Imperative
Location: 205-207
Linda F. Bowen, MS, RAC, FRAPS – Temple University; Meredith Brown-Tuttle, RAC, US, EU – Regulatorium; Matt Medlin, PhD, RAC – Chiesi
Workshops

Favorite

Linda F. Bowen, MS, RAC, FRAPS – Temple University ### 551690###Workshop Leader @@@ Meredith Brown-Tuttle, RAC, US, EU – Regulatorium ### 535518###Speaker @@@ Matt Medlin, PhD, RAC – Chiesi ### 551691###Speaker
8:00 AM - 4:00 PM

Regulatory Strategy for the Biologics Regulatory Professional
8:00 AM - 4:00 PM

Regulatory Strategy for the Biologics Regulatory Professional
Location: 208-209
William Sietsema, PhD – Caladrius Biosciences Inc.; Linda F. Bowen, MS, RAC, FRAPS – Temple University; Kamali Gill Chance, MPH, PhD, RAC – Biosciences Corporation LLC; Jean Dehdashti, MSc, RAC – US FDA; Vanessa D'Souza, PhD – Pfizer Inc.; Ning F. Go, MA, MD – Amgen; Monica Meacham, PhD – NantBio; Lei Xu, MD, PhD – US FDA
Workshops

Favorite

William Sietsema, PhD – Caladrius Biosciences Inc. ### 573564###Workshop Leader @@@ Linda F. Bowen, MS, RAC, FRAPS – Temple University ### 551690###Speaker @@@ Kamali Gill Chance, MPH, PhD, RAC – Biosciences Corporation LLC ### 535467###Speaker @@@ Jean Dehdashti, MSc, RAC – US FDA ### 602170###Speaker @@@ Vanessa D'Souza, PhD – Pfizer Inc. ### 573561###Speaker @@@ Ning F. Go, MA, MD – Amgen ### 573562###Speaker @@@ Monica Meacham, PhD – NantBio ### 593806###Speaker @@@ Lei Xu, MD, PhD – US FDA ### 602169###Speaker
8:00 AM - 4:00 PM

Toolkit for the Emerging Regulatory Leader
8:00 AM - 4:00 PM

Toolkit for the Emerging Regulatory Leader
Location: 109
Minnie Baylor-Henry – B-Henry & Associates; Jennifer Owen-O’Quill, MDiv – Voltage Leadership Consulting
Workshops

Favorite

Minnie Baylor-Henry – B-Henry & Associates ### 593801###Workshop Leader @@@ Jennifer Owen-O’Quill, MDiv – Voltage Leadership Consulting ### 593800###Workshop Leader
8:00 AM - 4:00 PM

US Regulatory Essentials, Pharmaceuticals and Biologics
8:00 AM - 4:00 PM

US Regulatory Essentials, Pharmaceuticals and Biologics
Location: 118-120
Alan V. McEmber, MS,RAC – Shire; Nancy Bower, MS, DABT – Eisai Inc; Kevin Dransfield, B.Sc. – Boehringer Ingelheim Pharmaceuticals, Inc.; Wilmar Estrada – Onesource Regulatory; Amanda Goodwin – Eisai, Inc.; Alicia Jeannotte, MS – Shire; Mary L. Mease, RPH, MPH – IQVIA
Workshops

Favorite

Alan V. McEmber, MS,RAC – Shire ### 552866###Workshop Leader @@@ Nancy Bower, MS, DABT – Eisai Inc ### 573551###Speaker @@@ Kevin Dransfield, B.Sc. – Boehringer Ingelheim Pharmaceuticals, Inc. ### 573552###Speaker @@@ Wilmar Estrada – Onesource Regulatory ### 609890###Speaker @@@ Amanda Goodwin – Eisai, Inc. ### 573554###Speaker @@@ Alicia Jeannotte, MS – Shire ### 609889###Speaker @@@ Mary L. Mease, RPH, MPH – IQVIA ### 573556###Speaker
8:00 AM - 4:00 PM

Demystifying the EU MDR and IVDR: From Transition to Implementation (Intermediate to Advanced)
8:00 AM - 4:00 PM

Demystifying the EU MDR and IVDR: From Transition to Implementation (Intermediate to Advanced)
Location: 211 (Breakout 215-216)
Bassil Akra, PhD – TÜV SÜD Product Service GmbH; Connie Del Buono, BA Biology,Microbiology – Synoptyx Inc.; Sabina Hoekstra-van den Bosch, PharmD, FRAPS – Central Committee on Research Involving Human Subjects (CCMO); Sue Spencer, Director – UL - Notified Body; Erica F. Conway, PhD – BSI; Melissa Day, RN, BSN, MBA – Johnson & Johnson; Caroline Dore Geraghty, MB,BCh, BAO, LRCP&SI, MSc Allergy, Dip Dermatology – National Standards Authority of Ireland; Alex A. M Laan, Dipl. Ing. – DEKRA Certification B.V.; Keith Morel, BSc (Physics) ARCS DIC PhD (Plasma Physics) – Qserve; Madu Oji, PhD – Baxter Healthcare Limited; Simon Richards – Alere; David Rutledge, PharmD, FCCP, FAHA, – Abbott Medical Devices; Peter Schroeer – Johnson & Johnson; Anja Wiersma, PhD – mi-CE consultancy; Joachim Wilke, PhD MSc – Medtronic GmbH; John Wilkinson, OBE – MHRA
Workshops

Favorite

Bassil Akra, PhD – TÜV SÜD Product Service GmbH ### 535482###Workshop Leader @@@ Connie Del Buono, BA Biology,Microbiology – Synoptyx Inc. ### 574722###Workshop Leader @@@ Sabina Hoekstra-van den Bosch, PharmD, FRAPS – Central Committee on Research Involving Human Subjects (CCMO) ### 574720###Workshop Leader @@@ Sue Spencer, Director – UL - Notified Body ### 535447###Workshop Leader @@@ Erica F. Conway, PhD – BSI ### 535513###Speaker @@@ Melissa Day, RN, BSN, MBA – Johnson & Johnson ### 593744###Speaker @@@ Caroline Dore Geraghty, MB,BCh, BAO, LRCP&SI, MSc Allergy, Dip Dermatology – National Standards Authority of Ireland ### 593746###Speaker @@@ Alex A. M Laan, Dipl. Ing. – DEKRA Certification B.V. ### 585231###Speaker @@@ Keith Morel, BSc (Physics) ARCS DIC PhD (Plasma Physics) – Qserve ### 535522###Speaker @@@ Madu Oji, PhD – Baxter Healthcare Limited ### 593745###Speaker @@@ Simon Richards – Alere ### 585116###Speaker @@@ David Rutledge, PharmD, FCCP, FAHA, – Abbott Medical Devices ### 585117###Speaker @@@ Peter Schroeer – Johnson & Johnson ### 574724###Speaker @@@ Anja Wiersma, PhD – mi-CE consultancy ### 574723###Speaker @@@ Joachim Wilke, PhD MSc – Medtronic GmbH ### 573373###Speaker @@@ John Wilkinson, OBE – MHRA ### 574719###Speaker
10:00 AM - 10:30 AM

Beverage Break
10:00 AM - 10:30 AM

Beverage Break
Location: Level 1 & 2 Burrard Foyer

Favorite
12:00 PM - 1:00 PM

Lunch
12:00 PM - 1:00 PM

Lunch
Location: Ballroom D

Favorite
2:30 PM - 3:00 PM

Beverage Break
2:30 PM - 3:00 PM

Beverage Break
Location: Level 1 & 2 Burrard Foyer

Favorite
4:30 PM - 5:30 PM

First-Timer Welcome
4:30 PM - 5:30 PM

First-Timer Welcome
Location: West Ballroom AB
Sarah Michel, CSP – Velvet Chainsaw Consulting

Favorite

Sarah Michel, CSP – Velvet Chainsaw Consulting ### 542411###Moderator
6:00 PM - 7:30 PM

Grand Opening of Exhibit Hall and Taste of Vancouver
6:00 PM - 7:30 PM

Grand Opening of Exhibit Hall and Taste of Vancouver
Location: West Building Exhibit Hall A & B1

Favorite
6:00 PM - 7:30 PM

RAPS Central Open
6:00 PM - 7:30 PM

RAPS Central Open
Location: West Building Exhibit Hall A & B1

Favorite
Wednesday, October 3, 2018
7:00 AM - 8:30 AM

Continental Breakfast
7:00 AM - 8:30 AM

Continental Breakfast
Location: West Ballroom AB

Favorite
7:00 AM - 6:00 PM

Registration Open
7:00 AM - 6:00 PM

Registration Open
Location: Exhibit Hall Lobby (outside B1)

Favorite
8:30 AM - 9:30 AM

Convergence Community Gathering
8:30 AM - 9:30 AM

Convergence Community Gathering
Location: West Ballroom AB
Sarah Michel, CSP – Velvet Chainsaw Consulting
Plenary

Favorite

Sarah Michel, CSP – Velvet Chainsaw Consulting ### 542411###Moderator
9:30 AM - 10:30 AM

Beverage Break in the Exhibit Hall
9:30 AM - 10:30 AM

Beverage Break in the Exhibit Hall
Location: West Building Exhibit Hall A & B1

Favorite
9:30 AM - 4:00 PM

Exhibit Hall Open
9:30 AM - 4:00 PM

Exhibit Hall Open
Location: West Building Exhibit Hall A & B1

Favorite
9:30 AM - 4:00 PM

RAPS Central Open
9:30 AM - 4:00 PM

RAPS Central Open
Location: West Building Exhibit Hall A & B1

Favorite
10:30 AM - 11:00 AM

510(k): Deciding When to Submit for a Change to an Existing Device
10:30 AM - 11:00 AM

510(k): Deciding When to Submit for a Change to an Existing Device
Location: 118-120
Adrienne Lenz, RAC US – Hyman, Phelps, & McNamara
Medical Devices

Favorite

Adrienne Lenz, RAC US – Hyman, Phelps, & McNamara ### 535486###Session Leader
10:30 AM - 11:30 AM

MDSAP Program Update: Are You Ready?
10:30 AM - 11:30 AM

MDSAP Program Update: Are You Ready?
Location: 205-207
Patricia L. Murphy – BSI Group America Inc.; David Boudreau, ing – Health Canada; Alexander Crosby – Intertek; Ashleigh Dawley – ICON PLC
Medical Devices

Favorite

Patricia L. Murphy – BSI Group America Inc. ### 535517###Session Leader @@@ David Boudreau, ing – Health Canada ### 570151###Speaker @@@ Alexander Crosby – Intertek ### 609887###Speaker @@@ Ashleigh Dawley – ICON PLC ### 609888###Speaker
10:30 AM - 12:00 PM

Achieving Drug Registration Success with Limited Clinical Data in Global Markets
10:30 AM - 12:00 PM

Achieving Drug Registration Success with Limited Clinical Data in Global Markets
Location: 121-122
Roxanne Tavakkol, MS – Mallinckrodt Pharmaceuticals; Ahmed Abouelnour, MSc., RAC – Methapharm Inc.; Mary C. Speagle, BSc, RAC – TPIreg, Innomar Strategies
Biopharmaceuticals (includes Biologics)

Favorite

Roxanne Tavakkol, MS – Mallinckrodt Pharmaceuticals ### 535490###Session Leader @@@ Ahmed Abouelnour, MSc., RAC – Methapharm Inc. ### 535483###Speaker @@@ Mary C. Speagle, BSc, RAC – TPIreg, Innomar Strategies ### 535506###Speaker
10:30 AM - 12:00 PM

Broad Stakeholder Panel Debate on Global Impact and Implementation of the EU Medical Device Regulations MDR and IVDR
10:30 AM - 12:00 PM

Broad Stakeholder Panel Debate on Global Impact and Implementation of the EU Medical Device Regulations MDR and IVDR
Location: 211
Gert W. Bos, FRAPS – Qserve; Bassil Akra, PhD – TÜV SÜD Product Service GmbH; Jesús Rueda Rodríguez – MedTech Europe; John Wilkinson, OBE – MHRA
Medical Devices

Favorite

Gert W. Bos, FRAPS – Qserve ### 535440###Session Leader @@@ Bassil Akra, PhD – TÜV SÜD Product Service GmbH ### 535482###Speaker @@@ Jesús Rueda Rodríguez – MedTech Europe ### 574717###Speaker @@@ John Wilkinson, OBE – MHRA ### 574719###Speaker
10:30 AM - 12:00 PM

Building Bridges - Nutrition and Novel Diagnostic Technologies Personalizing Health & Disease Management
10:30 AM - 12:00 PM

Building Bridges: Nutrition and Novel Diagnostic Technologies Personalizing Health & Disease Management
Location: 116-117
Manfred Ruthsatz, PhD, RPh, DABT, RAC, FRAPS – Nestle Health Science; Anju Aggarwal, PhD – University of WA/ Department of Epidemiology/ School of Public Health; Ahmed El-SOHEMY, PhD – University of Toronto / Nutrigenomix Inc.; William Yan, PhD – Health Canada
Multiple Products

Favorite

Manfred Ruthsatz, PhD, RPh, DABT, RAC, FRAPS – Nestle Health Science ### 535536###Session Leader @@@ Anju Aggarwal, PhD – University of WA/ Department of Epidemiology/ School of Public Health ### 593902###Speaker @@@ Ahmed El-SOHEMY, PhD – University of Toronto / Nutrigenomix Inc. ### 593901###Speaker @@@ William Yan, PhD – Health Canada ### 593882###Speaker
10:30 AM - 12:00 PM

Latin America Forum
10:30 AM - 12:00 PM

Latin America Forum
Location: 109-110
Rafael Pérez Cristiá, MD, PhD – Center for State Control of Drugs and Medical Devices (CECMED), Ministry of Public Health, Cuba; Silvia Bendiner – Mapi SRS, an ICON plc Company; Stephanie Anderson, MSc – Mapi SRS, an ICON plc Company; Lawrence Liberti, PhD – CIRS (Centre for Innovation in Regulatory Science); Princess M. V Osbourne, PharmD – CARPHA's Caribbean Regulatory System; Raphael Sanches Pereira – ANVISA; Julio Sánchez y Tépoz, Esq – Mexican Regulatory Agency, COFEPRIS; Bettina Ziegele, MA – Paul-Ehrlic- Institut (Germany)
Health Authority Forum

Favorite

Rafael Pérez Cristiá, MD, PhD – Center for State Control of Drugs and Medical Devices (CECMED), Ministry of Public Health, Cuba ### 574329###Session Leader @@@ Silvia Bendiner – Mapi SRS, an ICON plc Company ### 574330###Session Leader @@@ Stephanie Anderson, MSc – Mapi SRS, an ICON plc Company ### 619898###Speaker @@@ Lawrence Liberti, PhD – CIRS (Centre for Innovation in Regulatory Science) ### 574331###Speaker @@@ Princess M. V Osbourne, PharmD – CARPHA's Caribbean Regulatory System ### 595326###Speaker @@@ Raphael Sanches Pereira – ANVISA ### 620117###Speaker @@@ Julio Sánchez y Tépoz, Esq – Mexican Regulatory Agency, COFEPRIS ### 574336###Speaker @@@ Bettina Ziegele, MA – Paul-Ehrlic- Institut (Germany) ### 573550###Speaker
10:30 AM - 12:00 PM

Beyond Due Diligence: You Bought It, Now What?
10:30 AM - 12:00 PM

Beyond Due Diligence: You Bought It, Now What?
Location: 212-214
Alan V. McEmber, MS,RAC – Shire; Anjali Kumar, PhD, FAHA – Shire; Mihaela MacNair, PhD – Biogen; Ruth Turner – Shire
Acumen Builders

Favorite

Alan V. McEmber, MS,RAC – Shire ### 552866###Session Leader @@@ Anjali Kumar, PhD, FAHA – Shire ### 595195###Speaker @@@ Mihaela MacNair, PhD – Biogen ### 595196###Speaker @@@ Ruth Turner – Shire ### 555674###Speaker
10:30 AM - 12:00 PM

The EU Clinical Trial Regulation: Preparing for Implementation
10:30 AM - 12:00 PM

The EU Clinical Trial Regulation: Preparing for Implementation
Location: 202-204
Adriaan N. Fruijtier, M.Sc. – CATS Consultants GmbH; Michael Craig, BSc (Pharm) MPSI – PAREXEL Consulting; Seán Kilbride, PhD – Regeneron Pharmaceuticals; Paolo Voltolina – CSL Behring
Biopharmaceuticals (includes Biologics)

Favorite

Adriaan N. Fruijtier, M.Sc. – CATS Consultants GmbH ### 535444###Session Leader @@@ Michael Craig, BSc (Pharm) MPSI – PAREXEL Consulting ### 535462###Speaker @@@ Seán Kilbride, PhD – Regeneron Pharmaceuticals ### 593795###Speaker @@@ Paolo Voltolina – CSL Behring ### 601543###Speaker
11:00 AM - 12:00 PM

The CDRH Case for Quality: Shifting the Regulatory Mindset from Compliance to Quality
11:00 AM - 12:00 PM

The CDRH Case for Quality: Shifting the Regulatory Mindset from Compliance to Quality
Location: 118-120
Stephanie Christopher, MA, CCRC, FACRP – Medical Device Innovation Consortium; Rachelle Fitzgerald, RAC – Hologic, Inc.; George J. Serafin, MSc – Grant Thornton LLP; Francisco Vicenty – US FDA; George Zack – Two Harbors Consulting, LLC
Medical Devices

Favorite

Stephanie Christopher, MA, CCRC, FACRP – Medical Device Innovation Consortium ### 535495###Session Leader @@@ Rachelle Fitzgerald, RAC – Hologic, Inc. ### 620115###Speaker @@@ George J. Serafin, MSc – Grant Thornton LLP ### 609886###Speaker @@@ Francisco Vicenty – US FDA ### 535496###Speaker @@@ George Zack – Two Harbors Consulting, LLC ### 580309###Speaker
11:30 AM - 12:00 PM

More Emphasis on Toxicological Risk Assessments in Medical Device Safety Evaluation
11:30 AM - 12:00 PM

More Emphasis on Toxicological Risk Assessments in Medical Device Safety Evaluation
Location: 205-207
Albrecht Poth – Health Care - Medical Devices
Medical Devices

Favorite

Albrecht Poth – Health Care - Medical Devices ### 535530###Session Leader
12:00 PM - 1:30 PM

Grab and Go Lunch and Open Exhibit Time
12:00 PM - 1:30 PM

Grab and Go Lunch and Open Exhibit Time
Location: West Building Exhibit Hall A & B1

Favorite
12:15 PM - 1:00 PM

Simplifying Regulatory Processes for Post-Approval Changes (Sponsored by: Veeva Systems)
12:15 PM - 1:00 PM

Simplifying Regulatory Processes for Post-Approval Changes (Sponsored by: Veeva Systems)
Location: West Building Exhibit Hall A & B1
Rachel Belani – Veeva Systems; Marc Gabriel – Veeva Systems

Favorite

Rachel Belani – Veeva Systems ### 618568###Speaker @@@ Marc Gabriel – Veeva Systems ### 618567###Speaker
12:15 PM - 1:15 PM

Solution Circles Open House
12:15 PM - 1:15 PM

Solution Circles Open House
Location: West Building Exhibit Hall A & B1 (next to RAPS Central)
Sarah Michel, CSP – Velvet Chainsaw Consulting

Favorite

Sarah Michel, CSP – Velvet Chainsaw Consulting ### 542411###Moderator
1:30 PM - 2:00 PM

The Role of the Regulatory Affairs Professional in the Commercialization of Innovative Health Technology Products
1:30 PM - 2:00 PM

The Role of the Regulatory Affairs Professional in the Commercialization of Innovative Health Technology Products
Location: 205-207
Tara M. Creaven-Capasso, RAC, RQAP-GLP – Caduceus Medical Development Ltd.; Marie Marlow – M Squared Associates, Inc.
Medical Devices

Favorite

Tara M. Creaven-Capasso, RAC, RQAP-GLP – Caduceus Medical Development Ltd. ### 535476###Session Leader @@@ Marie Marlow – M Squared Associates, Inc. ### 580310###Speaker
1:30 PM - 2:15 PM

Impactful Consumer Claims – Will FDA’s Planned Overhaul of Food Claims Move the Needle as Consumers Look for Other Benefits
1:30 PM - 2:15 PM

Impactful Consumer Claims – Will FDA’s Planned Overhaul of Food Claims Move the Needle as Consumers Look for Other Benefits
Location: 116-117
Jena L. Rostorfer, MS, RD – Abbott Nutrition; Joseph E. Clayton – International Food Information Council; Jessica Parsons O'Connell, JD, MPH – Covington & Burling LLP
Health-Related Foods

Favorite

Jena L. Rostorfer, MS, RD – Abbott Nutrition ### 535497###Session Leader @@@ Joseph E. Clayton – International Food Information Council ### 601539###Speaker @@@ Jessica Parsons O'Connell, JD, MPH – Covington & Burling LLP ### 601540###Speaker
1:30 PM - 2:30 PM

A Current View of the De Novo Process: Impacts from the 21st Century Cures Act and FDASIA
1:30 PM - 2:30 PM

A Current View of the De Novo Process: Impacts from the 21st Century Cures Act and FDASIA
Location: 118-120
Angela G. Huber, PhD, RAC – Medtronic; Sergio M. de del Castillo – US FDA; William D. Voorhees, III, PhD – MED Institute Inc.
Medical Devices

Favorite

Angela G. Huber, PhD, RAC – Medtronic ### 535459###Session Leader @@@ Sergio M. de del Castillo – US FDA ### 595325###Speaker @@@ William D. Voorhees, III, PhD – MED Institute Inc. ### 573372###Speaker
1:30 PM - 3:00 PM

AI and How It Can Be Used to Change Health Products
1:30 PM - 3:00 PM

AI and How It Can Be Used to Change Health Products
Location: 212-214
Margaret Mucha, MJ, RAC, FRAP, CQA – Watson Health Imaging; David Boudreau, ing – Health Canada; John Daley – IBM Watson Health; Joshua Schulman (Virtual Presenter), PhD – MaxQ-AI; Rika Wakao, PhD – Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Multiple Products

Favorite

Margaret Mucha, MJ, RAC, FRAP, CQA – Watson Health Imaging ### 579833###Session Leader @@@ David Boudreau, ing – Health Canada ### 570151###Speaker @@@ John Daley – IBM Watson Health ### 570150###Speaker @@@ Joshua Schulman (Virtual Presenter), PhD – MaxQ-AI ### 570146###Speaker @@@ Rika Wakao, PhD – Pharmaceuticals and Medical Devices Agency (PMDA), Japan ### 579834###Speaker
1:30 PM - 3:00 PM

Challenges and Opportunities with GDUFA II Implementation
1:30 PM - 3:00 PM

Challenges and Opportunities with GDUFA II Implementation
Location: 121-122
Robert Iser, M.S. – PAREXEL Consulting; Kurt R. Karst, Attorney – Hyman, Phelps & McNamara, P.C.; Marcy Macdonald, MBA, RAC – Amneal Pharmaceuticals
Biopharmaceuticals (includes Biologics)

Favorite

Robert Iser, M.S. – PAREXEL Consulting ### 535466###Session Leader @@@ Kurt R. Karst, Attorney – Hyman, Phelps & McNamara, P.C. ### 535512###Speaker @@@ Marcy Macdonald, MBA, RAC – Amneal Pharmaceuticals ### 598729###Speaker
1:30 PM - 3:00 PM

European Forum
1:30 PM - 3:00 PM

European Forum
Location: 109-110
Patricia Anderson, MSc, RAC, FRAPS – RedHill Biopharma Ltd.; Gert W. Bos, FRAPS – Qserve; Karl-Heinz Huemer, MD, PhD – Austrian Medicines Agency; Andrea Laslop, MD – Austrian Federal Agency for Safety in Health Care; John Wilkinson, OBE – MHRA; Bettina Ziegele, MA – Paul-Ehrlic- Institut (Germany)
Health Authority Forum

Favorite

Patricia Anderson, MSc, RAC, FRAPS – RedHill Biopharma Ltd. ### 573388###Moderator @@@ Gert W. Bos, FRAPS – Qserve ### 535440###Moderator @@@ Karl-Heinz Huemer, MD, PhD – Austrian Medicines Agency ### 573393###Speaker @@@ Andrea Laslop, MD – Austrian Federal Agency for Safety in Health Care ### 573431###Speaker @@@ John Wilkinson, OBE – MHRA ### 574719###Speaker @@@ Bettina Ziegele, MA – Paul-Ehrlic- Institut (Germany) ### 573550###Speaker
1:30 PM - 3:00 PM

What’s the Real Deal with Real World Evidence in Regulatory Affairs?
1:30 PM - 3:00 PM

What’s the Real Deal with Real World Evidence in Regulatory Affairs?
Location: 202-204
Emily Huddle – Gilead Sciences; Patricia Keegan, MD – US FDA; Angela Nicole. Johnson, BFA, MSE, PMP, RAC; Seema Parikh, MBBS MFPM – Parexel International
Biopharmaceuticals (includes Biologics)

Favorite

Emily Huddle – Gilead Sciences ### 600341###Session Leader @@@ Patricia Keegan, MD – US FDA ### 574718###Speaker @@@ Angela Nicole. Johnson, BFA, MSE, PMP, RAC ### 535453###Speaker @@@ Seema Parikh, MBBS MFPM – Parexel International ### 535471###Speaker
1:30 PM - 3:00 PM

Ensuring your Quality Management System is Ready for the New EU MDR Beyond the Requirements of ISO 13485:2016
1:30 PM - 3:00 PM

Ensuring your Quality Management System is Ready for the New EU MDR Beyond the Requirements of ISO 13485:2016
Location: 211
Kimberly Trautman, MSc – NSF International; Laila Gurney, MSc, RAC – GE Healthcare; Brian Ludovico – NSF International
Medical Devices

Favorite

Kimberly Trautman, MSc – NSF International ### 535494###Session Leader @@@ Laila Gurney, MSc, RAC – GE Healthcare ### 535492###Speaker @@@ Brian Ludovico – NSF International ### 598488###Speaker
2:00 PM - 3:00 PM

Postmarketing Comparison in Latin America: Is There a Trend?
2:00 PM - 3:00 PM

Postmarketing Comparison in Latin America: Is There a Trend?
Location: 205-207
Maria G. Fuentes, Eng. – GE Healthcare; Yadira A. Sandoval Eslava, Pharmaceutical & Insdustry Administration – Arthrex; Dulce Valle, Eng. – AMID
Medical Devices

Favorite

Maria G. Fuentes, Eng. – GE Healthcare ### 535524###Session Leader @@@ Yadira A. Sandoval Eslava, Pharmaceutical & Insdustry Administration – Arthrex ### 535525###Speaker @@@ Dulce Valle, Eng. – AMID ### 535526###Speaker
2:15 PM - 3:00 PM

Probiotics: The Current Regulatory Continuum From Food to Drug
2:15 PM - 3:00 PM

Probiotics: The Current Regulatory Continuum From Food to Drug
Location: 116-117
Amy Mackey, PhD – Abbott Nutrition; Andrea Wong, PhD – Council for Responsible Nutrition; William Yan, PhD – Health Canada
Multiple Products

Favorite

Amy Mackey, PhD – Abbott Nutrition ### 535538###Session Leader @@@ Andrea Wong, PhD – Council for Responsible Nutrition ### 601542###Speaker @@@ William Yan, PhD – Health Canada ### 593882###Speaker
2:30 PM - 3:00 PM

Risk Management: Pitfalls and Perspectives on Getting to World Class
2:30 PM - 3:00 PM

Risk Management: Pitfalls and Perspectives on Getting to World Class
Location: 118-120
Kareem Elwakil – PwC
Medical Devices

Favorite

Kareem Elwakil – PwC ### 535510###Session Leader
3:00 PM - 3:45 PM

Establishing a Compliance Platform to Meet MDR and IVDR Requirements (Sponsored by: AMPLEXOR Life Sciences)
3:00 PM - 3:45 PM

Establishing a Compliance Platform to Meet MDR and IVDR Requirements (Sponsored by: AMPLEXOR Life Sciences)
Location: West Building Exhibit Hall A & B1
David Gwyn – AMPLEXOR

Favorite

David Gwyn – AMPLEXOR ### 618571###Speaker
3:00 PM - 4:00 PM

Beverage Break in the Exhibit Hall
3:00 PM - 4:00 PM

Beverage Break in the Exhibit Hall
Location: West Building Exhibit Hall A & B1

Favorite
3:15 PM - 3:45 PM

Solution Circles
3:15 PM - 3:45 PM

Solution Circles
Location: West Building Exhibit Hall A & B1 (next to RAPS Central)
Sarah Michel, CSP – Velvet Chainsaw Consulting

Favorite

Sarah Michel, CSP – Velvet Chainsaw Consulting ### 542411###Moderator
3:15 PM - 4:00 PM

How to Work Efficiently With International Colleagues
3:15 PM - 4:00 PM

How to Work Efficiently With International Colleagues
Location: 121-122
Nicole Landreville, Eng, RAC, FRAPS – GE Healthcare; bradley Hossack, Bsc – Stryker Corporation
Conversations that Matter

Favorite

Nicole Landreville, Eng, RAC, FRAPS – GE Healthcare ### 549200###Moderator @@@ bradley Hossack, Bsc – Stryker Corporation ### 549201###Moderator
3:15 PM - 4:00 PM

Interactions With Health Authorities (Biopharmaceuticals)
3:15 PM - 4:00 PM

Interactions With Health Authorities (Biopharmaceuticals)
Location: 109-110
Don Boyer, HBSc., RAC, FRAP – BOYER@RegulatorySolns; Susan Stewart, JD – Kaleido Biosciences
Conversations that Matter

Favorite

Don Boyer, HBSc., RAC, FRAP – BOYER@RegulatorySolns ### 535533###Moderator @@@ Susan Stewart, JD – Kaleido Biosciences ### 549202###Moderator
3:15 PM - 4:00 PM

RAC Mini-Session
3:15 PM - 4:00 PM

RAC Mini-Session
Location: Meeting Room 118-120

Favorite
4:00 PM - 4:30 PM

Risk Management Across Quality Management Systems: Applying the revised ISO 13485 Requirements
4:00 PM - 4:30 PM

Risk Management Across Quality Management Systems: Applying the revised ISO 13485 Requirements
Location: 118-120
Kareem Elwakil – PwC
Medical Devices

Favorite

Kareem Elwakil – PwC ### 535510###Session Leader
4:00 PM - 4:45 PM

New Challenges for Novel Food Ingredient Approvals
4:00 PM - 4:45 PM

New Challenges for Novel Food Ingredient Approvals
Location: 116-117
Paul Hanlon, PhD – Abbott Nutrition; Alex Eapen, PhD – Cargill; Shahrzad Tafazoli, PhD – Intertek Regulatory & Scientific Consultancy
Health-Related Foods

Favorite

Paul Hanlon, PhD – Abbott Nutrition ### 535535###Session Leader @@@ Alex Eapen, PhD – Cargill ### 598681###Speaker @@@ Shahrzad Tafazoli, PhD – Intertek Regulatory & Scientific Consultancy ### 555676###Speaker
4:00 PM - 5:00 PM

How Regulatory Impacts the Business Strategy Portfolio
4:00 PM - 5:00 PM

How Regulatory Impacts the Business Strategy Portfolio
Location: 212-214
Kimberly Belsky, M.S. – Mallinckrodt Pharmaceuticals; Winifred Wu, MBA, FRAPS – Strategic Regulatory Partners, LLC
Acumen Builders

Favorite

Kimberly Belsky, M.S. – Mallinckrodt Pharmaceuticals ### 535468###Session Leader @@@ Winifred Wu, MBA, FRAPS – Strategic Regulatory Partners, LLC ### 574710###Speaker
4:00 PM - 5:00 PM

How to Prepare for the Upcoming CFDA (China FDA) Overseas Inspection
4:00 PM - 5:00 PM

How to Prepare for the Upcoming CFDA (China FDA) Overseas Inspection
Location: 205-207
Zeli Yu, RAC , Global – YUZELI MEDTECCONSULTANT Inc.; JINGYAN Wang – Freelance
Medical Devices

Favorite

Zeli Yu, RAC , Global – YUZELI MEDTECCONSULTANT Inc. ### 535443###Session Leader @@@ JINGYAN Wang – Freelance ### 606824###Speaker
4:00 PM - 5:30 PM

Canada Forum
4:00 PM - 5:30 PM

Canada Forum
Location: 109-110
Don Boyer, HBSc., RAC, FRAP – BOYER@RegulatorySolns; David Boudreau, ing – Health Canada; Catherine Parker – Health Canada; John Patrick Stewart – Health Canada
Health Authority Forum

Favorite

Don Boyer, HBSc., RAC, FRAP – BOYER@RegulatorySolns ### 535533###Session Leader @@@ David Boudreau, ing – Health Canada ### 570151###Speaker @@@ Catherine Parker – Health Canada ### 595311###Speaker @@@ John Patrick Stewart – Health Canada ### 595310###Speaker
4:00 PM - 5:30 PM

Defining 'Sufficient' Clinical Evidence in order to Fulfill the Requirements of the EU MDR
4:00 PM - 5:30 PM

Defining 'Sufficient' Clinical Evidence in order to Fulfill the Requirements of the EU MDR
Location: 211
Elizabeth M. Rose, RAC (US), MST – Mapi SRS, an ICON PLC company; Mary Beth Henderson, PhD, MBA – Regulatory & Clinical Research Institute, Inc.; Bassil Akra, PhD – TÜV SÜD Product Service GmbH; Jozeph Kraus, Pharm D – Amsterdam University Medical Centra
Medical Devices

Favorite

Elizabeth M. Rose, RAC (US), MST – Mapi SRS, an ICON PLC company ### 535472###Session Leader @@@ Mary Beth Henderson, PhD, MBA – Regulatory & Clinical Research Institute, Inc. ### 593598###Speaker @@@ Bassil Akra, PhD – TÜV SÜD Product Service GmbH ### 535482###Speaker @@@ Jozeph Kraus, Pharm D – Amsterdam University Medical Centra ### 535503###Speaker
4:00 PM - 5:30 PM

Different Aspects of Innovation in Clinical Trials
4:00 PM - 5:30 PM

Different Aspects of Innovation in Clinical Trials
Location: 121-122
Wayne Amchin, RAC, Cert in Health Informatics, Cert in Drug Dev and RegSci – FDA/CDER/OND/DCRP; Gautam Maitra, Fil.Lic – AC Immune SA; Patricia Keegan, MD – US FDA; Susan Yule, B. Pharm – Roche
Biopharmaceuticals (includes Biologics)

Favorite

Wayne Amchin, RAC, Cert in Health Informatics, Cert in Drug Dev and RegSci – FDA/CDER/OND/DCRP ### 535529###Session Leader/Speaker @@@ Gautam Maitra, Fil.Lic – AC Immune SA ### 535456###Speaker @@@ Patricia Keegan, MD – US FDA ### 574718###Panelist @@@ Susan Yule, B. Pharm – Roche ### 600340###Speaker
4:00 PM - 5:30 PM

Regulatory Strategies for Accelerated Development Programs
4:00 PM - 5:30 PM

Regulatory Strategies for Accelerated Development Programs
Location: 202-204
Mary Ellen Cosenza, US and EU RAC, DABT – MEC Regulatory & Toxicology Consulting, LLC; Vishal Bhatnagar, MD – US FDA; Carrie-Lynn Langlais Furr, PhD, RAC – AmpliPhi Biosciences; Jamie L. Robinson, RAC – Genentech (Roche); Judy Vong, MS – Amgen
Biopharmaceuticals (includes Biologics)

Favorite

Mary Ellen Cosenza, US and EU RAC, DABT – MEC Regulatory & Toxicology Consulting, LLC ### 535436###Session Leader @@@ Vishal Bhatnagar, MD – US FDA ### 535437###Speaker @@@ Carrie-Lynn Langlais Furr, PhD, RAC – AmpliPhi Biosciences ### 535516###Speaker @@@ Jamie L. Robinson, RAC – Genentech (Roche) ### 535434###Speaker @@@ Judy Vong, MS – Amgen ### 535435###Speaker
4:30 PM - 5:30 PM

Integrating Human Factors into Design Controls
4:30 PM - 5:30 PM

Integrating Human Factors into Design Controls
Location: 118-120
Bryant Foster, MS Human Factors – Research Collective; Margaret Koga, BSME, AAMI Faculty Member – Teragram LLC
Medical Devices

Favorite

Bryant Foster, MS Human Factors – Research Collective ### 554046###Session Leader @@@ Margaret Koga, BSME, AAMI Faculty Member – Teragram LLC ### 535515###Speaker
4:45 PM - 5:30 PM

Modernizing Regulations for Specialized Foods: A Multi-Stakeholder Approach
4:45 PM - 5:30 PM

Modernizing Regulations for Specialized Foods: A Multi-Stakeholder Approach
Location: 116-117
Berenice Ocampo, M.S. – Abbott Nutrition; Jessica Parsons O'Connell, JD, MPH – Covington & Burling LLP; William Yan, PhD – Health Canada
Health-Related Foods

Favorite

Berenice Ocampo, M.S. – Abbott Nutrition ### 535531###Session Leader @@@ Jessica Parsons O'Connell, JD, MPH – Covington & Burling LLP ### 601540###Speaker @@@ William Yan, PhD – Health Canada ### 593882###Speaker
5:00 PM - 5:30 PM

China Restructure of Food & Drug (Medical Device) Administration
5:00 PM - 5:30 PM

China Restructure of Food & Drug (Medical Device) Administration
Location: 205-207
Amra Racic, MBA – Medtronic; Davey Dehui Han, MS, MD – CAMDI Expert Committee for Regulatory Compliance Professional Training & Exchange
Medical Devices

Favorite

Amra Racic, MBA – Medtronic ### 535477###Speaker @@@ Davey Dehui Han, MS, MD – CAMDI Expert Committee for Regulatory Compliance Professional Training & Exchange ### 598306###Speaker
6:00 PM - 9:00 PM

Dine-Arounds
6:00 PM - 9:00 PM

Dine-Arounds
Location: West Ballroom Foyer

Favorite
Thursday, October 4, 2018
7:00 AM - 8:30 AM

Continental Breakfast
7:00 AM - 8:30 AM

Continental Breakfast
Location: West Ballroom AB

Favorite
7:00 AM - 6:00 PM

Registration Open
7:00 AM - 6:00 PM

Registration Open

Favorite
7:15 AM - 8:15 AM

RAC Holders’ Breakfast
7:15 AM - 8:15 AM

RAC Holders’ Breakfast
Location: West Ballroom AB

Favorite
7:30 AM - 8:15 AM

NetWORTHing Strategies for Growing Your Network
7:30 AM - 8:15 AM

NetWORTHing Strategies for Growing Your Network
Location: 109-110
Sarah Michel, CSP – Velvet Chainsaw Consulting
Conversations that Matter

Favorite

Sarah Michel, CSP – Velvet Chainsaw Consulting ### 542411###Moderator
8:30 AM - 9:15 AM

Comparability Protocols as a Regulatory Strategy for NDAs, ANDAs, and BLAs
8:30 AM - 9:15 AM

Comparability Protocols as a Regulatory Strategy for NDAs, ANDAs, and BLAs
Location: 202-204
Donald N. Klein, CMC SME – PAREXEL
Biopharmaceuticals (includes Biologics)

Favorite

Donald N. Klein, CMC SME – PAREXEL ### 535520###Session Leader
8:30 AM - 9:30 AM

CDRH Forum
8:30 AM - 9:30 AM

CDRH Forum
Location: 109-110
Margaret Mucha, MJ, RAC, FRAP, CQA – Watson Health Imaging; Sergio M. de del Castillo – US FDA; Bakul Patel, MBA – Food and Drug Administration, Center For Device and Radiological Health; Vasum Peiris, MD, MPH, FAAP, FACC, FASE – U.S. Food and Drug Administration, CDRH; Francisco Vicenty – US FDA
Health Authority Forum

Favorite

Margaret Mucha, MJ, RAC, FRAP, CQA – Watson Health Imaging ### 579833###Session Leader @@@ Sergio M. de del Castillo – US FDA ### 595325###Speaker @@@ Bakul Patel, MBA – Food and Drug Administration, Center For Device and Radiological Health ### 535474###Speaker @@@ Vasum Peiris, MD, MPH, FAAP, FACC, FASE – U.S. Food and Drug Administration, CDRH ### 585001###Speaker @@@ Francisco Vicenty – US FDA ### 535496###Speaker
8:30 AM - 9:30 AM

Notified Bodies Navigating the EU MDR and IVDR Changes
8:30 AM - 9:30 AM

Notified Bodies Navigating the EU MDR and IVDR Changes
Location: 211
Philippe Auclair, Pharma Dr, PhD , FRAPS – Abbott; Suzanne Halliday, D.Phil. – BSI; Sue Spencer, Director – UL - Notified Body
Medical Devices

Favorite

Philippe Auclair, Pharma Dr, PhD , FRAPS – Abbott ### 535445###Session Leader @@@ Suzanne Halliday, D.Phil. – BSI ### 535446###Speaker @@@ Sue Spencer, Director – UL - Notified Body ### 535447###Speaker
8:30 AM - 9:30 AM

Regulatory and Legal Implications for Orphan Drug Exclusivity in the US and Europe
8:30 AM - 9:30 AM

Regulatory and Legal Implications for Orphan Drug Exclusivity in the US and Europe
Location: 121-122
Jessica E. Foley, M.S., RAC – Gaia Regulatory Sciences, LLC; Kurt R. Karst, Attorney – Hyman, Phelps & McNamara, P.C.
Biopharmaceuticals (includes Biologics)

Favorite

Jessica E. Foley, M.S., RAC – Gaia Regulatory Sciences, LLC ### 535511###Session Leader @@@ Kurt R. Karst, Attorney – Hyman, Phelps & McNamara, P.C. ### 535512###Speaker
8:30 AM - 9:30 AM

Statistical Methods for the RA Professional
8:30 AM - 9:30 AM

Statistical Methods for the RA Professional
Location: 118-120
Keith Morel, BSc (Physics) ARCS DIC PhD (Plasma Physics) – Qserve; Austin Foley – Stryker; Marc Speck; Roseann M. White, MA – DCRI
Medical Devices

Favorite

Keith Morel, BSc (Physics) ARCS DIC PhD (Plasma Physics) – Qserve ### 535522###Session Leader @@@ Austin Foley – Stryker ### 606926###Speaker @@@ Marc Speck ### 606927###Speaker @@@ Roseann M. White, MA – DCRI ### 606928###Speaker
8:30 AM - 9:30 AM

Understanding Medical Device Recalls in a Changing Environment
8:30 AM - 9:30 AM

Understanding Medical Device Recalls in a Changing Environment
Location: 205-207
Rita Hoffman, RAC – The FDA Group; Andrea Chamblee, Esq., RAC, RAPS Fellow – GWU School of Medicine and Public Health; Anu Gaur, PhD, MBA, MSRA, RAC – Medical Devices Industry
Medical Devices

Favorite

Rita Hoffman, RAC – The FDA Group ### 535451###Session Leader @@@ Andrea Chamblee, Esq., RAC, RAPS Fellow – GWU School of Medicine and Public Health ### 535470###Speaker @@@ Anu Gaur, PhD, MBA, MSRA, RAC – Medical Devices Industry ### 555681###Speaker
8:30 AM - 9:30 AM

LDTs: US-based Labs Will Have to Follow US and EU Regulation - Convergence and Divergence
8:30 AM - 9:30 AM

LDTs: US-based Labs Will Have to Follow US and EU Regulation - Convergence and Divergence
Location: 116-117
Julien S. Senac, PhD – GMED North America; Lubna Syed, RAC – Janssen (a Johnson & Johnson company)
In Vitro Diagnostics

Favorite

Julien S. Senac, PhD – GMED North America ### 535509###Session Leader @@@ Lubna Syed, RAC – Janssen (a Johnson & Johnson company) ### 598428###Speaker
9:30 AM - 10:30 AM

Beverage Break in the Exhibit Hall
9:30 AM - 10:30 AM

Beverage Break in the Exhibit Hall
Location: West Building Exhibit Hall A & B1

Favorite
9:30 AM - 4:00 PM

Exhibit Hall Open
9:30 AM - 4:00 PM

Exhibit Hall Open
Location: West Building Exhibit Hall A & B1

Favorite
9:30 AM - 4:00 PM

RAPS Central Open
9:30 AM - 4:00 PM

RAPS Central Open
Location: West Building Exhibit Hall A & B1

Favorite
9:45 AM - 10:15 AM

Solution Circles
9:45 AM - 10:15 AM

Solution Circles
Location: West Building Exhibit Hall A & B1 (next to RAPS Central)
Sarah Michel, CSP – Velvet Chainsaw Consulting

Favorite

Sarah Michel, CSP – Velvet Chainsaw Consulting ### 542411###Moderator
10:30 AM - 11:00 AM

Conformity Assessment Under the New European IVD Regulation and the Role and Expectations of EU Notified Bodies
10:30 AM - 11:00 AM

Conformity Assessment Under the New European IVD Regulation and the Role and Expectations of EU Notified Bodies
Location: 116-117
Erica F. Conway, PhD – BSI
In Vitro Diagnostics

Favorite

Erica F. Conway, PhD – BSI ### 535513###Session Leader
10:30 AM - 11:00 AM

The Precertification Program and Emerging Regulatory Framework
10:30 AM - 11:00 AM

The Precertification Program and Emerging Regulatory Framework
Location: 118-120
Megha Sinha, RAC – PwC; Bakul Patel, MBA – Food and Drug Administration, Center For Device and Radiological Health
Medical Devices

Favorite

Megha Sinha, RAC – PwC ### 535527###Session Leader @@@ Bakul Patel, MBA – Food and Drug Administration, Center For Device and Radiological Health ### 535474###Speaker
10:30 AM - 11:30 AM

Implementation of the New Medical European Regulation in Non-European Member States
10:30 AM - 11:30 AM

Implementation of the New Medical European Regulation in Non-European Member States
Location: 211
Waiss Faissal, Pharma Dr, MSc Biomedical Engineering – G-MED North America; Gert W. Bos, FRAPS – Qserve; Heidi Horsch, PhD – confinis
Medical Devices

Favorite

Waiss Faissal, Pharma Dr, MSc Biomedical Engineering – G-MED North America ### 535521###Session Leader @@@ Gert W. Bos, FRAPS – Qserve ### 535440###Speaker @@@ Heidi Horsch, PhD – confinis ### 593923###Speaker
10:30 AM - 11:30 AM

What are the Practical CFDA Compliant Clinical Trial Tips in China in 2018?
10:30 AM - 11:30 AM

What are the Practical CFDA Compliant Clinical Trial Tips in China in 2018?
Location: 205-207
Jason Zhang, MD – China Med Device, LLC
Medical Devices

Favorite

Jason Zhang, MD – China Med Device, LLC ### 535502###Session Leader
10:30 AM - 11:30 AM

The Regulatory Profession: Act II
10:30 AM - 11:30 AM

The Regulatory Profession: Act II
Location: 212-214
Carolina Panico, MD PhD – US FDA; Don Boyer, HBSc., RAC, FRAP – BOYER@RegulatorySolns; Jennifer L. Brown, MS – Pfizer; Daniela Drago, PhD, RAC – George Washington Univeristy
Acumen Builders

Favorite

Carolina Panico, MD PhD – US FDA ### 535532###Session Leader @@@ Don Boyer, HBSc., RAC, FRAP – BOYER@RegulatorySolns ### 535533###Speaker @@@ Jennifer L. Brown, MS – Pfizer ### 598724###Speaker @@@ Daniela Drago, PhD, RAC – George Washington Univeristy ### 535534###Speaker
10:30 AM - 12:00 PM

CBER/CDER Forum
10:30 AM - 12:00 PM

CBER/CDER Forum
Location: 109-110
Kimberly Belsky, M.S. – Mallinckrodt Pharmaceuticals; Wayne Amchin, RAC, Cert in Health Informatics, Cert in Drug Dev and RegSci – FDA/CDER/OND/DCRP; Christopher Joneckis, PhD – US FDA; Janet Woodcock (Virtual Presenter) – US FDA
Health Authority Forum

Favorite

Kimberly Belsky, M.S. – Mallinckrodt Pharmaceuticals ### 535468###Session Leader @@@ Wayne Amchin, RAC, Cert in Health Informatics, Cert in Drug Dev and RegSci – FDA/CDER/OND/DCRP ### 535529###Speaker @@@ Christopher Joneckis, PhD – US FDA ### 601550###Speaker @@@ Janet Woodcock (Virtual Presenter) – US FDA ### 596742###Speaker
10:30 AM - 12:00 PM

Brexit: Solution Planning
10:30 AM - 12:00 PM

Brexit: Solution Planning
Location: 202-204
Parastoo Karoon, PhD, MSc – Parexel International; Michael Craig, BSc (Pharm) MPSI – PAREXEL Consulting; Kathrin Schalper, PhD, RAC – Accenture Applied Life Sciences, LLP; Venkat Reddy Sunkara – Johnson Matthey Plc
Biopharmaceuticals (includes Biologics)

Favorite

Parastoo Karoon, PhD, MSc – Parexel International ### 535484###Session Leader @@@ Michael Craig, BSc (Pharm) MPSI – PAREXEL Consulting ### 535462###Speaker @@@ Kathrin Schalper, PhD, RAC – Accenture Applied Life Sciences, LLP ### 535439###Speaker @@@ Venkat Reddy Sunkara – Johnson Matthey Plc ### 535433###Speaker
10:30 AM - 12:00 PM

Hear from the Experts: Current Developments in Advertising and Promotion
10:30 AM - 12:00 PM

Hear from the Experts: Current Developments in Advertising and Promotion
Location: 121-122
Glenn N. Byrd, MBA, RAC – AstraZeneca; Alan Kirschenbaum, JD – Hyman, Phelps & McNamara, P.C.; Dale A. Cooke, MA – PhillyCooke Consulting; Micheline Awad, MBA – Neurocrine Biosciences, Inc.
Biopharmaceuticals (includes Biologics)

Favorite

Glenn N. Byrd, MBA, RAC – AstraZeneca ### 535430###Session Leader @@@ Alan Kirschenbaum, JD – Hyman, Phelps & McNamara, P.C. ### 535469###Speaker @@@ Dale A. Cooke, MA – PhillyCooke Consulting ### 535431###Speaker @@@ Micheline Awad, MBA – Neurocrine Biosciences, Inc. ### 535432###Speaker
11:00 AM - 12:00 PM

Is My Software a Medical Device? New Laws, Regulations and Guidance Documents That Can Impact Your Business's Future
11:00 AM - 12:00 PM

Is My Software a Medical Device? New Laws, Regulations and Guidance Documents That Can Impact Your Business's Future
Location: 118-120
Elizabeth M. Rose, RAC (US), MST – Mapi SRS, an ICON PLC company; Sara Jafari, PhD – LNE/G-MED; Bakul Patel, MBA – Food and Drug Administration, Center For Device and Radiological Health; Melissa Walker, MS, RAC, FRAPS – Graematter, Inc.
Medical Devices

Favorite

Elizabeth M. Rose, RAC (US), MST – Mapi SRS, an ICON PLC company ### 535472###Session Leader @@@ Sara Jafari, PhD – LNE/G-MED ### 593604###Speaker @@@ Bakul Patel, MBA – Food and Drug Administration, Center For Device and Radiological Health ### 535474###Speaker @@@ Melissa Walker, MS, RAC, FRAPS – Graematter, Inc. ### 609472###Speaker
11:00 AM - 12:00 PM

“Legacy” IVD Products: Strategy to Obtain Clinical Data in View of CE Certification Under the IVDR
11:00 AM - 12:00 PM

“Legacy” IVD Products: Strategy to Obtain Clinical Data in View of CE Certification Under the IVDR
Location: 116-117
Julien S. Senac, PhD – GMED North America; Sue Spencer, Director – UL - Notified Body
In Vitro Diagnostics

Favorite

Julien S. Senac, PhD – GMED North America ### 535509###Session Leader @@@ Sue Spencer, Director – UL - Notified Body ### 535447###Speaker
11:30 AM - 12:00 PM

Urgent Actions For Manufacturers To Ensure You Are Ready For EU Medical Device Regulation (MDR) Implementation
11:30 AM - 12:00 PM

Urgent Actions For Manufacturers To Ensure You Are Ready For EU Medical Device Regulation (MDR) Implementation
Location: 211
Adrian T. Keene, BSc (Hons) – NAMSA
Medical Devices

Favorite

Adrian T. Keene, BSc (Hons) – NAMSA ### 535507###Session Leader
11:30 AM - 12:00 PM

Crafting your Career as Regulatory Affairs Professional: Opportunities and Challenges
11:30 AM - 12:00 PM

Crafting your Career as Regulatory Affairs Professional: Opportunities and Challenges
Location: 212-214
Pallavi Trivedi, MPH, RAC – Trident Pharmaceuticals limited & Spinos Clinical Research Uk
Acumen Builders

Favorite

Pallavi Trivedi, MPH, RAC – Trident Pharmaceuticals limited & Spinos Clinical Research Uk ### 535465###Session Leader
12:00 PM - 1:30 PM

Grab and Go Lunch and Open Exhibit Time
12:00 PM - 1:30 PM

Grab and Go Lunch and Open Exhibit Time
Location: West Building Exhibit Hall A & B1

Favorite
12:15 PM - 1:00 PM

Cuban Pharmaceutical and Biotechnology Industries: High Technology Medicines from a Developing Nation (Sponsored by: BioCubaFarma)
12:15 PM - 1:00 PM

Cuban Pharmaceutical and Biotechnology Industries: High Technology Medicines from a Developing Nation (Sponsored by: BioCubaFarma)
Location: West Building Exhibit Hall A & B1
Normando E. Iznaga Escobar – BioCubaFarma, Havana, Cuba; Yair Quiñones Maya – Center of Genetic Engineering and Biotechnology (CIGB), Havana, Cuba

Favorite

Normando E. Iznaga Escobar – BioCubaFarma, Havana, Cuba ### 618572###Speaker @@@ Yair Quiñones Maya – Center of Genetic Engineering and Biotechnology (CIGB), Havana, Cuba ### 618573###Speaker
12:15 PM - 1:15 PM

Solution Circles
12:15 PM - 1:15 PM

Solution Circles
Location: West Building Exhibit Hall A & B1 (next to RAPS Central)
Sarah Michel, CSP – Velvet Chainsaw Consulting

Favorite

Sarah Michel, CSP – Velvet Chainsaw Consulting ### 542411###Moderator
1:30 PM - 2:30 PM

FDA’s Latest Initiatives to Improve Development of Pediatric Medical Devices
1:30 PM - 2:30 PM

FDA’s Latest Initiatives to Improve Development of Pediatric Medical Devices
Location: 118-120
Michael C. Morton, RAC – Michael C. Morton Regulatory Consulting LLC; Lee Grant – Medtronic Spine & Biologics; Robert Kroslowitz – Berlin Heart Inc.; Vasum Peiris, MD, MPH, FAAP, FACC, FASE – U.S. Food and Drug Administration, CDRH
Medical Devices

Favorite

Michael C. Morton, RAC – Michael C. Morton Regulatory Consulting LLC ### 555679###Session Leader @@@ Lee Grant – Medtronic Spine & Biologics ### 573371###Speaker @@@ Robert Kroslowitz – Berlin Heart Inc. ### 573370###Speaker @@@ Vasum Peiris, MD, MPH, FAAP, FACC, FASE – U.S. Food and Drug Administration, CDRH ### 585001###Speaker
1:30 PM - 2:30 PM

Technical Documentation Requirements Under the European In Vitro Diagnostics Regulation
1:30 PM - 2:30 PM

Technical Documentation Requirements Under the European In Vitro Diagnostics Regulation
Location: 116-117
Gert W. Bos, FRAPS – Qserve; Kedar Pai – BD; Florianne Torset-Bonfillou, MS – G-MED North America; Anja Wiersma, PhD – mi-CE consultancy
In Vitro Diagnostics

Favorite

Gert W. Bos, FRAPS – Qserve ### 535440###Session Leader @@@ Kedar Pai – BD ### 598425###Speaker @@@ Florianne Torset-Bonfillou, MS – G-MED North America ### 579831###Speaker @@@ Anja Wiersma, PhD – mi-CE consultancy ### 574723###Speaker
1:30 PM - 3:00 PM

Developing Biosimilars for the Global Market
1:30 PM - 3:00 PM

Developing Biosimilars for the Global Market
Location: 121-122
Cecil J. Nick, BSc (Hons.) – PAREXEL International; Kirsten Messmer, PhD, RAC – PPD; Catherine Parker – Health Canada; Andrea Laslop, MD – Austrian Federal Agency for Safety in Health Care
Biopharmaceuticals (includes Biologics)

Favorite

Cecil J. Nick, BSc (Hons.) – PAREXEL International ### 535464###Session Leader/Speaker @@@ Kirsten Messmer, PhD, RAC – PPD ### 595312###Speaker @@@ Catherine Parker – Health Canada ### 595311###Panelist @@@ Andrea Laslop, MD – Austrian Federal Agency for Safety in Health Care ### 573431###Panelist
1:30 PM - 3:00 PM

What Does the Future Hold for the Regulatory Professional?
1:30 PM - 3:00 PM

What Does the Future Hold for the Regulatory Professional?
Location: 212-214
Linda F. Bowen, MS, RAC, FRAPS – Temple University; Aman Khera – PRA Health Sciences; Oliver Steck – Deloitte & Touche LLP
Acumen Builders

Favorite

Linda F. Bowen, MS, RAC, FRAPS – Temple University ### 551690###Session Leader @@@ Aman Khera – PRA Health Sciences ### 593742###Speaker @@@ Oliver Steck – Deloitte & Touche LLP ### 593741###Speaker
1:30 PM - 3:00 PM

Korea: What’s New in Regulation and Reimbursement?
1:30 PM - 3:00 PM

Korea: What’s New in Regulation and Reimbursement?
Location: 109-110
Young Kim – Synex Consulting Ltd.; Myung Soo Ahn, MSRsc, Rph – Ministry of Food and Drug Safety; Rachel Chung – Synex Consulting Ltd.; Pauline Lieu, PhD – Dexcom
Health Authority Forum

Favorite

Young Kim – Synex Consulting Ltd. ### 535499###Session Leader @@@ Myung Soo Ahn, MSRsc, Rph – Ministry of Food and Drug Safety ### 535501###Speaker @@@ Rachel Chung – Synex Consulting Ltd. ### 535500###Speaker @@@ Pauline Lieu, PhD – Dexcom ### 620118###Speaker
1:30 PM - 3:00 PM

Thinking with the End in Mind: Using Product Development Plans to Prepare and Execute a Successful Regulatory Strategy
1:30 PM - 3:00 PM

Thinking with the End in Mind: Using Product Development Plans to Prepare and Execute a Successful Regulatory Strategy
Location: 202-204
Lauren Neighbours, PhD, RAC – PSI CRO; Clark N. Eid, PhD, PMP, RAC – St. Jude Children's Research Hospital; Meredith Brown-Tuttle, RAC, US, EU – Regulatorium
Biopharmaceuticals (includes Biologics)

Favorite

Lauren Neighbours, PhD, RAC – PSI CRO ### 535438###Session Leader @@@ Clark N. Eid, PhD, PMP, RAC – St. Jude Children's Research Hospital ### 535479###Speaker @@@ Meredith Brown-Tuttle, RAC, US, EU – Regulatorium ### 535518###Speaker
2:00 PM - 3:00 PM

Regulatory Case Studies in Artificial Intelligence
2:00 PM - 3:00 PM

Regulatory Case Studies in Artificial Intelligence
Location: 205-207
Tracey Fox, MS, RAC – IBM; Lisa Baumhardt, MT (ASCP), MS, MJ, RAC – IBM Watson Health; Yu Zhao, MBA, MS – Medtronic
Medical Devices

Favorite

Tracey Fox, MS, RAC – IBM ### 535448###Session Leader @@@ Lisa Baumhardt, MT (ASCP), MS, MJ, RAC – IBM Watson Health ### 535449###Speaker @@@ Yu Zhao, MBA, MS – Medtronic ### 570060###Speaker
2:00 PM - 3:00 PM

Combination Products in the EU: Impact of Article 117 of the Medical Device Regulation (MDR) on the Pharmaceutical Industry
2:00 PM - 3:00 PM

Combination Products in the EU: Impact of Article 117 of the Medical Device Regulation (MDR) on the Pharmaceutical Industry
Location: 211
Theresa Jeary, BSc (Hons), MSc – Lloyd's Register; April Kent – Amgen; Karin Schulze – SFL
Multiple Products

Favorite

Theresa Jeary, BSc (Hons), MSc – Lloyd's Register ### 535537###Session Leader @@@ April Kent – Amgen ### 620120###Speaker @@@ Karin Schulze – SFL ### 620121###Speaker
2:30 PM - 3:00 PM

Demystifying RAPS Fellowship
2:30 PM - 3:00 PM

Demystifying RAPS Fellowship
Location: 118-120
Nicole Landreville, Eng, RAC, FRAPS – GE Healthcare; Denise McEachern, JD, RAC, FRAPS; Elaine Messa, RAC, FRAPS – Messa Consulting Group LLC; Diana Salditt, FRAPS – Medtronic

Favorite

Nicole Landreville, Eng, RAC, FRAPS – GE Healthcare ### 549200###Moderator @@@ Denise McEachern, JD, RAC, FRAPS ### 609883###Moderator @@@ Elaine Messa, RAC, FRAPS – Messa Consulting Group LLC ### 609885###Moderator @@@ Diana Salditt, FRAPS – Medtronic ### 609884###Moderator
3:00 PM - 4:00 PM

Beverage Break in the Exhibit Hall
3:00 PM - 4:00 PM

Beverage Break in the Exhibit Hall
Location: West Building Exhibit Hall A & B1

Favorite
3:15 PM - 3:45 PM

Solution Circles
3:15 PM - 3:45 PM

Solution Circles
Location: West Building Exhibit Hall A & B1 (next to RAPS Central)
Sarah Michel, CSP – Velvet Chainsaw Consulting

Favorite

Sarah Michel, CSP – Velvet Chainsaw Consulting ### 542411###Moderator
3:15 PM - 4:00 PM

Interactions With Health Authorities (Medical Devices)
3:15 PM - 4:00 PM

Interactions With Health Authorities (Medical Devices)
Location: 109-110
Don Boyer, HBSc., RAC, FRAP – BOYER@RegulatorySolns; Susan Stewart, JD – Kaleido Biosciences
Conversations that Matter

Favorite

Don Boyer, HBSc., RAC, FRAP – BOYER@RegulatorySolns ### 535533###Speaker @@@ Susan Stewart, JD – Kaleido Biosciences ### 549202###Speaker
3:15 PM - 4:00 PM

Navigating the Gray
3:15 PM - 4:00 PM

Navigating the Gray
Location: 121-122
Nicole Landreville, Eng, RAC, FRAPS – GE Healthcare; David Chadwick, PhD, RAC, FRAPS – Cook Medical
Conversations that Matter

Favorite

Nicole Landreville, Eng, RAC, FRAPS – GE Healthcare ### 549200###Moderator @@@ David Chadwick, PhD, RAC, FRAPS – Cook Medical ### 549204###Moderator
3:15 PM - 4:00 PM

RAC Mini-Session
3:15 PM - 4:00 PM

RAC Mini-Session
Location: 118-120

Favorite
4:00 PM - 4:30 PM

A Change in Definition for Performance Evaluation: The Transition from EU IVD Directive to IVD Regulation
4:00 PM - 4:30 PM

A Change in Definition for Performance Evaluation: The Transition from EU IVD Directive to IVD Regulation
Location: 116-117
Erica F. Conway, PhD – BSI
In Vitro Diagnostics

Favorite

Erica F. Conway, PhD – BSI ### 535513###Session Leader
4:00 PM - 4:45 PM

The Global View of UDI
4:00 PM - 4:45 PM

The Global View of UDI
Location: 211
Amra Racic, MBA – Medtronic; Tania Pearson, MS – Medtronic; Jesús Rueda Rodríguez – MedTech Europe; Salvatore Scalzo (Virtual Presenter) – European Commission
Medical Devices

Favorite

Amra Racic, MBA – Medtronic ### 535477###Session Leader @@@ Tania Pearson, MS – Medtronic ### 620119###Speaker @@@ Jesús Rueda Rodríguez – MedTech Europe ### 574717###Speaker @@@ Salvatore Scalzo (Virtual Presenter) – European Commission ### 585006###Speaker
4:00 PM - 5:00 PM

Comparison Between the EU MDR Vigilance and Other National Incident Reporting Requirements
4:00 PM - 5:00 PM

Comparison Between the EU MDR Vigilance and Other National Incident Reporting Requirements
Location: 205-207
Ronald Rakos, PhD, MBA, RAC – BSI; Suzanne Halliday, D.Phil. – BSI
Medical Devices

Favorite

Ronald Rakos, PhD, MBA, RAC – BSI ### 535475###Session Leader @@@ Suzanne Halliday, D.Phil. – BSI ### 535446###Speaker
4:00 PM - 5:30 PM

Japan Forum
4:00 PM - 5:30 PM

Japan Forum
Location: 109-110
Nobumasa Nakashima, PhD – PMDA; Hiromi Kumada – PMDA; Tomoyuki Miyasaka – MHLW; Madoka Murakami, PhD – PMDA; Mari Shirotani, PhD – PMDA
Health Authority Forum

Favorite

Nobumasa Nakashima, PhD – PMDA ### 595307###Session Leader @@@ Hiromi Kumada – PMDA ### 595305###Speaker @@@ Tomoyuki Miyasaka – MHLW ### 595306###Speaker @@@ Madoka Murakami, PhD – PMDA ### 595304###Speaker @@@ Mari Shirotani, PhD – PMDA ### 595303###Speaker
4:00 PM - 5:30 PM

Regulatory Considerations for Digital Health
4:00 PM - 5:30 PM

Regulatory Considerations for Digital Health
Location: 202-204
Guliz Guler – GSK Consumer Healthcare; Mike Benecky, PhD – GSK Pharma Global Regulatory Affairs Precision and Digital Medicine; Bakul Patel, MBA – Food and Drug Administration, Center For Device and Radiological Health
Biopharmaceuticals (includes Biologics)

Favorite

Guliz Guler – GSK Consumer Healthcare ### 593615###Session Leader/Speaker @@@ Mike Benecky, PhD – GSK Pharma Global Regulatory Affairs Precision and Digital Medicine ### 593620###Speaker @@@ Bakul Patel, MBA – Food and Drug Administration, Center For Device and Radiological Health ### 535474###Speaker
4:00 PM - 5:30 PM

Cybersecurity Compliance: Global Considerations for Protecting the Healthcare Infrastructure
4:00 PM - 5:30 PM

Cybersecurity Compliance: Global Considerations for Protecting the Healthcare Infrastructure
Location: 118-120
Michelle Jump, RAC, MS, MSRS – Nova Leah; Suzanne Schwartz, MD, MBA – US FDA
Medical Devices

Favorite

Michelle Jump, RAC, MS, MSRS – Nova Leah ### 535528###Session Leader @@@ Suzanne Schwartz, MD, MBA – US FDA ### 593621###Speaker
4:00 PM - 5:30 PM

Health Canada’s Regulatory Review of Drugs and Devices: Initiatives to Improve Access to Therapeutic Products (Co-sponsored by CAPRA)
4:00 PM - 5:30 PM

Health Canada’s Regulatory Review of Drugs and Devices: Initiatives to Improve Access to Therapeutic Products (Co-sponsored by CAPRA)
Location: 212-214
Larry Colero – Novo Nordisk Canada Inc.; Queenia Lee – CAPRA; Megan Bettle, PhD – Health Canada; Lisa Chartrand – Hoffmann La-Roche Limited; Hieu Vu
Multiple Products

Favorite

Larry Colero – Novo Nordisk Canada Inc. ### 584206###Session Leader @@@ Queenia Lee – CAPRA ### 535463###Session Leader @@@ Megan Bettle, PhD – Health Canada ### 554005###Speaker @@@ Lisa Chartrand – Hoffmann La-Roche Limited ### 584207###Speaker @@@ Hieu Vu ### 609852###Speaker
4:00 PM - 5:30 PM

Human Gene Editing and Advanced Therapies: How Will FDA, EMA and Gene Therapy Mix?
4:00 PM - 5:30 PM

Human Gene Editing and Advanced Therapies: How Will FDA, EMA and Gene Therapy Mix?
Location: 121-122
Angela Nicole. Johnson, BFA, MSE, PMP, RAC; Rachael Anatol, PhD – US FDA; Kevin D. Healy, PhD, RAC – Enzyvant Therapeutics, Inc.; Venkata (Sravan) Jaggumantri, PhD – PRA Health Sciences
Biopharmaceuticals (includes Biologics)

Favorite

Angela Nicole. Johnson, BFA, MSE, PMP, RAC ### 535453###Session Leader @@@ Rachael Anatol, PhD – US FDA ### 601544###Speaker @@@ Kevin D. Healy, PhD, RAC – Enzyvant Therapeutics, Inc. ### 535498###Speaker @@@ Venkata (Sravan) Jaggumantri, PhD – PRA Health Sciences ### 535488###Speaker
4:45 PM - 5:30 PM

Labeling According to the EU MDR
4:45 PM - 5:30 PM

Labeling According to the EU MDR
Location: 211
Amra Racic, MBA – Medtronic; Jesús Rueda Rodríguez – MedTech Europe; Joachim Wilke, PhD MSc – Medtronic GmbH
Medical Devices

Favorite

Amra Racic, MBA – Medtronic ### 535477###Session Leader @@@ Jesús Rueda Rodríguez – MedTech Europe ### 574717###Speaker @@@ Joachim Wilke, PhD MSc – Medtronic GmbH ### 573373###Speaker
5:00 PM - 5:30 PM

Navigating Through Technical File Sampling in the In Vitro Diagnostic Device Regulation (IVDR)
5:00 PM - 5:30 PM

Navigating Through Technical File Sampling in the In Vitro Diagnostic Device Regulation (IVDR)
Location: 116-117
Nick Baker, MSc – Lloyd's Register
In Vitro Diagnostics

Favorite

Nick Baker, MSc – Lloyd's Register ### 535523###Session Leader
6:00 PM - 7:30 PM

Closing Reception—Next Stop: Philadelphia
6:00 PM - 7:30 PM

Closing Reception—Next Stop: Philadelphia
Location: Pan Pacific Hotel; Ocean View Suites (Gallery Level)

Favorite