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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
8:00 AM - 10:00 AM

Workshop Registration
8:00 AM - 10:00 AM

Workshop Registration
9:00 AM - 5:00 PM

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

Advanced Leadership Workshop
Trista Schoonmaker, PCC – COPIA Coaching and Consulting; Ginger Swassing – Device and Diagnostic Regulatory LLC
Workshops

Trista Schoonmaker, PCC – COPIA Coaching and Consulting ### 593803###Workshop Leader @@@ Ginger Swassing – 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
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

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
Patricia Anderson, RAC, FRAPS; Andrea Laslop, MD – Austrian Federal Agency of Safety in Health Care; Matthias Dormeyer, PhD – MDC RegAffairs GmbH; Karl-Heinz Huemer, MD, PhD; Isabelle Lefebvre, MSc. RA – Valeant; Beate R. Schmidt, MSc, MDRA, RAC – Benefits Regulatory Consulting; Piet Vervaet, MD; Bettina Ziegele (to be confirmed), MA – Paul-Ehrlic- Institut (Germany)
Workshops

Patricia Anderson, RAC, FRAPS ### 573388###Workshop Leader @@@ Andrea Laslop, MD – Austrian Federal Agency of Safety in Health Care ### 573431###Workshop Leader @@@ Matthias Dormeyer, PhD – MDC RegAffairs GmbH ### 573390###Speaker @@@ Karl-Heinz Huemer, MD, PhD ### 573393###Speaker @@@ Isabelle Lefebvre, MSc. RA – Valeant ### 573389###Speaker @@@ Beate R. Schmidt, MSc, MDRA, RAC – Benefits Regulatory Consulting ### 573538###Speaker @@@ Piet Vervaet, MD ### 573549###Speaker @@@ Bettina Ziegele (to be confirmed), 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
William Sietsema, PhD – Caladrius Biosciences Inc.; Linda F. Bowen, MS, RAC, FRAPS – Temple University; Kamali Gill Chance, MPH, PhD, RAC – Biosciences Corporation LLC; Vanessa D'Souza, PhD – Pfizer Inc.; Ning F. Go, MA, MD – Amgen; Monica Meacham, PhD – NantBio
Workshops

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 @@@ Vanessa D'Souza, PhD – Pfizer Inc. ### 573561###Speaker @@@ Ning F. Go, MA, MD – Amgen ### 573562###Speaker @@@ Monica Meacham, PhD – NantBio ### 593806###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
Minnie Baylor-Henry – B-Henry & Associates; Jennifer Owen-O’Quill – Voltage Leadership Consulting

Minnie Baylor-Henry – B-Henry & Associates ### 593801###Workshop Leader @@@ Jennifer Owen-O’Quill – 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
David Chadwick, PhD, RAC, FRAPS – Cook Medical; Tony Blank; Rita Hoffman, RAC – The FDA Group; Lorry Weaver Huffman, MT (ASCP), CLS – Qserve Group US, Inc.; Tom Rish, BS – Greenlight Guru
Workshops

David Chadwick, PhD, RAC, FRAPS – Cook Medical ### 549204###Workshop Leader @@@ Tony Blank ### 573383###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)
Bassil Akra, PhD – TÜV SÜD Product Service GmbH; Connie Del Buono – 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 Stange – TÜV SÜD; Erik Vollebregt, LLM – Axon Lawyers; Joachim Wilke, PhD MSc – Medtronic GmbH; John Wilkinson, OBE – MHRA
Workshops

Bassil Akra, PhD – TÜV SÜD Product Service GmbH ### 535482###Workshop Leader @@@ Connie Del Buono – 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 Stange – 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!
Ayse Baker, PhD, MBA, FRAPS – Chugai Pharma USA; Meredith Brown-Tuttle, RAC, US, EU – Regulatorium; Ruth Turner – Shire
Workshops

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
12:30 PM - 1:30 PM

Lunch
12:30 PM - 1:30 PM

Lunch
3:00 PM - 3:30 PM

Beverage Break
3:00 PM - 3:30 PM

Beverage Break
Tuesday, October 2, 2018
7:00 AM - 8:00 AM

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

Workshop Continental Breakfast
7:00 AM - 9:00 AM

Workshop Registration
7:00 AM - 9:00 AM

Workshop Registration
7:00 AM - 6:00 PM

Registration Open
7:00 AM - 6:00 PM

Registration Open
8:00 AM - 4:00 PM

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

Advanced Leadership Workshop
Trista Schoonmaker, PCC – COPIA Coaching and Consulting; Ginger Swassing – Device and Diagnostic Regulatory LLC
Workshops

Trista Schoonmaker, PCC – COPIA Coaching and Consulting ### 593803###Workshop Leader @@@ Ginger Swassing – 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
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

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
Linda F. Bowen, MS, RAC, FRAPS – Temple University; Meredith Brown-Tuttle, RAC, US, EU – Regulatorium; Matt Medlin, PhD, RAC – Chiesi
Workshops

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
William Sietsema, PhD – Caladrius Biosciences Inc.; Linda F. Bowen, MS, RAC, FRAPS – Temple University; Kamali Gill Chance, MPH, PhD, RAC – Biosciences Corporation LLC; Vanessa D'Souza, PhD – Pfizer Inc.; Ning F. Go, MA, MD – Amgen; Monica Meacham, PhD – NantBio
Workshops

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 @@@ Vanessa D'Souza, PhD – Pfizer Inc. ### 573561###Speaker @@@ Ning F. Go, MA, MD – Amgen ### 573562###Speaker @@@ Monica Meacham, PhD – NantBio ### 593806###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
Minnie Baylor-Henry – B-Henry & Associates; Jennifer Owen-O’Quill – Voltage Leadership Consulting
Workshops

Minnie Baylor-Henry – B-Henry & Associates ### 593801###Workshop Leader @@@ Jennifer Owen-O’Quill – 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
Alan McEmber, MS,RAC; Nancy Bower, MS, DABT – Eisai Inc; Kevin Dransfield, B.Sc. – Boehringer Ingelheim Pharmaceuticals, Inc.; Amanda Goodwin; Mary L. Mease, RPH, MPH – IQVIA
Workshops

Alan McEmber, MS,RAC ### 552866###Workshop Leader @@@ Nancy Bower, MS, DABT – Eisai Inc ### 573551###Speaker @@@ Kevin Dransfield, B.Sc. – Boehringer Ingelheim Pharmaceuticals, Inc. ### 573552###Speaker @@@ Amanda Goodwin ### 573554###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)
Bassil Akra, PhD – TÜV SÜD Product Service GmbH; Connie Del Buono – 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 – BSI; Melissa Day, RN, BSN, MBA – Johnson & Johnson; Caroline Doregeraghty – National Standards Authority of Ireland; Alex Laan – DEKRA Certification B.V.; Keith Morel, BSc (Physics) ARCS DIC PhD (Plasma Physics) – Qserve; Madu Oji – Baxter Healthcare Limited; Simon Richards – Alere; David Rutledge, PharmD, FCCP, FAHA, – Abbott Vascular; Peter Schroeer – Johnson & Johnson; Anja Wiersma, PhD – mi-CE consultancy; Joachim Wilke, PhD MSc – Medtronic GmbH; John Wilkinson, OBE – MHRA
Workshops

Bassil Akra, PhD – TÜV SÜD Product Service GmbH ### 535482###Workshop Leader @@@ Connie Del Buono – 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 – BSI ### 535513###Speaker @@@ Melissa Day, RN, BSN, MBA – Johnson & Johnson ### 593744###Speaker @@@ Caroline Doregeraghty – National Standards Authority of Ireland ### 593746###Speaker @@@ Alex Laan – DEKRA Certification B.V. ### 585231###Speaker @@@ Keith Morel, BSc (Physics) ARCS DIC PhD (Plasma Physics) – Qserve ### 535522###Speaker @@@ Madu Oji – Baxter Healthcare Limited ### 593745###Speaker @@@ Simon Richards – Alere ### 585116###Speaker @@@ David Rutledge, PharmD, FCCP, FAHA, – Abbott Vascular ### 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
12:00 PM - 1:00 PM

Lunch
12:00 PM - 1:00 PM

Lunch
2:30 PM - 3:00 PM

Beverage Break
2:30 PM - 3:00 PM

Beverage Break
4:30 PM - 5:30 PM

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

First-Timer Welcome
Sarah Michel, CSP – Velvet Chainsaw Consulting

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
6:00 PM - 7:30 PM

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

RAPS Central Open
Wednesday, October 3, 2018
7:00 AM - 8:30 AM

Continental Breakfast
7:00 AM - 8:30 AM

Continental Breakfast
7:00 AM - 6:00 PM

Registration Open
7:00 AM - 6:00 PM

Registration Open
8:30 AM - 9:30 AM

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

Convergence Community Gathering
Sarah Michel, CSP – Velvet Chainsaw Consulting
Plenary

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
9:30 AM - 4:00 PM

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

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

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

RAPS Central Open
9:45 AM - 10:30 AM

Sponsored Education Session
9:45 AM - 10:30 AM

Sponsored Education Session
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
Adrienne Lenz, RAC US – Hyman, Phelps, & McNamara
Medical Devices

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?
Patricia L. Murphy – BSI Group America Inc.; David Boudreau, ing – Health Canada
Medical Devices

Patricia L. Murphy – BSI Group America Inc. ### 535517###Session Leader @@@ David Boudreau, ing – Health Canada ### 570151###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
Roxanne Tavakkol, MS – Mallinckrodt Pharmaceuticals; Ahmed Abouelnour, RAC – Methapharm Inc.; Mary C. Speagle, BSc, RAC – Therapeutic Products Inc
Biopharmaceuticals (includes Biologics)

Roxanne Tavakkol, MS – Mallinckrodt Pharmaceuticals ### 535490###Session Leader @@@ Ahmed Abouelnour, RAC – Methapharm Inc. ### 535483###Speaker @@@ Mary C. Speagle, BSc, RAC – Therapeutic Products Inc ### 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
Gert W. Bos, FRAPS – Qserve; Jesús Rueda Rodríguez – MedTech Europe; John Wilkinson, OBE – MHRA
Medical Devices

Gert W. Bos, FRAPS – Qserve ### 535440###Session Leader @@@ 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
Manfred Ruthsatz, PhD, RPh, DABT, RAC, FRAPS – Nestle Health Science; Anju Aggarwal – UW, Public Health, Seattle, US; Ahmed El-SOHEMY – Nutrigenomix; William Yan, PhD – Health Canada
Multiple Products

Manfred Ruthsatz, PhD, RPh, DABT, RAC, FRAPS – Nestle Health Science ### 535536###Session Leader @@@ Anju Aggarwal – UW, Public Health, Seattle, US ### 593902###Speaker @@@ Ahmed El-SOHEMY – Nutrigenomix ### 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
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; Lawrence Liberti, PhD – CIRS (Centre for Innovation in Regulatory Science); William Maier, MD, PhD – Mapi Group (an ICON plc company); Princess Osbourne – CARPHA's Caribbean Regulatory System; Julio Sánchez y Tépoz, Esq – Mexican Regulatory Agency, COFEPRIS; Bettina Ziegele (to be confirmed), MA – Paul-Ehrlic- Institut (Germany)
Health Authority Forum

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 @@@ Lawrence Liberti, PhD – CIRS (Centre for Innovation in Regulatory Science) ### 574331###Speaker @@@ William Maier, MD, PhD – Mapi Group (an ICON plc company) ### 574332###Speaker @@@ Princess Osbourne – CARPHA's Caribbean Regulatory System ### 595326###Speaker @@@ Julio Sánchez y Tépoz, Esq – Mexican Regulatory Agency, COFEPRIS ### 574336###Speaker @@@ Bettina Ziegele (to be confirmed), 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?
Alan McEmber, MS,RAC; Ron Guido – IRX Therapeutics, Inc; Anjali Kumar, PhD, FAHA – Shire; Mihaela MacNair, PhD – Biogen; Ruth Turner – Shire
Acumen Builders

Alan McEmber, MS,RAC ### 552866###Session Leader @@@ Ron Guido – IRX Therapeutics, Inc ### 595197###Speaker @@@ 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
Adriaan N. Fruijtier, M.Sc. – CATS Consultants GmbH; Michael Craig, BSc (Pharm) MPSI – PAREXEL Consulting; Seán Kilbride, PhD – Regeneron Pharmaceuticals
Biopharmaceuticals (includes Biologics)

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
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
Stephanie Christopher, MA, CCRC, FACRP – Medical Device Innovation Consortium; Joseph Sapiente; Francisco Vicenty – US FDA; George Zack – Two Harbors Consulting, LLC
Medical Devices

Stephanie Christopher, MA, CCRC, FACRP – Medical Device Innovation Consortium ### 535495###Session Leader @@@ Joseph Sapiente ### 580308###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
Albrecht Poth – Health Care - Medical Devices
Medical Devices

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
12:15 PM - 1:00 PM

Sponsored Education Session
12:15 PM - 1:00 PM

Sponsored Education Session
12:15 PM - 1:15 PM

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

Solution Circles Open House
Sarah Michel, CSP – Velvet Chainsaw Consulting

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
Tara M. Creaven-Capasso, RAC, RQAP-GLP – Caduceus Medical Development Ltd.; Marie Marlow – M Squared Associates, Inc.
Medical Devices

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
Jena L. Rostorfer, MS, RD – Abbott Nutrition
Health-Related Foods

Jena L. Rostorfer, MS, RD – Abbott Nutrition ### 535497###Session Leader
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
Angela G. Huber, PhD, RAC – Medtronic; Sergio M. de del Castillo – US FDA; William D. Voorhees, III, PhD – MED Institute Inc.
Medical Devices

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
Meg Mucha, MJ, RAC, FRAP, CQA; David Boudreau, ing – Health Canada; John Daley – IBM Watson Health; Joshua Schulman, PhD – MaxQ-AI; Rika Wakao, PhD – Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Multiple Products

Meg Mucha, MJ, RAC, FRAP, CQA ### 579833###Session Leader @@@ David Boudreau, ing – Health Canada ### 570151###Speaker @@@ John Daley – IBM Watson Health ### 570150###Speaker @@@ Joshua Schulman, 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
Robert Iser, M.S. – PAREXEL Consulting; Kurt R. Karst, Attorney – Hyman, Phelps & McNamara, P.C.
Biopharmaceuticals (includes Biologics)

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

European Forum
1:30 PM - 3:00 PM

European Forum
Gert W. Bos, FRAPS – Qserve; Karl-Heinz Huemer, MD, PhD; Andrea Laslop, MD – Austrian Federal Agency of Safety in Health Care; John Wilkinson, OBE – MHRA; Bettina Ziegele (to be confirmed), MA – Paul-Ehrlic- Institut (Germany)
Health Authority Forum

Gert W. Bos, FRAPS – Qserve ### 535440###Moderator @@@ Karl-Heinz Huemer, MD, PhD ### 573393###Speaker @@@ Andrea Laslop, MD – Austrian Federal Agency of Safety in Health Care ### 573431###Speaker @@@ John Wilkinson, OBE – MHRA ### 574719###Speaker @@@ Bettina Ziegele (to be confirmed), 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?
Seema Parikh, MBBS MFPM – Parexel International; Angela Nicole. Johnson, BFA, MSE, PMP, RAC – CTI Clinical Trials & Consulting; Patricia Keegan, MD – US FDA
Biopharmaceuticals (includes Biologics)

Seema Parikh, MBBS MFPM – Parexel International ### 535471###Speaker @@@ Angela Nicole. Johnson, BFA, MSE, PMP, RAC – CTI Clinical Trials & Consulting ### 535453###Speaker @@@ Patricia Keegan, MD – US FDA ### 574718###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
Kimberly Trautman, MSc – NSF International
Medical Devices

Kimberly Trautman, MSc – NSF International ### 535494###Session Leader
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?
Maria G. Fuentes, Eng. – GE Healthcare; Yadira Sandoval; Dulce Valle
Medical Devices

Maria G. Fuentes, Eng. – GE Healthcare ### 535524###Session Leader @@@ Yadira Sandoval ### 535525###Speaker @@@ Dulce Valle ### 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
Amy Mackey, PhD – Abbott Nutrition; William Yan, PhD – Health Canada
Multiple Products

Amy Mackey, PhD – Abbott Nutrition ### 535538###Session Leader @@@ 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
Kareem Elwakil – PwC
Medical Devices

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

Sponsored Education Session
3:00 PM - 3:45 PM

Sponsored Education Session
3:00 PM - 4:00 PM

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

Beverage Break in the Exhibit Hall
3:15 PM - 3:45 PM

Solution Circles
3:15 PM - 3:45 PM

Solution Circles
Sarah Michel, CSP – Velvet Chainsaw Consulting

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
Nicole Landreville, Eng, RAC, FRAPS – GE Healthcare; bradley Hossack, Bsc – Stryker Corporation
Conversations that Matter

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
3:15 PM - 4:00 PM

Interactions With Health Authorities
Don Boyer, HBSc., RAC, FRAP – BOYER@RegulatorySolns; Susan Stewart, JD – Kaleido Biosciences
Conversations that Matter

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
4:00 PM - 4:30 PM

A Best Practice for Applying Risk Management to ISO 13485
4:00 PM - 4:30 PM

A Best Practice for Applying Risk Management to ISO 13485
Medical Devices
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
Paul Hanlon, PhD – Abbott Nutrition; Heidi Bialk; Shahrzad Tafazoli, PhD – Intertek Regulatory & Scientific Consultancy
Health-Related Foods

Paul Hanlon, PhD – Abbott Nutrition ### 535535###Session Leader @@@ Heidi Bialk ### 555675###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
Kimberly Belsky, M.S. – Mallinckrodt Pharmaceuticals; Winifred Wu, MBA, FRAPS – Strategic Regulatory Partners, LLC
Acumen Builders

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
Zeli Yu, RAC , Global – YUZELI MEDTECCONSULTING
Medical Devices

Zeli Yu, RAC , Global – YUZELI MEDTECCONSULTING ### 535443###Session Leader
4:00 PM - 5:30 PM

Canada Forum
4:00 PM - 5:30 PM

Canada Forum
Don Boyer, HBSc., RAC, FRAP – BOYER@RegulatorySolns; Cathy Parker – Health Canada; John Patrick Stewart – Health Canada
Health Authority Forum

Don Boyer, HBSc., RAC, FRAP – BOYER@RegulatorySolns ### 535533###Session Leader @@@ Cathy 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
Elizabeth M. Rose, RAC (US), MST – Mapi Group, 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 – Academic Medical Hospital of the University of Amsterdam
Medical Devices

Elizabeth M. Rose, RAC (US), MST – Mapi Group, 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 – Academic Medical Hospital of the University of Amsterdam ### 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
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
Biopharmaceuticals (includes Biologics)

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

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

Regulatory Strategies for Accelerated Development Programs
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)

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
Bryant Foster – Research Collective; Margaret Koga, BSME, AAMI Faculty Member – Teragram LLC
Medical Devices

Bryant Foster – 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
Berenice Ocampo, M.S. – Abbott Nutrition; Pei-Ju Chou – Food and Drug Administration, Ministry of Health and Welfare, R.O.C.; William Yan, PhD – Health Canada
Health-Related Foods

Berenice Ocampo, M.S. – Abbott Nutrition ### 535531###Session Leader @@@ Pei-Ju Chou – Food and Drug Administration, Ministry of Health and Welfare, R.O.C. ### 593881###Speaker @@@ William Yan, PhD – Health Canada ### 593882###Speaker
5:00 PM - 5:30 PM

China Restructure
5:00 PM - 5:30 PM

China Restructure
Amra Racic, MBA – Medtronic
Medical Devices

Amra Racic, MBA – Medtronic ### 535477###Speaker
6:00 PM - 9:00 PM

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

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

Continental Breakfast
7:00 AM - 8:30 AM

Continental Breakfast
7:00 AM - 6:00 PM

Registration Open
7:00 AM - 6:00 PM

Registration Open
7:15 AM - 8:15 AM

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

RAC Holders’ Breakfast
7:30 AM - 8:15 AM

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

NetWORTHing Strategies for Growing Your Network
Sarah Michel, CSP – Velvet Chainsaw Consulting
Conversations that Matter

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
Donald N. Klein, CMC SME – PAREXEL
Biopharmaceuticals (includes Biologics)

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
Meg Mucha, MJ, RAC, FRAP, CQA; 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

Meg Mucha, MJ, RAC, FRAP, CQA ### 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
Philippe Auclair, Pharma Dr, PhD , FRAPS – Abbott; Suzanne Halliday, D.Phil. – BSI; Sue Spencer, Director – UL - Notified Body
Medical Devices

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
Jessica E. Foley, M.S., RAC – Gaia Regulatory Sciences, LLC; Kurt R. Karst, Attorney – Hyman, Phelps & McNamara, P.C.
Biopharmaceuticals (includes Biologics)

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
Keith Morel, BSc (Physics) ARCS DIC PhD (Plasma Physics) – Qserve
Medical Devices

Keith Morel, BSc (Physics) ARCS DIC PhD (Plasma Physics) – Qserve ### 535522###Session Leader
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
Rita Hoffman, RAC – The FDA Group; Anu Gaur, PhD, MBA, MSRA, RAC
Medical Devices

Rita Hoffman, RAC – The FDA Group ### 535451###Session Leader @@@ Anu Gaur, PhD, MBA, MSRA, RAC ### 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
Julien S. Senac, PhD – GMED North America
In Vitro Diagnostics

Julien S. Senac, PhD – GMED North America ### 535509###Session Leader
9:30 AM - 10:30 AM

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

Beverage Break in the Exhibit Hall
9:30 AM - 4:00 PM

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

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

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

RAPS Central Open
9:45 AM - 10:15 AM

Solution Circles
9:45 AM - 10:15 AM

Solution Circles
Sarah Michel, CSP – Velvet Chainsaw Consulting

Sarah Michel, CSP – Velvet Chainsaw Consulting ### 542411###Moderator
9:45 AM - 10:30 AM

Sponsored Education Session
9:45 AM - 10:30 AM

Sponsored Education Session
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
Erica F. Conway – BSI
In Vitro Diagnostics

Erica F. Conway – 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
Megha Sinha, RAC – PwC; Bakul Patel, MBA – Food and Drug Administration, Center For Device and Radiological Health
Medical Devices

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
Waiss Faissal, Pharma Dr, MSc Biomedical Engineering – G-MED North America; Gert W. Bos, FRAPS – Qserve; Heidi Horsch, PhD – confinis
Medical Devices

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?
Jason Zhang, MD – China Med Device, LLC
Medical Devices

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
Carolina Panico, MD PhD – US FDA; Don Boyer, HBSc., RAC, FRAP – BOYER@RegulatorySolns; Daniela Drago, PhD, RAC – George Washington Univeristy
Acumen Builders

Carolina Panico, MD PhD – US FDA ### 535532###Session Leader @@@ Don Boyer, HBSc., RAC, FRAP – BOYER@RegulatorySolns ### 535533###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
Kimberly Belsky, M.S. – Mallinckrodt Pharmaceuticals; Patricia Keegan, MD – US FDA; Peter W. Marks, MD, PhD – US FDA; Janet Woodcock (Virtual Presenter) – US FDA
Health Authority Forum

Kimberly Belsky, M.S. – Mallinckrodt Pharmaceuticals ### 535468###Session Leader @@@ Patricia Keegan, MD – US FDA ### 574718###Speaker @@@ Peter W. Marks, MD, PhD – US FDA ### 574711###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
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, MSc – Johnson Matthey Plc
Biopharmaceuticals (includes Biologics)

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, MSc – 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
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)

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
Elizabeth M. Rose, RAC (US), MST – Mapi Group, an ICON PLC company; Sara Jafari, PhD – LNE/G-MED; Bakul Patel, MBA – Food and Drug Administration, Center For Device and Radiological Health
Medical Devices

Elizabeth M. Rose, RAC (US), MST – Mapi Group, 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
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
Julien S. Senac, PhD – GMED North America; Sue Spencer, Director – UL - Notified Body
In Vitro Diagnostics

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
Adrian T. Keene, BSc (Hons) – NAMSA
Medical Devices

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
Pallavi Trivedi, MPH, RAC – Trident Pharmaceuticals limited and Spinos Lifesciences and Research
Acumen Builders

Pallavi Trivedi, MPH, RAC – Trident Pharmaceuticals limited and Spinos Lifesciences and Research ### 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
12:15 PM - 1:00 PM

Sponsored Education Session
12:15 PM - 1:00 PM

Sponsored Education Session
12:15 PM - 1:15 PM

Solution Circles
12:15 PM - 1:15 PM

Solution Circles
Sarah Michel, CSP – Velvet Chainsaw Consulting

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
Michael C. Morton, RAC – Michael C. Morton Regulatory Consulting LLC; Lee Grant – Medtronic; Robert Kroslowitz – Berlin Heart Inc.; Vasum Peiris, MD, MPH, FAAP, FACC, FASE – U.S. Food and Drug Administration, CDRH
Medical Devices

Michael C. Morton, RAC – Michael C. Morton Regulatory Consulting LLC ### 555679###Session Leader @@@ Lee Grant – Medtronic ### 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
Gert W. Bos, FRAPS – Qserve; Florianne Torset-Bonfillou, MS – LNE / G-MED North America; Anja Wiersma, PhD – mi-CE consultancy
In Vitro Diagnostics

Gert W. Bos, FRAPS – Qserve ### 535440###Session Leader @@@ Florianne Torset-Bonfillou, MS – LNE / 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
Cecil J. Nick – PAREXEL International; Kirsten Messmer – PPD; Cathy Parker – Health Canada; Andrea Laslop, MD – Austrian Federal Agency of Safety in Health Care
Biopharmaceuticals (includes Biologics)

Cecil J. Nick – PAREXEL International ### 535464###Session Leader @@@ Kirsten Messmer – PPD ### 595312###Speaker @@@ Cathy Parker – Health Canada ### 595311###Panelist @@@ Andrea Laslop, MD – Austrian Federal Agency of 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?
Linda F. Bowen, MS, RAC, FRAPS – Temple University; Aman Khera – PRA Health Sciences; Oliver Steck – Deloitte & Touche LLP
Acumen Builders

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?
Young Kim – Synex Consulting Ltd.; Rachel Chung – Synex Consulting Ltd.; Myung Soo Ahn, MSRsc, Rph – Ministry of Food and Drug Safety
Health Authority Forum

Young Kim – Synex Consulting Ltd. ### 535499###Session Leader @@@ Rachel Chung – Synex Consulting Ltd. ### 535500###Speaker @@@ Myung Soo Ahn, MSRsc, Rph – Ministry of Food and Drug Safety ### 535501###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
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)

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
Tracey Fox, MS, RAC – IBM; Lisa Baumhardt, MT (ASCP), MS, MJ, RAC – IBM Watson Health; Yu Zhao, MBA, MS – Medtronic
Medical Devices

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
Theresa Jeary – Lloyd's Register
Multiple Products

Theresa Jeary – Lloyd's Register ### 535537###Session Leader
2:30 PM - 3:00 PM

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

Demystifying RAPS Fellowship
3:00 PM - 3:45 PM

Sponsored Education Session
3:00 PM - 3:45 PM

Sponsored Education Session
3:00 PM - 4:00 PM

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

Beverage Break in the Exhibit Hall
3:15 PM - 3:45 PM

Solution Circles
3:15 PM - 3:45 PM

Solution Circles
Sarah Michel, CSP – Velvet Chainsaw Consulting

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

Interactions With Health Authorities
3:15 PM - 4:00 PM

Interactions With Health Authorities
Don Boyer, HBSc., RAC, FRAP – BOYER@RegulatorySolns; Susan Stewart, JD – Kaleido Biosciences
Conversations that Matter

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
Paul Brooks – RAPS; Nicole Landreville, Eng, RAC, FRAPS – GE Healthcare; David Chadwick, PhD, RAC, FRAPS – Cook Medical
Conversations that Matter

Paul Brooks – RAPS ### 549203###Moderator @@@ 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
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
Erica F. Conway – BSI
In Vitro Diagnostics

Erica F. Conway – 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
Amra Racic, MBA – Medtronic; Jackie Rae Elkin – Medtronic; Jesús Rueda Rodríguez – MedTech Europe; Salvatore Scalzo (Virtual Presenter) – European Commission
Medical Devices

Amra Racic, MBA – Medtronic ### 535477###Session Leader @@@ Jackie Rae Elkin – Medtronic ### 555680###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
Ronald Rakos, PhD, MBA, RAC – BSI; Suzanne Halliday, D.Phil. – BSI
Medical Devices

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
Nobumasa Nakashima, PhD – PMDA; Hiromi Kumada – PMDA; Tomoyuki Miyasaka – MHLW; Madoka Murakami, PhD – PMDA; Mari Shirotani, PhD – PMDA
Health Authority Forum

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
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)

Guliz Guler – GSK Consumer Healthcare ### 593615###Session Leader @@@ 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
Michelle Jump, RAC, MS, MSRS – Nova Leah; Suzanne Schwartz, MD, MBA – US FDA
Medical Devices

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)
Larry Colero – Novo Nordisk Canada Inc.; Queenia Lee – CAPRA; Vikesh Srivastava – Health Canada; Megan Bettle, PhD – Health Canada; Lisa Chartrand – Hoffmann La-Roche Limited
Multiple Products

Larry Colero – Novo Nordisk Canada Inc. ### 584206###Session Leader @@@ Queenia Lee – CAPRA ### 535463###Session Leader @@@ Vikesh Srivastava – Health Canada ### 554004###Speaker @@@ Megan Bettle, PhD – Health Canada ### 554005###Speaker @@@ Lisa Chartrand – Hoffmann La-Roche Limited ### 584207###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?
Angela Nicole. Johnson, BFA, MSE, PMP, RAC – CTI Clinical Trials & Consulting; Kevin D. Healy, PhD, RAC – Enzyvant Therapeutics, Inc.; Venkata (Sravan) Jaggumantri, PhD – PRA Health Sciences; Peter W. Marks, MD, PhD – US FDA
Biopharmaceuticals (includes Biologics)

Angela Nicole. Johnson, BFA, MSE, PMP, RAC – CTI Clinical Trials & Consulting ### 535453###Session Leader @@@ Kevin D. Healy, PhD, RAC – Enzyvant Therapeutics, Inc. ### 535498###Speaker @@@ Venkata (Sravan) Jaggumantri, PhD – PRA Health Sciences ### 535488###Speaker @@@ Peter W. Marks, MD, PhD – US FDA ### 574711###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
Amra Racic, MBA – Medtronic; Jesús Rueda Rodríguez – MedTech Europe; Joachim Wilke, PhD MSc – Medtronic GmbH
Medical Devices

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)
Nick Baker – Lloyd's Register
In Vitro Diagnostics

Nick Baker – 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