Full Schedule

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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
Workshops
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 – GE Healthcare; Bradley Hossack; Patrick Lee; Megha Deviprasad Iyer
Workshops

Nicole Landreville – GE Healthcare ### 549200###Workshop Leader @@@ Bradley Hossack ### 549201###Speaker @@@ Patrick Lee ### 549205###Speaker @@@ Megha Deviprasad Iyer ### 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
Workshops
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
Workshops
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
Workshops
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)
Workshops
9:00 AM - 5:00 PM

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

Optimizing Your Strategy: Expedited Pathways, Exclusivity, and More!
Workshops
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
2:30 PM - 3:00 PM

Beverage Break
2:30 PM - 3:00 PM

Beverage Break
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
Workshops
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 – GE Healthcare; Bradley Hossack; Patrick Lee; Megha Deviprasad Iyer
Workshops

Nicole Landreville – GE Healthcare ### 549200###Workshop Leader @@@ Bradley Hossack ### 549201###Speaker @@@ Patrick Lee ### 549205###Speaker @@@ Megha Deviprasad Iyer ### 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
Workshops

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

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

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

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

US Regulatory Essentials, Pharmaceuticals and Biologics
Workshops
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)
Workshops
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
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 - 10:15 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

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.
Medical Devices

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

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

AI and How It Can Be Used to Change Health Products
10:30 AM - 12:00 PM

AI and How It Can Be Used to Change Health Products
Multiple Products
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; Oliver Bisazza – Medtech Europe
Medical Devices

Gert W. Bos, FRAPS – Qserve ### 535440###Session Leader @@@ Oliver Bisazza – Medtech Europe ### 535442###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
Multiple Products

Manfred Ruthsatz, PhD, RPh, DABT, RAC, FRAPS – Nestle Health Science ### 535536###Session Leader
10:30 AM - 12:00 PM

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

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

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

The EU Clinical Trial Regulation: Preparing for the Implementation
Adriaan N. Fruijtier, M.Sc. – CATS Consultants GmbH; Michael Craig, BSc (Pharm) MPSI – PAREXEL Consulting
Biopharmaceuticals (includes Biologics)

Adriaan N. Fruijtier, M.Sc. – CATS Consultants GmbH ### 535444###Session Leader @@@ Michael Craig, BSc (Pharm) MPSI – PAREXEL Consulting ### 535462###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
Medical Devices

Stephanie Christopher, MA, CCRC, FACRP – Medical Device Innovation Consortium ### 535495###Session Leader
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
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 - 2:00 PM

Comparability Protocols as a Regulatory Strategy for NDAs, ANDAs, and BLAs
1:30 PM - 2:00 PM

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
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
Medical Devices

Tara M. Creaven-Capasso, RAC, RQAP-GLP – Caduceus Medical Development ### 535476###Session Leader
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
Medical Devices

Angela G. Huber, PhD, RAC – Medtronic ### 535459###Session Leader
1:30 PM - 3:00 PM

European Forum
1:30 PM - 3:00 PM

European Forum
Health Authority Forum
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?
Ashley Butler, MHA – CTI - Consulting Organization; Seema Parikh, MBBS MFPM – Parexel International; Angela Nicole. Johnson, BFA, MSE, PMP, RAC – CTI Clinical Trials & Consulting; Robin Martin, RAC – Co-Founder
Biopharmaceuticals (includes Biologics)

Ashley Butler, MHA – CTI - Consulting Organization ### 535455###Session Leader @@@ Seema Parikh, MBBS MFPM – Parexel International ### 535471###Speaker @@@ Angela Nicole. Johnson, BFA, MSE, PMP, RAC – CTI Clinical Trials & Consulting ### 535453###Speaker @@@ Robin Martin, RAC – Co-Founder ### 535519###Speaker
1:30 PM - 3:00 PM

Beyond Due Diligence: You Bought It, Now What?
1:30 PM - 3:00 PM

Beyond Due Diligence: You Bought It, Now What?
Alan McEmber; Ruth Turner
Acumen Builders

Alan McEmber ### 552866###Session Leader @@@ Ruth Turner ### 555674###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

EMA and FDA: Sharing Inspectional Findings
2:00 PM - 3:00 PM

EMA and FDA: Sharing Inspectional Findings
Andrea Chamblee, Esq., RAC, RAPS Fellow – George Washington University
Biopharmaceuticals (includes Biologics)

Andrea Chamblee, Esq., RAC, RAPS Fellow – George Washington University ### 535470###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 – General Electric Healthcare
Medical Devices

Maria G. Fuentes – General Electric Healthcare ### 535524###Session Leader
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
Health-Related Foods

Amy Mackey, PhD – Abbott Nutrition ### 535538###Session Leader
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 - 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
Rainer Voelksen, RAC, FRAPS – RAPS; Nicole Landreville – GE Healthcare; Bradley Hossack
Conversations that Matter

Rainer Voelksen, RAC, FRAPS – RAPS ### 535491###Moderator @@@ Nicole Landreville – GE Healthcare ### 549200###Moderator @@@ Bradley Hossack ### 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
Conversations that Matter

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

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

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

Sponsored Education Session
3:15 PM - 4:00 PM

Sponsored Education 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

Defining 'Sufficient' Clinical Evidence in order to Fulfill the Requirements of the EU MDR.
4:00 PM - 4:45 PM

Defining 'Sufficient' Clinical Evidence in order to Fulfill the Requirements of the EU MDR.
Roshana Ahmed, M.A., RAC – Mapi SRS, an ICON plc Company
Medical Devices

Roshana Ahmed, M.A., RAC – Mapi SRS, an ICON plc Company ### 535480###Session Leader
4:00 PM - 4:45 PM

Modernizing Regulations for Specialized Foods: A Multi-Stakeholder Approach
4:00 PM - 4:45 PM

Modernizing Regulations for Specialized Foods: A Multi-Stakeholder Approach
Berenice Ocampo, M.S. – Abbott Nutrition
Health-Related Foods

Berenice Ocampo, M.S. – Abbott Nutrition ### 535531###Session Leader
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
Health Authority Forum
4:00 PM - 5:30 PM

How Regulatory Impacts the Business Strategy Portfolio
4:00 PM - 5:30 PM

How Regulatory Impacts the Business Strategy Portfolio
Acumen Builders
4:00 PM - 5:30 PM

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

Regulatory Strategies for Accelerated Development Programs
Jamie L. Robinson, RAC – Genentech (Roche); Carrie-Lynn Langlais Furr, PhD, RAC – AmpliPhi Biosciences; Judy Vong, MS – Amgen
Biopharmaceuticals (includes Biologics)

Jamie L. Robinson, RAC – Genentech (Roche) ### 535434###Session Leader @@@ Carrie-Lynn Langlais Furr, PhD, RAC – AmpliPhi Biosciences ### 535516###Speaker @@@ Judy Vong, MS – Amgen ### 535435###Speaker
4:00 PM - 5:30 PM

Integration of Noninvasive Wearable Sensors, Mobile Patient Apps and Healthcare Professional Dashboards: FDA Approval(s)/Developments and Opportunities in Multiple Therapeutic Areas
4:00 PM - 5:30 PM

Integration of Noninvasive Wearable Sensors, Mobile Patient Apps and Healthcare Professional Dashboards: FDA Approval(s)/Developments and Opportunities in Multiple Therapeutic Areas
Wayne Amchin, RAC, Cert in Health Informatics, Cert in Drug Dev and RegSci – FDA/CDER/OND/DCRP; Gautam Maitra, Fil.Lic – AC Immune SA
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
4:30 PM - 5:30 PM

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

Integrating Human Factors into Design Controls
Russ Branaghan, Phd – Research Collective, Arizona State University; Margaret Koga, BSME, AAMI Faculty Member – Teragram LLC; Bryant Foster – Research Collective
Medical Devices

Russ Branaghan, Phd – Research Collective, Arizona State University ### 535514###Session Leader @@@ Margaret Koga, BSME, AAMI Faculty Member – Teragram LLC ### 535515###Speaker @@@ Bryant Foster – Research Collective ### 554046###Speaker
4:45 PM - 5:30 PM

New Challenges for Novel Food Ingredient Approvals
4:45 PM - 5:30 PM

New Challenges for Novel Food Ingredient Approvals
Paul Hanlon, PhD – Abbott Nutrition; Heidi Bialk; Shahrzad Tafazoli
Health-Related Foods

Paul Hanlon, PhD – Abbott Nutrition ### 535535###Session Leader @@@ Heidi Bialk ### 555675###Speaker @@@ Shahrzad Tafazoli ### 555676###Speaker
4:45 PM - 5:30 PM

What is Enough Clinical Evidence Under the MDR?
4:45 PM - 5:30 PM

What is Enough Clinical Evidence Under the MDR?
Jozeph Kraus, Pharm D – Academic Medical Hospital of the University of Amsterdam
Medical Devices

Jozeph Kraus, Pharm D – Academic Medical Hospital of the University of Amsterdam ### 535503###Session Leader
5:00 PM - 5:30 PM

China Restructure
5:00 PM - 5:30 PM

China Restructure
Medical Devices
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
7:30 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 - 9:00 AM

What’s Important to Consider When Developing a Complex Generic Drug?
8:30 AM - 9:00 AM

What’s Important to Consider When Developing a Complex Generic Drug?
Robert Iser, M.S. – PAREXEL Consulting
Biopharmaceuticals (includes Biologics)

Robert Iser, M.S. – PAREXEL Consulting ### 535466###Session Leader
8:30 AM - 9:30 AM

CDRH Forum
8:30 AM - 9:30 AM

CDRH Forum
Health Authority Forum
8:30 AM - 9:30 AM

Impactful Communications
8:30 AM - 9:30 AM

Impactful Communications
Acumen Builders
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
Medical Devices

Philippe Auclair, Pharma Dr, PhD , FRAPS – Abbott ### 535445###Session Leader
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; Anupama Gaur
Medical Devices

Rita Hoffman, RAC – The FDA Group ### 535451###Session Leader @@@ Anupama Gaur ### 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, Ph.D. – GMED North America
In Vitro Diagnostics

Julien S. Senac, Ph.D. – GMED North America ### 535509###Session Leader
9:00 AM - 9:30 AM

Successfully Managing Priority Generic Submissions
9:00 AM - 9:30 AM

Successfully Managing Priority Generic Submissions
Robert Iser, M.S. – PAREXEL Consulting
Biopharmaceuticals (includes Biologics)

Robert Iser, M.S. – PAREXEL Consulting ### 535466###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
Medical Devices

Megha Sinha, RAC – PwC ### 535527###Session Leader
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
Medical Devices

Waiss Faissal, Pharma Dr, MSc Biomedical Engineering – G-MED North America ### 535521###Session Leader
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 – China Med Device, LLC
Medical Devices

Jason Zhang – 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
Health Authority Forum
10:30 AM - 12:00 PM

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

Brexit: Solution Planning
Parastoo Karoon – Parexel International; Kathrin Schalper, PhD, RAC – Accenture Applied Life Sciences, LLP; Venkat Reddy Sunkara, MSc – Johnson Matthey Plc; Mustafa A. Zaman, Bharm PhD MRPharmS – Parexel International Consulting
Biopharmaceuticals (includes Biologics)

Parastoo Karoon – Parexel International ### 535484###Session Leader @@@ Kathrin Schalper, PhD, RAC – Accenture Applied Life Sciences, LLP ### 535439###Speaker @@@ Venkat Reddy Sunkara, MSc – Johnson Matthey Plc ### 535433###Speaker @@@ Mustafa A. Zaman, Bharm PhD MRPharmS – Parexel International Consulting ### 535485###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
Medical Devices

Elizabeth M. Rose, RAC (US), MST – MAPI Group ### 535472###Session Leader
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, Ph.D. – GMED North America; Sue Spenser, Director – UL - Notified Body
In Vitro Diagnostics

Julien S. Senac, Ph.D. – GMED North America ### 535509###Session Leader @@@ Sue Spenser, 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 - 1:00 PM

Grab and Go Lunch and Open Exhibit Time
12:00 PM - 1:00 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 Morton
Medical Devices

Michael Morton ### 555679###Session Leader
1:30 PM - 3:00 PM

Crisis Management
1:30 PM - 3:00 PM

Crisis Management
Acumen Builders
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; Kamali Gill Chance, MPH, PhD, RAC – Biosciences Corporation LLC
Biopharmaceuticals (includes Biologics)

Cecil J. Nick – PAREXEL International ### 535464###Session Leader @@@ Kamali Gill Chance, MPH, PhD, RAC – Biosciences Corporation LLC ### 535467###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.; Myoung Soo Ahn, 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 @@@ Myoung Soo Ahn, 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, RAC – IBM
Medical Devices

Tracey Fox, RAC – IBM ### 535448###Session Leader
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

Navigating Through Technical File Sampling in the In Vitro Diagnostic Device Regulation (IVDR)
2:30 PM - 3:00 PM

Navigating Through Technical File Sampling in the In Vitro Diagnostic Device Regulation (IVDR)
In Vitro Diagnostics
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
Conversations that Matter

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

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

Navigating the Gray
Paul Brooks; Nicole Landreville – GE Healthcare; David Chadwick
Conversations that Matter

Paul Brooks ### 549203###Moderator @@@ Nicole Landreville – GE Healthcare ### 549200###Moderator @@@ David Chadwick ### 549204###Moderator
3:15 PM - 4:00 PM

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

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

Sponsored Education Session
3:15 PM - 4:00 PM

Sponsored Education 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 - 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 - 5:00 PM

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

Regulatory Considerations for Digital Health
Benjamin Chacko, PharmD, JD – Sanofi
Biopharmaceuticals (includes Biologics)

Benjamin Chacko, PharmD, JD – Sanofi ### 554023###Session Leader
4:00 PM - 5:30 PM

Japan Forum
4:00 PM - 5:30 PM

Japan Forum
Health Authority Forum
4:00 PM - 5:30 PM

The Global View of UDI
4:00 PM - 5:30 PM

The Global View of UDI
Jackie Elkin
Medical Devices

Jackie Elkin ### 555680###Session Leader
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 – Carestream Health
Medical Devices

Michelle Jump, RAC – Carestream Health ### 535528###Session Leader
4:00 PM - 5:30 PM

Health Canada’s Regulatory Review of Drugs and Devices: Initiatives to Improve Access to Therapeutic Products
4:00 PM - 5:30 PM

Health Canada’s Regulatory Review of Drugs and Devices: Initiatives to Improve Access to Therapeutic Products
Queenia Lee, BSC – CAPRA; Vikesh Srivastava – Health Canada; Megan Bettle – Health Canada
Multiple Products

Queenia Lee, BSC – CAPRA ### 535463###Session Leader @@@ Vikesh Srivastava – Health Canada ### 554004###Speaker @@@ Megan Bettle – Health Canada ### 554005###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 – Roivant Sciences; Derek Ansel, CCRA – PRA Health Sciences
Biopharmaceuticals (includes Biologics)

Angela Nicole. Johnson, BFA, MSE, PMP, RAC – CTI Clinical Trials & Consulting ### 535453###Session Leader @@@ Kevin D. Healy, PhD, RAC – Roivant Sciences ### 535498###Speaker @@@ Derek Ansel, CCRA – PRA Health Sciences ### 535487###Speaker
5:00 PM - 5:30 PM

EU MDR Labeling
5:00 PM - 5:30 PM

EU MDR Labeling
Medical Devices
6:00 PM - 7:30 PM

Closing Reception
6:00 PM - 7:30 PM

Closing Reception