Full Schedule

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Monday, September 23, 2019
7:15 AM - 8:15 AM

Breakfast
7:15 AM - 8:15 AM

Breakfast
Location: Ballroom AB

Favorite
7:15 AM - 5:30 PM

Registration Open
7:15 AM - 5:30 PM

Registration Open
Location: Registration Bridge East

Favorite
8:15 AM - 9:30 AM

Convergence LIVE: Where Community and Connecting Intersect
8:15 AM - 9:30 AM

Convergence LIVE: Where Community and Connecting Intersect
Location: Ballroom AB
Sarah Michel, CSP – Velvet Chainsaw Consulting; Linda F. Bowen, MS, RAC, FRAPS – Seattle Genetics, Inc.; Margaret Mucha, MJ, RAC, FRAP, CQA – Watson Health Imaging
Plenary

Favorite

Sarah Michel, CSP – Velvet Chainsaw Consulting ### 542411###Facilitator @@@ Linda F. Bowen, MS, RAC, FRAPS – Seattle Genetics, Inc. ### 551690###Facilitator @@@ Margaret Mucha, MJ, RAC, FRAP, CQA – Watson Health Imaging ### 579833###Facilitator
9:30 AM - 10:30 AM

Beverage Break
9:30 AM - 10:30 AM

Beverage Break
Location: Exhibit Hall A

Favorite
9:30 AM - 4:00 PM

Solution Center and RAPS Central Open
9:30 AM - 4:00 PM

Solution Center and RAPS Central Open
Location: Exhibit Hall A

Favorite
9:45 AM - 10:15 AM

Solution Circles
9:45 AM - 10:15 AM

Solution Circles
Location: RAPS Central, Exhibit Hall A

Favorite
9:45 AM - 10:15 AM

Solution Circle: Best Practices for Developing Product Strategies and Communicating to Internal and External Stakeholders
9:45 AM - 10:15 AM

Solution Circle: Best Practices for Developing Product Strategies and Communicating to Internal and External Stakeholders
Location: RAPS Central, Exhibit Hall A
Sue Hibbeln – Network Partners

Favorite

Sue Hibbeln – Network Partners ### 862300###Facilitator
9:45 AM - 10:15 AM

Solution Circle: Communicating Supply Chain Compliance Risk to Stakeholders (Sponsored by: Assent Compliance)
9:45 AM - 10:15 AM

Solution Circle: Communicating Supply Chain Compliance Risk to Stakeholders (Sponsored by: Assent Compliance)
Location: RAPS Central, Exhibit Hall A
Travis Miller – Assent

Favorite

Travis Miller – Assent ### 862308###Facilitator
9:45 AM - 10:15 AM

Solution Circle: How to Best Navigate Technical Disagreements in the New EU MDR Realm Between Notified Bodies and Competent Authorities
9:45 AM - 10:15 AM

Solution Circle: How to Best Navigate Technical Disagreements in the New EU MDR Realm Between Notified Bodies and Competent Authorities
Location: RAPS Central, Exhibit Hall A
Kimberly Trautman, MSc – NSF International

Favorite

Kimberly Trautman, MSc – NSF International ### 535494###Facilitator
9:45 AM - 10:15 AM

Solution Circle: Thinking on Your Feet: How to Shine Under Pressure
9:45 AM - 10:15 AM

Solution Circle: Thinking on Your Feet: How to Shine Under Pressure
Location: RAPS Central, Exhibit Hall A
Nancy Singer, JD, FRAPS – Compliance-Alliance

Favorite

Nancy Singer, JD, FRAPS – Compliance-Alliance ### 862304###Facilitator
10:30 AM - 12:00 PM

Advanced Therapies and Gene Editing – What’s in Store?
10:30 AM - 12:00 PM

Advanced Therapies and Gene Editing – What’s in Store?
Location: 202 A/B
Kirsten Messmer, PhD, RAC – PPD; John Noh, PharmD – Novartis Pharmaceuticals - ENTERPRISE; Aron F. Stein, PhD; Haroon Rashid Hashmi, MS, MPH – Ziopharm Oncology; Mary S. Newman, BS, MS – Audiences Therapeutic
Biopharmaceuticals (includes Biologics)

Favorite

Kirsten Messmer, PhD, RAC – PPD ### 595312###Session Leader @@@ John Noh, PharmD – Novartis Pharmaceuticals - ENTERPRISE ### 802030###Speaker @@@ Aron F. Stein, PhD ### 802031###Speaker @@@ Haroon Rashid Hashmi, MS, MPH – Ziopharm Oncology ### 825203###Speaker @@@ Mary S. Newman, BS, MS – Audiences Therapeutic ### 861203###Speaker
10:30 AM - 12:00 PM

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

Broad Stakeholder Panel Debate on Status of Implementation of the EU Medical Device Regulations MDR and IVDR
Location: 204 B
Gert Willem Bos, FRAPS – Qserve Group Inc. - ENTERPRISE; Bassil Akra, M.Sc, PhD – TUV SUD Product Service GmbH; Philippe Auclair, Pharma Dr, PhD , FRAPS – Abbott - ENTERPRISE; Duncan McPherson, MBBS FRCA – MHRA; Simon Richards, PhD – Abbott Rapid Diagnostics; Armin Ritzhaupt, PhD, MPH – European Medicines Agency; Sue Spencer – Qserve Group EU
Medical Devices (includes In Vitro Diagnostics)

Favorite

Gert Willem Bos, FRAPS – Qserve Group Inc. - ENTERPRISE ### 535440###Session Leader @@@ Bassil Akra, M.Sc, PhD – TUV SUD Product Service GmbH ### 535482###Panelist @@@ Philippe Auclair, Pharma Dr, PhD , FRAPS – Abbott - ENTERPRISE ### 535445###Panelist @@@ Duncan McPherson, MBBS FRCA – MHRA ### 844201###Panelist @@@ Simon Richards, PhD – Abbott Rapid Diagnostics ### 585116###Panelist @@@ Armin Ritzhaupt, PhD, MPH – European Medicines Agency ### 844383###Panelist @@@ Sue Spencer – Qserve Group EU ### 535447###Panelist
10:30 AM - 12:00 PM

Latest Trends and Relevant Topics in Orphan Drug Development and Regulation
10:30 AM - 12:00 PM

Latest Trends and Relevant Topics in Orphan Drug Development and Regulation
Location: 201 B
Martine Zimmermann – Alexion Pharmaceuticals; Megan O'Boyle – Phelan-McDermid Syndrome International Registry; Sabine Haubenreisser, MSc, PhD – European Medicines Agency; Nicole Wolanski – Food and Drug Administration; Anne Marie Finley, MS – Biotech Policy Group LLC
Biopharmaceuticals (includes Biologics)

Favorite

Martine Zimmermann – Alexion Pharmaceuticals ### 740303###Session Leader @@@ Megan O'Boyle – Phelan-McDermid Syndrome International Registry ### 850713###Speaker @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Speaker @@@ Nicole Wolanski – Food and Drug Administration ### 823754###Speaker @@@ Anne Marie Finley, MS – Biotech Policy Group LLC ### 850714###Moderator
10:30 AM - 12:00 PM

US FDA's Proposed Paradigm for Digital Health Oversight
10:30 AM - 12:00 PM

US FDA's Proposed Paradigm for Digital Health Oversight
Location: 204 C
Aaron Josephson, MS, CQIA(ASQ) – ML Strategies; Marisa Cruz – FDA; Michael Zagorski, RAC, CQA, CQE, MSBME, MEM; Benjamin Zegarelli, MS JD – Mintz Levin Cohn Ferris Glovsky and Popeo PC
Medical Devices (includes In Vitro Diagnostics)

Favorite

Aaron Josephson, MS, CQIA(ASQ) – ML Strategies ### 720658###Session Leader @@@ Marisa Cruz – FDA ### 832017###Speaker @@@ Michael Zagorski, RAC, CQA, CQE, MSBME, MEM ### 805587###Speaker @@@ Benjamin Zegarelli, MS JD – Mintz Levin Cohn Ferris Glovsky and Popeo PC ### 821949###Speaker
10:30 AM - 12:00 PM

Challenges in the Clinical Development of Biosimilars: Perspectives of the Innovator, Regulator and Sponsor
10:30 AM - 12:00 PM

Challenges in the Clinical Development of Biosimilars: Perspectives of the Innovator, Regulator and Sponsor
Location: 201C
Raymond A. Huml, MS, DVM, RAC – Quintiles; Partha Roy; Sarah Ringuette, MPH, RAC – ICON PLC
Biopharmaceuticals (includes Biologics)

Favorite

Raymond A. Huml, MS, DVM, RAC – Quintiles ### 740183###Session Leader @@@ Partha Roy ### 535464###Speaker @@@ Sarah Ringuette, MPH, RAC – ICON PLC ### 720637###Speaker
10:30 AM - 12:00 PM

egulatory Due Diligence: Investing in & Acquiring Viable Health Tech Companies
10:30 AM - 12:00 PM

Regulatory Due Diligence: Investing in & Acquiring Viable Health Tech Companies
Location: 201 A
Heikki Pitkanen, MSc – Lean Entries Ltd; Erik Vollebregt, LLM – Axon Lawyers
Business Acumen

Favorite

Heikki Pitkanen, MSc – Lean Entries Ltd ### 720645###Session Leader/Speaker @@@ Erik Vollebregt, LLM – Axon Lawyers ### 535481###Speaker
10:30 AM - 12:00 PM

LATAM Convergence: Changing the Paradigm of the Regulatory Sciences Landscape - Optimizing Reliance and Regulatory Capacities (Spanish simultaneous interpretation provided)
10:30 AM - 12:00 PM

LATAM Convergence: Changing the Paradigm of the Regulatory Sciences Landscape - Optimizing Reliance and Regulatory Capacities (Spanish simultaneous interpretation provided)
Location: 204 A
Rafael Pérez Cristiá, MD, PhD – Cuban Regulatory Agency (CECMED); Silvia Beatriz Bendiner – ICON plc; Maria Concepcion Prieto Yerro, MD, PhD – Spanish Agency for Medicines and Medical Devices; Andrea Laslop, MD; Bettina Ziegele, MA; Joao Paulo Ortega Terra – Brazilian Health Regulatory Agency (ANVISA); Valeria Teresa Garay – ANMAT, Argentina; Julio Sanchez Y Tepoz, Esq
Health Authority Forum

Favorite

Rafael Pérez Cristiá, MD, PhD – Cuban Regulatory Agency (CECMED) ### 574329###Session Leader @@@ Silvia Beatriz Bendiner – ICON plc ### 574330###Session Leader @@@ Maria Concepcion Prieto Yerro, MD, PhD – Spanish Agency for Medicines and Medical Devices ### 790292###Speaker @@@ Andrea Laslop, MD ### 573431###Speaker @@@ Bettina Ziegele, MA ### 573550###Speaker @@@ Joao Paulo Ortega Terra – Brazilian Health Regulatory Agency (ANVISA) ### 828566###Speaker @@@ Valeria Teresa Garay – ANMAT, Argentina ### 829509###Speaker @@@ Julio Sanchez Y Tepoz, Esq ### 816564###Speaker
10:30 AM - 12:00 PM

Medical Device Harmonization: Asia Pacific, Oceania and Impact of MDR
10:30 AM - 12:00 PM

Medical Device Harmonization: Asia Pacific, Oceania and Impact of MDR
Location: 203 A/B
Arthur Brandwood, BSc PhD FRAPS MIMMM CEng – Brandwood CKC; Lupi Trilaksono, SF, MM, Apt – Ministry of Health Republic of Indonesia
Medical Devices (includes In Vitro Diagnostics)

Favorite

Arthur Brandwood, BSc PhD FRAPS MIMMM CEng – Brandwood CKC ### 720655###Session Leader @@@ Lupi Trilaksono, SF, MM, Apt – Ministry of Health Republic of Indonesia ### 720628###Session Leader
12:00 PM - 1:00 PM

Lunch
12:00 PM - 1:00 PM

Lunch
Location: Exhibit Hall A

Favorite
12:15 PM - 12:45 PM

Solution Circles
12:15 PM - 12:45 PM

Solution Circles
Location: RAPS Central, Exhibit Hall A

Favorite
12:15 PM - 12:45 PM

Solution Circle: How to Best Navigate Technical Disagreements in the New EU MDR Realm Between Notified Bodies and Competent Authorities
12:15 PM - 12:45 PM

Solution Circle: How to Best Navigate Technical Disagreements in the New EU MDR Realm Between Notified Bodies and Competent Authorities
Location: RAPS Central, Exhibit Hall A
Kimberly Trautman, MSc – NSF International

Favorite

Kimberly Trautman, MSc – NSF International ### 535494###Facilitator
12:15 PM - 12:45 PM

Solution Circle: Key Concepts in Effective Communication
12:15 PM - 12:45 PM

Solution Circle: Key Concepts in Effective Communication
Location: RAPS Central, Exhibit Hall A
Janet L. Michener Whipple – Validant

Favorite

Janet L. Michener Whipple – Validant ### 760776###Facilitator
12:15 PM - 12:45 PM

Solution Circle: Navigating the regulatory career as an emerging young professional
12:15 PM - 12:45 PM

Solution Circle: Navigating the regulatory career as an emerging young professional

Favorite
12:15 PM - 12:45 PM

Solution Circle: Regulatory Writing
12:15 PM - 12:45 PM

Solution Circle: Regulatory Writing
Location: RAPS Central, Exhibit Hall A
Meredith Brown-Tuttle, RAC, FRAPS

Favorite

Meredith Brown-Tuttle, RAC, FRAPS ### 535518###Facilitator
12:15 PM - 12:45 PM

Solution Circle: What to Say in Those Oh No! Moments When You Get Handed Regulator Questions
12:15 PM - 12:45 PM

Solution Circle: What to Say in Those Oh No! Moments When You Get Handed Regulator Questions
Location: RAPS Central, Exhibit Hall A
Robert Seevers, PhD – Pearl Pathways

Favorite

Robert Seevers, PhD – Pearl Pathways ### 741673###Facilitator
12:15 PM - 12:45 PM

Solutions Circle: Navigating the regulatory career as an emerging young professional
12:15 PM - 12:45 PM

Solutions Circle: Navigating the regulatory career as an emerging young professional
Location: RAPS Central, Exhibit Hall A
Joao Duarte, MSc, MPharm – Alexion Pharmaceuticals

Favorite

Joao Duarte, MSc, MPharm – Alexion Pharmaceuticals ### 720625###Facilitator
12:15 PM - 1:00 PM

Disrupting Regulatory Process for Device and Diagnostics (Sponsored by: Veeva, Inc)
12:15 PM - 1:00 PM

Disrupting Regulatory Process for Device and Diagnostics (Sponsored by: Veeva, Inc)
Location: Sponsor Theatre, Exhibit Hall A
Terri Howard, RAC – Veeva Systems; Annemien Pullen, PhD – Veeva Systems

Favorite

Terri Howard, RAC – Veeva Systems ### 863186###Speaker @@@ Annemien Pullen, PhD – Veeva Systems ### 863187###Speaker
1:00 PM - 1:55 PM

Estimating Regulatory (Registration) Probability of Success
1:00 PM - 1:55 PM

Estimating Regulatory (Registration) Probability of Success
Location: 201 C
Kimberly Belsky, MS; Rodger Thompson, BS, Mechanical Engineering, Missouri S&T – Sierra Decision Consulting; Jennifer R. Weidman – Mallinckrodt Pharmaceuticals
Biopharmaceuticals (includes Biologics)

Favorite

Kimberly Belsky, MS ### 535468###Session Leader @@@ Rodger Thompson, BS, Mechanical Engineering, Missouri S&T – Sierra Decision Consulting ### 743536###Speaker @@@ Jennifer R. Weidman – Mallinckrodt Pharmaceuticals ### 743537###Speaker
1:00 PM - 1:55 PM

Global Pediatric Drug Development Trivia
1:00 PM - 1:55 PM

Global Pediatric Drug Development Trivia
Location: 202 A/B
Lynne Marie Georgopoulos, RN, MSHS, RAC – Synteract; Linda McBride, R.Ph., RAC – Regulatory Professionals Inc
Biopharmaceuticals (includes Biologics)

Favorite

Lynne Marie Georgopoulos, RN, MSHS, RAC – Synteract ### 720661###Session Leader @@@ Linda McBride, R.Ph., RAC – Regulatory Professionals Inc ### 720634###Session Leader
1:00 PM - 1:55 PM

Interactions with Health Authorities
1:00 PM - 1:55 PM

Interactions with Health Authorities
Location: 204 A
Don E. Boyer, HBSc., RAC, FRAP; Susan B. Stewart, JD – Kaleido Biosciences; Nobuhiro Handa, MD, PhD; Sabine Haubenreisser, MSc, PhD – European Medicines Agency; Kazuhiro Kajiyama, PhD; Duncan McPherson, MBBS FRCA – MHRA
Health Authority Forum

Favorite

Don E. Boyer, HBSc., RAC, FRAP ### 535533###Session Leader @@@ Susan B. Stewart, JD – Kaleido Biosciences ### 549202###Session Leader @@@ Nobuhiro Handa, MD, PhD ### 770532###Speaker @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Speaker @@@ Kazuhiro Kajiyama, PhD ### 770530###Speaker @@@ Duncan McPherson, MBBS FRCA – MHRA ### 844201###Speaker
1:00 PM - 1:55 PM

Models of Regulatory Support at Academic Medical Centers and Strategies for Collaborating with Industry
1:00 PM - 1:55 PM

Models of Regulatory Support at Academic Medical Centers and Strategies for Collaborating with Industry
Location: 201 A
Amanda Baumann Parrish, PhD, RAC; Inna Strakovsky, MRA, RAC – University of Pennsylvania (Div of Translational Medicine and Human Genetics)
Business Acumen

Favorite

Amanda Baumann Parrish, PhD, RAC ### 720663###Session Leader @@@ Inna Strakovsky, MRA, RAC – University of Pennsylvania (Div of Translational Medicine and Human Genetics) ### 720660###Speaker
1:00 PM - 1:55 PM

QMS Implementation of the MDR and IVDR
1:00 PM - 1:55 PM

QMS Implementation of the MDR and IVDR
Location: 204 B
Mindy McCann – Qserve Group Inc. - ENTERPRISE; Sharon L. Murphy, MBA – Hologic, Inc.
Medical Devices (includes In Vitro Diagnostics)

Favorite

Mindy McCann – Qserve Group Inc. - ENTERPRISE ### 720640###Session Leader @@@ Sharon L. Murphy, MBA – Hologic, Inc. ### 855745###Speaker
1:00 PM - 1:55 PM

Regulatory Challenges of Real-World Artificial Intelligence (AI) and Machine Learning (ML) in MedTech
1:00 PM - 1:55 PM

Regulatory Challenges of Real-World Artificial Intelligence (AI) and Machine Learning (ML) in MedTech
Location: 204C
Pamela J. Weagraff, MBA – Quintiles; Pat Baird, MBA, MS – Philips; Samir Shah
Medical Devices (includes In Vitro Diagnostics)

Favorite

Pamela J. Weagraff, MBA – Quintiles ### 720649###Session Leader @@@ Pat Baird, MBA, MS – Philips ### 805710###Speaker @@@ Samir Shah ### 805709###Speaker
1:00 PM - 1:55 PM

Regulatory Considerations for Companion Diagnostics
1:00 PM - 1:55 PM

Regulatory Considerations for Companion Diagnostics
Location: 203 A/B
Vihanga Pahalawatta, MS, PhD, RAC-US – Abbott - ENTERPRISE; Armin Ritzhaupt, PhD, MPH – European Medicines Agency; Reiko Yanagihara, PhD
Medical Devices (includes In Vitro Diagnostics)

Favorite

Vihanga Pahalawatta, MS, PhD, RAC-US – Abbott - ENTERPRISE ### 743792###Session Leader @@@ Armin Ritzhaupt, PhD, MPH – European Medicines Agency ### 844383###Speaker @@@ Reiko Yanagihara, PhD ### 770527###Speaker
1:00 PM - 1:55 PM

The Chemistry, Manufacturing, and Controls (CMC) Trivia
1:00 PM - 1:55 PM

The Chemistry, Manufacturing, and Controls (CMC) Trivia
Location: 201 B
Carolina Panico, MD, PhD – US FDA; Daniela Drago, PhD, RAC – George Washington University
Biopharmaceuticals (includes Biologics)

Favorite

Carolina Panico, MD, PhD – US FDA ### 535532###Moderator @@@ Daniela Drago, PhD, RAC – George Washington University ### 535534###Speaker
2:05 PM - 3:00 PM

Managing the Requirements of the EU Medical Device Regulation General Safety and Performance Requirement 10.4.1.
2:05 PM - 3:00 PM

Managing the Requirements of the EU Medical Device Regulation General Safety and Performance Requirement 10.4.1.
Location: 204 B
Adrian Keene, BSc (Hons) – NAMSA; Duncan McPherson, MBBS FRCA – MHRA
Medical Devices (includes In Vitro Diagnostics)

Favorite

Adrian Keene, BSc (Hons) – NAMSA ### 535507###Session Leader @@@ Duncan McPherson, MBBS FRCA – MHRA ### 844201###Speaker
2:05 PM - 3:00 PM

Novel Approaches in the Development of Oncology Drugs
2:05 PM - 3:00 PM

Novel Approaches in the Development and Review of Oncology Drugs
Location: 201 B
Marissa Braff, PhD, RAC – Seattle Genetics, Inc.; Lauren H. Cutler, MBS, RAC – Seattle Genetics, Inc.; Lisa Chao, PhD – Merck & Co Inc.; Tamy Kim, PharmD – FDA
Biopharmaceuticals (includes Biologics)

Favorite

Marissa Braff, PhD, RAC – Seattle Genetics, Inc. ### 743494###Session Leader @@@ Lauren H. Cutler, MBS, RAC – Seattle Genetics, Inc. ### 743495###Speaker @@@ Lisa Chao, PhD – Merck & Co Inc. ### 757439###Speaker @@@ Tamy Kim, PharmD – FDA ### 838301###Panelist
2:05 PM - 3:00 PM

Recognition and Appropriate Use of Voluntary Consensus Standards and Conformity Assessment in Premarket Submissions
2:05 PM - 3:00 PM

Recognition and Appropriate Use of Voluntary Consensus Standards and Conformity Assessment in Premarket Submissions
Location: 203 A/B
Jianchao Zeng, RAC (US) – CDRH, US FDA; Scott Colburn, MS, BSN – Food and Drug Administration
Medical Devices (includes In Vitro Diagnostics)

Favorite

Jianchao Zeng, RAC (US) – CDRH, US FDA ### 720659###Session Leader @@@ Scott Colburn, MS, BSN – Food and Drug Administration ### 805714###Speaker
2:05 PM - 3:00 PM

The Regulatory Intelligence Profession – Then and Now
2:05 PM - 3:00 PM

The Regulatory Intelligence Profession – Then and Now
Location: 201 A
Kirsten Messmer, PhD, RAC – PPD; Daanish Ashraf, PharmD – Biogen - ENTERPRISE; Oliver Steck; Joao Duarte, MSc, MPharm – Alexion Pharmaceuticals
Business Acumen

Favorite

Kirsten Messmer, PhD, RAC – PPD ### 595312###Session Leader @@@ Daanish Ashraf, PharmD – Biogen - ENTERPRISE ### 743776###Speaker @@@ Oliver Steck ### 593741###Speaker @@@ Joao Duarte, MSc, MPharm – Alexion Pharmaceuticals ### 720625###Panelist
2:05 PM - 3:00 PM

The Trials and Tribulations of Handling Legacy Products from a GMP and Regulatory Perspective
2:05 PM - 3:00 PM

The Trials and Tribulations of Handling Legacy Products from a GMP and Regulatory Perspective
Location: 202 A/B
John C. Lockwood, CQA, RAC, CSQE – Pearl Pathways; Jerry L. Chapman, BS, MBA – FDAzilla; Mark Louis Slisz – Pearl Pathways
Biopharmaceuticals (includes Biologics)

Favorite

John C. Lockwood, CQA, RAC, CSQE – Pearl Pathways ### 720641###Session Leader @@@ Jerry L. Chapman, BS, MBA – FDAzilla ### 786902###Speaker @@@ Mark Louis Slisz – Pearl Pathways ### 740308###Speaker
2:05 PM - 3:00 PM

Accelerating Innovative Device Strategy: From Modernizing the 510(k) to Improving the De Novo
2:05 PM - 3:00 PM

Accelerating Innovative Device Strategy: From Modernizing the 510(k) to Improving the De Novo
Location: 204 C
Mac McKeen, MBA, RAC – Boston Scientific Corporation; Marjorie Shulman – FDA; Natalia Remmel, PhD – Proscia, Inc
Medical Devices (includes In Vitro Diagnostics)

Favorite

Mac McKeen, MBA, RAC – Boston Scientific Corporation ### 772303###Moderator @@@ Marjorie Shulman – FDA ### 772335###Speaker @@@ Natalia Remmel, PhD – Proscia, Inc ### 855736###Speaker
2:05 PM - 3:00 PM

Brexit: Charting a Course Post-UK Departure
2:05 PM - 3:00 PM

Brexit: Charting a Course Post-UK Departure
Location: 201 C
Kimberly Belsky, MS; Michael Craig, BSc (Pharm) MPSI – PAREXEL International; Armin Ritzhaupt, PhD, MPH – European Medicines Agency
Biopharmaceuticals (includes Biologics)

Favorite

Kimberly Belsky, MS ### 535468###Chair @@@ Michael Craig, BSc (Pharm) MPSI – PAREXEL International ### 535462###Speaker @@@ Armin Ritzhaupt, PhD, MPH – European Medicines Agency ### 844383###Speaker
2:05 PM - 3:00 PM

Orthopedic Collaboration Highway: A Conversation with Notified Bodies, FDA, & Industry Advocacy Group, OSMA
2:05 PM - 3:00 PM

Orthopedic Collaboration Highway: A Conversation with Notified Bodies, FDA, & Industry Advocacy Group, OSMA
Location: 204 A
Stacey E. Bonnell, MBA – Depuy- Synthes Headquarters; Bassil Akra, M.Sc, PhD – TUV SUD Product Service GmbH; Raquel A. Peat, PhD – Food and Drug Administration; Monisha Phillips
Medical Devices (includes In Vitro Diagnostics)

Favorite

Stacey E. Bonnell, MBA – Depuy- Synthes Headquarters ### 757430###Session Leader @@@ Bassil Akra, M.Sc, PhD – TUV SUD Product Service GmbH ### 535482###Speaker @@@ Raquel A. Peat, PhD – Food and Drug Administration ### 772337###Speaker @@@ Monisha Phillips ### 855743###Speaker
3:00 PM - 3:45 PM

Cross-functional Approach to Operationalizing M&A Transactions Across Regulatory, Quality and Supply Chain (Sponsored by: GENPACT (UK) LTD.)
3:00 PM - 3:45 PM

Cross-functional Approach to Operationalizing M&A Transactions Across Regulatory, Quality and Supply Chain (Sponsored by: GENPACT (UK) LTD.)
Location: Sponsor Theatre, Exhibit Hall A

Favorite
3:00 PM - 4:00 PM

Beverage Break
3:00 PM - 4:00 PM

Beverage Break
Location: Exhibit Hall A

Favorite
3:15 PM - 3:45 PM

Solution Circles
3:15 PM - 3:45 PM

Solution Circles
Location: RAPS Central, Exhibit Hall A

Favorite
3:15 PM - 3:45 PM

Solution Circle: ALo Prosciences: A Novel LATAM Initiative Supporting the Regional and Global Regulatory Professional's Communities
3:15 PM - 3:45 PM

Solution Circle: ALo Prosciences: A Novel LATAM Initiative Supporting the Regional and Global Regulatory Professional's Communities
Location: RAPS Central, Exhibit Hall A
Silvia Beatriz Bendiner – ICON plc; Julio Sanchez Y Tepoz, Esq

Favorite

Silvia Beatriz Bendiner – ICON plc ### 574330###Facilitator @@@ Julio Sanchez Y Tepoz, Esq ### 816564###Facilitator
3:15 PM - 3:45 PM

Solution Circle: EU MDR: How Are You Implementing the Creation of PSURs?
3:15 PM - 3:45 PM

Solution Circle: EU MDR: How Are You Implementing the Creation of PSURs?
Location: RAPS Central, Exhibit Hall A
Nancy J. Morrison, RAC – Regulatory and Quality Solutions LLC - Enterprise

Favorite

Nancy J. Morrison, RAC – Regulatory and Quality Solutions LLC - Enterprise ### 757434###Facilitator
3:15 PM - 3:45 PM

Solution Circle: How to Best Navigate Technical Disagreements in the New EU MDR Realm Between Notified Bodies and Competent Authorities
3:15 PM - 3:45 PM

Solution Circle: How to Best Navigate Technical Disagreements in the New EU MDR Realm Between Notified Bodies and Competent Authorities
Location: RAPS Central, Exhibit Hall A
Kimberly Trautman, MSc – NSF International

Favorite

Kimberly Trautman, MSc – NSF International ### 535494###Facilitator
3:15 PM - 3:45 PM

Solution Circle: Pediatric Drug Development
3:15 PM - 3:45 PM

Solution Circle: Pediatric Drug Development
Location: RAPS Central, Exhibit Hall A
Klaus Rose – klausrose Consulting

Favorite

Klaus Rose – klausrose Consulting ### 716660###Facilitator
3:15 PM - 3:45 PM

Solution Circle: Risk Management: The Heart of Quality, Cost, Delivery and Regulatory Compliance
3:15 PM - 3:45 PM

Solution Circle: Risk Management: The Heart of Quality, Cost, Delivery and Regulatory Compliance
Location: RAPS Central, Exhibit Hall A
Janet L. Michener Whipple – Validant

Favorite

Janet L. Michener Whipple – Validant ### 760776###Facilitator
3:15 PM - 3:45 PM

Solution Circle: Strategy Discussion on Staying Current as an RA Professional
3:15 PM - 3:45 PM

Solution Circle: Strategy Discussion on Staying Current as an RA Professional
Location: RAPS Central, Exhibit Hall A
Maria Worth – Network Partners

Favorite

Maria Worth – Network Partners ### 862647###Facilitator
4:00 PM - 5:30 PM

CDRH Forum
4:00 PM - 5:30 PM

CDRH Forum
Location: 204 A
Mac McKeen, MBA, RAC – Boston Scientific Corporation; Sean M. Boyd, MPH – US Food and Drug Administration; Adam Evan Saltman, MD PhD; Marjorie Shulman – FDA
Health Authority Forum

Favorite

Mac McKeen, MBA, RAC – Boston Scientific Corporation ### 772303###Session Leader @@@ Sean M. Boyd, MPH – US Food and Drug Administration ### 772334###Speaker @@@ Adam Evan Saltman, MD PhD ### 772336###Speaker @@@ Marjorie Shulman – FDA ### 772335###Speaker
4:00 PM - 5:30 PM

Current Developments and Trends in Advertising and Promotion
4:00 PM - 5:30 PM

Current Developments and Trends in Advertising and Promotion
Location: 201C
Glenn N. Byrd, MBA – GByrd Ad-Promo Solutions, LLC; Kimberly Belsky, MS; Dale Cooke, MA, JD – PhillyCooke Consulting
Biopharmaceuticals (includes Biologics)

Favorite

Glenn N. Byrd, MBA – GByrd Ad-Promo Solutions, LLC ### 535430###Session Leader @@@ Kimberly Belsky, MS ### 535468###Speaker @@@ Dale Cooke, MA, JD – PhillyCooke Consulting ### 535431###Speaker
4:00 PM - 5:30 PM

How Novel Diagnostics Support Nutrition-Based Health and Disease Management
4:00 PM - 5:30 PM

How Novel Diagnostics Support Nutrition-Based Health and Disease Management
Location: 202 A/B
Manfred Ruthsatz, PhD, RPh, DABT, RAC, FRAPS, CC – -; Jim Kaput, PhD – Vydiant; Jessica O'Connell, JD, MPH
Biopharmaceuticals (includes Biologics)

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Manfred Ruthsatz, PhD, RPh, DABT, RAC, FRAPS, CC – - ### 535536###Session Leader @@@ Jim Kaput, PhD – Vydiant ### 790482###Speaker @@@ Jessica O'Connell, JD, MPH ### 601540###Speaker
4:00 PM - 5:30 PM

How to Review and Compile the Clinical Data in a Clinical Evaluation Report
4:00 PM - 5:30 PM

How to Review and Compile the Clinical Data in a Clinical Evaluation Report
Location: 204 B
Evangeline D. Loh, PhD, RAC (US, EU) – Cook Inc; Christopher Brodrick, MSc – GMED North America; Heather L. Crawford, RAC, CBA – Emergo Group Inc; Dona Occhipinti, MPH, CCRP – Hill-Rom Services Pte Ltd
Medical Devices (includes In Vitro Diagnostics)

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Evangeline D. Loh, PhD, RAC (US, EU) – Cook Inc ### 720644###Session Leader @@@ Christopher Brodrick, MSc – GMED North America ### 802195###Speaker @@@ Heather L. Crawford, RAC, CBA – Emergo Group Inc ### 823763###Speaker @@@ Dona Occhipinti, MPH, CCRP – Hill-Rom Services Pte Ltd ### 830647###Speaker
4:00 PM - 5:30 PM

Implementing Risk Based Decision Making Throughout the Entire Product Life Cycle
4:00 PM - 5:30 PM

Implementing Risk Based Decision Making Throughout the Entire Product Life Cycle
Location: 204 C
Tiea Theurer, ASQ CQE, CQM/OE; Jose M. Justiniano, MS Eng, MBA, RAC, CQE, CRE, CQA, CSSBB, CQM&OE – Ethicon Endo Surgery Inc; Barbara Young, CQE, CQA, CBA, CRE, CQM/OE
Medical Devices (includes In Vitro Diagnostics)

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Tiea Theurer, ASQ CQE, CQM/OE ### 720639###Session Leader @@@ Jose M. Justiniano, MS Eng, MBA, RAC, CQE, CRE, CQA, CSSBB, CQM&OE – Ethicon Endo Surgery Inc ### 805712###Speaker @@@ Barbara Young, CQE, CQA, CBA, CRE, CQM/OE ### 805713###Speaker
4:00 PM - 5:30 PM

Real-World Evidence in Regulatory Effectiveness Decisions
4:00 PM - 5:30 PM

Real-World Evidence in Regulatory Effectiveness Decisions
Location: 201B
Daryl Spinner, PhD – Evidera; Seema Betigeri, MS, PhD – Merck & Co., Inc; Sabine Haubenreisser, MSc, PhD – European Medicines Agency; Laura Koontz, PhD; Joshua Ransom, PhD – Medidata Solutions
Biopharmaceuticals (includes Biologics)

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Daryl Spinner, PhD – Evidera ### 740313###Session Leader @@@ Seema Betigeri, MS, PhD – Merck & Co., Inc ### 828929###Speaker @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Speaker @@@ Laura Koontz, PhD ### 828928###Speaker @@@ Joshua Ransom, PhD – Medidata Solutions ### 825199###Speaker
4:00 PM - 5:30 PM

Clarifying Patient Centered Policy: A Framework for Incorporating Patient Perspectives in FDA Regulatory Decision Making
4:00 PM - 5:30 PM

Clarifying Patient Centered Policy: A Framework for Incorporating Patient Perspectives in FDA Regulatory Decision Making
Location: 201 A
Carrie M. Kuehn, MA, MPH, LPD, RAC – Northeastern University, Boston MA; Diane Maloney, JD – FDA/CBER; Michael Manganiello – HCM Strategists; Carolyn Hiller, MBA
Business Acumen

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Carrie M. Kuehn, MA, MPH, LPD, RAC – Northeastern University, Boston MA ### 720643###Session Leader @@@ Diane Maloney, JD – FDA/CBER ### 858265###Speaker @@@ Michael Manganiello – HCM Strategists ### 786901###Speaker @@@ Carolyn Hiller, MBA ### 743541###Panelist
4:00 PM - 5:30 PM

Recent Developments in China Medical and IVD Devices: Submission, Modifications, MAH, Legal Agents and the Implications
4:00 PM - 5:30 PM

Recent Developments in China Medical and IVD Devices: Submission, Modifications, MAH, Legal Agents and the Implications
Location: 203 A/B
Grace Fu Palma, MBA – China Med Device; Yu Jing Yang, MS – Abbott Diabetes Care
Medical Devices (includes In Vitro Diagnostics)

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Grace Fu Palma, MBA – China Med Device ### 720651###Session Leader @@@ Yu Jing Yang, MS – Abbott Diabetes Care ### 802196###Speaker
6:00 PM - 9:00 PM

Dine Arounds (Departures at 6:00 pm and 6:30 pm)
6:00 PM - 9:00 PM

Dine Arounds (Departures at 6:00 pm and 6:30 pm)
Location: Departs from Registration Bridge East

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