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Saturday, September 21, 2019
7:00 AM - 8:00 AM

Workshop Breakfast
7:00 AM - 8:00 AM

Workshop Breakfast
Location: Grand Hall

Favorite
7:00 AM - 8:00 AM

Workshop Registration
7:00 AM - 8:00 AM

Workshop Registration
Location: Registration Bridge East

Favorite
8:00 AM - 9:00 AM

Workshop Welcome
8:00 AM - 9:00 AM

Workshop Welcome
Location: Ballroom AB
Sarah Michel, CSP – Velvet Chainsaw Consulting

Favorite

Sarah Michel, CSP – Velvet Chainsaw Consulting ### 542411###Facilitator
9:00 AM - 5:00 PM

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

Advanced Leadership Workshop
Location: 202 AB
Trista Schoonmaker, PCC – COPIA Coaching and Consulting; Virginia Ann Swassing, RAC (US and EU)
Preconference Workshop

Favorite

Trista Schoonmaker, PCC – COPIA Coaching and Consulting ### 593803###Facilitator @@@ Virginia Ann Swassing, RAC (US and EU) ### 593804###Facilitator
9:00 AM - 5:00 PM

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

Developing Your Global Medical Device Regulatory Strategy
Location: 201 A
Nicole Landreville, P.Eng, RAC, FRAPS – GE Healthcare Madison WI USA (Madison, WI); Megha Iyer, MS, RAC – Thermo Fisher Scientific; Bradley Hossack, Bsc – Stryker - ENTERPRISE; Patrick Lee, PE, MS, MBA, RAC – BioCardia Inc.
Preconference Workshop

Favorite

Nicole Landreville, P.Eng, RAC, FRAPS – GE Healthcare Madison WI USA (Madison, WI) ### 549200###Workshop Leader @@@ Megha Iyer, MS, RAC – Thermo Fisher Scientific ### 549206###Speaker @@@ Bradley Hossack, Bsc – Stryker - ENTERPRISE ### 549201###Speaker @@@ Patrick Lee, PE, MS, MBA, RAC – BioCardia Inc. ### 549205###Speaker
9:00 AM - 5:00 PM

Key Elements to Consider in the Technical Documentation of Drug-Devices Combination Products for Europe
9:00 AM - 5:00 PM

Key Elements to Consider in the Technical Documentation of Drug-Devices Combination Products for Europe
Location: 204 A
Waiss Faissal, PharmD – Voisins Consulting Life Science; Adrian Gammeter, BSc – Confinis AG - Enterprise; Viky Gilles Daniel Verna, MS BME, MS Pharm, RAC – confinis corporation
Preconference Workshop

Favorite

Waiss Faissal, PharmD – Voisins Consulting Life Science ### 535521###Workshop Leader @@@ Adrian Gammeter, BSc – Confinis AG - Enterprise ### 805719###Speaker @@@ Viky Gilles Daniel Verna, MS BME, MS Pharm, RAC – confinis corporation ### 805720###Speaker
9:00 AM - 5:00 PM

Moving Beyond IVDR Requirements to Fulfillment
9:00 AM - 5:00 PM

Moving Beyond IVDR Requirements to Fulfillment
Location: 204 B
Connie Angela Del Buono – Synoptyx Inc.; Lorry W. Huffman, MT (ASCP), CLS – Qserve Group US. Inc; Simon Richards, PhD – Abbott Rapid Diagnostics; Andreas Stange, PhD – T�V S�D Product Service GmbH; Anja Wiersma, PhD
Preconference Workshop

Favorite

Connie Angela Del Buono – Synoptyx Inc. ### 574722###Workshop Leader @@@ Lorry W. Huffman, MT (ASCP), CLS – Qserve Group US. Inc ### 573387###Speaker @@@ Simon Richards, PhD – Abbott Rapid Diagnostics ### 585116###Speaker @@@ Andreas Stange, PhD – T�V S�D Product Service GmbH ### 585266###Speaker @@@ Anja Wiersma, PhD ### 574723###Speaker
9:00 AM - 5:00 PM

Pediatric Drug Development Regulatory Strategies for Global Success
9:00 AM - 5:00 PM

Pediatric Drug Development Regulatory Strategies for Global Success
Location: 201C
Kimberly Belsky, MS; Karl-Heinz Huemer, MD, PhD – AGES (Austrian Agency for Health & Food Safety); Linda McBride, R.Ph., RAC – Regulatory Professionals Inc; Dara Wambach, MA – Regulatory Professionals Inc
Preconference Workshop

Favorite

Kimberly Belsky, MS ### 535468###Workshop Leader @@@ Karl-Heinz Huemer, MD, PhD – AGES (Austrian Agency for Health & Food Safety) ### 573393###Speaker @@@ Linda McBride, R.Ph., RAC – Regulatory Professionals Inc ### 720634###Speaker @@@ Dara Wambach, MA – Regulatory Professionals Inc ### 751666###Speaker
9:00 AM - 5:00 PM

Regulatory Intelligence Strategies for Biopharmaceutical Development
9:00 AM - 5:00 PM

Regulatory Intelligence Strategies for Biopharmaceutical Development
Location: 201 B
Joao Duarte, MSc, MPharm – Alexion Pharmaceuticals; Kirsten Messmer, PhD, RAC – PPD; Linda F. Bowen, MS, RAC, FRAPS – Seattle Genetics, Inc.; Janet Vessotskie, PhD MPH
Preconference Workshop

Favorite

Joao Duarte, MSc, MPharm – Alexion Pharmaceuticals ### 720625###Workshop Leader @@@ Kirsten Messmer, PhD, RAC – PPD ### 595312###Workshop Leader @@@ Linda F. Bowen, MS, RAC, FRAPS – Seattle Genetics, Inc. ### 551690###Speaker @@@ Janet Vessotskie, PhD MPH ### 757435###Speaker
9:00 AM - 5:00 PM

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

Toolkit for the Emerging Regulatory Leader
Location: 203 AB
Jennifer Owen-O'Quill, MDiv
Preconference Workshop

Favorite

Jennifer Owen-O'Quill, MDiv ### 720624###Workshop Leader
9:00 AM - 5:00 PM

Demystifying the EU MDR: From Transition to Implementation
9:00 AM - 5:00 PM

Demystifying the EU MDR: From Transition to Implementation
Location: 204C
Bassil Akra, M.Sc, PhD – TUV SUD Product Service GmbH; Sabina Hoekstra-van den Bosch, PharmD FRAPS – Central Committee on Human Research; Erik Vollebregt, LLM – Axon Lawyers; Mindy McCann – Qserve Group Inc. - ENTERPRISE; Rita Guzzetta, MBA – Medtronic Inc.; Joanna Develter – Edwards Lifesciences; Melissa Day, RN, BSN, MBA – Johnson & Johnson; Gert Willem Bos, FRAPS – Qserve Group Inc. - ENTERPRISE; Alexandra Jantzen Schroeder, PhD – BSI - ENTERPRISE; Philippe Auclair, Pharma Dr, PhD , FRAPS – Abbott - ENTERPRISE
Preconference Workshop

Favorite

Bassil Akra, M.Sc, PhD – TUV SUD Product Service GmbH ### 535482###Workshop Leader @@@ Sabina Hoekstra-van den Bosch, PharmD FRAPS – Central Committee on Human Research ### 574720###Workshop Leader @@@ Erik Vollebregt, LLM – Axon Lawyers ### 535481###Speaker @@@ Mindy McCann – Qserve Group Inc. - ENTERPRISE ### 720640###Speaker @@@ Rita Guzzetta, MBA – Medtronic Inc. ### 766092###Speaker @@@ Joanna Develter – Edwards Lifesciences ### 863149###Speaker @@@ Melissa Day, RN, BSN, MBA – Johnson & Johnson ### 593744###Speaker @@@ Gert Willem Bos, FRAPS – Qserve Group Inc. - ENTERPRISE ### 535440###Speaker @@@ Alexandra Jantzen Schroeder, PhD – BSI - ENTERPRISE ### 855738###Speaker @@@ Philippe Auclair, Pharma Dr, PhD , FRAPS – Abbott - ENTERPRISE ### 535445###Speaker
10:30 AM - 11:00 AM

Workshop Refreshment Break
10:30 AM - 11:00 AM

Workshop Refreshment Break
Location: 200 Level Foyer

Favorite
12:30 PM - 1:30 PM

Workshop Lunch
12:30 PM - 1:30 PM

Workshop Lunch
Location: Grand Hall

Favorite
3:00 PM - 3:30 PM

Workshop Refreshment Break
3:00 PM - 3:30 PM

Workshop Refreshment Break
Location: 200 Level Foyer

Favorite
5:00 PM - 6:00 PM

Workshop Wrap-up Social Hour
5:00 PM - 6:00 PM

Workshop Wrap-up Social Hour
Location: Field House

Favorite
Sunday, September 22, 2019
7:00 AM - 8:00 AM

Workshop Breakfast
7:00 AM - 8:00 AM

Workshop Breakfast
Location: Grand Hall

Favorite
7:00 AM - 8:00 AM

Workshop Registration
7:00 AM - 8:00 AM

Workshop Registration
Location: Registration Bridge East

Favorite
7:00 AM - 6:00 PM

Registration Open
7:00 AM - 6:00 PM

Registration Open
Location: Registration Bridge East

Favorite
8:00 AM - 4:00 PM

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

Advanced Leadership Workshop
Location: 202 AB
Trista Schoonmaker, PCC – COPIA Coaching and Consulting
Preconference Workshop

Favorite

Trista Schoonmaker, PCC – COPIA Coaching and Consulting ### 593803###Workshop Leader
8:00 AM - 4:00 PM

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

Developing Your Global Medical Device Regulatory Strategy
Location: 201 A
Nicole Landreville, P.Eng, RAC, FRAPS – GE Healthcare Madison WI USA (Madison, WI); Megha Iyer, MS, RAC – Thermo Fisher Scientific; Bradley Hossack, Bsc – Stryker - ENTERPRISE; Patrick Lee, PE, MS, MBA, RAC – BioCardia Inc.
Preconference Workshop

Favorite

Nicole Landreville, P.Eng, RAC, FRAPS – GE Healthcare Madison WI USA (Madison, WI) ### 549200###Workshop Leader @@@ Megha Iyer, MS, RAC – Thermo Fisher Scientific ### 549206###Speaker @@@ Bradley Hossack, Bsc – Stryker - ENTERPRISE ### 549201###Speaker @@@ Patrick Lee, PE, MS, MBA, RAC – BioCardia Inc. ### 549205###Speaker
8:00 AM - 4:00 PM

Regulatory Intelligence Strategies for Biopharmaceutical Development
8:00 AM - 4:00 PM

Regulatory Intelligence Strategies for Biopharmaceutical Development
Location: 201 B
Joao Duarte, MSc, MPharm – Alexion Pharmaceuticals; Kirsten Messmer, PhD, RAC – PPD; Linda F. Bowen, MS, RAC, FRAPS – Seattle Genetics, Inc.; Janet Vessotskie, PhD MPH
Preconference Workshop

Favorite

Joao Duarte, MSc, MPharm – Alexion Pharmaceuticals ### 720625###Workshop Leader @@@ Kirsten Messmer, PhD, RAC – PPD ### 595312###Workshop Leader @@@ Linda F. Bowen, MS, RAC, FRAPS – Seattle Genetics, Inc. ### 551690###Speaker @@@ Janet Vessotskie, PhD MPH ### 757435###Speaker
8:00 AM - 4:00 PM

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

Toolkit for the Emerging Regulatory Leader
Location: 203 AB
Jennifer Owen-O'Quill, MDiv
Preconference Workshop

Favorite

Jennifer Owen-O'Quill, MDiv ### 720624###Workshop Leader
8:00 AM - 4:00 PM

Drug Development in EU: Regulatory Standards, Support and New Approaches
8:00 AM - 4:00 PM

Drug Development in EU: Regulatory Standards, Support and New Approaches
Location: 204 B
Andrea Laslop, MD; Matthias Dormeyer, Dr; Sabine Haubenreisser, MSc, PhD – European Medicines Agency; Karl-Heinz Huemer, MD, PhD – AGES (Austrian Agency for Health & Food Safety); Jan Mueller-Berghaus (virtual presenter), MD; Bjorn Oddvar Strom, MPharm, PdD – Norwegian Medicines Agency; Maria Concepcion Prieto Yerro, MD, PhD – Spanish Agency for Medicines and Medical Devices
Preconference Workshop

Favorite

Andrea Laslop, MD ### 573431###Workshop Leader @@@ Matthias Dormeyer, Dr ### 573390###Speaker @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Speaker @@@ Karl-Heinz Huemer, MD, PhD – AGES (Austrian Agency for Health & Food Safety) ### 573393###Speaker @@@ Jan Mueller-Berghaus (virtual presenter), MD ### 790291###Speaker @@@ Bjorn Oddvar Strom, MPharm, PdD – Norwegian Medicines Agency ### 850710###Speaker @@@ Maria Concepcion Prieto Yerro, MD, PhD – Spanish Agency for Medicines and Medical Devices ### 790292###Speaker
8:00 AM - 4:00 PM

EU MDR Annex II Technical Documentation Details: Too Much? Too Little? What is “Just Right”?
8:00 AM - 4:00 PM

EU MDR Annex II Technical Documentation Details: Too Much? Too Little? What is “Just Right”?
Location: 204 C (Breakout 201 C)
Virginia Ann Swassing, RAC (US and EU); Ibim Tariah, PhD – Regulatory & Quality Solutions LLC; Janet L. Michener Whipple – Validant; Deborah Madsen – Madsen QRC, LLC; Julien Senac, PhD; Kimberly Snyder – Validant
Preconference Workshop

Favorite

Virginia Ann Swassing, RAC (US and EU) ### 593804###Workshop Leader @@@ Ibim Tariah, PhD – Regulatory & Quality Solutions LLC ### 757431###Speaker @@@ Janet L. Michener Whipple – Validant ### 760776###Speaker @@@ Deborah Madsen – Madsen QRC, LLC ### 850712###Facilitator @@@ Julien Senac, PhD ### 535509###Facilitator @@@ Kimberly Snyder – Validant ### 850711###Facilitator
8:00 AM - 4:00 PM

Integrating Human Factors into Your Next Regulatory Submission: Lemons or Lemonade?
8:00 AM - 4:00 PM

Integrating Human Factors into Your Next Regulatory Submission: Lemons or Lemonade?
Location: 204 A
Renee Bailey; Patricia A. Patterson; Jessie Huisinga, PhD – Agilis Consulting Group, LLC
Preconference Workshop

Favorite

Renee Bailey ### 720626###Workshop Leader @@@ Patricia A. Patterson ### 766104###Speaker @@@ Jessie Huisinga, PhD – Agilis Consulting Group, LLC ### 766105###Speaker
10:00 AM - 10:30 AM

Workshop Refreshment Break
10:00 AM - 10:30 AM

Workshop Refreshment Break
Location: 200 Level Foyer

Favorite
12:00 PM - 1:00 PM

Workshop Lunch
12:00 PM - 1:00 PM

Workshop Lunch
Location: Grand Hall

Favorite
2:30 PM - 3:00 PM

Workshop Refreshment Break
2:30 PM - 3:00 PM

Workshop Refreshment Break
Location: 200 Level Foyer

Favorite
4:30 PM - 5:30 PM

Convergence Kick-off: Getting the Most out of Your Convergence Journey
4:30 PM - 5:30 PM

Convergence Kick-off: Getting the Most out of Your Convergence Journey
Location: Ballroom AB
Sarah Michel, CSP – Velvet Chainsaw Consulting
Plenary

Favorite

Sarah Michel, CSP – Velvet Chainsaw Consulting ### 542411###Facilitator
5:45 PM - 7:15 PM

Convergence Welcome Reception and Solution Center Grand Opening
5:45 PM - 7:15 PM

Convergence Welcome Reception and Solution Center Grand Opening
Location: Exhibit Hall A

Favorite
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)

Favorite

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)

Favorite

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)

Favorite

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)

Favorite

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

Favorite

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)

Favorite

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

Favorite
Tuesday, September 24, 2019
7:15 AM - 8:15 AM

Breakfast
7:15 AM - 8:15 AM

Breakfast
Location: Ballroom AB

Favorite
7:15 AM - 8:15 AM

RAC Breakfast
7:15 AM - 8:15 AM

RAC 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 Community Gathering
8:15 AM - 9:30 AM

Convergence Community Gathering
Location: Ballroom AB
Sarah Michel, CSP – Velvet Chainsaw Consulting; Don E. Boyer, HBSc., RAC, FRAP; Paul Brooks – RAPS; Ashley Brown
Plenary

Favorite

Sarah Michel, CSP – Velvet Chainsaw Consulting ### 542411###Facilitator @@@ Don E. Boyer, HBSc., RAC, FRAP ### 535533###Speaker @@@ Paul Brooks – RAPS ### 549203###Speaker @@@ Ashley Brown ### 720652###Speaker
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: Communicating to Internal and External Stakeholders
9:45 AM - 10:15 AM

Solution Circle: Communicating to Internal and External Stakeholders
Location: RAPS Central, Exhibit Hall A
Philippe Auclair, Pharma Dr, PhD , FRAPS – Abbott - ENTERPRISE

Favorite

Philippe Auclair, Pharma Dr, PhD , FRAPS – Abbott - ENTERPRISE ### 535445###Facilitator
9:45 AM - 10:15 AM

Solution Circle: Information Overload-3 Seconds and Next!
9:45 AM - 10:15 AM

Solution Circle: Information Overload-3 Seconds and Next!
Location: RAPS Central, Exhibit Hall A
Kimberly Belsky, MS

Favorite

Kimberly Belsky, MS ### 535468###Facilitator
9:45 AM - 10:15 AM

Solution Circle: Regulatory Strategy and Change Management During M&A Activity
9:45 AM - 10:15 AM

Solution Circle: Regulatory Strategy and Change Management During M&A Activity
Location: RAPS Central, Exhibit Hall A
Kelly Marco – PwC; Megha Sinha, RAC

Favorite

Kelly Marco – PwC ### 862650###Facilitator @@@ Megha Sinha, RAC ### 535527###Facilitator
9:45 AM - 10:15 AM

Solution Circle: When to Request a Pre-Submission Meeting With FDA
9:45 AM - 10:15 AM

Solution Circle: When to Request a Pre-Submission Meeting With FDA
Location: RAPS Central, Exhibit Hall A
Mac McKeen, MBA, RAC – Boston Scientific Corporation

Favorite

Mac McKeen, MBA, RAC – Boston Scientific Corporation ### 772303###Facilitator
9:45 AM - 10:15 AM

Solution Circle: Working More Efficiently with International Colleagues
9:45 AM - 10:15 AM

Solution Circle: Working More Efficiently with International Colleagues
Location: RAPS Central, Exhibit Hall A
Nicole Landreville, P.Eng, RAC, FRAPS – GE Healthcare Madison WI USA (Madison, WI)

Favorite

Nicole Landreville, P.Eng, RAC, FRAPS – GE Healthcare Madison WI USA (Madison, WI) ### 549200###Facilitator
10:30 AM - 12:00 PM

Europe Forum
10:30 AM - 12:00 PM

Europe Forum
Location: 204 A
Sabine Haubenreisser, MSc, PhD – European Medicines Agency; Karl-Heinz Huemer, MD, PhD – AGES (Austrian Agency for Health & Food Safety); Andrea Laslop, MD; Armin Ritzhaupt, PhD, MPH – European Medicines Agency; Maria Concepcion Prieto Yerro, MD, PhD – Spanish Agency for Medicines and Medical Devices; Bettina Ziegele, MA
Health Authority Forum

Favorite

Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Session Leader @@@ Karl-Heinz Huemer, MD, PhD – AGES (Austrian Agency for Health & Food Safety) ### 573393###Speaker @@@ Andrea Laslop, MD ### 573431###Speaker @@@ Armin Ritzhaupt, PhD, MPH – European Medicines Agency ### 844383###Speaker @@@ Maria Concepcion Prieto Yerro, MD, PhD – Spanish Agency for Medicines and Medical Devices ### 790292###Speaker @@@ Bettina Ziegele, MA ### 573550###Speaker
10:30 AM - 12:00 PM

Artificial Intelligence (AI) in Pharma: The Future Arrived Yesterday
10:30 AM - 12:00 PM

Artificial Intelligence (AI) in Pharma: The Future Arrived Yesterday
Location: 201 A
Dany DeGrave, Eng./Bio. – Unconventional Innovation; Oliver Steck
Business Acumen

Favorite

Dany DeGrave, Eng./Bio. – Unconventional Innovation ### 720654###Session Leader @@@ Oliver Steck ### 593741###Speaker
10:30 AM - 12:00 PM

Cannabinoids: Therapeutic Applications and Regulatory Pathways
10:30 AM - 12:00 PM

Cannabinoids: Therapeutic Applications and Regulatory Pathways
Location: 202 A/B
Judith R. Plon, MBA, RAC; Karen Long, MSc, RAC; Jessica O'Connell, JD, MPH
Biopharmaceuticals (includes Biologics)

Favorite

Judith R. Plon, MBA, RAC ### 757440###Session Leader @@@ Karen Long, MSc, RAC ### 757441###Speaker @@@ Jessica O'Connell, JD, MPH ### 601540###Speaker
10:30 AM - 12:00 PM

Don’t Blow Your Big Chance: How to Win with FDA and EMA Regulators
10:30 AM - 12:00 PM

Don’t Blow Your Big Chance: How to Win with FDA and EMA Regulators
Location: 201 C
Cynthia A. DiBiasi – 3D Communications; Meredith Brown-Tuttle, RAC, FRAPS; Bert Regeer, MD – 3D Communications - ENTERPRISE; Robert Seevers, PhD – Pearl Pathways
Biopharmaceuticals (includes Biologics)

Favorite

Cynthia A. DiBiasi – 3D Communications ### 746322###Session Leader @@@ Meredith Brown-Tuttle, RAC, FRAPS ### 535518###Speaker @@@ Bert Regeer, MD – 3D Communications - ENTERPRISE ### 720656###Speaker @@@ Robert Seevers, PhD – Pearl Pathways ### 741673###Speaker
10:30 AM - 12:00 PM

Human Factors in Your Hands: Developing Compliant Medical Devices While Optimizing Patient Usability
10:30 AM - 12:00 PM

Human Factors in Your Hands: Developing Compliant Medical Devices While Optimizing Patient Usability
Location: 204 C
Louise Place, MTOPRA – Cambridge Design Partnership; Tabitha Solomon
Medical Devices (includes In Vitro Diagnostics)

Favorite

Louise Place, MTOPRA – Cambridge Design Partnership ### 720650###Session Leader @@@ Tabitha Solomon ### 856123###Speaker
10:30 AM - 12:00 PM

IVDR: 2022 is NOT Far Away
10:30 AM - 12:00 PM

IVDR: 2022 is NOT Far Away
Location: 204 B
Mindy McCann – Qserve Group Inc. - ENTERPRISE; Simon Richards, PhD – Abbott Rapid Diagnostics; Sue Spencer – Qserve Group EU
Medical Devices (includes In Vitro Diagnostics)

Favorite

Mindy McCann – Qserve Group Inc. - ENTERPRISE ### 720640###Session Leader @@@ Simon Richards, PhD – Abbott Rapid Diagnostics ### 585116###Speaker @@@ Sue Spencer – Qserve Group EU ### 535447###Speaker
10:30 AM - 12:00 PM

Japan Regulatory Updates: Pharmaceuticals and Medical Devices Act (PMD Act) and Real World Evidence (RWE) Utilization
10:30 AM - 12:00 PM

Japan Regulatory Updates: Pharmaceuticals and Medical Devices Act (PMD Act) and Real World Evidence (RWE) Utilization
Location: 203 A/B
Nobumasa Nakashima, PhD; Nobuhiro Handa, MD, PhD; Kazuhiro Kajiyama, PhD; Manabu Fukuzawa – MHLW
Medical Devices (includes In Vitro Diagnostics)

Favorite

Nobumasa Nakashima, PhD ### 595307###Session Leader @@@ Nobuhiro Handa, MD, PhD ### 770532###Speaker @@@ Kazuhiro Kajiyama, PhD ### 770530###Speaker @@@ Manabu Fukuzawa – MHLW ### 595306###Speaker
10:30 AM - 12:00 PM

Overview and Update of FDA's Drug Development Tools: Qualification Programs and Fit-for-Purpose Initiative
10:30 AM - 12:00 PM

Overview and Update of FDA's Drug Development Tools: Qualification Programs and Fit-for-Purpose Initiative
Location: 201 B
Ann Robbins, PhD – Ann Robbins LLC; Vikram Sinha; Beth Walton – FDA
Biopharmaceuticals (includes Biologics)

Favorite

Ann Robbins, PhD – Ann Robbins LLC ### 720642###Session Leader @@@ Vikram Sinha ### 802193###Speaker @@@ Beth Walton – FDA ### 862659###Speaker
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: EU-IVDR: How Lessons Learned From EU-MDR Can Help Focus EU-IVDR Implementation
12:15 PM - 12:45 PM

Solution Circle: EU-IVDR: How Lessons Learned From EU-MDR Can Help Focus EU-IVDR Implementation
Location: RAPS Central, Exhibit Hall A
Gert Willem Bos, FRAPS – Qserve Group Inc. - ENTERPRISE

Favorite

Gert Willem Bos, FRAPS – Qserve Group Inc. - ENTERPRISE ### 535440###Facilitator
12:15 PM - 12:45 PM

Solution Circle: Improving the Review and Approval Process for Advertising and Promotion
12:15 PM - 12:45 PM

Solution Circle: Improving the Review and Approval Process for Advertising and Promotion
Location: RAPS Central, Exhibit Hall A
Dale Cooke, MA, JD – PhillyCooke Consulting

Favorite

Dale Cooke, MA, JD – PhillyCooke Consulting ### 535431###Facilitator
12:15 PM - 12:45 PM

Solution Circle: Optimizing Communication between Regulatory and Key Stakeholders
12:15 PM - 12:45 PM

Solution Circle: Optimizing Communication between Regulatory and Key Stakeholders
Location: RAPS Central, Exhibit Hall A
Kevin Healy, PhD, RAC – Enzyvant Therapeutics

Favorite

Kevin Healy, PhD, RAC – Enzyvant Therapeutics ### 535498###Facilitator
12:15 PM - 12:45 PM

Solution Circle: Past Regulatory Approvals: The Commercialization Continuum, Identifying Partners, Reimbursement and International Expansion Strategies
12:15 PM - 12:45 PM

Solution Circle: Past Regulatory Approvals: The Commercialization Continuum, Identifying Partners, Reimbursement and International Expansion Strategies
Location: RAPS Central, Exhibit Hall A
Luis Jimenez – Brandwood CKC

Favorite

Luis Jimenez – Brandwood CKC ### 862654###Facilitator
12:15 PM - 12:45 PM

Solution Circle: Promoting Increased Patient Engagement in a “Patient-centered” Organization
12:15 PM - 12:45 PM

Solution Circle: Promoting Increased Patient Engagement in a “Patient-centered” Organization
Location: RAPS Central, Exhibit Hall A
Carrie M. Kuehn, MA, MPH, LPD, RAC – Northeastern University, Boston MA

Favorite

Carrie M. Kuehn, MA, MPH, LPD, RAC – Northeastern University, Boston MA ### 720643###Facilitator
12:15 PM - 12:45 PM

Solution Circle: Regulatory Intelligence: Staying on the Front-Line
12:15 PM - 12:45 PM

Solution Circle: Regulatory Intelligence: Staying on the Front-Line
Location: RAPS Central, Exhibit Hall A
Kirsten Messmer, PhD, RAC – PPD

Favorite

Kirsten Messmer, PhD, RAC – PPD ### 595312###Facilitator
12:15 PM - 1:00 PM

Essentials of Regulatory Digital Transformations: How Leaders Can Drive Both Compliance and Growth (Sponsored by: Mareana Inc.)
12:15 PM - 1:00 PM

Essentials of Regulatory Digital Transformations: How Leaders Can Drive Both Compliance and Growth (Sponsored by: Mareana Inc.)
Location: Sponsor Theatre, Exhibit Hall A

Favorite
1:00 PM - 1:55 PM

Applying FDA’s Rules in the New World of Online Marketing and Crowdsourcing
1:00 PM - 1:55 PM

Applying FDA’s Rules in the New World of Online Marketing and Crowdsourcing
Location: 203 AB
Suzanne Levy Friedman, JD, M. Bioethics – Hogan Lovells US LLP - ENTERPRISE
Medical Devices (includes In Vitro Diagnostics)

Favorite

Suzanne Levy Friedman, JD, M. Bioethics – Hogan Lovells US LLP - ENTERPRISE ### 720647###Session Leader
1:00 PM - 1:55 PM

Being Medical Device Recalls Ready
1:00 PM - 1:55 PM

Being Medical Device Recalls Ready
Location: 204 C
Rita R. Hoffman, RAC – Food and Drug Administration; Adam Evan Saltman, MD PhD
Medical Devices (includes In Vitro Diagnostics)

Favorite

Rita R. Hoffman, RAC – Food and Drug Administration ### 535451###Session Leader @@@ Adam Evan Saltman, MD PhD ### 772336###Speaker
1:00 PM - 1:55 PM

Canada Forum
1:00 PM - 1:55 PM

Canada Forum
Location: 204 A
Don E. Boyer, HBSc., RAC, FRAP; David Boudreau, ing – Health Canada; Veronica Yip, BSc., RAQC; Marianne Tang, B.Sc. MBA
Health Authority Forum

Favorite

Don E. Boyer, HBSc., RAC, FRAP ### 535533###Session Leader @@@ David Boudreau, ing – Health Canada ### 570151###Speaker @@@ Veronica Yip, BSc., RAQC ### 767648###Speaker @@@ Marianne Tang, B.Sc. MBA ### 816565###Speaker
1:00 PM - 1:55 PM

Ensuring Regulatory Alignment with Innovative Virtual Siteless Clinical Design Trial Methodologies and Wearables to Support Drug Development
1:00 PM - 1:55 PM

Ensuring Regulatory Alignment with Innovative Virtual Siteless Clinical Design Trial Methodologies and Wearables to Support Drug Development
Location: 202 A/B
Crystal Browning, MS – Pfizer - ENTERPRISE; Joy Chen, PhD – Pfizer, Inc; Jay Nayar, MS, RAC – Verily
Biopharmaceuticals (includes Biologics)

Favorite

Crystal Browning, MS – Pfizer - ENTERPRISE ### 720646###Session Leader @@@ Joy Chen, PhD – Pfizer, Inc ### 801622###Speaker @@@ Jay Nayar, MS, RAC – Verily ### 801623###Speaker
1:00 PM - 1:55 PM

The Use of Artificial Intelligence in Decision Making
1:00 PM - 1:55 PM

The Use of Artificial Intelligence in Decision Making
Location: 201 B
Matthew Rich – PricewaterhouseCoopers LLP; Rachel Mercado; Megha Sinha, RAC
Biopharmaceuticals (includes Biologics)

Favorite

Matthew Rich – PricewaterhouseCoopers LLP ### 720653###Session Leader @@@ Rachel Mercado ### 757442###Speaker @@@ Megha Sinha, RAC ### 535527###Speaker
1:00 PM - 1:55 PM

When to Bring in the Consultants
1:00 PM - 1:55 PM

When To Bring In The Consultants
Location: 201 A
Andrew S. Verderame, RAC, MBA – Pharmalex; Steven J. Knapp, MS, PharmD, RPh – Antares Pharma, Inc.
Business Acumen

Favorite

Andrew S. Verderame, RAC, MBA – Pharmalex ### 720629###Session Leader @@@ Steven J. Knapp, MS, PharmD, RPh – Antares Pharma, Inc. ### 751663###Speaker
1:00 PM - 1:55 PM

European IVDR: State of the Implementation
1:00 PM - 1:55 PM

European IVDR: State of the Implementation
Location: 204 B
Julien Senac, PhD; Erik Vollebregt, LLM – Axon Lawyers
Medical Devices (includes In Vitro Diagnostics)

Favorite

Julien Senac, PhD ### 535509###Session Leader @@@ Erik Vollebregt, LLM – Axon Lawyers ### 535481###Speaker
1:00 PM - 1:55 PM

Microbiome: Regulatory Challenges and Opportunities
1:00 PM - 1:55 PM

Microbiome: Regulatory Challenges and Opportunities
Location: 201 C
Miranda Johnson, PhD – Janssen Pharmaceuticals; Rebecca Lipsitz; Susan B. Stewart, JD – Kaleido Biosciences; Jim Weston, MBA – Sears Therapeutics, Inc
Biopharmaceuticals (includes Biologics)

Favorite

Miranda Johnson, PhD – Janssen Pharmaceuticals ### 757438###Session Leader @@@ Rebecca Lipsitz ### 805711###Speaker @@@ Susan B. Stewart, JD – Kaleido Biosciences ### 549202###Speaker @@@ Jim Weston, MBA – Sears Therapeutics, Inc ### 855335###Speaker
2:05 PM - 3:00 PM

Cultural Intelligence in the Global and Digital Arena
2:05 PM - 3:00 PM

Cultural Intelligence in the Global and Digital Arena
Location: 201 A
Annalisa Nash Fernandez
Business Acumen

Favorite

Annalisa Nash Fernandez ### 720631###Session Leader
2:05 PM - 3:00 PM

Develop a Strategy to Obtain Enough Clinical Data for CE Marking of New and “Legacy” Products Under EU IVDR
2:05 PM - 3:00 PM

Develop a Strategy to Obtain Enough Clinical Data for CE Marking of New and “Legacy” Products Under EU IVDR
Location: 204 B
Julien Senac, PhD; Connie Angela Del Buono – Synoptyx Inc.
Medical Devices (includes In Vitro Diagnostics)

Favorite

Julien Senac, PhD ### 535509###Session Leader @@@ Connie Angela Del Buono – Synoptyx Inc. ### 574722###Speaker
2:05 PM - 3:00 PM

Drug-Device Combination Products Through Different Regulatory Perspectives (MDD, MDR, MDSAP)
2:05 PM - 3:00 PM

Drug-Device Combination Products Through Different Regulatory Perspectives (MDD, MDR, MDSAP)
Location: 204 C
Waiss Faissal, PharmD – Voisins Consulting Life Science; David Boudreau, ing – Health Canada; Adrian Gammeter, BSc – Confinis AG - Enterprise; Viky Gilles Daniel Verna, MS BME, MS Pharm, RAC – confinis corporation
Multiple

Favorite

Waiss Faissal, PharmD – Voisins Consulting Life Science ### 535521###Session Leader @@@ David Boudreau, ing – Health Canada ### 570151###Speaker @@@ Adrian Gammeter, BSc – Confinis AG - Enterprise ### 805719###Speaker @@@ Viky Gilles Daniel Verna, MS BME, MS Pharm, RAC – confinis corporation ### 805720###Speaker
2:05 PM - 3:00 PM

Interactions with Health Authorities
2:05 PM - 3:00 PM

Interactions with Health Authorities
Location: 204 A
Don E. Boyer, HBSc., RAC, FRAP; Susan B. Stewart, JD – Kaleido Biosciences; Duncan McPherson, MBBS FRCA – MHRA; Armin Ritzhaupt, PhD, MPH – European Medicines Agency; Reiko Yanagihara, PhD
Health Authority Forum

Favorite

Don E. Boyer, HBSc., RAC, FRAP ### 535533###Session Leader @@@ Susan B. Stewart, JD – Kaleido Biosciences ### 549202###Session Leader @@@ Duncan McPherson, MBBS FRCA – MHRA ### 844201###Speaker @@@ Armin Ritzhaupt, PhD, MPH – European Medicines Agency ### 844383###Speaker @@@ Reiko Yanagihara, PhD ### 770527###Speaker
2:05 PM - 3:00 PM

Advanced Therapies and RNA-based Therapeutics: Opportunities and Challenges
2:05 PM - 3:00 PM

Advanced Therapies and RNA-based Therapeutics: Opportunities and Challenges
Location: 201 B
Kevin Healy, PhD, RAC – Enzyvant Therapeutics; Sabine Haubenreisser, MSc, PhD – European Medicines Agency; Tracy Meffen, MS, CQA, RAC – Genevant
Biopharmaceuticals (includes Biologics)

Favorite

Kevin Healy, PhD, RAC – Enzyvant Therapeutics ### 535498###Session Leader @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Speaker @@@ Tracy Meffen, MS, CQA, RAC – Genevant ### 720627###Speaker
2:05 PM - 3:00 PM

China CER and EU CER: Different Logic on Clinical Evaluation Between Device Under Application and Equivalent Device
2:05 PM - 3:00 PM

China CER and EU CER: Different Logic on Clinical Evaluation Between Device Under Application and Equivalent Device
Location: 203 A/B
Michael Yan – Qserve Group Inc. - ENTERPRISE; Jasmin Hunter – Qserve Group Inc. - ENTERPRISE
Medical Devices (includes In Vitro Diagnostics)

Favorite

Michael Yan – Qserve Group Inc. - ENTERPRISE ### 720632###Session Leader @@@ Jasmin Hunter – Qserve Group Inc. - ENTERPRISE ### 757436###Speaker
2:05 PM - 3:00 PM

Considerations for a Global Clinical Trial: 1572, National Laws and Clinical Trial Regulation
2:05 PM - 3:00 PM

Considerations for a Global Clinical Trial: 1572, National Laws and Clinical Trial Regulation
Location: 201 C
Abhijit P. Pangu, M. Pharm – Regulatory Professionals Inc.; Marci P. Aderiye, MS
Biopharmaceuticals (includes Biologics)

Favorite

Abhijit P. Pangu, M. Pharm – Regulatory Professionals Inc. ### 720657###Session Leader @@@ Marci P. Aderiye, MS ### 802032###Speaker
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: Challenges with Virtual Siteless Clinical Trials
3:15 PM - 3:45 PM

Solution Circle: Challenges with Virtual Siteless Clinical Trials
Location: RAPS Central, Exhibit Hall A
Crystal Browning, MS – Pfizer - ENTERPRISE

Favorite

Crystal Browning, MS – Pfizer - ENTERPRISE ### 720646###Facilitator
3:15 PM - 3:45 PM

Solution Circle: Leveraging Influence: What’s Holding You Back?
3:15 PM - 3:45 PM

Solution Circle: Leveraging Influence: What’s Holding You Back?
Location: RAPS Central, Exhibit Hall A
Vihanga Pahalawatta, MS, PhD, RAC-US – Abbott - ENTERPRISE

Favorite

Vihanga Pahalawatta, MS, PhD, RAC-US – Abbott - ENTERPRISE ### 743792###Facilitator
3:15 PM - 3:45 PM

Solution Circle: Managing Change During Remediation
3:15 PM - 3:45 PM

Solution Circle: Managing Change During Remediation
Location: RAPS Central, Exhibit Hall A
Susan Speicher – Network Partners

Favorite

Susan Speicher – Network Partners ### 862658###Facilitator
3:15 PM - 3:45 PM

Solution Circle: Orphan Drugs
3:15 PM - 3:45 PM

Solution Circle: Orphan Drugs
Location: RAPS Central, Exhibit Hall A
Anne Marie Finley, MS – Biotech Policy Group LLC

Favorite

Anne Marie Finley, MS – Biotech Policy Group LLC ### 850714###Facilitator
3:15 PM - 3:45 PM

Solution Circle: Regulator Pre-consultations: Formal, Informal or Not at All?
3:15 PM - 3:45 PM

Solution Circle: Regulator Pre-consultations: Formal, Informal or Not at All?
Location: RAPS Central, Exhibit Hall A
Arthur Brandwood, BSc PhD FRAPS MIMMM CEng – Brandwood CKC

Favorite

Arthur Brandwood, BSc PhD FRAPS MIMMM CEng – Brandwood CKC ### 720655###Facilitator
4:00 PM - 5:30 PM

CBER/OCE/CDER Forum
4:00 PM - 5:30 PM

CBER/OCE/CDER Forum
Location: 204 A
Carol Rehkopf, MS; Tamy Kim, PharmD – FDA; Peter Stein, MD – FDA; Celia M. Witten, PhD, MD – FDA
Health Authority Forum

Favorite

Carol Rehkopf, MS ### 858249###Moderator @@@ Tamy Kim, PharmD – FDA ### 838301###Speaker @@@ Peter Stein, MD – FDA ### 821434###Speaker @@@ Celia M. Witten, PhD, MD – FDA ### 796730###Speaker
4:00 PM - 5:30 PM

Global Use of Unique Device Identification (UDI)
4:00 PM - 5:30 PM

Global Use of Unique Device Identification (UDI)
Location: 203 A/B
Lena Cordie-Bancroft – Qualitas Professional Services, LLC; Hans-Heiner Junker (Virtual Presenter); Nancy J. LeMaster, MBA – Nancy J LeMaster Consulting; Terrie Reed, MSc
Medical Devices (includes In Vitro Diagnostics)

Favorite

Lena Cordie-Bancroft – Qualitas Professional Services, LLC ### 743793###Session Leader @@@ Hans-Heiner Junker (Virtual Presenter) ### 858257###Speaker @@@ Nancy J. LeMaster, MBA – Nancy J LeMaster Consulting ### 838240###Speaker @@@ Terrie Reed, MSc ### 855825###Speaker
4:00 PM - 5:30 PM

MDIC’s Clinical Dx Program
4:00 PM - 5:30 PM

MDIC’s Clinical Dx Program
Location: 204 C
Carolyn Hiller, MBA; Jaime Houghton, MS, MT(ASCP) – Sysmex America Inc; Louis Jacques, MD – ADVI; Timothy T. Stenzel, MD, PhD – FDA
Medical Devices (includes In Vitro Diagnostics)

Favorite

Carolyn Hiller, MBA ### 743541###Session Leader @@@ Jaime Houghton, MS, MT(ASCP) – Sysmex America Inc ### 805708###Speaker @@@ Louis Jacques, MD – ADVI ### 805707###Speaker @@@ Timothy T. Stenzel, MD, PhD – FDA ### 772342###Speaker
4:00 PM - 5:30 PM

Patents and FDA Exclusivities for Drugs and Biologics
4:00 PM - 5:30 PM

Patents and FDA Exclusivities for Drugs and Biologics
Location: 201 B
Shana Cyr, PhD, JD – Finnegan LLP; Kurt R. Karst, Attorney – American University Washington College of Law
Biopharmaceuticals (includes Biologics)

Favorite

Shana Cyr, PhD, JD – Finnegan LLP ### 720636###Speaker @@@ Kurt R. Karst, Attorney – American University Washington College of Law ### 535512###Speaker
4:00 PM - 5:30 PM

Patient Preference Data to Support Drug Development and Regulatory Decision Making
4:00 PM - 5:30 PM

Patient Preference Data to Support Drug Development and Regulatory Decision Making
Location: 202 A/B
Leo Russo, PhD – Pfizer Inc.; Sara Eggers, PhD; Bennett S. Levitan, MD-PhD – Johnson & Johnson Pharmaceutical R&D
Biopharmaceuticals (includes Biologics)

Favorite

Leo Russo, PhD – Pfizer Inc. ### 838239###Session Leader @@@ Sara Eggers, PhD ### 755508###Speaker @@@ Bennett S. Levitan, MD-PhD – Johnson & Johnson Pharmaceutical R&D ### 755507###Speaker
4:00 PM - 5:30 PM

Use of Real World Evidence and Data in the Regulatory Space from Industry Perspective and Health Canada Plain Language Labeling Regulations Update (Hosted by CAPRA)
4:00 PM - 5:30 PM

Use of Real World Evidence and Data in the Regulatory Space from Industry Perspective and Health Canada Plain Language Labeling Regulations Update (Hosted by CAPRA)
Location: 201 C
Queenia Lee; Cathy Y. Lau, PhD – Johnson & Joshnson (Janssen Pharmeceutica R&D); Robert Platt, PhD; Veronica Yip, BSc., RAQC
Multiple

Favorite

Queenia Lee ### 720635###Session Leader @@@ Cathy Y. Lau, PhD – Johnson & Joshnson (Janssen Pharmeceutica R&D) ### 767647###Speaker @@@ Robert Platt, PhD ### 791680###Speaker @@@ Veronica Yip, BSc., RAQC ### 767648###Speaker
4:00 PM - 5:30 PM

Your Future as a Regulatory Professional in the Digital World
4:00 PM - 5:30 PM

Your Future as a Regulatory Professional in the Digital World
Location: 201 A
Aman Khera – Worldwide Clinical Trials; Linda F. Bowen, MS, RAC, FRAPS – Seattle Genetics, Inc.; Oliver Steck; Lindsey Summers, MBA – Green Key Resources
Business Acumen

Favorite

Aman Khera – Worldwide Clinical Trials ### 593742###Session Leader @@@ Linda F. Bowen, MS, RAC, FRAPS – Seattle Genetics, Inc. ### 551690###Speaker @@@ Oliver Steck ### 593741###Speaker @@@ Lindsey Summers, MBA – Green Key Resources ### 802197###Speaker
4:00 PM - 5:30 PM

Transitioning from MDD to MDR: Case Studies, Tips, and Lessons Learned from Large-Scale Implementations of the EU MDR
4:00 PM - 5:30 PM

Transitioning from MDD to MDR: Case Studies, Tips, and Lessons Learned from Large-Scale Implementations of the EU MDR
Location: 204 B
Lisa M. Casavant, MME – Regulatory and Quality Solutions LLC - Enterprise; Caroline Byrd – Leica Biosystems Richmond, Inc.; Robert K. Lally, BSc, MBA, CEng – Stryker - ENTERPRISE; Patrick McCullagh – DePuy Synthes, Johnson & Johnson; Nancy J. Morrison, RAC – Regulatory and Quality Solutions LLC - Enterprise; Ibim Tariah, PhD – Regulatory & Quality Solutions LLC
Medical Devices (includes In Vitro Diagnostics)

Favorite

Lisa M. Casavant, MME – Regulatory and Quality Solutions LLC - Enterprise ### 765192###Session Leader @@@ Caroline Byrd – Leica Biosystems Richmond, Inc. ### 757433###Speaker @@@ Robert K. Lally, BSc, MBA, CEng – Stryker - ENTERPRISE ### 765193###Speaker @@@ Patrick McCullagh – DePuy Synthes, Johnson & Johnson ### 861881###Speaker @@@ Nancy J. Morrison, RAC – Regulatory and Quality Solutions LLC - Enterprise ### 757434###Speaker @@@ Ibim Tariah, PhD – Regulatory & Quality Solutions LLC ### 757431###Speaker
5:45 PM - 7:30 PM

Party with a Purpose: Regulatory Gives Back
5:45 PM - 7:30 PM

Party with a Purpose: Regulatory Gives Back
Location: Philadelphia Marriott Downtown, Franklin Hall B

Favorite