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• A
• Accelerating Innovative Device Strategy: From Modernizing the 510(k) to Improving the De Novo
  Favorite
  Mac McKeen, MBA, RAC – Boston Scientific Corporation ### 772303###Moderator @@@ Marjorie Shulman – FDA ### 772335###Speaker @@@ Natalia Remmel, PhD – Proscia, Inc ### 855736###Speaker
• Advanced Leadership Workshop
  Favorite
  Trista Schoonmaker, PCC – COPIA Coaching and Consulting ### 593803###Facilitator @@@ Virginia Ann Swassing, RAC (US and EU) ### 593804###Facilitator
• Advanced Leadership Workshop
  Favorite
  Trista Schoonmaker, PCC – COPIA Coaching and Consulting ### 593803###Workshop Leader
• Advanced Therapies and Gene Editing – What’s in Store?
  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
• Advanced Therapies and RNA-based Therapeutics: Opportunities and Challenges
  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
• Applying FDA’s Rules in the New World of Online Marketing and Crowdsourcing
  Favorite
  Suzanne Levy Friedman, JD, M. Bioethics – Hogan Lovells US LLP - ENTERPRISE ### 720647###Session Leader
• Artificial Intelligence (AI) in Pharma: The Future Arrived Yesterday
  Favorite
  Dany DeGrave, Eng./Bio. – Unconventional Innovation ### 720654###Session Leader @@@ Oliver Steck ### 593741###Speaker
• B
• Being Medical Device Recalls Ready
  Favorite
  Rita R. Hoffman, RAC – Food and Drug Administration ### 535451###Session Leader @@@ Adam Evan Saltman, MD PhD ### 772336###Speaker
• Brexit: Charting a Course Post-UK Departure
  Favorite
  Kimberly Belsky, MS ### 535468###Chair @@@ Michael Craig, BSc (Pharm) MPSI – PAREXEL International ### 535462###Speaker @@@ Armin Ritzhaupt, PhD, MPH – European Medicines Agency ### 844383###Speaker
• Broad Stakeholder Panel Debate on Status of Implementation of the EU Medical Device Regulations MDR and IVDR
  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
• C
• Canada 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
• Cannabinoids: Therapeutic Applications and Regulatory Pathways
  Favorite
  Judith R. Plon, MBA, RAC ### 757440###Session Leader @@@ Karen Long, MSc, RAC ### 757441###Speaker @@@ Jessica O'Connell, JD, MPH ### 601540###Speaker
• CBER/OCE/CDER 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
• CDRH 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
• Challenges in the Clinical Development of Biosimilars: Perspectives of the Innovator, Regulator and Sponsor
  Favorite
  Raymond A. Huml, MS, DVM, RAC – Quintiles ### 740183###Session Leader @@@ Partha Roy ### 535464###Speaker @@@ Sarah Ringuette, MPH, RAC – ICON PLC ### 720637###Speaker
• China CER and EU CER: Different Logic on Clinical Evaluation Between Device Under Application and Equivalent Device
  Favorite
  Michael Yan – Qserve Group Inc. - ENTERPRISE ### 720632###Session Leader @@@ Jasmin Hunter – Qserve Group Inc. - ENTERPRISE ### 757436###Speaker
• Clarifying Patient Centered Policy: A Framework for Incorporating Patient Perspectives in FDA Regulatory Decision Making
  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
• Considerations for a Global Clinical Trial: 1572, National Laws and Clinical Trial Regulation
  Favorite
  Abhijit P. Pangu, M. Pharm – Regulatory Professionals Inc. ### 720657###Session Leader @@@ Marci P. Aderiye, MS ### 802032###Speaker
• Convergence Community Gathering
  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
• Convergence Kick-off: Getting the Most out of Your Convergence Journey
  Favorite
  Sarah Michel, CSP – Velvet Chainsaw Consulting ### 542411###Facilitator
• Convergence LIVE: Where Community and Connecting Intersect
  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
• Cross-functional Approach to Operationalizing M&A Transactions Across Regulatory, Quality and Supply Chain (Sponsored by: GENPACT (UK) LTD.)
  Favorite
• Cultural Intelligence in the Global and Digital Arena
  Favorite
  Annalisa Nash Fernandez ### 720631###Session Leader
• Current Developments and Trends in Advertising and Promotion
  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
• D
• Demystifying the EU MDR: From Transition to Implementation
  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
• Develop a Strategy to Obtain Enough Clinical Data for CE Marking of New and “Legacy” Products Under EU IVDR
  Favorite
  Julien Senac, PhD ### 535509###Session Leader @@@ Connie Angela Del Buono – Synoptyx Inc. ### 574722###Speaker
• Developing Your Global Medical Device Regulatory Strategy
  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
• Developing Your Global Medical Device Regulatory Strategy
  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
• Disrupting Regulatory Process for Device and Diagnostics (Sponsored by: Veeva, Inc)
  Favorite
  Terri Howard, RAC – Veeva Systems ### 863186###Speaker @@@ Annemien Pullen, PhD – Veeva Systems ### 863187###Speaker
• Don’t Blow Your Big Chance: How to Win with FDA and EMA Regulators
  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
• Drug Development in EU: Regulatory Standards, Support and New Approaches
  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
• Drug-Device Combination Products Through Different Regulatory Perspectives (MDD, MDR, MDSAP)
  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
• E
• Ensuring Regulatory Alignment with Innovative Virtual Siteless Clinical Design Trial Methodologies and Wearables to Support Drug Development
  Favorite
  Crystal Browning, MS – Pfizer - ENTERPRISE ### 720646###Session Leader @@@ Joy Chen, PhD – Pfizer, Inc ### 801622###Speaker @@@ Jay Nayar, MS, RAC – Verily ### 801623###Speaker
• Essentials of Regulatory Digital Transformations: How Leaders Can Drive Both Compliance and Growth (Sponsored by: Mareana Inc.)
  Favorite
• Estimating Regulatory (Registration) Probability of Success
  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
• EU MDR Annex II Technical Documentation Details: Too Much? Too Little? What is “Just Right”?
  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
• Europe 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
• European IVDR: State of the Implementation
  Favorite
  Julien Senac, PhD ### 535509###Session Leader @@@ Erik Vollebregt, LLM – Axon Lawyers ### 535481###Speaker
• G
• Global Pediatric Drug Development Trivia
  Favorite
  Lynne Marie Georgopoulos, RN, MSHS, RAC – Synteract ### 720661###Session Leader @@@ Linda McBride, R.Ph., RAC – Regulatory Professionals Inc ### 720634###Session Leader
• Global Use of Unique Device Identification (UDI)
  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
• H
• How Novel Diagnostics Support Nutrition-Based Health and Disease Management
  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
• How to Review and Compile the Clinical Data in a Clinical Evaluation Report
  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
• Human Factors in Your Hands: Developing Compliant Medical Devices While Optimizing Patient Usability
  Favorite
  Louise Place, MTOPRA – Cambridge Design Partnership ### 720650###Session Leader @@@ Tabitha Solomon ### 856123###Speaker
• I
• Implementing Risk Based Decision Making Throughout the Entire Product Life Cycle
  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
• Integrating Human Factors into Your Next Regulatory Submission: Lemons or Lemonade?
  Favorite
  Renee Bailey ### 720626###Workshop Leader @@@ Patricia A. Patterson ### 766104###Speaker @@@ Jessie Huisinga, PhD – Agilis Consulting Group, LLC ### 766105###Speaker
• Interactions with Health Authorities
  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
• Interactions with Health Authorities
  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
• IVDR: 2022 is NOT Far Away
  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
• J
• Japan Regulatory Updates: Pharmaceuticals and Medical Devices Act (PMD Act) and Real World Evidence (RWE) Utilization
  Favorite
  Nobumasa Nakashima, PhD ### 595307###Session Leader @@@ Nobuhiro Handa, MD, PhD ### 770532###Speaker @@@ Kazuhiro Kajiyama, PhD ### 770530###Speaker @@@ Manabu Fukuzawa – MHLW ### 595306###Speaker
• K
• Key Elements to Consider in the Technical Documentation of Drug-Devices Combination Products for Europe
  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
• L
• LATAM Convergence: Changing the Paradigm of the Regulatory Sciences Landscape - Optimizing Reliance and Regulatory Capacities (Spanish simultaneous interpretation provided)
  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
• Latest Trends and Relevant Topics in Orphan Drug Development and Regulation
  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
• M
• Managing the Requirements of the EU Medical Device Regulation General Safety and Performance Requirement 10.4.1.
  Favorite
  Adrian Keene, BSc (Hons) – NAMSA ### 535507###Session Leader @@@ Duncan McPherson, MBBS FRCA – MHRA ### 844201###Speaker
• MDIC’s Clinical Dx Program
  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
• Medical Device Harmonization: Asia Pacific, Oceania and Impact of MDR
  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
• Microbiome: Regulatory Challenges and Opportunities
  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
• Models of Regulatory Support at Academic Medical Centers and Strategies for Collaborating with Industry
  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
• Moving Beyond IVDR Requirements to Fulfillment
  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
• N
• Novel Approaches in the Development and Review of Oncology Drugs
  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
• O
• Orthopedic Collaboration Highway: A Conversation with Notified Bodies, FDA, & Industry Advocacy Group, OSMA
  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
• Overview and Update of FDA's Drug Development Tools: Qualification Programs and Fit-for-Purpose Initiative
  Favorite
  Ann Robbins, PhD – Ann Robbins LLC ### 720642###Session Leader @@@ Vikram Sinha ### 802193###Speaker @@@ Beth Walton – FDA ### 862659###Speaker
• P
• Patents and FDA Exclusivities for Drugs and Biologics
  Favorite
  Shana Cyr, PhD, JD – Finnegan LLP ### 720636###Speaker @@@ Kurt R. Karst, Attorney – American University Washington College of Law ### 535512###Speaker
• Patient Preference Data to Support Drug Development and Regulatory Decision Making
  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
• Pediatric Drug Development Regulatory Strategies for Global Success
  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
• Q
• QMS Implementation of the MDR and IVDR
  Favorite
  Mindy McCann – Qserve Group Inc. - ENTERPRISE ### 720640###Session Leader @@@ Sharon L. Murphy, MBA – Hologic, Inc. ### 855745###Speaker
• R
• Real-World Evidence in Regulatory Effectiveness Decisions
  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
• Recent Developments in China Medical and IVD Devices: Submission, Modifications, MAH, Legal Agents and the Implications
  Favorite
  Grace Fu Palma, MBA – China Med Device ### 720651###Session Leader @@@ Yu Jing Yang, MS – Abbott Diabetes Care ### 802196###Speaker
• Recognition and Appropriate Use of Voluntary Consensus Standards and Conformity Assessment in Premarket Submissions
  Favorite
  Jianchao Zeng, RAC (US) – CDRH, US FDA ### 720659###Session Leader @@@ Scott Colburn, MS, BSN – Food and Drug Administration ### 805714###Speaker
• Regulatory Challenges of Real-World Artificial Intelligence (AI) and Machine Learning (ML) in MedTech
  Favorite
  Pamela J. Weagraff, MBA – Quintiles ### 720649###Session Leader @@@ Pat Baird, MBA, MS – Philips ### 805710###Speaker @@@ Samir Shah ### 805709###Speaker
• Regulatory Considerations for Companion 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
• Regulatory Due Diligence: Investing in & Acquiring Viable Health Tech Companies
  Favorite
  Heikki Pitkanen, MSc – Lean Entries Ltd ### 720645###Session Leader/Speaker @@@ Erik Vollebregt, LLM – Axon Lawyers ### 535481###Speaker
• Regulatory Intelligence Strategies for Biopharmaceutical Development
  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
• Regulatory Intelligence Strategies for Biopharmaceutical Development
  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
• S
• Solution Circle: Best Practices for Developing Product Strategies and Communicating to Internal and External Stakeholders
  Favorite
  Sue Hibbeln – Network Partners ### 862300###Facilitator
• Solution Circle: Navigating the regulatory career as an emerging young professional
  Favorite
• Solution Circle: ALo Prosciences: A Novel LATAM Initiative Supporting the Regional and Global Regulatory Professional's Communities
  Favorite
  Silvia Beatriz Bendiner – ICON plc ### 574330###Facilitator @@@ Julio Sanchez Y Tepoz, Esq ### 816564###Facilitator
• Solution Circle: Challenges with Virtual Siteless Clinical Trials
  Favorite
  Crystal Browning, MS – Pfizer - ENTERPRISE ### 720646###Facilitator
• Solution Circle: Communicating Supply Chain Compliance Risk to Stakeholders (Sponsored by: Assent Compliance)
  Favorite
  Travis Miller – Assent ### 862308###Facilitator
• Solution Circle: Communicating to Internal and External Stakeholders
  Favorite
  Philippe Auclair, Pharma Dr, PhD , FRAPS – Abbott - ENTERPRISE ### 535445###Facilitator
• Solution Circle: EU MDR: How Are You Implementing the Creation of PSURs?
  Favorite
  Nancy J. Morrison, RAC – Regulatory and Quality Solutions LLC - Enterprise ### 757434###Facilitator
• Solution Circle: EU-IVDR: How Lessons Learned From EU-MDR Can Help Focus EU-IVDR Implementation
  Favorite
  Gert Willem Bos, FRAPS – Qserve Group Inc. - ENTERPRISE ### 535440###Facilitator
• Solution Circle: How to Best Navigate Technical Disagreements in the New EU MDR Realm Between Notified Bodies and Competent Authorities
  Favorite
  Kimberly Trautman, MSc – NSF International ### 535494###Facilitator
• Solution Circle: How to Best Navigate Technical Disagreements in the New EU MDR Realm Between Notified Bodies and Competent Authorities
  Favorite
  Kimberly Trautman, MSc – NSF International ### 535494###Facilitator
• Solution Circle: How to Best Navigate Technical Disagreements in the New EU MDR Realm Between Notified Bodies and Competent Authorities
  Favorite
  Kimberly Trautman, MSc – NSF International ### 535494###Facilitator
• Solution Circle: Improving the Review and Approval Process for Advertising and Promotion
  Favorite
  Dale Cooke, MA, JD – PhillyCooke Consulting ### 535431###Facilitator
• Solution Circle: Information Overload-3 Seconds and Next!
  Favorite
  Kimberly Belsky, MS ### 535468###Facilitator
• Solution Circle: Key Concepts in Effective Communication
  Favorite
  Janet L. Michener Whipple – Validant ### 760776###Facilitator
• Solution Circle: Leveraging Influence: What’s Holding You Back?
  Favorite
  Vihanga Pahalawatta, MS, PhD, RAC-US – Abbott - ENTERPRISE ### 743792###Facilitator
• Solution Circle: Managing Change During Remediation
  Favorite
  Susan Speicher – Network Partners ### 862658###Facilitator
• Solution Circle: Optimizing Communication between Regulatory and Key Stakeholders
  Favorite
  Kevin Healy, PhD, RAC – Enzyvant Therapeutics ### 535498###Facilitator
• Solution Circle: Orphan Drugs
  Favorite
  Anne Marie Finley, MS – Biotech Policy Group LLC ### 850714###Facilitator
• Solution Circle: Past Regulatory Approvals: The Commercialization Continuum, Identifying Partners, Reimbursement and International Expansion Strategies
  Favorite
  Luis Jimenez – Brandwood CKC ### 862654###Facilitator
• Solution Circle: Pediatric Drug Development
  Favorite
  Klaus Rose – klausrose Consulting ### 716660###Facilitator
• Solution Circle: Promoting Increased Patient Engagement in a “Patient-centered” Organization
  Favorite
  Carrie M. Kuehn, MA, MPH, LPD, RAC – Northeastern University, Boston MA ### 720643###Facilitator
• Solution Circle: Regulator Pre-consultations: Formal, Informal or Not at All?
  Favorite
  Arthur Brandwood, BSc PhD FRAPS MIMMM CEng – Brandwood CKC ### 720655###Facilitator
• Solution Circle: Regulatory Intelligence: Staying on the Front-Line
  Favorite
  Kirsten Messmer, PhD, RAC – PPD ### 595312###Facilitator
• Solution Circle: Regulatory Strategy and Change Management During M&A Activity
  Favorite
  Kelly Marco – PwC ### 862650###Facilitator @@@ Megha Sinha, RAC ### 535527###Facilitator
• Solution Circle: Regulatory Writing
  Favorite
  Meredith Brown-Tuttle, RAC, FRAPS ### 535518###Facilitator
• Solution Circle: Risk Management: The Heart of Quality, Cost, Delivery and Regulatory Compliance
  Favorite
  Janet L. Michener Whipple – Validant ### 760776###Facilitator
• Solution Circle: Strategy Discussion on Staying Current as an RA Professional
  Favorite
  Maria Worth – Network Partners ### 862647###Facilitator
• Solution Circle: Thinking on Your Feet: How to Shine Under Pressure
  Favorite
  Nancy Singer, JD, FRAPS – Compliance-Alliance ### 862304###Facilitator
• Solution Circle: What to Say in Those Oh No! Moments When You Get Handed Regulator Questions
  Favorite
  Robert Seevers, PhD – Pearl Pathways ### 741673###Facilitator
• Solution Circle: When to Request a Pre-Submission Meeting With FDA
  Favorite
  Mac McKeen, MBA, RAC – Boston Scientific Corporation ### 772303###Facilitator
• Solution Circle: Working More Efficiently with International Colleagues
  Favorite
  Nicole Landreville, P.Eng, RAC, FRAPS – GE Healthcare Madison WI USA (Madison, WI) ### 549200###Facilitator
• Solutions Circle: Navigating the regulatory career as an emerging young professional
  Favorite
  Joao Duarte, MSc, MPharm – Alexion Pharmaceuticals ### 720625###Facilitator
• T
• The Chemistry, Manufacturing, and Controls (CMC) Trivia
  Favorite
  Carolina Panico, MD, PhD – US FDA ### 535532###Moderator @@@ Daniela Drago, PhD, RAC – George Washington University ### 535534###Speaker
• The Regulatory Intelligence Profession – Then and Now
  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
• The Trials and Tribulations of Handling Legacy Products from a GMP and Regulatory Perspective
  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
• The Use of Artificial Intelligence in Decision Making
  Favorite
  Matthew Rich – PricewaterhouseCoopers LLP ### 720653###Session Leader @@@ Rachel Mercado ### 757442###Speaker @@@ Megha Sinha, RAC ### 535527###Speaker
• Toolkit for the Emerging Regulatory Leader
  Favorite
  Jennifer Owen-O'Quill, MDiv ### 720624###Workshop Leader
• Toolkit for the Emerging Regulatory Leader
  Favorite
  Jennifer Owen-O'Quill, MDiv ### 720624###Workshop Leader
• Transitioning from MDD to MDR: Case Studies, Tips, and Lessons Learned from Large-Scale Implementations of the EU MDR
  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
• U
• US FDA's Proposed Paradigm for Digital Health Oversight
  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
• 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)
  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
• W
• When To Bring In The Consultants
  Favorite
  Andrew S. Verderame, RAC, MBA – Pharmalex ### 720629###Session Leader @@@ Steven J. Knapp, MS, PharmD, RPh – Antares Pharma, Inc. ### 751663###Speaker
• Y
• Your Future as a Regulatory Professional in the Digital World
  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