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Biopharma (includes Biologics)
Monday, Sep 14
10:00 AM – 11:30 AM EDT

Orphan Precedent and the Continued Evolution of the Orphan Drug Framework
Mark Rutter – Biogen - ENTERPRISE; Kristina Larsson, MSc – European Medicines Agency; Janet Maynard, MD, MHS – US Food and Drug Administration; Martine Zimmermann, PharmD – Alexion Pharmaceuticals
Biopharma (includes Biologics)
Monday, Sep 14
10:00 AM – 11:30 AM EDT

Recent Developments of the US Legislative/Policy Environment and Impact on Medical Products, Pricing and Patient Access
Anne Marie Finley, MS, RAC – Biotech Policy Group LLC; Kendra Martello, JD – Neurocrine Biosciences; Mallory O'Connor, MPH – Mallinckrodt
Biopharma (includes Biologics)
Monday, Sep 14
10:00 AM – 11:30 AM EDT

Work-sharing, Reliance, and Other Novel Approaches to Accelerating Review, Approvals, and Access
Robert Stringer – Brandwood CKC; Tina Kim-Hafken, MS; Michael Shum – Therapeutic Goods Administration - ENTERPRISE; Dianne Spillman – US Food and Drug Administration; Melissa Hunt, MSc – Health Canada
Biopharma (includes Biologics)
Monday, Sep 14
12:00 PM – 1:30 PM EDT

Advanced Therapy - What Is It?
Kirsten Messmer, PhD, RAC – PPD; Kamali G. Chance, PhD, MPH, RAC – BioSciences Corporation; Tobias Fleischmann, Dr. rer. nat., Dipl. Biol. – PPD; Ana Hidalgo-Simon, MD, PhD – European Medicines Agency
Biopharma (includes Biologics)
Monday, Sep 14
12:00 PM – 1:30 PM EDT

How to Be Patient-centric in Regulatory Affairs?
Alexis Reisin Miller, JD; Joao Duarte, MSc MPharm – Alexion Pharmaceuticals; Nathalie Bere, MPH – European Medicines Agency; Andrea Furia-Helms, MPH – US Food and Drug Administration; Danielle Boyce, MPH
Biopharma (includes Biologics)
Monday, Sep 14
2:05 PM – 3:00 PM EDT

Cannabis and Plant Derived Products as Pharmaceutical Products: Challenges and Harmonization
Ahmed Abouelnour, MSc., RAC – Medicago; John Joines, RPh, RAC – PPD; Michael Craig, BSc Pharm – PAREXEL International
Biopharma (includes Biologics)
Monday, Sep 14
2:05 PM – 3:00 PM EDT

Rx to OTC Switch – Expanding Self-Care by Enabling Consumer Decision-Making
Erin Oliver, MS, MBA, RAC, FRAPS – GlaxoSmithKline - ENTERPRISE; Kristen Brinkdopke, MBA – GSK Consumer Healthcare; Amanda Pike-McCrudden, MAA – U.S. Food and Drug Administration
Biopharma (includes Biologics)
Monday, Sep 14
2:05 PM – 3:00 PM EDT

Thinking Big About the Future of Real-Time Review – A Catalyst Reaching Far Beyond Oncology
Richard Jahn, JD, MS – Pfizer; Linda Bowen, MS, RAC, FRAPS – Seattle Genetics, Inc.; Heidi Christl Marchand, PharmD – Gilead Sciences Inc. - ENTERPRISE
Biopharma (includes Biologics)
Tuesday, Sep 15
9:35 AM – 10:30 AM EDT

Are You RMAT Ready? Insights and Lessons Learned for Success
Kirsten Messmer, PhD, RAC – PPD; Stephen Westover, RAC – Cook MyoSite Incorporated; Mary A. Lokuta, PhD – Mallinckrodt
Biopharma (includes Biologics)
Tuesday, Sep 15
9:35 AM – 10:30 AM EDT

Brexit – Moving Forward and Leveraging the Experience
Kimberly Belsky, MS – Mallinckrodt Pharmaceuticals; Michael Craig, BSc Pharm – PAREXEL International; Liam Keary – Mallinckrodt Pharmaceuticals (Specialty Brands Principal Office); Keith McDonald, FRPharmS, FFPM(hon) – Medicines & Healthcare Products Regulatory Agency (MHRA)
Biopharma (includes Biologics)
Tuesday, Sep 15
9:35 AM – 10:30 AM EDT

Manufacturing Quality: Lessons Learned from dealing with the Nitrosamine Impurities Case and Covid-19
Shereen Marie Nennig, BS; Tom Cosgrove – Covington & Burling LLP; Andrei Spinei, MPharm, MSc – European Medicines Agency
Biopharma (includes Biologics)
Tuesday, Sep 15
11:00 AM – 12:30 PM EDT

Harnessing Regulatory Intelligence to Drive Change: Lessons Learned from Industry Forum and Individual Company Approach
William J. Timmons, n/a – Deloitte; Darin Seth Oppenheimer, FRAPS, RAC, DRsc – Merck; Oliver Steck – Deloitte & Touche LLP
Biopharma (includes Biologics)
Tuesday, Sep 15
11:00 AM – 12:30 PM EDT

Regulatory-Grade Evidence: Is There Global Consensus On Existing Real-World Evidence (RWE) Frameworks?
Ilker Oztop, PhD – Janssen Pharmaceuticals; Dharmi Shah, PharmD – Sanofi - ENTERPRISE; Eric Faulkner, MPH – Evidera; Xavier Kurz, MD, MSc, PhD – European Medicines Agency
Biopharma (includes Biologics)
Tuesday, Sep 15
11:00 AM – 12:30 PM EDT

Spurring Innovation and Accelerating Approval During a Crisis
Anne Marie Finley, MS, RAC – Biotech Policy Group LLC; Marco Cavaleri, PhD; Sascha Haverfield, PhD – Takeda Pharmaceuticals; Alan Liss, PhD
Biopharma (includes Biologics)
Tuesday, Sep 15
1:00 PM – 2:30 PM EDT

AdPromo: Same, Similar, or Superior Claims
Glenn N. Byrd, MBA – GByrd Ad-Promo Solutions, LLC; Jennifer L. Kelley, MS, RAC – Sanofi; Alan G. Minsk, Esq. – Arnall Golden Gregory, LLP
Biopharma (includes Biologics)
Tuesday, Sep 15
1:00 PM – 2:30 PM EDT

Ensuring (Creating) Clinical Trial Diversity
Anne Marie Finley, MS, RAC – Biotech Policy Group LLC; Richardae Araojo, PharmD, MS – FDA; Anne Marie Inglis, PhD; Neena Nizar – The Jansens Foundation
Biopharma (includes Biologics)
Tuesday, Sep 15
1:00 PM – 2:30 PM EDT

Gene Editing – Where are We Now?
Kirsten Messmer, PhD, RAC – PPD; Daniel O'Connell – Intellia Therapeutics, Inc.; Aron Stein, PhD – Sangamo Therapeutics, Inc.; James Valentine – Hyman, Phelps & McNamara PC
Biopharma (includes Biologics)
Wednesday, Sep 16
10:35 AM – 11:30 AM EDT

Benefit-Risk from the Lens of the Patient
Alexis Reisin Miller, JD; Emily C. Freeman, MSc, PhD – Lundbeck Pharmaceuticals LLC; Priya Bahri, PhD – European Medicines Agency (EMA)
Biopharma (includes Biologics)
Wednesday, Sep 16
10:35 AM – 11:30 AM EDT

The Journey from Compassion to Affirmation - The Use of Expanded Access Trial Data in Drug Approvals
Anne Marie Finley, MS, RAC – Biotech Policy Group LLC; Roxanne Tavakkol, MS, RAC – Mallinckrodt Pharmaceuticals (Specialty Brands Principal Office); Philippe MOTTE, PhD, MBA – GENFIT
Biopharma (includes Biologics)
Wednesday, Sep 16
10:35 AM – 11:30 AM EDT

The Regulatory Strategy of Drug Competition
Kimberly Belsky, MS; Christine E. Kobryn, PhD – Pfizer - ENTERPRISE; Scott M. Lassman, JD – Lassman Law+Policy
Biopharma (includes Biologics)
Wednesday, Sep 16
12:05 PM – 1:00 PM EDT

Introduction to Advanced Therapies: Focusing on Regulatory Considerations for the Development of CAR-T Cell Immunotherapy Products
Kirsten Messmer, PhD, RAC – PPD; Richard Dennett – PPD; Ana Hidalgo-Simon, MD, PhD – European Medicines Agency
Biopharma (includes Biologics)
Wednesday, Sep 16
12:05 PM – 1:00 PM EDT

Introduction to the Over the Counter Monograph Reform in the 2020 CARES Act
Daniel Paul Keravich, MSc, MBA , RAC – GlaxoSmithKline; Theresa Michele, MD – US Food and Drug Administration; Barbara Kochanowski, PhD – CHPA consumer healthcare products association
Biopharma (includes Biologics)
Wednesday, Sep 16
12:05 PM – 1:00 PM EDT

The Secrets of Creating an Effective Regulatory Strategy and Avoiding Disastrous Mistakes
Daniela Drago, PhD, RAC – Biogen - ENTERPRISE; Susan Carino, MBA, MS, PMP, RAC – Integrated Project Management Company, Inc.; Fortunato Senatore, MD, PhD, FACC – US Food and Drug Administration
Biopharma (includes Biologics)
Business Acumen
Monday, Sep 14
10:00 AM – 11:30 AM EDT

Building a Complete, Effective Communication Strategy as a Regulatory Affairs Professional
Gregory Morehouse – Abbott Laboratores
Business Acumen
Monday, Sep 14
12:00 PM – 1:30 PM EDT

The Future of the Regulatory Professional in the Digital World
Aman Khera, BSc Hons. MTOPRA – Worldwide Clinical Trials; Linda Bowen, MS, RAC, FRAPS – Seattle Genetics, Inc.; Oliver Steck – Deloitte & Touche LLP; Lindsey Summers, MBA – Green Key Resources
Business Acumen
Monday, Sep 14
2:05 PM – 3:00 PM EDT

Technology and Innovation Case Studies in Regulatory Affairs
Brian Wellins, MBA – PPD; Rob Connelly, MBA – Certara
Business Acumen
Tuesday, Sep 15
9:35 AM – 10:30 AM EDT

Are You Ready for the Next Big Merger or Acquisition? Navigating a Successful M&A in a Dynamic Regulatory Environment
Megha Sinha, RAC; Brian Riewerts – PwC
Business Acumen
Tuesday, Sep 15
11:00 AM – 12:30 PM EDT

Leadership Insights for Regulatory Professionals—Personal Brand Management
Ruba Hadidi, M.Eng, PMP – Integrated Project Management Inc.
Business Acumen
Tuesday, Sep 15
1:00 PM – 2:30 PM EDT

Don’t Let a Crisis Become a Disaster
Eric Hill, MS, PMP – Integrated Project Management Company, Inc.; Patricia Reardon, PhD, PMP – Integrated Project Management Company, Inc.
Business Acumen
Wednesday, Sep 16
10:35 AM – 11:30 AM EDT

Regulatory Insights Throughout The Commercialization Realm and Product Life Cycle
Paul B. Cook, PhD, PMP; Tina M. Purcell, PharmD, BCPS, PMP – Astellas Pharma Global Development, Inc.; Janaki M. Subramanyam, MS, RAC – Allena Pharmaceuticals Inc.; Eyal Golan, MBA, PMP – Integrated Project Management; Tammy Phinney; Joanne E. Totosy de Zepetnek, MSc, PhD – Rhythm Pharmaceuticals
Business Acumen
Wednesday, Sep 16
12:05 PM – 1:00 PM EDT

Regulatory Career Development Pathways, Risks and Rewards - Understanding Potential Obstacles and Breaking Down Barriers
Donna M. Haire, M.S. – The Eriah Group, LLC
Business Acumen
Health Authority Forum
Monday, Sep 14
10:00 AM – 11:30 AM EDT

Europe Forum
Sabine Haubenreisser, MSc, PhD – European Medicines Agency; Falk Ehmann, MD, PhD, MSc, – European Medicines Agency; Ana Hidalgo-Simon, MD, PhD – European Medicines Agency; Jan Mueller-Berghaus, MD; Karl-Heinz Huemer, MD, PhD – AGES (Austrian Agency for Health & Food Safety); Maria Concepción Prieto Yerro, MD, PhD – Spanish Agency for Medicines and Medical Devices; Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency
Health Authority Forum
Monday, Sep 14
12:00 PM – 1:30 PM EDT

ICH, ICMRA and other Global Health Authority Collaboration – Exemplified by COVID-19 and Other Innovative Advancements from AI to AMR and Beyond
Lawrence Liberti, MSc, PhD – CIRS- Centre for Innovation in Regulatory Science; Agnes Saint-Raymond, MD – European Medicines Agency; Fergus Sweeney – European Medicines Agency; Celia Lourenco, PhD – Health Canada
Health Authority Forum
Monday, Sep 14
2:05 PM – 3:00 PM EDT

Regulatory Innovation at Health Canada: Advancing Agile Regulations for Drugs and Devices
Don E. Boyer, HBSc., RAC, FRAP; Elizabeth Toller – Health Canada; Tanya Ramsamy, PhD – Health Canada; Celia Lourenco, PhD – Health Canada; David Boudreau, ing – Health Canada; Catherine Hudon – Health Canada
Health Authority Forum
Tuesday, Sep 15
9:35 AM – 10:30 AM EDT

LATAM Forum: Driving Regulatory Convergence, Optimizing Regulatory Capacities and Innovation
Silvia B. Bendiner, BA – BENDINER NL; Yaquelin Rodríguez Valdés – Cuban Regulatory Authority (CECMED); Lawrence Liberti, MSc, PhD – CIRS- Centre for Innovation in Regulatory Science; Mario Alanis, PhD – CIRS- Centre for Innovation in Regulatory Science; Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency; Cesar Hernández – AEMPS
Health Authority Forum
Tuesday, Sep 15
11:00 AM – 12:30 PM EDT

CDRH Forum
Margaret Mucha (FRAPS), MJ, RAC, FRAP, CQA – Merge IBM; Heather Agler, PhD – US Food and Drug Administration; Binita Ashar, MD, MBA, FACS – US Food and Drug Administration; Daniel Caños, PhD, MPH – US Food and Drug Administration; William Maisel, MD, MPH – US Food and Drug Administration; Jeffrey Shuren, MD, JD – CDRH; Timothy T. Stenzel, MD, PhD – US Food and Drug Administration; Michelle Tarver, MD, PhD – US Food and Drug Administration; Eli Tomar, JD, MPH – US Food and Drug Administration
Health Authority Forum
Tuesday, Sep 15
1:00 PM – 2:30 PM EDT

Oncology Center of Excellence (OCE) Forum
Marissa Braff, PhD, RAC – Seattle Genetics, Inc.; Tamy Kim, PharmD – US Food and Drug Administration; Elleni Alebachew, MS – US Food and Drug Administration; Dianne Spillman – US Food and Drug Administration; Pamela Balcazar, MS – US Food and Drug Administration; Jessica Boehmer, MBA – US Food and Drug Administration
Health Authority Forum
Medical Devices (includes IVDs)
Monday, Sep 14
10:00 AM – 11:30 AM EDT

China NMPA (CFDA) Regulatory and Clinical Affairs Key Updates
Grace Fu Palma, MBA – China Med Device, LLC; Jason Liang – China Med Device, LLC; Xin Sun – West China Hospital, Sichuan University in Chengdu, China; Jane Lin – Johnson and Johnson Medical; Wei Shang, RAC, CQA; Lindsay Tao, MD – J&J Worldwide GA & Policy
Medical Devices (includes IVDs)
Monday, Sep 14
10:00 AM – 11:30 AM EDT

Opening Panel on EU MDR and IVDR
Gert Willem Bos, FRAPS – Qserve Group Inc.; Bassil Akra, PhD – QUNIQUE GmbH; Philippe Auclair, Pharma Dr, PhD , FRAPS – Abbott; Oliver Bisazza – MedTech Europe; Erica Conway, PhD – BSI (London); Laura de Vries, PhD – Dutch Health and Youth Care Inspectorate; Sabina Hoekstra-van den Bosch, PharmD, FRAPS – TUV SUD Product Service GmbH; Armin Ritzhaupt, PhD, MPH – European Medicines Agency; Sue Spencer – Qserve Group (United Kingdom); John Wilkinson, MBA – Global Medical Devices Nomenclature
Medical Devices (includes IVDs)
Monday, Sep 14
10:00 AM – 11:30 AM EDT

The Shifting Regulatory Framework for Digital Health Software: Where We’ve Been and What’s to Come
M. Jason Brooke, MSE, JD, CSQE; Bakul Patel, MSEE, MBA – Food And Drug Administration; Tracey Fox, MS, RAC – IBM Watson Health; David Vidal, JD
Medical Devices (includes IVDs)
Monday, Sep 14
12:00 PM – 1:30 PM EDT

Implementing Effective EU MDR Postmarket Surveillance (PMS) Processes to Deliver Your Periodic Safety Update Report (PSUR): Challenges and Practical Approaches
Adrian Keene, BSc (Hons) – NAMSA; Ludger Johannes Moeller – Medical Device Safety Service GmbH; Philippe Auclair, Pharma Dr, PhD , FRAPS – Abbott
Medical Devices (includes IVDs)
Monday, Sep 14
12:00 PM – 1:30 PM EDT

Medical Device Cybersecurity: Planning a Global Strategy
Michelle Lynn Jump, RAC – Stryker - ENTERPRISE; Suzanne Schwartz, MD, MBA – US Food and Drug Administration
Medical Devices (includes IVDs)
Monday, Sep 14
12:00 PM – 1:30 PM EDT

Transitioning From the Soft Transition: Technical Documentation and UDI
Maria Vrabie – Abbott; Mindy McCann – Qserve Group Inc. - ENTERPRISE; Jane Arnold-Round, B.Eng Msc.; Lena Cordie-Bancroft – Qualitas Professional Services, LLC
Medical Devices (includes IVDs)
Monday, Sep 14
2:05 PM – 3:00 PM EDT

FDA Medical Device Submissions in a Changing Regulatory Landscape, Including 510(k) and Denovo Process
Mac McKeen, RAC, FRAPS, MBA, RAC FRAPS MBA – Boston Scientific - ENTERPRISE; Marjorie Shulman – US Food and Drug Administration; Peter Yang, PhD – Division of Submission Support, Office of Regulatory Programs, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration
Medical Devices (includes IVDs)
Monday, Sep 14
2:05 PM – 3:00 PM EDT

How to Apply Risk to Your Total Product Life Cycle Using ISO 14971:2019
Tom Rish
Medical Devices (includes IVDs)
Monday, Sep 14
2:05 PM – 3:00 PM EDT

Japan Forum: Amendment of the Pharmaceutical and Medical Device Act and Regulatory Updates in Japan
Tetsuya Kusakabe, PhD – PMDA; Junichi Ohishi, PhD – Pharmaceuticals and Medical Devices Agency (PMDA); Kanako Sasaki
Medical Devices (includes IVDs)
Tuesday, Sep 15
9:35 AM – 10:30 AM EDT

Do LDTs Have a Future? A Perspective from Both USA and EU Post IVD-R Implementation
Maurizio Suppo, PhD – Qarad; Hilary A. Baldwin – Caris Life Sciences
Medical Devices (includes IVDs)
Tuesday, Sep 15
9:35 AM – 10:30 AM EDT

Lessons Learned From First MDR/IVDR Certifications
Suzanne Elizabeth Halliday, MSc. D.Phil. – BSI - ENTERPRISE; Johnathon William Bis – BSI (London); Erica Conway, PhD – BSI (London); Royth Philippp von Hahn, PhD – TUV SUD Product Services
Medical Devices (includes IVDs)
Tuesday, Sep 15
9:35 AM – 10:30 AM EDT

New Legislations in South Korea to Provide Patients with Earlier Access to Breakthrough Medical Technologies
Young Kim – Synex Consulting Ltd.; Young Kyu Kang – Ministry of Food and Drug Safety, Korea; Seung Hwan Jung – Ministry of Food and Drug Safety, Korea; Young Wook Ahn – Ministry of Food and Drug Safety, Korea; Rachel Chung – Synex Consulting Ltd.
Medical Devices (includes IVDs)
Tuesday, Sep 15
11:00 AM – 12:30 PM EDT

Economic Operators Under MDR
Keith Morel, PhD – Qserve Group Inc. - ENTERPRISE; Susan Hibbeln, MS, RAC – Lumos Diagnostics; Ludger Johannes Moeller – Medical Device Safety Service GmbH; Erik Vollebregt; Suzanne Elizabeth Halliday, MSc. D.Phil. – BSI - ENTERPRISE; Royth Philippp von Hahn, PhD – TUV SUD Product Services
Medical Devices (includes IVDs)
Tuesday, Sep 15
11:00 AM – 12:30 PM EDT

FDA Emergency Use Authorization (EUA) program in response to COVID-19
Mac McKeen, RAC, FRAPS, MBA, RAC FRAPS MBA – Boston Scientific - ENTERPRISE; Angela Krueger – US Food and Drug Adminstration; Annabel Tsai, PhD – InBios
Medical Devices (includes IVDs)
Tuesday, Sep 15
11:00 AM – 12:30 PM EDT

Global Regulatory Transformation for Medical Devices and Diagnostics: Industry, FDA, and Notified Body Perspectives
Seth Goldenberg, PhD – Veeva Systems Inc.; Lori K. Holder, RAC – Alcon Laboratories Inc; Patrick Axtell, PhD – FDA; Bassil Akra, PhD – QUNIQUE GmbH
Medical Devices (includes IVDs)
Tuesday, Sep 15
1:00 PM – 2:30 PM EDT

Implementing Patient Input Across the Total Product Lifecyle of Medical Devices
Dan Stephens, PhD – Boston Scientific - ENTERPRISE; Michelle Tarver, MD, PhD; Olaf Hedrich, MD, F.A.C.C., F.H.R.S. – Boston Scientific (Marlborough); Stephanie Christopher, MA, CCRC, FACRP – Providence St. Joseph Health; Carrie M. Kuehn, MA, MPH, LPD, RAC – Evidation Health; Renee Marie Mitchell, MT (ASCP), CLS (NCA) – Boston Scientific - ENTERPRISE
Medical Devices (includes IVDs)
Tuesday, Sep 15
1:00 PM – 2:30 PM EDT

Leveraging Real World Data to Support Regulatory Decisions
Dan Stephens, PhD – Boston Scientific - ENTERPRISE; Misti Malone, PhD – US Food and Drug Administration; Robert Shipley, PhD – Boston Scientific - ENTERPRISE; Heather Colvin – Johnson & Johnson
Medical Devices (includes IVDs)
Tuesday, Sep 15
1:00 PM – 2:30 PM EDT

Software as Medical Device - Has AI Learned Too Much?
Bradley M. Thompson, MBA, JD, RAC – Epstein, Becker & Green; James Warren Monroe, MS, RAC, CQA – American Society for Quality; Jennifer Segui, MS; Lisa M. Baumhardt, MT (ASCP), MS, MJ, RAC, FRAP – IBM Watson Health Imaging
Medical Devices (includes IVDs)
Wednesday, Sep 16
10:35 AM – 11:30 AM EDT

An Insight into LATAM and Eurasian Economic Union Regional Regulatory Frameworks
Margaret Mucha (FRAPS), MJ, RAC, FRAP, CQA – Merge IBM; Monica Guaita, MSc(Eng) – MMGC SRL; Magdalena Ferrari del Sel, Msc (Eng) – MMGC SRL; Ruslan Kalachev, MA; Tatiana Nosova
Medical Devices (includes IVDs)
Wednesday, Sep 16
10:35 AM – 11:30 AM EDT

Companion Diagnostics in an Evolving Global Regulatory Landscape: Alignment of Co-Development Strategies for Diagnostics and Targeted Therapies
Kenneth Butz, M.Sc. – Pharmaceutical Product Development; Armin Ritzhaupt, PhD, MPH – European Medicines Agency
Medical Devices (includes IVDs)
Wednesday, Sep 16
10:35 AM – 11:30 AM EDT

Postmarket Surveillance Requirements of the EU MDR: Implementation Challenges and Solutions
Nancy J. Morrison, RAC – Regulatory and Quality Solutions LLC - Enterprise; Anjali Atal-Gupta, M.Ed, RAC (US, EU, Device) – Stryker Corporation; Jonathan Gimbel, PhD – Regulatory and Quality Solutions LLC - Enterprise; Caroline Byrd – Leica Biosystems Richmond, Inc.; Ibim Tariah, Former Notified Body Employee – Regulatory & Quality Solutions LLC; Amie Smirthwaite, PhD – MAETRICS
Medical Devices (includes IVDs)
Wednesday, Sep 16
12:05 PM – 1:00 PM EDT

Applying Human Factors Engineering for Successful FDA Submissions
Bassil Akra, PhD – QUNIQUE GmbH; Andrea Dwyer, MS, CHFP
Medical Devices (includes IVDs)
Wednesday, Sep 16
12:05 PM – 1:00 PM EDT

Clinical Evaluation Under the MDR With and Without Clinical Data
Rania Gerges – Qserve Group Inc. - ENTERPRISE; Jasmin Hunter – Qserve Group Inc. - ENTERPRISE; Jasmin Lindner, Dr. – Dr. Ebeling & Assoc. GmbH
Medical Devices (includes IVDs)
Wednesday, Sep 16
12:05 PM – 1:00 PM EDT

MDSAP Integration Across Medical Device Schemes Including MDR/IVDR
Maria Vrabie – Abbott; Patricia L. Murphy – BSI - ENTERPRISE; Kimberly Ann Trautman, MS
Medical Devices (includes IVDs)
Multiple
Monday, Sep 14
12:00 PM – 1:30 PM EDT

Combination Product Development in the Age of the Digital Revolution
Armin Ritzhaupt, PhD, MPH – European Medicines Agency; Ryan McGowan, BS Eng, MEng – AstraZeneca/MedImmune - ENTERPRISE; John Barr Weiner, JD – US Food and Drug Administration
Multiple
Networking & Entertainment
Tuesday, Oct 27
10:45 AM – 11:00 AM EDT

Meet the Speakers: International Regulatory Changes: Member States
Networking & Entertainment
Tuesday, Oct 27
10:45 AM – 11:00 AM EDT

Meet the Speakers: MDR: Lessons Learned
Networking & Entertainment
Wednesday, Oct 28
9:30 AM – 9:45 AM EDT

Meet the Speakers: Creating and Implementing Effective Post-market Clinical Follow-up Under the EU Medical Devices Regulation
Networking & Entertainment
Wednesday, Oct 28
9:30 AM – 9:45 AM EDT

Meet the Speakers: International Regulatory Landscape Changes
Networking & Entertainment
Wednesday, Oct 28
10:45 AM – 11:00 AM EDT

Meet the Speakers: Innovators and Regulators: Time to Collaborate
Networking & Entertainment
Wednesday, Oct 28
12:15 PM – 12:30 PM EDT

Meet the Speakers: Clinical Investigation under MDR
Networking & Entertainment
Wednesday, Oct 28
12:15 PM – 12:30 PM EDT

Meet the Speakers: Impact of Notified Body Representative Technical Documentation Sampling - It Affects Your MDR Compliance Workload
Networking & Entertainment
Wednesday, Oct 28
5:25 PM – 7:00 PM EDT

Virtual Culinary Experience
Networking & Entertainment
Plenary
Sunday, Sep 13
12:00 PM – 1:30 PM EDT

Convergence Kick-off: Regulatory Success in Times of Disruption
Sarah Michel, CSP – Velvet Chainsaw Consulting; Kimberly Belsky, MS; Megha Deviprasad Iyer, RAC – Thermo Fisher Scientific; Rabia Khan, PhD, MBA – Sensyne Health; David Fischel – Stereotaxis; Noël Wathion – European Medicines Agency (EMA)
Plenary
Tuesday, Sep 15
9:00 AM – 9:35 AM EDT

Professional Branding in a Virtual World
Sarah Michel, CSP – Velvet Chainsaw Consulting; Elena Kyria – Elemed
Plenary
Wednesday, Sep 16
10:00 AM – 10:35 AM EDT

Community Gathering: Getting Personal – The Impact of What we Do
Sarah Michel, CSP – Velvet Chainsaw Consulting; Bill McMoil – RAPS; Denise Fulton – RAPS; Linda Bowen, MS, RAC, FRAPS – Seattle Genetics, Inc.; David Jefferys, MD, FRAPS – Eisai; John Wilkinson, MBA – Global Medical Devices Nomenclature; Robert E. Yocher, MHSc, FRAPS – HeartWare, Inc.
Plenary
Solution Circles
Monday, Sep 14
10:00 AM – 10:30 AM EDT

Solution Circle: How can Modeling and Simulation be used to Support MRI Safety Labeling of Medical Devices?
David Gross, PhD, PE – MED Institute Inc.
Solution Circles
Monday, Sep 14
10:00 AM – 10:30 AM EDT

Solution Circle: How to Make Your Tech Work FOR not AGAINST You at Virtual Regulatory Meetings
Jim DiBiasi – 3D Communications
Solution Circles
Monday, Sep 14
10:00 AM – 10:30 AM EDT

Solution Circle: RA Strategy Considerations for the Development of a CDx for Rare Diseases
Sophie Gaillardon – ARUP Laboratories
Solution Circles
Monday, Sep 14
12:00 PM – 12:30 PM EDT

Solution Circle: EO Sterilization FDA Initiative to Reduce EO Levels
Mac McKeen, RAC FRAPS MBA – Boston Scientific - ENTERPRISE
Solution Circles
Monday, Sep 14
12:00 PM – 12:30 PM EDT

Solution Circle: Writing Under Pressure: Making it Easy
Nancy Singer, JD, FRAPS – Compliance-Alliance; Christine Rance
Solution Circles
Monday, Sep 14
2:05 PM – 2:35 PM EDT

Solution Circle: How to Leverage Technology in Virtual Regulatory Meetings to Give Your Team a Lifeline – in the Moment and Behind the Scenes
Jim Kelley – 3D Communications
Solution Circles
Monday, Sep 14
2:05 PM – 2:35 PM EDT

Solution Circle: Top 10 GMP Issues Observed from FDA Inspections
Robert Fish – EAS Consulting Group, LLC
Solution Circles
Tuesday, Sep 15
9:35 AM – 10:05 AM EDT

Solution Circle: Assessment of Applicable GSPR for a Pre-filled Syringe
Julia Frese
Solution Circles
Tuesday, Sep 15
9:35 AM – 10:05 AM EDT

Solution Circle: CDRH Appeals and the Role of the Ombudsman in Preventing and Resolving Disputes
Ken Skodacek – FDA
Solution Circles
Tuesday, Sep 15
9:35 AM – 10:30 AM EDT

Conversations That Matter - Interactions with Health Authorities (FDA/EMA Collaboration)
Don E. Boyer, HBSc., RAC, FRAP; Susan B. Stewart, JD, RAC, FRAPS – Kaleido Biosciences; Sabine Haubenreisser, MSc, PhD – European Medicines Agency; Anabela Marcal – European Medicines Agency
Solution Circles
Tuesday, Sep 15
10:00 AM – 10:30 AM EDT

Solution Circle: LinkedIn Hot Seat
Elena Kyria – Elemed; Sarah Michel, CSP – Velvet Chainsaw Consulting
Solution Circles
Tuesday, Sep 15
11:00 AM – 11:30 AM EDT

Solution Circle: How FDA Guidance 3D Printer Manufacturing Can Influence Stand-alone Software Medical Devices
Kristian Worziger Nielsen, MPhys
Solution Circles
Tuesday, Sep 15
11:00 AM – 11:30 AM EDT

Solution Circle: How to Break Through the Technology with Your Message in Virtual Regulatory Meetings
Cara Vivarelli-O’Neill, MPH – 3D Communications
Solution Circles
Tuesday, Sep 15
11:00 AM – 11:30 AM EDT

Solution Circle: LinkedIn Hot Seat
Elena Kyria – Elemed; Sarah Michel, CSP – Velvet Chainsaw Consulting
Solution Circles
Tuesday, Sep 15
1:00 PM – 1:30 PM EDT

Solution Circle: How Will the FDA Regulate My Low Risk Device? Wellness, Mobile Apps and Decision Support Devices
Alexander Lee Friedman, PhD, RAC – Philips Healthcare - ENTERPRISE
Solution Circles
Tuesday, Sep 15
1:00 PM – 1:30 PM EDT

Solution Circle: Pediatric Medical Device Development – Update on Progression of the FDA Initiatives
Vasum Peiris, MD, MPH, FAAP, FACC, FASE; Amra Racic, MBA – Medtronic
Solution Circles
Wednesday, Sep 16
10:35 AM – 11:30 AM EDT

Conversations That Matter - Interactions with Health Authorities (US and EU Combination Products)
Don E. Boyer, HBSc., RAC, FRAP; Susan B. Stewart, JD, RAC, FRAPS – Kaleido Biosciences; John Barr Weiner, JD – US Food and Drug Administration; Armin Ritzhaupt, PhD, MPH – European Medicines Agency
Solution Circles
Wednesday, Sep 16
12:05 PM – 12:35 PM EDT

Solution Circle: How to Plan Your First Clinical Trial on Imaging-based Artificial Intelligence Device Under NMPA Supervision
Yuanyuan Yu, MS, RAC – Fosun Pharma- Healthcare
Solution Circles
Wednesday, Sep 16
12:05 PM – 12:35 PM EDT

Solution Circle: Parallel Global Submissions: Navigating the Space between Submission and Approval
Darwin Keith-Lucas, PMP – Integrated Project Management
Solution Circles
Sponsored Session
Monday, Sep 14
10:00 AM – 10:45 AM EDT

QMS Aspects of the IVDR (Sponsored by: BSI)
Stefan Burde, PhD – BSI
Sponsored Session
Monday, Sep 14
12:00 PM – 12:45 PM EDT

DEVICE L❤️VE Live! #18: Generating Sufficient Clinical Evidence Under EU MDR [Sponsored by: Regulatory & Quality Solutions (R&Q)]
Lisa M. Casavant, MME – Regulatory and Quality Solutions LLC - Enterprise; Jonathan Gimbel, PhD – Regulatory and Quality Solutions LLC - Enterprise; Celeste Maksim, PhD – Regulatory & Quality Solutions (R&Q); Nancy J. Morrison, RAC – Regulatory and Quality Solutions LLC - Enterprise; Ron Sills – Regulatory & Quality Solutions (R&Q); Amie Smirthwaite, PhD – MAETRICS
Sponsored Session
Tuesday, Sep 15
9:35 AM – 10:20 AM EDT

Evolving From Compliance Enablement to Strategic Value: Driving Further Adoption of Digital Tools in Regulatory Affairs and Lessons Learned From Global RIM Implementations (Sponsored by KPMG)
Rebecca James, RAC, MBA – KPMG; Brian Williams – KPMG
Sponsored Session