Starting in 2020, IPAC-RS organized a number of roundtables with thought leaders to discuss key regulatory and scientific topics in respiratory products. Continuing that practice, in 2021, IPAC-RS launched a new series focusing on drug-device combination products with digital components, and digital-health opportunities and challenges more broadly. Presented by subject matter experts in the pharmaceutical sciences, this is a unique opportunity to learn about the latest research and regulatory trends focused on digital devices.
IPAC-RS REGULATORY ROUNDTABLE
IPAC-RS hosted a Roundtable: A Conversation with the FDA: Perspectives in the Time of COVID-19 on November 2, 2020. Click here to review the summary of the webinar.
IPAC-RS DIGITAL-DEVICE ROUNDTABLES
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The first webinar in the series, What is a Digital Biomarker and Why Is It Important? was held on September 10, 2021.
Moderators:
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Marta Lombardini, Ph.D., Device Development Manager, Chiesi Group
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Lee Nagao, Ph.D., Senior Director Science, Regulation & Policy, Faegre Drinker Biddle & Reath LLP, IPAC-RS Secretariat
Click here to view a recording of this webinar. PDFs of the presentations are available below.
The Progression of Digital Biomarkers in Clinical Trials and Beyond
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James Blakemore, Ph.D., Senior Consultant, Strategy Group, Medical Technology Division, Cambridge Consultants
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Joe Corrigan, CEng MIMechE, Head of Intelligent Healthcare, Global Medical Technology, Cambridge Consultants
Realizing the Vision of Digitally Enabled, Patient-Centric Clinical Trials
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Marissa Dockendorf, Ph.D., Director, Global Digital Analytics & Technologies, Merck Research Laboratories
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Bryan J. Hansen, Ph.D., Associate Principal Scientist, Global Digital Analytics and Technologies, Merck Research Laboratories
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The second webinar in the series, Beyond Usability/Human Factors for Digital Healthcare was held on Tuesday, September 21, 2021.
Moderators:
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Marta Lombardini, Ph.D., Device Development Manager, Chiesi Group
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Fredrik Mannerstråle, Director Regulatory CMC, Medical Devices and Combination Products, AstraZeneca
Click here for a recording of the webinar. PDFs of the presentations are available below.
Designing Digital Healthcare: HFE and UX in Partnership
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Julian Dixon, HF Consulting Director, Team Consulting
Beyond Usability/Human Factors for Digital Healthcare (pdf not available)
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Ian Culverhouse, Ph.D., Co-Founder, Rebus Medical Ltd.
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The third webinar Digital Devices: Manufacturing and Design Considerations was held on Wednesday, September 29, 2021.
Moderators:
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S. Prasad Peri, Ph.D., Senior Director, Global Specialty Regulatory Affairs, CMC, Teva Branded Pharmaceutical Products R&D Inc.
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Daniela Gramaglia, Ph.D., Design Control and Documentation Specialist, Chiesi Group
Click here to view a recording of this webinar. PDFs of the presentations are available below.
Design of Connected Devices with High Functionality, Good Usability and Low Environment Impact
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Andreas Meliniotis, Director, Device Development, Vectura
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Phil Swanbury, Director, Device Development, Vectura
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Stathis Louridas, Ph.D., Head of Electronics and Software, Team Consulting
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Brennan Miles, Managing Consultant – Drug Delivery, Team Consulting
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The fourth webinar Business Case for Digital Devices was held on Monday, October 4, 2021.
Moderators:
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S. Prasad Peri, Ph.D., Senior Director, Global Specialty Regulatory Affairs, CMC, Teva Branded Pharmaceutical Products R&D Inc.
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Robyn Parker, MS, Associate Director, Global Regulatory Affairs, Sunovion
Click here to view a recording of this webinar. PDFs of the presentations are available below.
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David Pettigrew, DPhil, Vice President Global Accounts, BrightInsight
Business Case for Digital Inhaler Devices: A pharma company perspective
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Ulf Ericsson, MS, Vice President Drug Development, Nanologica
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The fifth webinar Digital Devices: Regulatory Challenges and Considerations was held on Monday, November 22, 2021.
Click here to view a partial recording of this webinar.
Moderators:
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S. Prasad Peri, Ph.D., Senior Director, Global Specialty Regulatory Affairs, CMC, Teva Branded Pharmaceutical Products R&D Inc.
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Fredrik Mannerstråle, Director Regulatory CMC, Medical Devices and Combination Products, AstraZeneca
Speaker:
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Robert Berlin, JD, M.P.H., Head of US Regulatory Policy, GlaxoSmithKline