IPAC-RS ROUNDTABLES - 2023
IPAC-RS is continuing its Roundtable series in 2023, supplementing the podium presentations held at the IPAC-RS/RDD Joint session that addressed Regulatory, Science and Technology Innovations Enabling Novel and Improved OINDP Design, Development and Manufacturing.
Upcoming IPAC-RS Roundtable topics include:
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Advancing Sustainability of Device and Container Closure Systems (Part III)
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Sustainability - Alternate Propellants
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Advanced Data Analytics
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Regulatory Evolution
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The first webinar of 2023, Advancing Sustainability of Device and Container Closure Systems (Part II) was held on February 7, 2023.
Moderator:
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Jacqueline Green, Global Business Development Manager, H&T Presspart [Introduction]
Presenters:
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Christian Meusinger, Vice President Global Quality & Regulatory, Nemera [Presentation]
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Paulo Cavacas, Business Development Manager, Borealis [Presentation]
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Valéry Rebizant, Delrin® Global Sustainability Leader and Sustainability Marketing Leader, DuPont [Presentation]
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Rob Haley, Global Director of Program Management – Medical, Drug Delivery Device, Celanese [Presentation]
Panelists:
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Edward Jackson, Device Development Team Leader, Kindeva Drug Delivery
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Marc Severin, Program Manager Sustainability and Innovation, Presspart
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Beate Treffler, Regional Sales Manager Europe, Healthcare Polymer Solutions, Avient Colorants Germany GmbH
Click here to view a recording of this webinar. PDFs of the presentations are linked above.
Click here to view the Moderator, Presenter, and Panelist bios.
IPAC-RS ROUNDTABLES - 2022
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The second webinar in the 2022 series, Advancing Sustainability of Device and Container Closure Systems (Part I) was held on Wednesday, November 30, 2022.
Moderator: Lee Nagao, Ph.D., Senior Director - Science, Regulatory & Policy, Faegre Drinker Biddle & Reath, LLP, IPAC-RS SecretariatI
Presentations:
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Sustainability from a Plastic Raw Material Solutions Perspective
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Beate Treffler, Regional Sales Manager Europe, Healthcare Polymer Solutions, Avient Colorants Germany GmbH
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Contributing to More Sustainable Drug Delivery Devices
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Marc Severin, Program Manager Sustainability and Innovation, Presspart
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LCA for Devices, Eco-Design, Circularity
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Christian Pommereau, Principal Engineer, Technology Platform Development, Sanofi
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Switching to Sustainable Materials for our Current Devices
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Edward Jackson, Device Development Team Leader, Kindeva Drug Delivery
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Click here to view a recording of this webinar. PDFs of the presentations are linked above.
Click here to view the Moderator and Presenter bios.
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The first webinar in the 2022 series, Patient Centric Product Design was held on September 22, 2022.
Moderator: Jeremy Clarke, Ph.D., Senior Fellow, Manufacturing Science & Technology, Global Supply Chain, GSK
Panelists:
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Gregor Anderson, MSc, Managing Director, Pharmacentric Solutions
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Juan Cheng, Ph.D., RAC, Device Development, Merck Research Labs (MRL) Merck
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Sven Stegemann, Ph.D., Professor of Patient Centric Drug Design and Manufacturing, Graz University of Technology
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Paul Upham, Head, Smart Devices, Roche/Genentech
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Róisín Wallace, B.Sc., MRSC, Head of Global Device Development, Viatris
Click here to view a recording of this webinar. A PDF of the presentation is available here.
Click here to view the Moderator and Panelists bios.
IPAC-RS DIGITAL-DEVICE ROUNDTABLES - 2021
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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
IPAC-RS REGULATORY ROUNDTABLE 2020
In 2020, 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.