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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. 

 

The upcoming IPAC-RS Roundtable topics include:

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  • Sustainability - Alternate Propellants​

  • Advanced Data Analytics​

  • Regulatory Evolution

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  • The first webinar of 2023, Advancing Sustainability of Device and Container Closure Systems (Part II) is scheduled for Tuesday, February 7, 2023 at 10:00 AM - 12:00 PM US ET.   Click here to register.

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Moderator:

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Presenters:

  • Christian Meusinger, Vice President Global Quality & Regulatory, Nemera

  • Paulo Cavacas, Business Development Manager, Borealis

  • Valéry Rebizant, Delrin® Global Sustainability Leader and Sustainability Marketing Leader, DuPont

  • Rob Haley, Global Director of Program Management – Medical, Drug Delivery Device, Celanese

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Panelists:

  • Edward Jackson, Device Development Team Leader, Kindeva Drug Delivery

  • Marc Severin, Program Manager Sustainability and Innovation, Presspart

  • Beate Treffler, Regional Sales Manager Europe, Healthcare Polymer Solutions, Avient Colorants Germany GmbH

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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.    

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​​Moderator:  Lee Nagao, Ph.D., Senior Director - Science, Regulatory & Policy, Faegre Drinker Biddle & Reath, LLP, IPAC-RS SecretariatI

 

Presentations:

 

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​

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Panelists:

  • Gregor Anderson, MSc, Managing Director, Pharmacentric Solutions

  • Juan Cheng, Ph.D., RAC, Device Development, Merck Research Labs (MRL) Merck

  • Sven Stegemann, Ph.D., Professor of Patient Centric Drug Design and Manufacturing, Graz University of Technology

  • Paul Upham, Head, Smart Devices, Roche/Genentech

  • Róisín Wallace, B.Sc., MRSC, Head of Global Device Development, Viatris

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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.

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IPAC-RS DIGITAL-DEVICE ROUNDTABLES - 2021

Publications

Presentations 

Comments on Guidances

Reference Links

  • The first webinar in the series, What is a Digital Biomarker and Why Is It Important? was held on September 10, 2021. 

Moderators:

  • Marta Lombardini, Ph.D., Device Development Manager, Chiesi Group

  • Lee Nagao, Ph.D., Senior Director Science, Regulation & Policy, Faegre Drinker Biddle & Reath LLP, IPAC-RS Secretariat

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Click here to view a recording of this webinar.  PDFs of the presentations are available below. 

Introduction

The Progression of Digital Biomarkers in Clinical Trials and Beyond

  • James Blakemore, Ph.D., Senior Consultant, Strategy Group, Medical Technology Division, Cambridge Consultants

  • Joe Corrigan, CEng MIMechE, Head of Intelligent Healthcare, Global Medical Technology, Cambridge Consultants

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Realizing the Vision of Digitally Enabled, Patient-Centric Clinical Trials

  • Marissa Dockendorf, Ph.D., Director, Global Digital Analytics & Technologies, Merck Research Laboratories

  • 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:

  • Marta Lombardini, Ph.D., Device Development Manager, Chiesi Group

  • 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.  

Introduction

Designing Digital Healthcare:  HFE and UX in Partnership

  • Julian Dixon, HF Consulting Director, Team Consulting

 

Beyond Usability/Human Factors for Digital Healthcare  (pdf not available)​

  • 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:

  • S. Prasad Peri, Ph.D., Senior Director, Global Specialty Regulatory Affairs, CMC, Teva Branded Pharmaceutical Products R&D Inc.

  • 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. 

Introduction

Design of Connected Devices with High Functionality, Good Usability and Low Environment Impact

  • Andreas Meliniotis, Director, Device Development, Vectura

  • Phil Swanbury, Director, Device Development, Vectura

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Practical Considerations for Developing Software in Connected Health Solutions and the Assessment of Sustainability in Respiratory Devices

  • Stathis Louridas, Ph.D., Head of Electronics and Software, Team Consulting

  • 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:

  • S. Prasad Peri, Ph.D., Senior Director, Global Specialty Regulatory Affairs, CMC, Teva Branded Pharmaceutical Products R&D Inc.

  • 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.

Introduction

Business Case for Digital Inhaler Devices: A platform provider’s perspective on creating a compelling user experience and driving adoption

  • David Pettigrew, DPhil, Vice President Global Accounts, BrightInsight

​Business Case for Digital Inhaler Devices:  A pharma company perspective

  • 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:

  • S. Prasad Peri, Ph.D., Senior Director, Global Specialty Regulatory Affairs, CMC, Teva Branded Pharmaceutical Products R&D Inc.

  • Fredrik Mannerstråle, Director Regulatory CMC, Medical Devices and Combination Products, AstraZeneca 

Speaker:

  • Robert Berlin, JD, M.P.H., Head of US Regulatory Policy, GlaxoSmithKline

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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.

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