The fifth webinar in the series, Digital Devices:  Regulatory Challenges and Considerations is scheduled for Monday, November 22, 2021 at 10:00 AM - 12:00 PM US ET.   

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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

 

Speakers:

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

• Claudia Vincenzi, Ph. D., Quality Specialist, Pharmaceutical Quality office, European Medicines Agency (EMA)
   

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Webinar Program and Abstracts:

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I.     Welcome and Overview of Webinar

• Moderators:  Prasad Peri and Fredrik Mannerstråle

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II.    Prescription Drug Use-Related Software – Current Status and Possible Future State

• Robert Berlin, GlaxoSmithKline

In this presentation, Mr. Berlin will describe FDA’s proposed framework for the regulation of Prescription Drug Use-Related Software (PDURS) and anticipated next steps in its development.  The PDURS framework, which was announced through the establishment of a public docket, “Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments,” 83 FR 58574 (Nov. 20, 2018), seeks to address the emergence of software that accompanies a drug.  This may include sensors embedded within an inhaler that track dosing, and potentially patient adherence.  Per the framework the output of such software may be regulated as required or promotional labeling.

Building on this framework, FDA has committed to issuing guidance.  That commitment has not only been reflected in the Agency’s Unified Agenda, but is now included within the Prescription Drug User Fee Amendments (PDUFA) VII draft commitment letter.  The framework left open important questions that should be addressed in the guidance, including where in labeling information on outputs should be placed, as well as clarifying the criteria for when materials should be included within labeling.  The establishment of clear expectations through guidance will help to drive innovation in this space, and support patient needs.
 

III.    Digital Health Technologies used with Medicinal Products – EU regulatory considerations

• Claudia Vincenzi, European Medicines Agency (EMA)

 

We live in an era of person-centered digital transformation. Digital technologies are embedded in our daily lives and digital health technologies (DHTs) have the potential to revolutionize patient care. Different players are involved in the regulation of DHTs in Europe, especially when DHTs are used in conjunction with medicinal products. The demarcation between areas of responsibility of the different regulators is sometimes blurred. The recent Medical Device Regulation implementation has contributed to the level of complexity of the regulatory landscape. Dr. Vincenzi will share some of the considerations that arose during the assessment of recent DHTs used in combination with medicinal products. Her presentation will take us through a case study, prepared in collaboration with the marketing authorization holder of a dry powder inhaler that can be used with an optional digital sensor. The case study will open a window on the dialogue between EMA and the company and the opportunities and challenges encountered. This example is only one of the first steppingstones in the journey of regulation of DHTs: what else can we see on the European horizon?
 

IV.     Moderated Q&A Session with the speakers

Click to view Speaker and Moderator Bios.  Feel free to share the registration information with interested colleagues.

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