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Wed, May 22


Insife Office + Global teleconference

Device vigilance - global device reporting and combination products

This Global Regulatory Intelligence Club for PV focus meeting is to share and compare notes on how to handle devices in the PV area. The meeting will be held physically in the Copenhagen area and it will also be possible to join via conference call

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Device vigilance - global device reporting and combination products
Device vigilance - global device reporting and combination products

Time & Location

May 22, 2019, 1:00 PM – 5:00 PM GMT+2

Insife Office + Global teleconference, Automatikvej 1, 3. Floor, 2860 Søborg, Denmark

About the event

Device vigilance and combination products - what are the regulatory requirements now and in the near future? How do we tackle this in practice in Industry?

Zealand pharma and Novo Nordisk will be providing their pitch to some of the key dilemmas that they are looking at currently - The meeting is intended as a roundtable dicussion, so please propare some inputs for the meeting.

This meeting is for members only, please write to for membership questions.

This focus meeting will be held at Insife's offices

Agenda, 22-MAY 2019

13:00-13:30 CET: Introduction to the focus group participants

- Welcome to the network / event introduction

- Introduction by each participant

By Insife + All

13:30-14:30 CET

Charting the challenges – what are the current and future dilemmas with device vigilance and combination products?

- Pitch by Zealand pharma

- Pitch by Novo Nordisk

- Other inputs from the members – round the table

By Zealand Pharma, Novo Nordisk, All

14:30-14:45 CET


14:45-15:45 CET

Diving into the regulatory landscape

- Current state of reporting in the EEA: MEDDEV, BFARM reporting and other reporting obligations

- Preparing for the EU MDR – anticipated and known changes, e.g. MIR form and EUDAMED. What will be the impacts?

- Current and future state in the USA: FDA Medwatch / eMDR and Combination products, what are the complications now and how are the recently revised regulatory timelines impacting plans?

- Japan reporting and RoW – new challenges in the horizon?

- The pervasive future of eDevices and Regulations – Can we see any alignment of interests? and what is the impact for PV?

Facilitated by Insife, All

15:45-16:20 CET

Focused discussion on key areas of interest

- Based on the consolidated input and expressed interests of the group, issues and solutions will be discussed

Facilitated by Insife, All

16:20-17:00 CET

Benchmarking needs

- How do we best benchmark device vigilance / device reporting and combination products?

- A quick look at what is in HALO already and decisions on what to add for future benchmarking purposes

Demo by insife, All

17:00 CET

Meeting end

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