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
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 grip@insife.com 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
Break
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