Thu, Jun 06|
LEO Pharma A/S
Safety risk management requirements
This Global Regulatory Intelligence Club for PV focus meeting is to share and compare notes on handling safety risk management including risk minimization measures 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
Jun 06, 2019, 1:00 PM – 5:00 PM GMT+2
LEO Pharma A/S, Industriparken 32, 2750 Ballerup, Denmark
About the event
Safety risk management is a complex process to deliver globally, considering cross territorial requirements and involvement of various business units. The members at the day will pitch 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 email@example.com for membership questions.
This focus meeting will be held at LEO Pharma in Ballerup
Agenda, 06-JUN 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
Charting the challenges – what are the current and future dilemmas with safety risk management?
- Pitch by Insife
- Pitch by each member – round the table
By Insife, All
Diving into the regulatory landscape
Current state of risk management – where in the globe do we see the current issues. And are we able to harmonize i.e re-use the Risk Management Documents produced across geographies?
- Managing global (core) to local Risk Management Plans – deviations and revisions etc
- Risk minimization and regulatory commitments – from identification of an action to actual local tracking. How do we achieve compliance? Do we need to prove effectiveness?
- US, Shared REMS – any experience? Is there a value in practice?
- Benefit-risk – when to start? – is the Industry product value proposition challenged by HTAs, pay-per-cure etc?
Facilitated by Insife, All
- How do we best benchmark safety risk management?
- A quick look at what is in HALO already and decisions on what to add for future benchmarking purposes
Demo by insife, All