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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

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Safety risk management requirements
Safety risk management requirements

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 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

13:30-14:30 CET

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

14:30-14:45 CET


14:45-16:20 CET

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

16:20-17:00 CET

Benchmarking needs

- 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

17:00 CET

Meeting end

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