Thu, Aug 29
|Insife Inc. 101 Hudson St
Safety signal and risk management requirements (US)
This Global Regulatory Intelligence Club for PV focus meeting is to share and compare notes on handling safety signals and risk management including risk minimization measures in the PV area. The meeting will be held physically in Jersey City.
Time & Location
Aug 29, 2019, 1:00 PM – 5:00 PM EDT
Insife Inc. 101 Hudson St, 101 Hudson St, Jersey City, NJ 07302, USA
About the event
Safety risk management is a complex process to deliver globally, considering cross territorial requirements and involvement of various business units. The process is closely aligned to signal management, yet does not necessarily include the same stakeholders and regulatory requiements. 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 of GRIP, but we are inviting all potential new members at a no-cost or commitment basis for this meeting. Please go ahead and sign-up and we will provide you a complimentary pass for the day - or write to grip@insife.com for membership questions.
This focus meeting will be held at our offices in Jersey City.
Agenda, 29-AUG 2019
13:00-13:30 ET: Introduction to the focus group participants
- Welcome to the network / event introduction
- Introduction by each participant
By Insife + All
13:30-14:30 ET
Charting the challenges – what are the current and future dilemmas with safety signal and risk management?
- Pitch by Insife
- Pitch by each member – round the table
By Insife, All
14:30-14:45 ET
Break
14:45-16:20 ET
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?
- Signal management requirements - from signal detection to notifications - where in the globe do we see requirements and where are the issues?
Facilitated by Insife, All
16:20-17:00 ET
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 ET
Meeting end