Turn a new obligation into tasks for each product
Alerts reads a new obligation against your registrations and names the products it applies to. Workbench works out what each product needs, and Atlas holds the approved actions with an owner and a date.
The guideline names a requirement, not your products
A new guideline says what holders must do, in general terms. Someone then works out which products, programmes and procedures it applies to, writes the tasks and chases the owners by email. The reasoning usually stays in that person's notes.
Atorvastatin Ostra 20 mg3 h ago
ANVISA renewal fee is due in 4 days and no payment is recorded
Proposed: Remind Maja and finance today
Ticagrelor Ostra 90 mg6 h ago
Two Day 106 answers are still unassigned, 9 days to go
Proposed: Assign both to Klara and draft Q4 from the batch data
From a published obligation to owned tasks
Alerts reads the obligation
Alerts read EMA's EU implementation strategy for ICH E2D(R1) and matched it to four centralised Ostra products, two of them with patient support programmes.
Workbench drafts the actions
Workbench reads the guideline against each matched product and drafts one action per product, citing the guidance and the Atlas record it applies to.
Atlas holds the work
Approved actions land on each product's timeline with an owner and a date, such as the PSP intake update for Adalimumab Ostra 40 mg under EMEA/H/C/005180.
Split a pharmacovigilance obligation by product
Alerts matched the ICH E2D(R1) implementation strategy to four Ostra products. Workbench works out what each one needs and who owns it in Atlas.
What's up next?EMA's E2D(R1) implementation strategy is out. What does it mean for our Adalimumab and Etanercept patient support programmes, and do Infliximab and Trastuzumab need anything?
- understanding your question…
4 Ostra centralised products · EU · ICH E2D(R1) safety data sources
- EudraVigilance does not yet take the new E2B(R3) source values for PSP reports. EMA will add them through change management.
1. Short answer
Under E2D(R1), reports from a patient support programme come from a solicited source, so both PSP intake procedures need updating. Infliximab and Trastuzumab run no PSP and are covered by the PV procedure update.
2. Actions by product
3. To approve
- Approve the PSP intake tasks for Nina and Rok on the Atlas timeline.
- Ask Rita to revise the PV procedure for solicited sources and digital platforms.
- Check EMA's EudraVigilance notes before coding PSP reports with the new values.
Each action traced to the guidance and the record
Registrations in scope
The reading lists the registrations an obligation applies to, such as EMEA/H/C/005180 and EMEA/H/C/005733, and says why each one matched.
Guidance cited per action
Each action Workbench drafts cites the guideline or strategy it rests on and the Atlas record it applies to, so a reviewer can check the step.
Owner and date recorded
Once approved, each action sits on the product's Atlas timeline with an owner and a date, next to that product's other procedures.
Related on Regunaut
- New obligations under the package include environmental risk assessment for legacy products.
- Marketing authorisation holders will need shortage prevention plans under the new rules.
- Antimicrobials face new antimicrobial stewardship requirements.
Turn the next obligation into product tasks
See Alerts, Workbench and Atlas on your own products and markets in a 30-minute walkthrough.