Pharmacovigilance in Studies and Social Media
Safety data from clinical and non-interventional studies and from your own digital channels — collected, assessed, coded and reported.
What does pharmacovigilance in studies and social media involve?
Suspected cases do not only arise as spontaneous reports from the market. They arise in clinical trials and non-interventional studies — and they arise wherever your company itself talks to patients and healthcare professionals: under a post on your social media channel, in the contact form, in the comments section of your website. In both cases the same chain applies: collect, medically assess, code, document and report on time.
Why does it matter?
If someone mentions a possible side effect in a comment on a channel that your company operates or is responsible for, this may give rise to a reporting obligation — and the clock runs from the day on which anyone in the company becomes aware of it, not from when it is forwarded to pharmacovigilance. That is why every company needs a defined process for its own channels: who screens, how often, how it is documented and how the case gets into processing. In studies, the second typical break lies at the interface between sponsor, CRO and safety database — anything that is not reconciled regularly there will come to light in the periodic report at the latest.
Who needs it?
Sponsors of clinical trials subject to SUSAR reporting. Marketing authorisation holders conducting non-interventional studies or patient support programmes. And every company that runs its own social media profiles, a website with a comment or contact function, or a newsletter — even if marketing and pharmacovigilance are far apart organisationally.
What do the regulations require?
- GVP Module VI — collection and reporting of suspected adverse reactions, expressly including those from digital media that the company operates or is responsible for
- GVP Module VI — four minimum criteria for a valid case: identifiable reporter, identifiable patient, suspected adverse reaction and medicinal product
- Reporting deadlines of 15 and 90 days respectively from awareness within the company — for post-authorisation suspected cases
- Regulation (EU) No 536/2014, Article 42 — SUSAR reporting by the sponsor to EudraVigilance
- MedDRA for coding, ICH E2B(R3) for the transmission format
How VigiPRO supports you
- Medical single case assessment of cases from studies and from your own digital channels
- Data management and MedDRA coding
- Evaluation of cumulative data and listings, including reconciliation with the CRO, partners and safety database
- Periodic reports for studies and authorised medicinal products, including DSURs
- Setting up a documented screening and reporting process for your own channels: responsibility, interval, filing, handover
- Training marketing, social media management and customer contact staff to recognise reportable matters
Why VigiPRO
Single case processing, periodic reports and training sit within the same team at VigiPRO. The path from a comment on your channel or a study case to the report is therefore one chain, without a handover between two service providers. VigiPRO’s references include pharmacovigilance in non-interventional studies for one of the world’s largest research-based pharmaceutical companies.
Frequently asked questions
Do we have to monitor our social media channels?
For channels that your company operates or is responsible for, yes — GVP Module VI expects regular screening and the collection of the suspected cases reported there. You do not have to actively search third-party forums and platforms. But if you become aware of a case, you treat it like any other.
When does a comment become a reportable case?
When the four minimum criteria come together: identifiable reporter, identifiable patient, suspected adverse reaction and medicinal product. If one of them is missing, the case is not valid — it is documented nonetheless, and follow-up is carried out. If the missing information is subsequently received, the case becomes reportable.
How does SUSAR reporting differ from spontaneous reporting?
In clinical trials, the sponsor reports SUSARs to EudraVigilance under Article 42 of Regulation (EU) No 536/2014: fatal and life-threatening cases within 7 days, all others within 15 days. After authorisation, the deadlines of 15 and 90 days respectively apply.
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