The current EU pharmacovigilance legislation was adopted by the European Parliament and Council of Ministers in December 2010. The legislation has been effective since July 2012. Archemin helps its customers to put the necessary regulatory Pharmacovigilance systems and processes in place as part of a Quality Management System.
- 24/24, 7/7 availability
- Weekly literature reports
- Written Procedures
- ICSR collection
- Reporting to health authorities
- Risk Management Systems & Risk Management Plans
- Pharmacovigilance training
- Benefit-risk assessments
Full or partial transfer of pharmacovigilance activities
- Centralised storage of safety information in an Adverse Event database
- Reporting to national health authorities / EMEA on a National level through the EVWEB tool
- MeDRA coding
- Editing Periodic Safety Update Reports
- Development of CTD modules 1.8.1 (Description of the Pharmacovigilance system) and 1.8.2. (Risk management)
Post-Approval Safety Studies (PASS)
A Post-Authorisation Safety Study will be imposed on the Market Authoisation Holder if there are concerns about the risks of an authorised medicinal product.
Randomized controlled trials with pre-specified, adjudicated endpoints are used to determine the efficacy of medicinal products prior to a registration application. Usually these studies are not adequately powered to reliably assess risk. Point estimates of adverse event incidence will be extremely imprecise and the confidence intervals wide when the absolute number of events is small. Thus, safety must be evaluated further using data from spontaneous Adverse Reaction* reporting, by means of meta-analyses, observational databases, or Post-Approval Safety Studies that involve real-life long-term dosing, in patients with various co-morbidities, who receive other drug treatments concomitantly and present various other risk factors.
(also see Clinical Research).
* an Adverse Reaction is defined as a response to a medicinal product which is noxious and unintended (this includes effects at normal dosing, or resulting for medication errors or resulting from use outside the terms of the marketing authorisation including the misuse and abuse of the medicinal product).
Auditing of existing pharmacovigilance systems
Want to know more / require a quote ?
Send your request to pharmacovigilance [at] archemin [dot] eu