Pharmacovigilance – Keeping Watch – for untoward events

Pharmacovigilance (PV) is the term used to describe the science of detecting, collecting and evaluating information from healthcare providers and patients on the adverse effects of medicinal products (including Herbal and Traditional medicines) with a view to identifying new information about the hazards associated with a particular medicine. As this new informtion becomes available it is passed back to the healtch care providers and patients by way of amended product information with the ultimate aim of preventing harm to patients.
As clinical trials carried out during the development of a new medicine involve several thousand patients at most; less common “side effects” are often unknown and will not have been experienced at the time a drug enters the market.

The roots of the term are:

pharmakon (Greek), “drug”
vigilare (Latin), “to keep awake or alert, to keep watch”

During the process of “keeping watch” a number of Adverse Events (AEs) will be reported. An AE is defined as:

Any untoward medical occurance in a patient administered a medicinal product and which does not necessarily have a casual relationship with the treatment.

The discipline of Pharmacovigilance is particularly concerned with identifying those events where a casual realtionship can be established i.e an Adverse Drug Reaction (ADR), which are officially described as:

"A response to a drug which is noxious and unintended, and which occurs at doses normally used… for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function."

Legal Framework within the EU

European legislation Article 8(3)(ia) of Directive 2001/83/EC requires the Marketing Authorisation holder (MAH) of a medicinal product to have an appropriate system of pharmacovigilance in place. This system requires the services of a Qualified Person who specialises in Pharmacovigilance (QPPV).

Does it affect your company?

The obligation is the same whether the MAH is an innovative pharma company or a generics company. Herbal medicines are also covered.

Is your company equipped to Keep Watch?

As this is a legal requirement you must have a system in place by the time you make your first application for a medical product. You have two main options:

Run your own system, incurring large set up costs and requiring employment of a highly skilled team.
Let Cambridge Regulatory Services handle your daily pharmacovigilance needs with our expert in-house team - at a very competitive rate.

Our Services - Keeping Watch on your marketed products

System Set up

Provision of client – tailored SOPS and completion of Module 1.8.1.
Risk Management Plans.
Use of in-house Pharmacovigilance computerised system for monitoring of data.
Named QPPV/EUQPPV on application form.

Ongoing Activities
Detection

Carrying out of regular literature searches.
Monitoring of Health Authority PV databases where appropriate.

Collection/Collation

Comprehensive Adverse Event management (tracking, coding and follow-up) from all sources including spontaneous reports.

Evaluation/Review

Medical Safety Assessment of individual case reports.
Electronic Reporting to EMEA and European Health Authorities of Adverse Events.
Expedited reporting of Serious Adverse Reactions.
Preparation and submission of PSURs.

Our Team

Responsible Person for EudraVigilance information.
EEA Qualified Person for pharmacovigilance and Local Qualified Person/Representatives where required in any EU member state.

Quality Assurance

QC of all in-house PV activites carried out.
Audits performed on CambReg’s Europoean PV Associates.
Prepartion for Health Authority insepections.

Want us to Keep Watch for you?

Contact us to discuss your Pharmacovigilance needs further.