Medicinal products for human use

Pharmacovigilance is the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problems.

The main objectives of pharmacovigilance are:

• preventing harm from adverse reactions in humans arising either from the use of authorized medicinal products, within or outside the terms of marketing authorization, or from occupational exposure.
• promoting the safe and effective use of medicinal products, through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public.

Pharmacovigilance is therefore an activity contributing to the patients' protection and public health.

Medicinal products for veterinary use

Pharmacovigilance in veterinary products is a set of activities intended to understand and continuously evaluate the efficacy and safety of veterinary medicinal products. This identifies and quantifies the efficacy and known and unknown risks, in order to ensure an adequate benefit/risk balance and minimize or avoid risks.

The aim of veterinary pharmacovigilance is to ensure:

• Safe use of veterinary medicinal products in animals
• The safety of foods of animal origin
• The safety of people in contact with veterinary medicinal products
• Environmental safety

For all this, there is a legal obligation, in terms of veterinary pharmacovigilance, for authorities and pharmaceutical companies of developing certain minimum activities which provide a safe use of these products.

Audits

A pharmacovigilance system is a system in its own entity in which each and every one of its processes must be integrated into a system of quality management and, accordingly, has to be audited periodically to ensure its robustness.

We realize that today quality management is one of the areas on which health authority inspections lay more emphasis. For this reason, we have a team of experienced auditors not only in the design and maintenance of quality management systems, but also in all technical aspects of the daily management of a pharmacovigilance system. This knowledge, along with the practice derived from conducting numerous internal audits and counseling pharmaceutical companies during health authorities inspections, qualify our team to provide your company any service related to pharmacovigilance audits and support on inspections.

Clinical trials

A clinical trial is any investigation on human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s) under investigation. It also attempts to identify any adverse reactions to one or more investigational medicinal product(s) under investigation, and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) under investigation, with the aim of ascertaining its (their) safety and/or efficacy.

Cosmetovigilance

The purpose of cosmetovigilance is to collect, analyze and evaluate adverse reactions occurred in consumers in order to identify any potential risks and ensure consumer safety during use of the different cosmetic products.

As a result of the publication of the new regulation, Cosmetovigilance acquires a new and more important role in the market of cosmetics and personal care products.

The person responsible for marketing a cosmetic product is required to comply with a series of activities to ensure its safety in human use.

Medical devices

The surveillance system on medical devices aims to improve the protection of consumers' health and safety, by notifying adverse events occurring with a medical device, its registration and assessment, timely actions and their submission to stakeholders.

According to current legislation in this area and guide MEDDEV, there are certain mandatory activities to ensure the safety of medical devices.

Dictionaries

HUMAN MEDICINES

Article 57 (2) of Regulation 1235/2010 establishes that marketing authorization holders are required to enter and update information on human medicines registered in Europe in the database created by the EMA for this purpose (Extended EudraVigilance Medicinal Product Dictionary XEVMPD).

Similarly, the sponsor of a clinical trial must enter the information on investigational drugs in XEVMPD as established on the Detailed guidance on the collection, verification and presentation of adverse event / reaction reports from clinical trials arising on medicinal products for human use "('CT-3').

COSMETICS

Introduction of information of cosmetic products in the CPNP (Cosmetic Products Notification Portal).

The CPNP is the site where the cosmetic industry must submit all the information related to its cosmetic products, both those with a permanent and continuous presence in the market and the new products to be introduced from July 2013.

This portal is available since January 2012, and its use will be mandatory from July 2013.

Scientific information

The huge amount of resources available today for obtaining scientific information for professionals makes increasingly difficult to obtain rapid and accurate information on a specific topic under study. Success in obtaining relevant and quality information lies in:

• The definition of the objective of the search
• Proper design of the search strategy
• Proper selection of information sources
• A review by a specialist