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Monday, August 19, 2013

The contributors and authorities role to facilitate a smooth and efficient pharmacovigilance process

Pharmacoviligance is preferably conducted continuously in the pre- and post-authorization phase – from research, development, access and use of medicinal products and the timing of pharmacovigilance and post marketing surveillance.

Expert language translation is critical in facilitating a smooth and efficient pharmacovigilance process. It is important that qualified language translation is performed, for example, of the study synopsis, the informed consent, in the submissions (if deemed necessary by the country authority), in the public access to the information.


The main industrial organizations with a real interest in pharmacovigilance are the pharmaceutical companies, medical device manufacturers, clinical research organizations (CROs) and other outsourcing partners such as language translation organizations. Pharmaceutical companies, medical device manufacturers and CROs need to establish standard operating procedures (SOPs) for their pharmacovigilance departments. The SOPs should also include the content published on their respective websites. Data collection is one responsibility of these departments, which in some companies report directly to senior management and even the CEO. Here language plays an important role. It is vital that the same medical terms are used and translated correctly so that the database can be understood and disseminated worldwide.

In Europe, the new legislation1 strengthens the companies’ pharmacovigilance systems without adding either administrative burden or cost. At the same time, it allows authorities to make the industry legally responsible to carry out Post-Authorization Safety Studies (PASS), and share them within three database systems: EudraVigilance, EudraPharm and the European Pharmacovigilance Issues Tracking Tool. With this uniformity requirement, translations are extremely important so that a uniform language is used and understood. Because of these future requirements, LSPs will be very much involved and may even have to work with each other’s SOPs to achieve uniformity.


The health care insurance industry is another important client for pharmacovigilance data, at least in the U.S. Payors have several interest levels for these datasets. Reimbursement can be driven by data demonstrating that a certain treatment is very effective and can result in long-term health care cost savings. On the other hand, it is equally important for the payors to understand that adverse events can increase health care costs drastically, especially if they are potentially associated with long-term harm to the patients.

Therefore, these organizations need access to pharmacovigilance databases, preferably in a language understandable to the organization. Often this requires translations from a range of languages into English.

Competent authority

In the EU, the competent authority is the regulatory authority. In some other jurisdictions the competent authority is a subset of the regulatory authority with added expertise. The charter of the competent authority thus includes the responsibility for pharmacovigilance, in which marketing authorizations are held. The competent authority has the ultimate power of retracting the market authorization, if it is deemed necessary.

With these contributors’ roles in mind, it is often a best practice for pharmaceutical, medical device companies and CROs to work with a qualified LSP who understands the intent and the requirement for a common database with a common medical language. An experienced LSP can help expedite reports and adequately participate in the creation of the worldwide database.


1 New EU Pharmacovigilance Legislation – Key Concepts, European Medicines Agency, EMA/186974/2012


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