Drug-safety requirements are governed by regimentations.

Pharmacovigilance & Risk Management

It's the law and a matter of ethics.

Pharmacovigilance – the term describes the proactive monitoring, collection, analysis and reporting of safety information on medicinal products both during clinical development and post marketing. Due to its undoubted importance, authorities worldwide demonstrate increasing awareness on Pharmacovigilance, with the three ICH regions taking the frontrunner’s position according to their outstanding responsibility. Increasing public pressure has led to high demands on establishing fast communication lines between practitioners and drug users, pharmaceutical industry and society.
Therefore a whole arsenal of legislative requirements has been implemented during the last years in these regions, naturally emphasising the early stages of a new drug’s life cycle.
Pharmacovigilance planning has by now become an essential issue for the long-term success of any drug on the market, as malfunction of the pharmacovigilance system and communication channels may lead to license retraction!

Modern instant communication channels put manufacturers and marketers of medicinal drugs and medical devices into the position to report adverse drug reactions immediately to their competent authorities. Therefore, current legislation demands from the liable manufacturer to inform concerned authorities rapidly about serious adverse events and other drug-safety related issues occurring during a products marketing lifetime.
Failures in compliance with these requirements could make the difference between keeping your drug on the market and being forced to withdraw it.

Therefore, early planning of your Pharmacovigilance strategy is crucial to the success of your product.

PharmaLex’s Pharmacovigilance team is specialized in the management of all these issues – dealing with possible authority concerns as well as with industrial needs. We develop and implement custom-tailored Pharmacovigilance strategies for your medicinal product from early clinical stages through pre-marketing up to the established Pharmacovigilance activities in post-marketing stages. In addition, during the approval process we provide the Safety Specification, Summary of Pharmacovigilance System (SPS) and EU Risk Management Plan (EU-RMP) to be submitted at the time of licence application of your drug.

What PharmaLex can do for you?