SubscribeUntil recently, the imagination of outsourcing of pharmacovigilance responsibilities and activities fell far behind the comfort zone of responsible pharmaceutical managers, as drug safety has traditionally been an independent, self-contained function in most pharmaceutical companies.
In addition, this field opens to unfamiliar grounds of difficult legal ramifications requiring high levels of inter disciplinary expertise. Nevertheless, as legislation and regulatory bodies are increasingly demanding more and more functions and tools to detect and to respond to safety concerns with any drug, the benefits of pharmacovigilance outsourcing become more evident.
Pharmacovigilance - the term describes the proactive monitoring, collection, analysis and reporting of safety information on medicinal products both in clinical development and post marketing. Due to its undoubted medical importance in protecting subsequent patients, competent authorities worldwide demonstrate an increasing awareness on Pharmacovigilance since several years.
The three ICH regions taking the frontrunner's position according to their predominant responsibility. Driven by medical comprehension as well as political and public pressure, this has lead to high demands on establishing fast communication lines between practitioners and drug users, medical 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 pharmacovigilance systems 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.
Current legislation requires from the liable manufacturer to inform concerned authorities rapidly about serious Adverse Drug Reactions (ADR) and other drug safety related events that are occurring during the developmental and marketing periods of a drug, such as Suspected Unexpected Serious Adverse Reaction (SUSAR) in clinical development or other immediately reporting events in later stages of a drug's lifecycle.
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 pharmaceutical products.
To meet all these proposed requirements, outsourcing of the pharmacovigilance process provides a cost effective solution, especially for small and medium sized pharmaceutical companies. This would avoid the high upfront investments and fixed overhead costs connected with setting up an in house drug safety system. And besides meeting the regulatory requirements, outsourcing would allow immediate participation in the efficiencies provided trough the imminent implementation of electronic SAE reporting.
Therefore, whether companies want to address their pharmacovigilance needs by having a full service safety program designed and implemented or out tasking of certain safety responsibilities for a single project or a single product, liaising with experienced pharmacovigilance partners most often represent an attractive solution to the immediate needs as described above. Even if a pharmaceutical company decides to develop their own drug safety group in house over the time, often there is need for external advice and possibly interim coverage until the team gets up to speed.
The most important benefits for an outsourcing solution are the easy of managing certain "peaks" and new demands, and the reduced cost for database infrastructure and licence cost for costly software programs. These key benefits allow to keep the internal headcount low, as no or only little corporate infrastructure is needed. As the pharmacovigilance provider normally lacks the specific product knowledge, effective transfer of drug information data is necessary.
This can be facilitated when liaising with a structurally competent partner who is able to assimilate the necessary product knowledge easily, e.g. with a comprehensive training programme and regular interactions with the core product team of the pharmaceutical company.
Another issue, the sharing of sensitive information should be addressed at the start of a collaboration to ensure that necessary confidence is installed properly right from the beginning With this in mind, the advantages of a long term become evident and the partner in pharmacovigilance should be chosen with caution. PharmaLex's Pharmacovigilance team is capable of managing all different aspects of this area satisfying considerable authority concerns as well as industrial needs.
The structure of our expert teams accounts for the development and implementation of Pharmacovigilance strategies for your medicinal product from early clinical stages to pre-marketing development program and to the classical Pharmacovigilance activities during its post marketing stages. In addition, during the approval process we can prepare 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?
- Proactive surveillance and reporting on relevant safety issues of drugs in clinical development and post marketing period: SUSAR, ICSR, expedited reporting.
- Assessment and information of regulatory authorities, clinicians and consumers regarding the safe use of medicines, especially in case of new additional scientific knowledge.
- Evaluation of risks and benefits of these drugs and medicines at different points of their lifecycle: PSUR, DSUR, ASR, risk benefit assessment.
- Preparation and design of systems and working procedures for reporting and research on adverse events of the drug in use: SPS, EU-RMP, risk minimization activities.
