Pharmacovigilance Agreements Training

SCOPE has developed training modules and guides to good practice in key areas of pharmacovigilance for staff working with national competent authorities to further improve their capacities and the capabilities of the EU pharmacovigilance network. SCOPE published the training material in 2016. Evaluation is as important as the training itself. It is an instrument to ensure that the knowledge from the training has been received by the apprentice and can help to identify areas that need to be further highlighted in future training. Ideally, a placement test should be done at the end of each workout. If this is not possible, it should be done as soon as possible. The evaluation should be such that the implementation does not last more than a few minutes. Multiple choice questions or an interview type evaluation are good modalities. Effective knowledge of drug safety and pharmacovigilance principles is necessary to get the most out of the course.

These training materials focus on national programmes for spontaneous reporting of adverse drug reactions (RDAs) by healthcare professionals and patients. They aim to provide National Competent Authorities (NAs) with a better understanding of the systems and practices available for the collection of A ER. Regulatory requirements and pharmacovigilance guidelines relevant to pharmaceutical trade agreements In November 2013, national competent authorities launched the Joint Action to Strengthen Pharmacovigilance Cooperation in Europe (SCOPE) to support pharmacovigilance operations within the European network, minimise duplication and make the most of the division of labour and resources. The European Medicines Agency (EMA) was a member of the project`s General Advisory Committee. Wear and tear on trained personnel is a challenge in itself, especially when the pharmacovigilance department is small. When a company is faced with a problem of high fluctuation, a system should be put in place, in addition to restrictive measures, to ensure adequate training of new employees. General topics for the training of all pharmacovigilance officers Missing infrastructures, such as slow internet connections, space for a large number of trainees, lack of equipment for the organization of video/web based trainings can, in some cases, be a challenge. A unique aspect of the requirement for pharmacovigilance activities is that with the growth of pharmaceutical and biotechnology activities, pharmacovigilance requirements will continue to increase, because even as products age on the market, the requirement for pharmacovigilance activities and compliance with regulatory obligations persist. When new products are admitted to the company, the function continues to grow. More products lead to an increase in turnover, which leads to more prescriptions and, consequently, a wider exposure of the population. Ultimately, more qualified personnel are needed to deal with an increased number of adverse drug reactions and all the resulting pharmacovigilance activities with regard to reporting to regulatory authorities.

The supply and demand situation for skilled labour is strongly skewed in favour of demand, given that this field is relatively new in India and elsewhere and that a large number of pharmaceutical companies are trying to relocate this function to India in order to benefit from cost arbitrage. Therefore, the workforce is limited at this stage, with long experience and extensive exposure. Therefore, the need for qualified resources to become highly qualified pharmacovigilance professionals is the imperative of the moment. . . .