Abstract:

Introduction:
Learning and knowledge about veterinary vaccines, involve difficulties that should be exceed. Once these products are placed on the market, the only accurate source of safety information usually is the client information and the technical leaflets. Although Pharmaceutical companies provide their own information when promotes their products, the deep knowledge of vaccines will only achieve when students access to scientific papers presenting results from studies, ideally, not-sponsored. The knowledge of the efficacy and safety profile of medicines and vaccines, is necessary to be a good clinical veterinarian. The safety profile of products is not a static thing. Post-marketing data can be considered as an important source of information and therefore, knowing how to report the negative consequences of medicines and vaccines is deemed necessary. In this context, students need to know how to inform the Spanish Regulatory Authority. Based on this reported information, National Regulatory Authorities will collect data and decide about the future of the medicines and vaccines which in the end, benefit to both, humans and animals.

Objective:
Students must learn the way to achieve the knowledge about the vaccine quality, and how to officially report vaccine lack of efficacy and/or their associated safety issues.

Method:
Vaccine knowledge activity is carried out by groups of 5 or 6 students (a total of 24 groups). Every group has to assist to a tutorial of 2 hours where the lecturer explains the way to develop the vaccine study. They are taught about the main quality properties (Purity, Potency, Efficacy and Safety), and the sources of information that they have to search. The lecturer explains and gives the students some papers where they can find the main basic information about vaccines that will be the base to start their own work. They are informed about the sources they can consult. The study will part from the information content in the prospect and technical sheet provided by the Spanish Regulatory Authority on line (CIMA-Vet), and also the European Medicines Agency (EMA). Students will find technical assessment elaborated by experts before the final approval to commercialization. Also, the students have to search scientist and reviews papers made by experts that help them to have a better knowledge of the vaccine. Subsequently they elaborate a report about the quality of the chosen vaccine. In the second part of this activity (1 hour), students will learn about how to fulfil an official sheet provided by the Spanish Health Ministry SHM (“tarjeta verde”) in order to report vaccine quality fails and safety issues associated with their use.

This practice is evaluated by the lecturer after the reception of the inform elaborated by any group and account for a maximum of 1 point to sum up in the global compute of the subject.

The items to give the punctuation are:
- ability to find good information;
- level of knowledge acquired;
- ability to organize and synthesize information;
- ability of the group to collaborate and share out the work.

Keywords:

Veterinary sciences, vaccine, pharmacovigilance, learning activities.