Suspected adverse event reporting and signal management are important in animal health to identify, assess and manage adverse reactions to veterinary medicinal products on animals. Their correct management ensure animal safety, public safety, particularly in food-producing animals, and regulatory compliance. The correct Adverse Event evaluation permit also to improve the safety and efficacy of animal health products and help to identify and manage risks associated with animal health products to protect animals, humans and the environment.
Starting with a review of the applicable regulations and guidance, the course will help the participant to understand, through practical exercises and examples, how to manage Suspected Adverse Event Reports, focusing on the quality aspects.
The second part of the training will focus on the signal management process and the participant will understand how to use the signal management in the EudraVigilance Veterinary DataWarehouse (EVVet DWH), how to correctly prioritize the signals received, how to evaluate them and how to record all the activities carried out in order to meet the quality requirements.