Is your internal personnel and sales force adequately trained? And your pharmacovigilance staff?

by: Leonardo Giraudo, Pharmacovigilance Compliance Expert @PQE Group

Abstract

Trained personnel play a vital role in ensuring medicinal safety in the animal health business. To achieve this, companies must focus on two primary goals: safety and efficacy of their products. Personnel involved in veterinary pharmacovigilance activities should receive initial and ongoing training to fulfill their roles and responsibilities effectively. Collaboration between quality assurance and pharmacovigilance staff is crucial in defining training needs, developing a training plan, and monitoring its efficacy. Different staff members require varied levels of pharmacovigilance training, with non-Pharmacovigilance staff focusing on basic concepts and recognizing adverse events, while pharmacovigilance staff should receive in-depth training on applicable regulations and guidelines. 

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Trained personnel helps to guarantee medicinal safety 

As a company that works in the animal health business, the safety and efficacy of the products that you are marketing are your two primary goals. In order to guarantee that you are able to manage these goals correctly you need appropriately qualified and trained personnel. All personnel involved in veterinary pharmacovigilance activities should receive initial and continued training related to their role and responsibilities. It is essential that all personnel that might have contact with the general public, internal or external to the company, know that a Validation Master Plan (VMP) can reveal adverse events and that this information must be collected in order to manage that product’s safety. 

Training fundamentals for a good pharmacovigilance system

In order to guarantee and maintain an adequate level of competencies, your quality assurance and pharmacovigilance staff must work together to define  the training needs, develop a training plan and monitor the efficacy of the training that has been done. The personnel can be divided in two macro-areas: The Pharmacovigilance staff, such as technical, clinical, regulatory affairs and audit staff, and non-Pharmacovigilance staff, such as sales and marketing staff. 

Different pharmacovigilance training requirements for different staff 

Your non-Pharmacovigilance staff must be trained primarily on the basic concept of pharmacovigilance. It is not necessary to delve deeply inside the guidelines and regulations, but these staff members need to recognize any Suspect Adverse Event. Your Pharmacovigilance staff must be trained deeply on pharmacovigilance applicable regulations and guidelines. Following the introduction of a new regulation and new guidelines, it is expected that all relevant personnel have been trained appropriately. An evaluation of their competences can be a good source of information on what training is needed in order to support the continuous improvement of their relevant skills. Remember to properly train your staff on your procedures and the guidance; in addition, your service provider, Local Representative and commercial partners can, and should, be involved in adverse event management. 

 
 
Bibliography 

COMMISSION IMPLEMENTING REGULATION (EU) 2021/1281 of 2 August 2021 laying down rules for the application of Regulation (EU) 2019/6 of the European Parliament and of the Council as regards good pharmacovigilance practice and on the format, content and summ. (2021). Bruxelles: Official Journal of the European Union. 

EMA/595115/2021 Guideline on veterinary good pharmacovigilance practices (VGVP) Module: Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files. (2021). Amsterdam: EMA. 

 

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