A pharmaceutical company is any commercial entity that may be associated with research, manufacturing, commercialization or distribution of medicinal products. This entity may or may not own the product license, and this factor may decide if this entity will or will not fall under the purview of pharmacovigilance regulations. That doesn’t prevent the company personnel from getting trained on basic pharmacovigilance requirements.

What do the regulations state?

The EMA GVP Module 1 states the following:

“All personnel involved in the performance of pharmacovigilance activities shall receive initial and continued training,….,Adequate training should also be considered by the organisation for those staff members to whom no specific pharmacovigilance tasks and responsibilities have been assigned but whose activities may have an impact on the pharmacovigilance system or the conduct of pharmacovigilance. Such activities include but are not limited to those related to clinical trials, technical product complaints, medical information, terminologies, sales and marketing, regulatory affairs, legal affairs and audits.”

Pharmacovigilance Team

The pharmacovigilance team should receive periodic training related to the written documents (E.g., SOPs), regulatory guidance documents as well as the recent changes in the regulatory requirements. Besides, the responsible persons (E.g., the QPPV) should also get trained and this should be documented appropriately.

Allied Departments

Apart from the pharmacovigilance personnel, it is likely that other department personnel also may come across adverse events. These include the clinical, quality, medical information, sales and marketing, regulatory affairs, and legal teams. Hence it is essential to train such personnel on pharmacovigilance.

Other Personnel

Besides, the administrative staff may also come across adverse events. Such staff may include those from front-office, or even the security personnel.

Full-time Vs Contractual Personnel

With the advent of automation, companies have started replacing the full-time staff with contractual or fixed-term employees. These personnel may or may not be on the company payroll, but may be associated with functions that can receive adverse events. Hence it is essential to document pharmacovigilance training for such personnel.

Training of external stakeholders

The pharmaceutical company may consider outsourcing some of its tasks, that may be related to pharmacovigilance, clinical research, medical information, or even commercialization. The entities handling the tasks may come across adverse events, and hence are required to be trained. The project-specific training may be provided by the sponsor, and it would be ideal if the following stakeholders have training procedures for their staff.

1. Distributors
2. Service Providers
3. Clinical Research Organization

Training Plan

It is recommended to maintain an annual training plan for the company personnel. A role-based training matrix is invaluable! Besides, an annual report for the trainings performed in the previous year should be documented along with the planned date and the date when the training was conducted.

Which aspects (bare minimum) should be covered?

1. Day Zero and four minimum criteria
2. Product efficacy issues and Product complaints
3. Pregnancy exposure
4. Follow-up
5. Expedited reporting and regulatory communication
6. Impact of non-reporting

When to undertake the training?

It is recommended to include pharmacovigilance training in the company induction program. The personnel should be trained before they take-on the activities within the company. For project-specific training, the personnel need to get trained at the time of onboarding.

Mode of Training

The company may decide to undertake face-to-face training, or through other means such as self-learning or even through remote processes. There is no doubt that face-to-face is the most effective mode of training. This may pose a challenge when the trainer is located in a different geography, where remote training is the only option. Self-learning is a very good option as the personnel can learn at their own pace.

Training Assessment, retraining and refresher training

It is advisable to assess if the company personnel have understood the pharmacovigilance requirements. This can be achieved with some kind of a quiz with minimum pass criteria. The personnel who score less should undergo retraining. Escalation should be in place if the personnel are unable to clear the quiz even after repeated trainings. Besides, there should be a process for periodic refresher training where the personnel are repeatedly made aware of their responsibilities.

Training Deviations

Appropriate documentation is essential if the personnel training is not completed on time. It is recommended to document this in the quality management system by means of deviations.

The pharmacovigilance requirements are ever-evolving and the activities are critical, with potential impact on public health. It is essential that the personnel are aware of their roles and responsibilities and there is appropriate documentation to support this. Training is one of the favorite areas for the auditors and inspectors and it is very likely that they would start with this topic; after all, an observation is quite likely!