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| Pharmacovigilance Training is Crucial to Business. |
Yes! You have read it right.
Pharmacovigilance training is crucial for your business better than any other PV activity. Training is one of the crucial components for running the business however, it gets neglected many times. Pharmaceutical companies or Contract Research Organizations (CRO) are set up pharmacovigilance training departments and develop some training modules for their employees and give self consolation that they have set up PV training as per recommendation from the Good Pharmacovigilance Practice modules (GVP).
GVP Module I – Pharmacovigilance systems and their quality systems emphasize the importance of PV training by mentioning a few of the following recommendations-
- A sufficient number of competent and appropriately qualified and trained personnel shall be available for the performance of pharmacovigilance activities [IR Art 10(1), Art 14(1)].
- The organization should ensure that adequate resources are available and that training is provided.
- All personnel involved in the performance of pharmacovigilance activities shall receive initial and continued training [IR Art 10(3), Art 14(2)].
- For marketing authorization holders, this training shall relate to the roles and responsibilities of the personnel [IR Art 10(3)].
- Training plans should be based on training needs assessment and should be subject to monitoring.
- The organization shall keep training plans and records for documenting, maintaining, and developing the competencies of personnel [IR Art 10(3), Art 14(2)].
- Training plans and records shall be kept and made available for audit and inspection [IR Art 10(3), Art 14(2)].
- The applicant or marketing authorization holder should provide the QPPV with training in relation to its pharmacovigilance system, which is appropriate for the role prior to the QPPV taking up the position and which is appropriately documented
- Where the QPPV has not completed basic medical training in accordance with Article 24 of Directive 2005/36/EC, the marketing authorization holder shall ensure that the QPPV is assisted by a medically trained person (i.e. in accordance with Article 24 of Directive 2005/36/EC) and this assistance shall be duly documented [IR Art 10(1)].
- Adequate training should also be considered by the organization for those staff members to whom no specific pharmacovigilance tasks and responsibilities.
In the majority of the organizations, the skeleton structure of training are as follow-
- Induction Training - Self-explanatory- Given at the time of induction
- Ongoing Training - Issue of new controlled documents (i.e. SOP, Work Instruction (WI), Job-Aid) or Revision of existing controlled documents
- Refresher Training - Periodic Training for controlled documents
- Adhoc Training - As an when it is needed. Publication of new regulatory guidelines or training imparted as a part of a regulatory inspection or findings from audit or inspection.
Provision of pharmacovigilance activity is one of the mandatory requirements to obtain marketing authorization in certain countries. After getting marketing authorization, an organization should continue to monitor the benefit-risk profile of the molecule. Trained pharmacovigilance professionals are required to carry out PV activity.
According to GVP, training shall relate to the roles and responsibilities of the personnel. However, many organizations failed to identify training requirements according to job-role which might lead to delay or failure in PV deliverables in terms of quality and quantity.
Let understand this with the ICSR example-
Let us assume if any organization processed 220 Individual Case Safety Report (ICSR)/cases per month by 3 persons (Data Entry, Quality Review, and Medical Review). We can say that 10 cases are processed per day with 48 mins of average processing time (considering 480mins per day work and 22 working days).
If we identify training gaps and planed targeted training and can able to reduce 20% (9.6 mins) of single case processing time. Then we can have 38.4 mins of average processing time and the same team can contribute 12.5 cases per day (instead of the previous 10 cases). That means we now have revised productivity of 275 cases per month i.e. ~ 25% rise compared to the previous month.
If the same example we go for higher processing time then productivity falls significantly.
If we extrapolate this with the large numbers then it significantly impacts our work efficiency and that leads to business.
This can be applied to the quality part also...In a general sense, data entry performed by a trained data entry person has a low or minimal error which leads to completion of quality review and medical review in a shorter time and ultimately productivity boost up and business also.
The training concept can be applied to other pharmacovigilance functions like literature review, aggregate reports, signal detection activities, etc.
Once the system improves, then we can have no or minor findings in audits and inspections. Ultimately, It is a WIN-WIN situation for any organization by strengthening training culture and periodic assessment of the effectiveness of training.
Signing Off.
Thank you.😊