May 7, 2022

Pharmacovigilance trainings: four basic considerations for establishment of training environment

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Pharmacovigilance trainings: You love it or hate it, but can not ignore it 

Yes, you read it right! You love it or hate it but can not ignore it. If someone says WHY? The reason is quite clear and simple..it is regulatory requirement👮

Need to understand further refer my previous blog "Pharmacovigilance Trainings: a succinct summary from GVP Modules"

First thing we need to understand that pharmacovigilance trainings fall under pharmacovigilance quality systems (GVP Module I – Pharmacovigilance systems and their quality systems) (consider it serious as other pharmacovigilance process).  

Below mention four basic considerations will save you from future observation from audit (internal/external) or regulatory inspection. 

Let's discuss some of them one by one - 

1. All person involved in pharmacovigilance training should receive initial and follow-up continuing trainings whether new or existing employee. 

New Employee: - New employee should undergo all necessary trainings according to job role and training plan. 

Let's understand this with possible trainings case processor/data entry role - 

  • Pharmacovigilance (PV) Trainings - Introduction of MedDRA and MedDRA coding, MedDRA  Term Selection: Points to Consider, Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products, ICH Guidelines (ICH E2A, ICH E2B and E2D at least)
  • Quality Perspective Trainings: GVP Module I- Pharmacovigilance systems and their quality system, Case level quality and Field level quality parameters or fields from the database, Organizational quality policy
  • Audit and Inspection Specific Trainings: Module-III - Pharmacovigilance Inspections and Module IV- Pharmacovigilance Audits
  • MAH/Organization specific controlled documents Trainings: Standard Operating Procedures (SOP), Work Instructions (WI), Job-Aid, Policy, Any other document deemed important by respective Marketing Authorization Holder (MAH) or organization.
  • Human Resource Trainings (not direct relation with pharmacovigilance but essential to understand organization DNA and work environment)
  • Database Trainings
  • Trainings assessment methodology 

Existing Employee: 

  • Training upon new introduction of controlled documents (SOP/WI/Job-Aid/Policy)
  • Change or update in regulatory guidelines
  • Change in PV database functionalities 
  • Changes/Updates in Safety Data Exchange Agreements (SDEA)- MAH, Distributors and Manufacture type
  • Trainings related to outcome of audit or findings of regulatory inspection
  • Quality related re-trainings
  • Periodic refresher trainings
2. Training plan and Training records- documented evidences that  proves person undergone sufficient relevant trainings which demonstrate competency for assigned job role

3.  Training of Non-Pharmacovigilance Persons - Any person who directly or indirectly involved in receipt of any type of safety information (which includes company's sales representative, receptionist, persons handling company's social media, HR & Admin, etc.)

4. If any organization uses training software or portal then relevant user manual or work instruction, audit trail, system generated outputs including compliance reports, user access management process, training allocation handling process is advisable to have documented.

In short, all staff should be appropriately trained with evidences of their training (theoretical and practical) in ongoing manner.