Definition

Qualified Person for Pharmacovigilance for India; responsible for PV system and compliance with CDSCO/PvPI. May be same as EU QPPV or designated locally.

Example

Designated QPPV resident in India or with clear availability for CDSCO communication.

Regulatory source

CDSCO, PvPI requirements

Common mistakes

No designated India QPPV or contact not reachable.

Inspector question

Who is your QPPV for India and how is availability ensured?

Related terms