Definition

Pharmacovigilance Risk Assessment Committee (EMA); assesses signals, recommends regulatory action, and oversees RMPs and referrals.

Example

PRAC review of a validated signal leading to SmPC update or referral.

Regulatory source

EMA PRAC, Regulation (EC) 726/2004

Common mistakes

Not monitoring PRAC agendas and outcomes for own products.

Inspector question

How do you track PRAC discussions relevant to your products?

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