Guideline on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations IV: Paediatric population
P.IV.A. Introduction:
P.IV.A.1.
Pharmacovigilance aspects specific to the paediatric population
P.IV.A.1.1.
Susceptibility to adverse reactions
P.IV.A.1.2.
Limited numbers of subjects in paediatric clinical trials
P.IV.A.1.5.
Clinical presentation of adverse reactions
P.IV.B.
Structures and processes
P.IV.B.1.
Risk management plan (RMP)
P.IV.B.2.
Management and reporting of adverse reactions
P.IV.B.2.2.
Other information relevant to the paediatric population
P.IV.B.3.
Periodic safety update report (PSUR)
P.IV.B.4.
Post-authorisation safety studies (PASS)
P.IV.B.6.
Safety communication
P.IV.C
Operation of the EU network
P.IV.C.1.
Roles and responsibilities
P.IV.C.1.1.
Marketing authorisation holder and applicant in the EU
P.IV.C.1.2.
European Medicines Agency
P.IV.C.1.2.1.
The Paediatric Committee (PDCO)
P.IV.C.2.
The paediatric investigation plan in the EU (PIP)
P.IV.C.3.
The risk management plan in the EU
P.IV.C.4.
The periodic update safety report in the EU
P.IV.C.5.
Designing a post-authorisation safety study and protocol submission in the EU
P.IV.C.6.
Signal management within the EU regulatory network
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