Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing …

There should be appropriate structures and processes in place to ensure that pharmacovigilance data and records are protected from destruction during the applicable record retention period.

Guidance for Industry - Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment , Clinical/Medical

− This is modified to “The principles and requirements for record keeping and archiving of documents obtained or resulting from the pharmacovigilance inspections referred to in III.B.5 …

Dec 12, 2017 · This new guidance on good pharmacovigilance practices (GVP) is organised into two types of chapters, namely Modules on pharmacovigilance processes and Product- or …

For most pharmacoepidemiologic studies, FDA recommends that sponsors validate diagnostic findings through a detailed review of at least a sample of medical records.

Oct 6, 2022 · The EMA published a guidance for applicants / MAHs involved in GVP inspections. It includes a detailed list of documents to be provided to GVP inspectors.

You can bring a bus, taxi, or goods vehicle registered in ASEAN countries into Singapore, if your vehicle has a valid ASEAN Public Service Vehicle Permit (PSVP) or ASEAN Goods Vehicle …

Document and Record Control description of the archiving arrangements for electronic and/or hardcopy versions of the PSMF should be provided, as well as an overview of the procedures …

to identify, record and address non-compliance which may pose a risk to public health; to use the inspection results as a basis for enforcement action, where considered necessary.