► Regulatory and procedural guideline: Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with considerations P.II on biological medicinal products finalised post-public consultation
► Regulatory and procedural guideline: EudraVigilance auditable requirement project - EudraVigilance training plan, adopted
► Regulatory and procedural guideline: EudraVigilance stakeholder change management plan
► Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
► Regulatory and procedural guideline: Draft guideline on good pharmacovigilance practices (GVP) - Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions, draft: consultation open
► Regulatory and procedural guideline: Draft guideline on good pharmacovigilance practices (GVP) - Module VI – Management and reporting of adverse reactions to medicinal products (Rev. 2), draft: consultation open
More details and source documents available on EMA website (see links section).