Pharmaceutical regulatory affairs consulting services Poland

Pharmaceutical consulting Poland

EMA procedural guidelines

► 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).

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EMA procedural guidelines