EMA: Draft concept paper on the need for revision of the note for guidance on manufacture of the finished dosage form

This concept paper addresses the need to update and revise the CPMP/QWP/486/95 note for guidance on manufacture of the finished dosage form (1). This guideline was originally adopted in September ...

FDA: Draft Guidance - Considerations for the Design of Early - Phase Clinical Trials of Cellular and Gene Therapy Products

This guidance provides recommendations to assist in designing early-phase clinical trials of CGT products. When this guidance is finalized, we believe it will clarify OCTGT’s current ...

FDA: Guidance for Industry: Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality

This guidance is intended to alert manufacturers of active pharmaceutical ingredients (APIs), pharmaceutical and medical device manufacturers of finished products, repackers, and others to the ...

EMA: Draft note for guidance on clinical investigation of medicinal products for treatment of asthma

This document is intended to provide guidance for the clinical evaluation of new medicinal products for the treatment of asthma. ...

EMA: Practical guidance on the extension of Commission decision annexes in the new accession country language

This Guidance outlines practical considerations concerning the phasing-in of Commission Decisions concerning CAPs in Croatia.The document provides further details on the inclusion of the new ...

EMA: Draft concept paper on the need for a reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development

The reflection paper (RP) should provide an overview of statistical principles with a potential of useful application in the context of the comparison of quality attributes as mentioned above. For ...

EMA: Draft guideline on adjustment for baseline covariate

The note for guidance on statistical principles for clinical trials (ICH E9) briefly addresses the problem of adjustment for covariates. It advises experimenters ‘to identify the covariates ...

GMP: Guideline on the European Drug Master File Procedure updated

The \"Guideline on Active Substance Master File Procedure\" which was developed by EMA\'s Quality Woring Party, describes the procedure that can be used to document an API\'s quality for a ...

GMP: WHO Guideline on Quality Risk Management finalised

Annex 2 of the new Technical Report 981 is a new WHO guideline on the implementation of a quality risk management system. The aim of this guideline is to assist the implementation of a QRM system, ...

GMP: GMP-Audits of manufacturers of active substances: Minimum Requirements on Audit Reports and Qualification of Auditors

The European Medicines Agency EMA specifies in one of its questions and answers documents on the GMP guideline under the heading \"EU GMP guide part II: Basic requirements for active substances ...

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