EMA: Draft guideline on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products

This guideline addresses the influence of pharmacogenomics on pharmacovigilance activities, including considerations on how to evaluate the pharmacovigilance related issues for medicinal products ...

EMA: Draft guideline on the investigation of subgroups in confirmatory clinical trials

Investigation into the effects of treatment in well-defined subsets of the trial population is an integral part of clinical trial planning, analysis and inference that follows the inspection of ...

EMA: EMA releases guidance on the use of pharmacogenomics to improve safety monitoring of medicines

The European Medicines Agency has released a draft guideline for public consultation which addresses how pharmacogenomics can support pharmacovigilance activities and in particular how the results ...

EMA: Procedure for orphan-medicinal-product designation: Guidance for sponsors

The EMA strongly encourages sponsors to request a pre-submission meeting prior to filing an application for orphan medicinal product designation. Pre-submission meetings for orphan designation are ...

EMA: Draft guideline on core SmPC and package leaflet for (99Mo/99mTc) generator

This guideline describes the information to be included in the Summary of Products Characteristics (SmPC) and Package Leaflet for (99Mo/99mTc) generator. ...

EMA: Guideline for the conduct of efficacy studies for non-steroidal anti-inflammatory drugs

The objective of this guideline is to specify recommendations for the design, conduct, and evaluation of studies for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) to be provided in support of an ...

GMP: Update: Electronic Submission of Marketing Authorisation Dossiers

The document describes the approach to the submission of a dossier in the electronical format in the context of the centralised procedure (since the 1st of January 2010, all paper submissions have ...

EMA: Guideline on clinical investigation of medicinal products in the treatment of lipid disorders

This document is the revised version of the ‘Note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders (CHMP/EWP/3020/03)’. It is intended to ...

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

In the recent past, several requests submitted for EMA scientific advice contained questions concerning the adequacy of planned inferential statistical approaches to compare quality attributes.For ...

GMP: Good Practice Guidelines for Blood Establishments as a Co-Operation between the EDQM/CoE and the EU Commission published

This document will show the necessary elements of a quality system of blood establishments and hospital blood banks that are required to comply with EU Directive 2005/62/EC. ...

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