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EMA: Explanatory note on fees payable to the European Medicines Agency

19.10.2010
Following the publication of the Rules for the implementation of Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures1 as last adopted by the Agency’s ...

FDA: Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND

19.10.2010
This guidance is intended to assist clinical investigators, sponsors, and sponsor-investigators in determining whether human research studies must be conducted under an investigational new drug ...

EMA: Scientific guideline: ICH guideline E16 Genomic biomarkers related to drug response: context, structure and format of qualification submissions - Step 4

11.10.2010
The guideline describes recommendations regarding context, structure and format of regulatory submissions for qualification of genomic biomarkers (as defined in ICH E15). Qualification is a ...

EMA: Scientific guideline: ICH guideline E2F : Note for guidance on development safety update report - Step 4

11.10.2010
The Development Safety Update Report (DSUR) proposed in this guideline is intended to be a common standard for periodic reporting on drugs under development (including marketed drugs that are ...

FDA: Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies

11.10.2010
This document provides guidance to sponsors and investigators on safety reporting requirements for human drug and biological products2 that are being investigated under an investigational new drug ...

Polish Registration Office: Information of the President of Registration Office (EDQM Standard Terms)

07.10.2010
Information of the President of Registration Office concerning supplement to Almanach related to EDQM Standard Terms. ...

Polish Ministry of Health: The project of the Act concerning Office of Registration of Medicinal Products, Medical Devices and Biocidal Products

07.10.2010
The Act determines the responsibilities of the President of the Registration Office and operating principles of the Registration Office. ...

EMA: Regulatory and procedural guideline: Reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples

24.09.2010
The purpose of this guidance document is to provide laboratories that perform the analysis of samples collected as part of a clinical trial, with information that will help them develop and ...

European Medicines Agency welcomes adoption of new pharmacovigilance legislation by European Parliament

24.09.2010
22/09/2010 - The European Medicines Agency welcomes the adoption of the new pharmacovigilance legislation by the European Parliament today. This is a major step towards the legislation coming into ...

EMA: Scientific guideline: Draft guideline on clinical investigation of medicinal products in the treatment of Chronic Obstructive Pulmonary Disease (COPD)

24.09.2010
This guideline is a revision of the CPMP Points to Consider on Clinical Investigation of Medicinal Products in the Chronic Treatment of Patients with Chronic Obstructive Pulmonary Disease ...

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