GMP: The new role of the Responsible Person for Good Distribution Practices

The European Commission is currently revising the \'Guideline on Good Distribution Practice of Medicinal Products for Human Use\". The current Guideline was first published in 1994. The new ...

GMP: Significant Changes in HPLC System Suitability: New USP Provisions Planned

A revision of General Chapter on Chromatography is proposed in the Pharmacopeial Forum (volume 38, edition 2). This new chapter has a major impact on system suitability tests (SST). ...

EMA: Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples

The purpose of this reflection paper is to provide laboratories that perform the analysis or evaluation of human samples collected as part of a clinical trial, with information that will help them ...

EMA: Guideline on the processing of renewals in the centralised procedure

This guideline considers issues associated with the processing of renewals in the centralised procedure, with an aim of giving procedural guidance to marketing authorisation holders (MAHs). It has ...

GMP: GMP Requirements for Pharmaceutical Excipients: NSF International publishes new Draft Standard

The NSF International is one of the U.S. American organisations which create standards for medical and cosmetic consumer goods and it has recently published a draft entitled \"Good Manufacturing ...

EMA: Reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems

This paper describes a basic package of information which could be relevant to confirm the sound pharmaceutical development and full characterisation of products of this type. ...

EMA: Reflection paper on risk mitigation measures related to the environmental risk assessment of veterinary medicinal products

This reflection paper provides a critical review of the adequacy/appropriateness of risk mitigation measures included in current marketing authorisations of veterinary medicinal products. ...

GMP: New Requirements for the Submission of Information on Medicinal Products - EMA publishes New Guidance for MAHs and a revised \"Legal Notice\"

The background to this catalogue of requirements is the provisions laid down in Article 57(2) of the new Regulation (EU) No 1235/2010. According to that regulation, the EMA requires these data to ...

GMP: Transitional Regulations for the New Pharmacovigilance Package: Commission\'s Q&A Document provides Clarity

Several provisions for pharmacovigilance have been newly defined among others with Regulation (EU) No 1235/2010 and Directive 2010/84/EU from 2010. Marketing authorisation holders are now ...

GMP: FDA\'s new web-based Training explains FDA Drug Regulatory Work

A new tool has been developed: the \"CDER World\", containing free e-learning modules with information about how CDER works. The respective modules deliver information based on the CDER ...

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