EMA: Reflection Paper on risk based Quality Management in Clinical Trials

The purpose of this reflection paper is to facilitate the development of a more systematic, prioritised, risk-based approach to quality management of clinical trials, to support the principles of ...

FDA: Time and Extent Applications for Nonprescription Drug Products

This guidance is intended to explain what information an applicant should submit to the Food and Drug Administration (FDA) to request that a drug product be included in the over-the¬counter (OTC) ...

FDA: Self-Selection Studies for Nonprescription Drug Products

This guidance is intended to provide recommendations to industry involved in developing and conducting self-selection studies to support an application for nonprescription drug products. A ...

GMP: EMA publishes two advisory Documents addressing a Number of Questions about centralised Admission Procedures

The EMA has recently published two documents concerning the centralised application procedures for new, generic and hybrid medicinal products. In the Q&A section on its website the European ...

TOPRA: EU Module 1 v1.4.1 Specification

This document specifies Module 1 of the electronic Common Technical Document (eCTD) for the European Union (“EU”). ...

EMA: Periodic Signal Detection for Centrally Authorised Products Based on Reaction Monitoring Reports

To describe the process by which identification of new safety signals for Centrally Authorised medicinal Products (CAPs) is conducted periodically in the Pharmacovigilance and Risk Management ...

GMP: Faster Sterility Tests for Biological Products

The FDA Center for Biologics Evaluation and Research (CBER) in Rockville, MD, published a poster that considers rapid sterility testing and compares different modern methods with compendial methods. ...

EMA: Concept paper on pharmacovigilance implementing measures released for consultation

The European Commission is seeking views from the public on a concept paper on implementing measures for the performance of activities related to the safety monitoring of medicines. ...

PMR: Non-pharmacy market of OTC products in Poland in 2011-2013

In 2009 the non-pharmacy market of OTC products (comprising medicines and dietary supplements) rose by around 11% year on year and exceeded PLN 1bn (€231m) for the first time on record. The year ...

EMA: EMA Procedural advice for users of the centralised procedure for generic/hybrid applications

This document addresses a number of questions which users of the Centralised Procedure may have. It provides an overview of the EMA position on issues, which are typically addressed during the ...

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