EMA: Guideline on user safety of topically administered veterinary medicinal products

Applications for marketing authorisations for veterinary medicinal products (VMPs) in the European Union are issued in accordance with Directive 2001/82/EC as amended by Directive 2004/28/EC and ...

EMA: Improving safety of first-in-human clinical trials

EMA starts EU-wide reflection on necessary changes to best practices. The European Medicines Agency (EMA) has started a review of the guidelines that describe first-in-human clinical trials and ...

EMA: Regulation of advanced therapy medicines

Report details concrete proposals to encourage development and authorisation of advanced therapy medicinal products (ATMPs) in the EU. The European Medicines Agency (EMA) today published a report ...

EMA: Draft guideline on core SmPC and package leaflet for gadoteric acid

This guideline describes the information to be included in the summary of products characteristics (SmPC) and package leaflet for gadoteric acid. ...

EMA: Draft guideline on the plant testing strategy for veterinary medicinal products

Plant toxicity tests are used in the terrestrial environmental risk assessment of veterinary medicinal products (VMPs) as described in the VICH guideline on environmental impact assessment for ...

FDA: Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification

This guidance is intended to assist submitters of a biomarker for qualification that conduct nonclinical studies for which histopathology is used as a reference or truth standard (Zhou et al. ...

FDA: Use of Electronic Health Record Data in Clinical Investigations

This guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties on the use of electronic ...

GMP: EMA\'s new Draft Guideline on the Sterilisation of Medicinal Products, APIs, Excipients and Primary Containers

As referred to in the European Pharmacopoeia, the procedure for terminal sterilisation of a medicinal product, an API, or an excipient is generally the method of choice. Yet, this might be ...

GMP: FDA´s new policy regarding grouping of supplements for CMC changes

On April 19, 2016 the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) released a new document outlining how supplements can be grouped together and submitted ...

GMP: EMA publishes QPPV Update

In April 2016 the European Medicines Agency (EMA) published the first issue of the quarterly issued \"QPPV Update - What´s new in Pharmacovigilance\". The \"QPPV Update\" replaces the ...

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