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Regulatory benefit - risk assessment; Different perspectives - A.H. Arnardóttir

Pharmaceutical legislation aims to ensure that only safe, effective and high quality medicinal products enter the market. Main...

Publicatie | 20-01-2017

Drug related safety issues affecting pregnancy outcome and concerning risk minimisation measures - I. Crijns

The majority of information on drug safety and especially human teratogenicity resulting from drug exposure during pregnancy...

Publicatie | 20-01-2017

Measuring the effect of risk minimization measures - I. Zomerdijk

With the new European pharmacovigilance legislation effective since 2012, monitoring the outcome of risk minimization measures...

Publicatie | 20-01-2017

Benefit Risk monitoring of pandemic influenza vaccines - L. Wijnans

In 2009 a new influenza A(H1N1) virus emerged in Mexico and developed into the first pandemic of the 21st century. In Europe,...

Publicatie | 20-01-2017

Studying use and risks of medicines in children: a European approach - S. de Bie

While pharmacovigilance systems have been around since the 1960s, the safe use of drugs in children has received relatively...

Publicatie | 20-01-2017

Pharmacovigilance of biopharmaceuticals - N.S. Vermeer

Biopharmaceuticals constitute an important and expanding group of medicinal products. Over the past decades, these products, in...

Publicatie | 20-01-2017

Comparative in vitro permeability testing as predictor for bioequivalence - M. Kubbinga

Because In vivo bioequivalence (BE) testing is relatively expensive, in vitro BE tests represent an important alternative to...

Publicatie | 20-01-2017

Studies on Long-Term Adverse Events in Pharmacoepidemiology - R. Duijnhoven

The detection and assessment of long-term adverse events associated with the use of medicines is difficult. Nevertheless, with...

Publicatie | 20-01-2017

Communicating Risk Effectively (CORE) study - S. Piening

To assure continued safe and effective drug use by patients, effective communication of identified safety issues to health care...

Publicatie | 20-01-2017

Geographic variation in efficacy and generalizability of pharmacological treatment in schizophrenia - T. Mattila

Placebo controlled randomized clinical trials are the preferred method for testing the efficacy of pharmaceutical compounds....

Publicatie | 20-01-2017