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Regulatory Challenges of Biopharmaceuticals - H.C. Ebbers

The safety profile of biopharmaceuticals may be affected by seemingly minor changes in the production process. This makes them...

Publicatie | 20-01-2017

Marketing authorisation of new medicines in the EU: towards evidence-based improvement - M. Putzeist

The current marketing authorisation system of medicinal products has been criticized for its’ demanding requirements and high...

Publicatie | 20-01-2017

Predicting and improving individual long-term outcome in patients with diabetes and nephropathy - F. Holtkamp

Therapy with agents intervening with the Renin-Angiotensin-Aldosterone-System (RAAS) are considered a cornerstone in reducing...

Publicatie | 20-01-2017

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