Pharma R&D Today
Ideas and Insight supporting all stages of Drug Discovery & Development
Joyce de Langen
Senior Solution Manager Pharmacovigilance
About the author:
I am a pharmacist by training. I joined Elsevier last month as Senior Solution Manager Pharmacovigilance. I am working in the pharmacovigilance and drug safety domain for more than 10 years. I started my professional career at the Netherlands Pharmacovigilance Centre for spontaneous adverse event reporting. After 6 years I teached pharmacotherapy and pharmacoepidemiology at the University of Utrecht and the last 5 years of my professional live I worked in the pharmaceutical industry (Abbott/AbbVie and Sanquin Plasma Products) in different roles within pharmacovigilance. Prior to working to Elsevier I was the qualified person for pharmacovigilance with Sanquin Plasma Products.
Posts by Joyce de Langen
Posted on January 15th, 2016 in Pharmacovigilance
Monitoring worldwide experience
The purpose of drugs is to cure or alleviate symptoms of disease. However, drugs do not only have therapeutic effects, they may also cause adverse drug reactions (ADRs). (more…)
Posted on December 16th, 2015 in Pharmacovigilance
Limitations of clinical trials and traditional post-marketing sources of safety information.
Due to limitations of pre-marketing clinical trials, there isn’t much information available once a medicinal product is authorized for marketing. (more…)
Posted on November 24th, 2015 in Pharmacovigilance
On 16 April 2014, the new EU Clinical Trial Regulation on medicines for human use was adopted. The purpose of the new Clinical Trial Regulation is to create an environment that is favourable for conducting clinical trials, with the highest standards for patient safety, within the EU. (more…)
Screening Scientific Literature for Adverse Drug Reactions: Relevant for Patient Safety or Just a Time-Consuming Regulatory Obligation?
Posted on November 16th, 2015 in Pharmacovigilance
An adverse drug reaction (ADR) is defined as any response to a medicinal product which is noxious and unintended. ADRs are a major public health problem, accounting for up to 5% of all hospital admissions and 28% of the emergency visits. Of all hospitalized patients, 5% experience an ADR during the hospitalization (more…)