European Commission appoints School academic as independent expert

Dr Daniel Morales, who is a Discovery Fellow at the School of Medicine, has been appointed by the European Commission to be an independent scientific expert for the Pharmacovigilance Risk Assessment Committee (PRAC). The PRAC is the European Medicine Agency committee responsible for assessing and monitoring the safety of human medicines.

Dr Morales’ role will involve being a member of the committee and providing scientific advice in order to help the assessment of all aspects of the risk management surrounding human medicine for around 600 million people across Europe. This includes the detection, assessment, minimisation and communication of the risk of adverse reactions in relation to the therapeutic effects of medicines. The role will also involve input to the design and evaluation of post-authorisation safety studies.

Speaking about the importance of medicines regulation, Dr Morales said, “Prescribing is the most common intervention we make to patients, but adverse effects cause significant morbidity and mortality. The objectives of pharmacovigilance are to promote the safe and effective use of drugs by providing reliable information for the assessment of the benefit-risk profile of marketed medicines and the minimisation of risk. 

”The information we have about a medicine before it is placed on the market is ultimately limited and complete knowledge of the benefit-risk of a medicine only comes to light after its approval. A key challenge is therefore obtaining robust evidence to identify and quantify safety concerns in a timely fashion to support decision making and to then implement changes in a complex legal framework that is fair and transparent for all stakeholders.”