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The EMA’s Safety Committee, which keeps an eye on the safety of all medicines for human use in the EU, has elected Swedish member Ulla Wändel Liminga as its new chair for a six-year term.
European Medicines Agency (EMA) Pharmacovigilance and Risk Assessment Committee July meeting, PrakThis was the last plenary session chaired by Sabine Straus, who is stepping down after serving two three-year terms.
Instead, Ulla Wändel Liminga, a pharmacist by training and scientific director of pharmacovigilance at the Swedish Medical Products Agency, will take on the leading role of the important safety committee.
“It feels a bit overwhelming at the moment, but I have worked in the field of pharmacovigilance for many years, so it would be exciting for me to be on the committee from a chair’s perspective,” she told Euractiv.
A challenging term
Wändel Liminga will serve as the third chair of the PRAC, having been one of two Swedish representatives to the organization since its inception in 2012. Ideally, she would serve for six years, as her term is three years with the option to serve another three years.
The next few years are likely to be challenging for PRAC in many ways.
Digitalization and innovative use of more real-world clinical data (as opposed to patient data from controlled medical studies) are opening up new possibilities for the way drugs are developed and monitored.
In addition, the EU will adopt new pharmaceutical legislation in the coming years, which will bring about organizational and potential regulatory changes.
this European Commission proposal Simplifying the EMA’s structure from six human medicines working committees to two main committees.
These committees include the Committee for Medicinal Products for Human Use (CHMP), which is responsible for recommending marketing authorisations, and the PRAC, which is responsible for monitoring the safety of human medicines.
Simplified safety procedures
“Our approach has matured over the past 10 to 15 years and today we have very well-developed risk and safety procedures that help us understand the safety of every drug, old and new,” says Wändel Liminga, explaining why she is not worried about regulatory changes.
She said the approach currently in place included “a comprehensive and very sensitive surveillance system that quickly picks up warning signals about new potential safety risks, either from member states or through EMA, and a robust process to further assess such signals”.
As a member of the National Committee, she also served as rapporteur for hundreds of new post-marketing safety data evaluations of pharmaceutical products.
Currently, there are around 300 substances or medicines in Sweden that require safety assessments, and the person responsible for about half of these assessments is Ulla Wändel Liminga himself.
However, as the new chair, she will hand over these powers to a new Swedish full member of the PRAC.
“For every product, the balance of risk and benefit is weighed, that is, the positive impact on the disease versus the possible and identified risks. Our role is to help monitor and evaluate safety and provide guidance on how to minimize the risks,” she said.
According to Ulla Wandel Liming, the spring of 2021, the year of the epidemic, was the most severe period of the epidemic in the history of PRAC.
“This work is very intense because we are closely monitoring the safety of the new COVID-19 vaccines, including safety assessments of some of the side effects that are occurring when these vaccines are started in large groups of people,” she explained.
Strong expertise
According to the EMA, Ulla Wändel Liminga has “extensive expertise in pharmacology, toxicology and pharmacovigilance.” She started working in pharmacovigilance about 25 years ago, but as early as 1993 she submitted a doctoral dissertation in medicine at Uppsala University on the detection of side effects of neuroleptics in animal models.
While the CHMP makes recommendations on whether a new drug should be placed on the European market, the PRAC plays a smaller role in the initial approval process, only advising on the risk management plan that pharmaceutical companies should follow.
“We advise the CHMP on pharmacovigilance and risk minimization activities for each new product in order to achieve optimal safety follow-up after marketing,” she said.
Ulla Wändel Liminga will take up her new role as PRAC Chair on 2 September.
(Author: Monica Kleja; Editors: Vasiliki Angouridi, Brian Maguire | Euractiv Advocacy Lab)
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