Our representative in the structures of the European Medicines Agency

Opublikowano:
A long table in a conference room. Seated at it are about 20 people. In the foreground is a middle-aged woman wearing a light pink jacket. Each person has a microphone, laptop and documents in front of him. Behind the participants is a row of flags of various countries and a flag of the European Union. The atmosphere is formal and professional.
Dr. Ewa Bałkowiec-Iskra from the Chair and Department of Experimental and Clinical Pharmacology at the Medical University of Warsaw leads the work of two EMA groups: the Central Nervous System Working Party and the Scientific Advice Working Party. She serves as chair of the former and as vice-chair of the latter.

Developing guidelines

Our researcher has been a member of the Central Nervous System Working Party (CNSWP) of the European Medicines Agency since 2022. That same year, she also assumed the role of vice-chair. On April 24 of this year, she was elected chair. This is a highly responsible position, as the CNSWP is tasked with developing and updating guidelines related to research programs on new therapeutic strategies in psychiatry and neurology. The group also provides substantive support to EMA’s scientific committees in assessing marketing authorization documentation. 

Providing scientific advice

The Scientific Advice Working Party (SAWP) of the European Medicines Agency is a multidisciplinary group of experts. It brings together scientists with expertise in both drug development and marketing authorization. Members of the SAWP are selected through a competitive process organized by the European Medicines Agency. The group provides scientific advice on issues related to pharmaceutical quality, preclinical and clinical research, and the qualification of new research methodologies. 

Dr. Ewa Bałkowiec-Iskra was elected vice-chair on May 21 of this year. Since joining the SAWP in 2017, she has prepared more than 400 scientific advice reports. Each of these reports typically addresses several to over a dozen questions submitted by the applicant regarding a planned or ongoing research program. Developing responses and identifying the optimal study design to demonstrate a positive benefit-risk ratio of the investigational product in the proposed population and indication – and to achieve its authorization – requires extensive scientific and regulatory experience as well as expert knowledge. 

Serving on the Committee for Human Medicinal Products

Dr. Ewa Bałkowiec-Iskra also serves as Poland’s delegate to the Committee for Medicinal Products for Human Use (CHMP). This committee issues opinions that form the basis for decisions by the European Commission or Council on whether to authorize a medicine in the European Union. 
As Poland’s delegate, she chaired the Strategic Review and Learning Meetings of both the SAWP and CHMP, held in Warsaw during Poland’s Presidency. These meetings addressed issues related to children’s and adolescents’ mental health, as well as the development of new psychotropic medications for use in pediatric populations.

 

Four people - three women and a man - sit behind a conference table. All are dressed formally in . On the table are laptops, microphones and water bottles. A large banner with the words “Polish Presidency of the EU Council 2025” is visible in the background.
A woman and a man are seated at the table. The man on the left is wearing a dark suit and white shirt, while the woman on the right is wearing a red outfit. On the table are microphones, water bottles, cups and nameplates.
Four people are seated at a conference table. The men are wearing navy blue jackets and white shirts. The man sitting second from the right speaks into a microphone. The first from the right sits a woman wearing a white jacket. She looks ahead. From the left sit a man and a woman. The woman is wearing a red jacket. Both are looking at the speaker. On the table are microphones, water bottles, cups and nameplates.