Regulatory Group

Anna Czubaj

Anna Czubaj

Leader

She is associated with the pharmaceutical industry for 14 years. She gained her experience working both in the the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (in the Registration Department of Medicinal Products) and in the pharmaceutical corporates. Since January 2017 associated with Sanofi-Aventis on position Regulatory Manager. Her experience deals with Rx and OTC medicinal products, clinical trials, food supplements and medical devices. She has participated in the work of Regulatory working group in INFARMA. She is responsible for conducting registration processes of new products, post-registration changes, MAH transfers and extending the period of validity of the permit in accordance with Polish and European procedures. She actively participated in preparations and transfer of medicinal products between companies. She is engaged in projects related to maintenance of CHC products particularly in development issues, introducing to the market, product labelling, advertisement and communication to consumers and specialists. Master of science in Pharmacy; Medical Academy in Warsaw.

Barbara Szklarek

Barbara Szklarek

Vice Leader

Since 1996 she is associated with the pharmaceutical industry and gained many years of professional experience in successive specialist positions. Her professional experience includes medicinal products (Rx and OTC) and food supplements, medical devices and cosmetics in the new product development and the effective maintenance of the current portfolio. Directly involved in registration projects in the countries of Central and Eastern Europe (CEE), with particular emphasis on Poland.
She has been working for USP from 2003, from 2008 in management positions as Regulatory Affairs Manager.
A graduate of the Faculty of Biotechnology at the Łódź University of Technology, she also completed Postgraduate Studies at the Faculty of Marketing and Management at the University of Łódź.

Members PASMI

Aboca
Adamed
Bayer
Biocodex
GSK
Haleon
IPSEN
IPSEN
JNJ
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KF
KLOSTERFRAU
MagnaPharm
Omega
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P&G Health

P&G Health

Polpharma
Polski Lek
RB
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Sanofi
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TEVA
Teva Polska
TZF

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USP Zdrowie
Verco
verco

Supporting Members