Agnieszka Rychlicka

- coordination of registration processes of medicinal products in EU procedures (DCP, MRP, CP) and national procedure
- preparation of locally required documents for regulatory submissions
- translating of product information from English to Polish, providing additional expertise reg. common texts when needed
- feedback and support in local regulations for above-country structures
- close cooperation with Distribution Department on timely implementation of approved variations in artworks
- artworks and printproofs approval

- In-Country managment of regulatory affairs in compliance with international and local regulations
- preparation of locally required documents for regulatory submissions
- following up with local health authorities regarding the required documentation
- translating of common information texts (SmPC, PIL, Labelling) from English to Polish, initiating of country level approvals, providing additional expertise for development of common texts when needed
- feedback and support on local regulations for above-country structures
- development and updates of artworks
- management of batch analysis requests raised by national authorities

Coordinating/submitting initial registrations, variations and renewals in MRP and DCP procedures.

Coordinating registration processes of human medicinal products (antiinfective, cardiovascular, musculo-skeletal system) in European Procedures, evaluation of MoH Approvals, cooperation with Ministry of Health and National Drugs Institute.