Qualified Person and Registration Department



Registration activity is conducted by Qualified Person and Registration Department (DOR).

The medicinal products registration processes are performed for the Pharmaceutical Research Institute as a marketing authorization holder, but also for the co-operating pharmaceutical companies. In the latter case, the documentation in the Common Technical Document (CTD) format is usually prepared as the final step of the drug development.

DOR main tasks include:

  1. preparing and maintaining a full registration dossier in the form of CTD,
  2. carrying out of national and European registration procedures (Centralized Procedure (CP), Decentralized Procedure (DCP) and Mutual Recognition Procedure (MRP)) and non-European registration procedures aimed at obtaining marketing authorizations for medicinal products in Poland and abroad,
  3. active participation in carrying out of national and European registration procedures for the ASMF (Active Substance Master File) for the medicinal products manufactured with the active substances produced in the IF and registered by other Marketing Authorization Holders,
  4. implementation of post-registration changes to the registration documentation and carrying out the change process.

Our services include:

  1. Preparation of the registration dossier.
  2. Assessment of the registration dossier.
  3. Carrying out of the registration process.
  4. Carrying out of the re-registration process.
  5. Conduct process of the post-registration changes.
  6. Coordination of the information documents and expert reports preparation.

Staff:

  • Scientific staff - 6 persons, including 1 workers with a doctoral degree

 Head:

 Magdalena Glice - QP regarding API

 Phone:

 (+48 22) 456 38 18

 Mobile

 (+48) 607 330 446

 E-mail:

 m.glice@ifarm.eu

 

 

 Bożenna Kosmacińska - QP

 Phone:

 (+48 22) 456 39 52

 Mobile

 (+48) 691 903 020

 E-mail:

 b.kosmacinska@ifarm.eu

 

 

 Maria Mazgajska – QP for Investigational Medicinal Product

 Phone:

 (+48 22) 456 38 02

 E-mail:

 m.mazgajska@ifarm.eu