QP Curriculum Development Working Group activities
With the release of the new Law on Drug and Medical Devices on May, 7th 2010, the need for development of relevant study programme for Qualified Person in the pharmaceutical industry has been officially recognized. Taking into account the pre-accession status of Serbia, harmonization with EU practice and policies has been emphasized. In particular, compliance with EU directives 2001/82/EC and 2001/83/EC, which detail the role of, and academic qualifications required by a QP will be necessary. In order to respond to this need which has been highlighted within the sector, the Faculty of Pharmacy, University of Belgrade took responsibility for establishing the relevant postgraduate course, and set this as one of the priorities of the Tempus PQPharm Project.
It was decided that the relevant study programme will be developed as the postgraduate specialisation offered as an advanced study programme for pharmacy graduates working in the pharmaceutical industry.
The Curriculum draft was presented to the Academic Council of the Faculty of Pharmacy University of Belgrade and approved at the Council Meeting on December, 23rd 2010. It was submitted to the Senate of the University of Belgrade and its approval obtained on April, 13th 2011. The extensive documentation requested for Study Programme accreditation was prepared and submitted for evaluation and accreditation to the Ministry of Education on June, 2nd 2011."
QP Curriculum (available only in Serbian)
Pilot Implementation of the Module 1
Pilot Implementation of the Module 1 of the QP study programme took place on April 13 – 17th, 2011 with the contribution of the Ministry of Health and the Medicines and Medical Devices Agency of Serbia. A total of 22 course participants were involved (of which, 12 professionals working in the pharmaceutical industry and 10 academic staff from the Faculty of Pharmacy, University of Belgrade). Intensive course work involved lectures, workshops and panel discussions. 17 course participants sit the written exam at the end of Module. The course participants were asked to provide feedback on the eduacational activities implemented. The overall satisfaction of participants was expressed with the average mark related to: General impression 4.94; Programme 4.89; Presentation contents 4.39; Course material 4.28; Discussion 4.72; Organisation 4.94. Course participants also suggested the topics of interest for further specialist training courses.
Adjacent to the QP Course Pilot Implementation two Panel discussions were organized:
- Harmonization with the EU Drug Regulatory Practice (April, 14th 2011)
- QP Certification Model in Serbia (April, 15th 2011).
Seminar Programme can be found here (login required).