Workshop on Medicinal Products Regulatory Monitoring
The Agency for Medicinal Products and Medical Devices organises a Workshop on Medicinal Products Regulatory Monitoring intended primarily for representatives of the marketing authorisation holders for finished medicinal products in the Republic of Croatia involved in regulatory and medical operations, as well as for all those who are interested in the marketing authorisation procedure for finished medicinal products.
The workshop will be led by the Agency's experts and the following topics will be covered:
1. Introduction to the regulatory cycle of medicinal products; the Medicinal Products Act;
2. European procedures; retro-CADREAC;
3. Medicinal product quality assessment during renewal and pharmaceutical variations;
4. Evaluation of non-clinical documentation;
5. Clinical and safety variations;
6. Frequently asked questions of the Committee for Medicinal Products; and
7. Exercises.
Date: April 23, 2009
Venue:
The workshop will be held in the castle Gjalski, Gredice Zabočke 7, Zabok, with the beginning at 10 a.m. (approximate duration is 4 hours). The number of participants is limited to 20.
Registration Fee
The workshop registration fee is HRK 800.00 + VAT (or HRK 976.00 in total), and it covers written materials, a coffee break and an attendance certificate.
Upon registering, payment of the registration fee can be made solely by wire transfer in favour of the giro account of the Agency for Medicinal Products and Medical Devices (ALMP) number: 2340009-1110133093, with company tax number or citizen's personal ID number written in the reference line, and participant's name and family name - »Radionica o regulativi lijeka« - written in the description of payment field. Proof of payment should be sent to the Agency no later than 2 days prior to the start of the workshop. In case of payment within 2 days of the start of the workshop, you will be asked to present the original payment order at your arrival.
Cancellation Period
If unable to attend, registered participants should notify the Agency (Ms Anamarija Čukman), no later than two days prior to the start of the workshop.
Registration Contact:
Ms Anamarija Čukman
e-mail: anamarija.cukman@almp.hr
Fax: 01 4884 110
