Workshop: Fundamentals of pharmacovigilance for marketing authorisation holders
The Agency for Medicinal Products and Medical Devices is organising a workshop on fundamentals of pharmacovigilance for marketing authorisation holders staff working in the field of pharmacovigilance in the Republic of Croatia. In accordance with the Ordinance on pharmacovigilance (National Gazette No 125/09), they are obliged to take such a training.
Under Article 17 of the Ordinance on pharmacovigilance (OG 125/09) the workshop includes the following topics:
- terms in pharmacovigilance
- spontaneous and motivated reporting of ADRs
- ADR reporting procedure, assessment of an ADR report, ICSR preparation
- PSUR preparation
- pharmacovigilance legislation (Republic of Croatia, European Union).
The workshop will be held on 28th February 2013 at the premises of the Croatian Agency for Medicinal Products and Medical Devices, Ulica Roberta Frangeša Mihanovića 9 (Sky office building), 1st floor, 1000 Zagreb, at 11 a.m. (duration of the workshop about 6 h).
Registration for participation
Please fill out the registration forms and submit them to Mr Armano Rajh via e-mail at armano.rajh@halmed.hr or fax at +385 1 4884 119, no later than 25th February 2013.
Registration form (.doc); (.pdf)
The number of participants is limited to 30, so we kindly ask you for an earlier registration.
Fee
The workshop fee is 1600.00 kn - TVA = 2000.00 kn and it includes printed material, coffee break and a certificate of attendance.
Fee payment
Upon registration, the payment of the fee will be exclusively via a pro-forma invoice that will be delivered to participants via mail/fax at addresse specified in the registration form(please indicate in the registration form how you would like to receive your pro-forma invoice).
Please send a copy of your money order to the following e-mail: armano.rajh@halmed.hr of fax: +385 1 4884 119 with a notice to the attention of Mr Armano Rajh, no later than 26th February 2013.
Termination period
In case of inability to attend, the registered participant should inform Mr Armano Rajh, no later than 25 February 2013.
Cancellation policy
In case of a cancellation or non-attendance, the following calculation scale of fee reduction will apply:
- Until 25th February 2013, the fee will be completely reimbursed
- From 26th February to 27 February 2013 the organiser withholds 30 % of the payment
- On 28 February 2013 or in the case of non-attendance, the organiser withholds 100 % of the payment.
