Educational course “Introduction to the Vigilance of Medical Devices”
The Agency for Medicinal Products and Medical Devices organises the educational course "Introduction to the Vigilance of Medical Devices”, to be held on Wednesday, 20 March 2013.
The course is intended to health care professionals and will be held at the HALMED premises, Ksaverska cesta 4 at noon (the duration is approx. 6 school hrs).
- HALMED - national competent authority
- Introduction to the vigilance of medical devices: definition, classification, placing on the market, registry of medical devices
- safety of medical devices
- regulatory framework and terms
- scope of vigilance
- system stakeholders
- adverse events: definition and criteria for reporting
- timeline for reporting
- exceptions to the rule
- users errors
- safety corrective measures: notion and types
- safety information: notion, elements, distribution
- Case examples of adverse events
- presentation of more than 50 adverse events and their assessment according to the criteria for reporting - interactive participation of participants
- Practical exercise
- population of forms for reporting adverse events
Krunoslav Kranjčec, MMedBiochem, HALMED
We would kindly ask you to submit the fulfilled registration form no later than 18 March 2013 electronically to Dr Karmela Kopčić (email@example.com or Dr Žarko Meštrović (firstname.lastname@example.org) or via fax +385 1 4884 110
The registration form is available here: .doc; .pdf
The number of participants is limited, so we kindly ask to register asap.
The course fee for health care professionals, academia and students is 500,00 kn + TVA = 625,00 kn, for competent authorities is 600,00 kn + TVA = 750,00 kn and for marketing authorisation holders and others is 1000,00 + TVA = 1.250,00 kn.
Upon application, the fee payment will be executed exclusively via pro-forma invoice that will be forwarded to the applicant by courier/fax to contacts indicated in the application form (it is necessary to indicate the mean by which the pro-forma invoice should be delivered).
We would kindly ask you to send a copy of the money order no later than 19 March 2013, electronically or by fax to Dr Žarko Meštrović (email@example.com) with a note "To the Medical Device Department”.
In the case of inability to attend, the registered participant should inform Dr Karmela Kopčić at +385 1 4884 114 or Dr Žarko Meštrović ao +385 1 4884 339 no later than 19 March 2013.
The organiser will apply to the Croatian Chamber of Physicions, Croatian Chamber of Pharmacists, Croatian Chamber of Medical Biochemists, Croatian Chamber of Nurses and Croatian Chamber of Health Care Professionals in order to receive the course accreditation.