Educational course “Introduction to medical devices vigilance”
The educational course "Introduction to medical devices vigilance”, organised by the Agency for Medicinal Products and Medical Devices (HALMED), will take place at the HALMED’s premises at Ksaverska cesta 4. The exact date will be announced when enough interested participants have been gathered (the approximate duration is 6 school hrs).
Topics
1. HALMED - national regulatory authority
2. Introduction to medical device vigilance
- medical devices in general: definitions, classification, placing on the market, medical device registry
- safety of medical devices
- aims of vigilance
- stakeholders in the system
- adverse incident: definitions and criteria for reporting
- time frame for reporting
- exceptions to the rules
- user errors
- safety corrective measures: notions and types
- safety information; notion, elements, distribution
3. Examples of adverse incidents
- presentation of more than 50 adverse incidents and their evaluation according to criteria for reporting - interactive participation from attendees
4. Practical exercise
- completion of application forms for notification of adverse incident
Course leader
Krunoslav Kranjčec, M. Med. Biochem., HALMED
Registration
We kindly ask you to submit the completed registration form electronically to Zrinka Riffer Turk, M.Pharm. (zrinka.riffer@halmed.hr), or via fax on +385 1 4884 110
Registration form
The registration form is available here: .doc; .pdf
The number of participants is limited, therefore we ask for an earlier registration.
Course fee
The course fee for the educational course for healthcare professionals, academia and students is 500,00 kn + VAT = 625,00 kn, for regulatory authorities 600,00 kn + VAT = 750,00 kn and for other marketing authorisation holders and others 1.000,00 kn + VAT = 1.250,00 kn.
Fee payment
After registration, the fee payment will be executed exclusively via pro-forma invoice that will be sent to the participant via mail/fax to the contacts indicated in the registration form (it is necessary to indicate how you would prefer to receive the pro-forma invoice).
The copy of money order should be sent electronically to Zrinka Riffer Turk, M.Pharm. (zrinka.riffer@halmed.hr), or via fax on +385 1 4884 110, with the attention to the "Department for Medical Devices”.
Cancellation policy
In case of inability to attend, the registered participant should inform Zrinka Riffer Turk, M.Pharm., on +385 1 4884 346.
Accreditation
The organiser will apply for continuing education credits at the Croatian Medical Chamber, Croatian Chamber of Pharmacists, Croatian Chamber of Medical Biochemists, Croatian Chamber of Nurses and Croatian Chamber of Healthcare Professionals.
