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- providing local contact person according to the specifications defined by National Institute of Pharmacy and Nutrition, Hungary
- management of suspected adverse reactions of registered medicinal products
- monitoring of the published literature by a contractual partner, search for suspected adverse drug reaction reports and other relevant drug safety related information
- compilation of Periodic Safety Update Report (PSUR) / providing consultative help for our clients in the compilation of the document
- compilation of Risk Management Plan (RMP) / providing consultative help for our clients in the compilation of the document
- help our clients in the planning, authorization, conduct of post-authorization studies, i.e. Post-Authorization Safety Study (PASS) and Post Authorization Efficacy Study (PAES)
- management of adverse events of development medicinal products
- compilation of Development Safety Update Report (DSUR) / providing consultative help for our clients in the compilation of the document
- continuous contact with the regulatory authority
- help clients in preparation and implementation of local
Authority audits
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