 Pharmacovigilance (PhV)
Consultancy & project management in
- Set up the PhV system for the customer with
- preparing SOPs
- preparing Risk Management Plan
- electronic registration at EVWEB and Competent Authories
- training of employees (sales and marketing)
- preparing and follow up of Safety Data Exchange Agreements
- consultancy in any items of pharmacovigilance
- coaching to Authorities' inspections or sponsor's audit
- Managing PhV system of the customer via Coldwell Pharma's own PhV system
- 24-hour surveillance via Qualified Person of EVWEB and multiple reporting to Competent Authories
- generation and maintenance of database
- literature search
- performing internal audits
- writing reports to EMA and/or Competent Authories
- Writing PSUR
- Writing Pharmacovigilance Master File
Contact in Pharmacovigilance issues:
Dr Csiktusnádi Kiss Gergely,
Qualified Person in Pharmacovigilance
Phone: +36 30 411 9657
E-mail: csiktusnadi.kiss.gergely@coldwell.hu |
Contact
Coldwell Pharma Bt.
established
in 2001 July
1028 Budapest, Gazda utca 41.
Hungary
Dr. Edit Kósa
managing director
Contact:
info@coldwell.hu
+3630 625 9842
code, design:
adamkobor |
