PharmaSupport offers you individual customized solutions across the pharmacovigilance process. Especially for small and medium-sized companies we supply you with adapted solutions to design an efficient pharmacovigilance system, optimize it and assure compliance to all regulatory aspects.
According to your requirements and preferences we can take over a complete service incl. external QPPV or we give you support on specific topics.
Our services for you:
Pharmacovigilance System according to the latest requirements of AMG/GVP
- Compilation / implementation and actualization of the PSMF according to the requirements of GVP module II "Pharmacovigilance System Master File"
- Compilation of the "Summary of Pharmacovigilance System" (Module 1.8.1 of the authorization dossier)
- Compilation, review, upkeep and training of your pharmacovigilance SOPs, especially related to the critical processes according to GVP module I "Pharmacovigilance systems and their Quality Systems"
- Integration of the pharmacovigilance processes into existing QS/QM-Systems
Case Management/ (electronic) Reporting of adverse drug reactions to authorities (ADR/ICSR)
Management of individual case safety reports based on spontaneous reports, literature reports or other reporting systems according to the GVP module VI "Management and Reporting of Adverse Reactions to Medicinal Products":
- Data management including follow up
- Qualified evaluation
- Identification of reportable cases
- MedDRA coding of reports
- Compilation of narratives
- Electronical reporting to the European Authorities according to ICH-E2B: Extended EudraVigilance Product Report Message / Medicinal Product Dictionary (XEVRPM/XEVMPD)
- Finding of the best technical conception for your situation in consideration of economic aspects and number of cases (external or internal database solution or direct reporting via EVWEB)
- Data entry and transmission to EMA
- Registration at EudraVigilance
Literature research, signal detection
- Performance of the required continuous literature research of the world wide scientific literature
- Database Research
- Continuous risk-benefit assessment
- Identification and assessment of safety signals according to GVP-Module IX "Signal management" / Implementation Regulation EU No. 520/2012.
Periodic Safety Update Reports (PSURs)
Since the 12th amendment of the AMG the compilation of periodic safety update reports is obligatory for all pharmaceutical entrepreneurs.
PharmaSupport offers you assistance to perform the risk-benefit assessment of your pharmaceuticals:
- Compilation of PSURs according to the current requirements of the GVP module VII "Periodic Safety Update Report"
- Implementation of a system ensuring effective preparing of PSURs
Risik-Management Plans (RPM)
Since the extended Directive 2001/83/EC respectively the 14th amendment of the AMG in general – apart from a few exceptions – a RMP has to be submitted together with the initial approval application.
For you PharmaSupport will take over
- Compilation of a needs and risk assessment
- Development of a concept of safety monitoring after the date of marketing authorization
- Compilation of RMPs according to the current requirements of the GVP module V "Risk Management Systems"
Qualified Person for Pharmacovigilance (QPPV)
- Taking over the function of the QPPV or of the so called "Stufenplanbeauftragter" according to §63a AMG by one of our qualified and experienced employees
- Supporting in function of deputy QPPV
And more
- Performance of system audits
- Trainings on pharmacovigilance topics
- Data entry and maintenance of products into the XEVMPD-Database
- Consulting service referring to labeling (compilation an actualization of SPCs, package leaflet, compilation and actualization of registration documents in CTD-Format, Module 2,4,5), medical writing)
- Incorporation in a network of experts offers further resources and competences