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Pharmacovigilance Management
- Guidance for regulatory compliance and
reporting to HPB, FDA and Europe (EMEA)
- Preparation of annual reports and critical
appraisals of ADR data
- Preparation of periodic safety updates (PSURs -
ICH-E2C)
- International reporting formats
- Advice on automated databases
ADR Help
Line
- Rapid access to safety data appraisal by
subscription service
Safety
Department Audits
Audits and procedural reviews -
- Assessing compliance with Canadian, FDA and EU
safety data reporting requirements
Training
Courses
Training offered to -
- Pharmaceutical Companies
- Drug Plan Managers
- Health Care Provider Groups
Access to
extensive network of Canadian researchers
Contacts for your research
needs in -
- Pharmacoepidemiology for case control, cohort
and record linkage studies
- Pharmacoeconomic studies
- Clinical trials
Researchers:
The Canadian Association for Population Therapeutics
www.capt-actp.com
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