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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