"I did not expect pharmacovigilance to be so exciting"
Participant, PV Module, MSc Course Regulatory Affairs for Biopharmaceuticals, (EUCRAF) 2011
"Best presentation of the whole course with examples from practice"
Participant, GCP Audits and Inspections, Organisation and Implementation of Cancer Clinical Trials, European Organisation for Research and Treatment of Cancer (EORTC) course 2011
Key Deliverables
- Customized training for epidemiology, drug safety, quality & project management, clinical development and therapeutic aspects
- Interactive workshops targeted at operational staff as well as continuous education of higher qualified staff members
- MSc Regulatory Affairs for Biopharmaceuticals, European Centre for Regulatory Affairs (EUCRAF) in collaboration with the University of Strasbourg: Module Pharmacovigilance (2010-2015)
Examples
- Specific tutorials on Non-Interventional Studies incl. PASS, signal/risk management, safety communication, performance monitoring
- Interactive workshops using case studies and coaching
- Customized training on inspection readiness with successful inspection outcome
- On-the-job training on specific deliverables, processes and concept, for example clinical development plan, product safety plan, operational implementation, set-up and maintenance of quality systems, process and organizational design, performance measurements