Training courses
A series of training courses on the principles and practice of global PV for those working in the Industry.
These courses have been designed to provide a guide for all those concerned with PV. The interactive programme will cover the PV principles and terminologies through to the current regulatory framework and its global impact, including post-authorisation medicinal product surveillance across global countries.
Our panel of experts will offer practical guidance throughout the course and use real-world examples and case studies to contribute to the development of your knowledge. There will also be ample opportunity to share your questions with the trainers and fellow professionals to enhance your understanding and knowledge of PV.
- Basic principles of patient safety
- An overview of the various sources of safety surveillance
- Data resources available for monitoring and evaluating drug safety
- Responding to safety signals
- Basic principles of risk evaluation and mitigation
- Proactive strategies for managing risk
- Principles of risk minimisation
- PASS and PAES
- The evolution of periodic safety update reports (PSURs)
- Periodic benefit-risk evaluation reports (PBRERs)
- Development safety update reports (DSURs)
- What do we submit and when to submit it?
- Practical aspects of compiling PSURs and PBRERs
- Anticipating drug safety issues in development of small molecules and biologics
- What specific and non-specific safety monitoring should be done?
- Handling safety signals in development
- Differences between pre-marketing studies and post-marketing experience
- The role of the Pharmacovigilance Risk Assessment Committee (PRAC) and SCOPE initiative
- Quality management systems and the pharmacovigilance system master file (PSMF)
- QPPV
- Expedited reporting: solicited vs spontaneous
- Periodic reports and signal management and use of Eudravigilance
- RMPs and risk minimisation
- Additional monitoring
- Pharmacovigilance inspections/audit
- Definitions of signals
- Regulatory guidance on signal detection by industry and regulators
- Resources for signal detection
- Quantitative vs qualitative signal detection
- Handling an important safety alert from regulators
- Assessment of risk
- Determining measures to respond to previously unidentified risks
- Continuing assessment and communication of risk-benefit
