Topics
- Assuring Compliance and its monitoring
- The impact of PV legislation changes and updates on industries and the best practices
- Risk management plans, strategies and new risk- benefit analysis tools to improve REMS reporting
- Preparing for PV audit and inspections and the role of QPPV
- New approaches for risk minimization and communication
- Implementing risk management and safety surveillance methodologies for medical devices
- Discussing the how IT and Social media effect Pharmacovigilance and Adverse events reporting
- Determining steps and strategies for more transparency and involvement of patients
- Importance of outsourcing and its effectiveness
- Discuss and review the use of databases and emerging tools for generation and detection of safety signals
- Harmonization of regulatory framework- developed and emerging markets
Who should Attend
Attendees from Directors, VPs, Managers, Heads, Consultants, Scientific Advisors, professionals and Research Scholars involved or interested in:
- Risk management
- Pharmacovigilance
- Pharmacoepidemiology
- Drug safety
- Clinical Pharmacology
- Drug Research & Development
- Information and Clinical Data Management
- Clinical Safety
- Clinical research & safety
- Medical product safety assessment
- Information technology
- Data analysis
- Health outcomes
- Medical information
- Clinical Trials & CRO’s
- Sales and Marketing
- Contract Manufacturing
