HOT CONFERENCE TOPICS
- Lessons learned from the risk minimization strategies
- Function of the Safety Management Teams
- Safety Review of products in development and post-marketing
- What are the potential uses for social media to improve drug safety?
- Vendor management and outsourcing of pharmacovigilance services
- New definitions in the Maternal Immunization (MI) Pharmacovigilance
- Risk Management Plans rule amendments
- Evolving themes for Safety Signal Detection in Clinical Development and post-Marketing
- New technologies in Pharmacovigilance
- Benefit-Risk Management
WHO WILL YOU MEET
Members of board, C-level, Senior Vice Presidents, Vice Presidents, Directors and Heads of departments from pharmaceutical involved in:
- Drug Safety
- Risk Management
- Clinical Safety
- Data management and data mining
- Safety & Risk Management
- Signal Detection
- Benefit-Risk Assessment
- Safety Evaluation
- Regulatory Affairs, Pharmacovigilance
- PV Governance
- Safety Surveillance
- Pharmacovigilance Operations
- PV Inspection and Audit Readiness
- Patient Support Programs
- Market Research Programs
- Medical Safety
- Medical Information
Global harmonization of Pharmacovigilance
24 October 2017, 15:00 – 16:00
- How should a global RM strategy for a product be implemented in local countries?
- How to adapt to changes in regulations from worldwide regulators?
- Understand CIOMS guidelines and methods of implementation by regulators
- How do different countries deal with multiple different requirements for PV reports?
- How are various ICH regions working to implement global harmonization practices in the areas of drug safety and risk management?
Risk Management Strategies and Risk Management Plans
24 October 2017, 16:00 – 17:00
- RMPs rule amendments and its implementation
- How to measure the effectiveness of RM strategies not only in the US and EU, but worldwide, wherever we market products?
- What new approaches and priorities should be considered in the Risk Minimization Activities?
- Main challenges and practical ways to approach safety measures
- What new approaches and mindset is required given the enhanced regulations?