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
- Pharmacovigilance
- 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
- Pharmacoepidemiology
PRE-CONFERENCE WORKSHOPS
Workshop A 15:00 - 16:00
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?
Workshop B 16:00 - 17:00
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?
