Vice President- Pharmacovigilance & Global Head
Implementation of GVP
Preparing and Maintaining Pharmacovigilance System Master Files
Reporting of adverse drug reactions – criteria, SOPs, and roles of stakeholders
Update of PBRERs, Risk Management Plans and Post-Authorisation Safety Studies (PASS) requirements
How to successfully and pro-actively pass inspections and audits
16:30 Panel Discussion: Ensuring Compliance in Patient Support Programmes (PSP): Leveraging Multi-Stakeholder Collaboration to Enhance Data Capture
• How do you realistically ensure patient adherence and prevent off-label use with the assistance of digital technologies?
• Interfacing both local and global markets research programmes to maximize data collection
• Effectively capturing all opportunities of patient interaction with pharmacists and healthcare providers to improve systematic inputs of information
• Ensuring quality standards in conduct of PSPs and Market Research Programmes (MRPs) in real-time
11:45 Post-Marketing Surveillance on Biosimilars in India: A Case Study on Collaborative Methods in Risk Minimization
• Collaboration of Industry and India’s National Programs to create a robust risk minimization system
• Understanding guidelines towards a specific type of product; Anti-tuberculosis and anti-hypertension as examples
• How can the risks of ADR be managed across different populations and ethnicities?
• Evaluating the effectiveness of educational programmes and controlled access