Deepa AroraVice President- Pharmacovigilance & Global Head
Dr Deepa Arora is a Physician having more than 15 years of experience in drug safety and clinical development in pharma industry and in academia. She has been in leadership and strategic roles in MNCs and Indian Pharma companies and successfully set up systems, developed teams and interacted with regulatory agencies in different regions including US, Europe, India and Australia. She is the Global Head for Drug Safety & Risk Management in Lupin Limited.
She has played an active role in developing awareness and skills of pharmacovigilance in the region by designing teaching modules for safety in medical institutions and training in pharmacovigilance workshops and courses. She is the author of the book Pharmacovigilance- An Industry Perspective.
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