Conference Schedule

Introduction to Chitkara University & Welcome Note

• Speaker - Mrs. Madhu Chitkara, Pro Chancellor, Chitkara University, Punjab

Introduction to Chitkara College of Pharmacy

• Speaker: Dr. Gurjeet Singh, Dean, Chitkara College of Pharmacy, Chitkara University, Punjab

About the conference

• Speaker: Mr. Sunil Verma, Dean, Department of Pharmacovigilance and Clinical Research, Chitkara University, Punjab
• Overview: Introduction to the conference, objectives, and importance of a robust global pharmacovigilance system.

Keynote Address: Global Pharmacovigilance Landscape and Emerging Trends

• Speaker: [Renowned Expert from WHO]
• Overview: Address the global landscape of pharmacovigilance, emphasizing the importance of international collaboration and the role of major regulatory bodies in shaping global drug safety.

EMEA Pharmacovigilance Guidelines: Current Framework and Future Directions

• Speaker: EMEA Expert
• Overview: Detailed insights into EMEA's current pharmacovigilance guidelines, recent updates, and implications for global drug safety practices.

FDA Pharmacovigilance Guidelines: Compliance and Best Practices

• Speaker: Expert from FDA
• Overview: An examination of the FDA’s pharmacovigilance policies, focusing on cross-border data sharing and its impact on global regulatory practices.

CDSCO Pharmacovigilance Guidelines: Regulatory Requirements and Implementation

• Speaker: Expert from CDSCO
• Overview: Detailed insights of the current pharmacovigilance regulations in India, recent revisions, and their impact on international drug safety protocols.

Pharmacovigilance in India: Insights from PvPI

• Speaker: Expert from PvPI
• Overview: Overview of India's pharmacovigilance framework, focusing on recent innovations under the Pharmacovigilance Programme of India (PvPI) and its regional impact.

Panel Discussion - Comparative Analysis of Pharmacovigilance Guidelines Across Regions

• Facilitator:
  • WHO Representative: Expert in global health and pharmacovigilance policy.
  • EMEA Representative: Specialist in European drug safety regulations.
  • FDA Representative: Authority on U.S. drug safety compliance.
  • CDSCO Representative: Expert in Indian pharmacovigilance regulations and practices.
• Moderator: Sunil Verma
• Overview: This panel aims to address the complexities and challenges of harmonizing pharmacovigilance regulations across different regions, with insights from top regulatory authorities. The discussion will explore how collaboration and strategic alignment can enhance global drug safety monitoring.

Lunch Break

Fundamentals of Pharmacovigilance System Setup

• Speaker: Industry Expert
• Overview: Essential steps and considerations in setting up a robust pharmacovigilance system globally.

Risk Management Strategies in Global Pharmacovigilance

• Speaker: [Risk Management Expert]
• Overview: Techniques for identifying, assessing, and managing risks associated with global pharmacovigilance.

Case Management and Adverse Event Reporting Best Practices

• Speaker: [Clinical Safety Specialist]
• Overview: Best practices in global case management and adverse event reporting to ensure compliance and efficiency.

Workshop: Implementing a Global Pharmacovigilance Database

• Facilitator: [IT and Database Management Expert]
• Overview: Hands-on session on setting up and managing a pharmacovigilance database that meets global standards.

Networking Break

Panel Discussion - Harmonizing Pharmacovigilance: Global Regulations and Collaborative Strategies

• Facilitator: 8-10 Industry Experts
• Moderator: Sunil Verma
• Overview: This panel aims to address the complexities and challenges of harmonizing pharmacovigilance regulations across different regions, with insights from top regulatory authorities. The discussion will explore how collaboration and strategic alignment can enhance global drug safety monitoring.

Day 1 Closing Remarks

• Speaker: Sunil Verma
• Overview: Summary of the day’s key learnings and preview of Day 2.