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Speakers

  1. Pharmacovigilance World 2024
  2. Speakers
  3. Amit Jadhav

Amit Jadhav


Director Global Patient Safety, Gene therapy I General medicine - Regeneron



Amit Jadhav is a physician by background and has 14 years of experience in the pharmaceutical industry, having worked in Pharmacovigilance, Early and Late Phase Clinical Development in Global Patient Safety role, and in Medical Affairs. Amit is currently involved in Exploratory trials, including First in Human (FIH) projects within Gene therapy and rare diseases therapy areas. Amit’s professional experience includes providing strategic safety input within clinical development programs, contributing to Marketing Authorisation Application (MAA) submissions, formulating and implementing risk minimisation measures by collaborating with global affiliates, conducting signal surveillance activities, performing effective due diligence, leading quality improvement projects, working closely with institutes for Post authorisation safety studies, KOL engagements, product launches and collaborating with alliance and co-development partners.



Amit Jadhav

Sessions


  • Wednesday - September 11, 2024 - 14:15

    Panel Discussion - Integrated Drug Safety Surveillance Systems: Fostering Collaboration for Enhanced Pharmacovigilance

    • Assessing the benefits and hurdles in forming a network that includes pharmaceutical companies, healthcare providers, and regulatory bodies for improved drug safety monitoring
    • Discussing strategies for standardizing data collection, reporting, and analysis across various organizations to ensure consistent and reliable pharmacovigilance
    • Investigating how AI, blockchain, and big data are transforming ADR detection and analysis, increasing the efficiency and precision of pharmacovigilance
    • Emphasizing the need for effective communication and collaboration among patients, healthcare providers, and regulatory bodies to establish a trust-based pharmacovigilance system
    • Detailing best practices and essential factors for successful collaborative pharmacovigilance, with a focus on regulatory compliance, data privacy, and cross-sector cooperation

  • Wednesday - September 11, 2024 - 14:45

    Case study: Development and implementation of Additional Risk Minimisation Measures

      Presentation

 

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