Wednesday - 1st November 2023

  • 08:50
  • Chairperson’s opening remarks

    Michael Ramcharan

    Michael Ramcharan Managing Director
    Reumat Consulting

Quality & Compliance

  • 09:00
  • Case Study - Supporting real inspections, and establishing and adhering to corrective action plans to enhance pharmacovigilance practices

    Bertrand Sailly

    Bertrand Sailly Associate Director, Pharmacovigilance and Medical Quality

  • 09:30
  • Auditing and Practical Aspects in PV, Hints & Tips

    Antje Baumgarten

    Antje Baumgarten Senior Global System Auditor
    Bayer Healthcare

  • 10:00
  • Quality Management Systems in Pharmacovigilance: Best Practices and Compliance

    • QMS principles and their role in pharmacovigilance.
    • Best practices for implementing QMS in pharmacovigilance processes.
    • How compliance with QMS standards contributes to patient safety and regulatory requirements.

    Lizanne Pistorius

    Lizanne Pistorius Senior Manager Global Patient Safety Operations, QMS & Risk Management
    Aimmune Therapeutics & Nestle Health Science

  • 10:30
  • Business Card Exchange with Morning Coffee/Tea & Discussion



Safety Signals & Risk Management

  • 10:50
  • Risk management During Drug development

    Mohamed Abdillahi

    Mohamed Abdillahi Director, Risk management Product Lead

  • 11:20
  • An industrial perspective: Post-marketing Signal Detection and management

    Nadia Hussain

    Nadia Hussain PV Operations Manager (Deputy ASR)

  • 11:50
  • Challenges and Solutions in Risk Management: A Post-Brexit UK Landscape

    Nick Nikberg

    Nick Nikberg Senior Patient Safety Specialist

  • 12:20
  • Developmental Risk Management - Safety and Risk management Activities During Clinical Trials

    Gauri Utturkar

    Gauri Utturkar Patient Safety Physician
    UCB Pharma

  • 12:50
  • Luncheon & Networking



  • 13:30
  • Assessing the Quality of ICSRs & the Impact on causality assessment

    • Spontaneous report
    • Quality
    • How is the quality of the notification evaluated?
    • Impact of quality reports on causal assessment


    Maria De Los Angeles Hernandez Loli

    Maria De Los Angeles Hernandez Loli Patient Safety Lead Cluster Ecuador - Peru
    Boehringer Ingelheim

  • 14:00
  • Case Study: Development and implementation of additional risk minimisation measure

    Amit Jadhav

    Amit Jadhav Director Global Patient Safety, Internal Medicine and Gene Therapy

  • 14:30
  • aRMMs implementation challenges

    Zina Sadeq

    Zina Sadeq Director, Regional PV & Alliance Management
    Amicus Therapeutics

Drug Safety Strategies, Colloboration & Regulatory updates

  • 15:00
  • Panel Discussion - Collaborative Approaches to Pharmacovigilance: Integrating Systems for Effective Safety Monitoring and Risk Management

    • The benefits and challenges of integrating pharmacovigilance systems across different organizations, including pharmaceutical companies, regulatory agencies, and healthcare providers.
    • Strategies for developing standardized processes and data sharing agreements to improve collaboration and streamline pharmacovigilance activities
    • The role of technology in facilitating collaborative approaches to pharmacovigilance, such as using AI and machine learning to automate ADR detection and analysis.
    • The importance of stakeholder engagement and communication in building trust and fostering collaboration among different organizations involved in pharmacovigilance
    • Best practices for successful implementation of collaborative pharmacovigilance initiatives

    Michael Ramcharan

    Michael Ramcharan Managing Director
    Reumat Consulting

    Petar Gjorgiev

    Petar Gjorgiev Global Safety Lead

    Mayssa Aboughannam

    Mayssa Aboughannam Country Safety Team Lead, GCC, Pakistan & Afghanistan
    Johnson & Johnson

    Gauri Utturkar

    Gauri Utturkar Patient Safety Physician
    UCB Pharma

    Mark Perrott

    Mark Perrott Founder and Managing Partner
    Axian Consulting Ltd

  • 15:30
  • Grab your Tea/Coffee



  • 15:50
  • Key operational learnings from a designed longitudinal RBM Pharmacovigilance study using RWD from a covid-19 vaccination program (population of 7 M spread across 295 counties)

    Aldir Medeiros Filho

    Aldir Medeiros Filho Former Senior Project Manager - Data Sciences Department
    Mitsubishi Tanabe Pharma Europe Ltd

  • 16:20
  • A Round Table on "Medical Errors”

    Michael Ramcharan

    Michael Ramcharan Managing Director
    Reumat Consulting

  • 16:50
  • Ensuring Drug Safety Through International Harmonization of Drug Regulatory Requirements in LATAM

    Cinthya Galicia Quintanar

    Cinthya Galicia Quintanar Senior Manager, Country Safety Lead

  • 17:20
  • Chairperson’s Closing Remark

    Michael Ramcharan

    Michael Ramcharan Managing Director
    Reumat Consulting

  • 17:30
  • Networking Drinks Session


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