Tuesday - 22nd November 2022 (Time Zone - GMT)

  • 09:20
  • Welcome Address & Platform Orientation - Orientation will focus on how to access and navigate the virtual conference platform for Live Sessions & Interactive Networking

  • 09:35
  • Chairperson’s opening remarks

      Watch Session
    Michael Ramcharan

    Michael Ramcharan Managing Director
    Reumat Consulting

  • 09:45
  • Ways to build successful PV partnerships in in-licensing scenarios and the role of PV in due-diligence processes

      Watch Session   Presentation
    Andreas Osanger

    Andreas Osanger Director - Therapeutic Area Lead Nephrology
    CSL Vifor

  • 10:45
  • Benefit-risk assessment of isoniazid preventive therapy in people living with HIV in Eritrea

      Watch Session   Presentation
    Mulugeta Russom

    Mulugeta Russom Pharmacoepidemiologist and Pharmacovigilance Specialist Head
    Eritrean Pharmacovigilance Centre

Drug Safety Strategies & Pharmacovigilance

  • 11:10
  • Panel Discussion - An Integrated care: Effective Implementation of vigilances systems

    • Separated vigilance systems can lead to the emergence of divergence in terms, definitions, variety of reporting forms and methods and the build of specific databases where cross analysis is no more possible.
    • To be more proactive and innovative in PV and to ensure that emerging problems are promptly recognized and solutions are effectively communicated
    • This integrated approach is very useful, especially for emerging countries to strengthen regulatory processes and to promote high standards of product vigilance for the protection of the health and safety of Citizens

      Watch Session
    Michael Ramcharan

    Michael Ramcharan Managing Director
    Reumat Consulting

    Andreas Osanger

    Andreas Osanger Director - Therapeutic Area Lead Nephrology
    CSL Vifor

    Siva Kumar

    Siva Kumar Global Phv Surveillance Physician Sr Manager, Medical Scientific Unit
    Teva Pharmaceuticals

    Siddhant Ekale

    Siddhant Ekale Enterprise Architect – Clinical Data Management

Safety Signals & Risk Management

  • 12:10
  • Risk minimization and management

    • Assessment with comprehensive data quality
    • Compliant safety system (GxP compliant, inspection-ready system)
    • Safety signals, effective trials, strategic risk assessment decisions

      Watch Session   Presentation
    Klaudija Marijanovic Barac

    Klaudija Marijanovic Barac EU & UK QPPV deputy
    Teva Pharmaceuticals

  • 12:35
  • Virtual Luncheon & Networking - Visit Exhibitor Booths & Network with your peers in our Lounge (Face to Face Video Chats)

     

                

  • 13:40
  • Fireside Chat - REMS Compliance and Inspection Readiness

      Watch Session
    Michael Ramcharan

    Michael Ramcharan Managing Director
    Reumat Consulting

    Nancy Dubois

    Nancy Dubois Head of Global Patient Safety US Region
    EMD Serono, Inc.

    Kal Elhoregy

    Kal Elhoregy Director, Risk Evaluation and Mitigation Strategies
    Amneal Pharmaceuticals

    Iva Galic

    Iva Galic Pharmacovigilance Inspector Expert
    HALMED

  • 14:10
  • Assessing the Quality of ICSRs & the Impact on causality assessment and signal evaluation

      Watch Session
    Maria De Los Angeles Hernandez Loli

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

  • 14:40
  • Case Study: Additional Risk Minimisation Measures from planning to execution

      Watch Session
    Eman Gomaa

    Eman Gomaa MEA PV Hub Lead
    AbbVie

  • 15:05
  • Visit Virtual Exhibitor Booths/Speed Networking at our Exclusive Lounge (Face to Face Video chat with Exhibitors and other attendees)

     

         

  • 15:20
  • The Safety Platform of Tomorrow in Production Today: Advancing Patient Safety through Innovation and Intelligence

      Watch Session
    Beena Wood

    Beena Wood Senior Vice President, Product Marketing
    ArisGlobal

    Elizabeth Smalley

    Elizabeth Smalley Director, Product Management, Data & Analytics
    ArisGlobal

Quality Assurance and Regulatory Compliance

  • 15:50
  • Why pharmacovigilance sometimes fails and how to bridge the gaps?

      Watch Session   Presentation
    Nancy Dubois

    Nancy Dubois Head of Global Patient Safety US Region
    EMD Serono, Inc.

  • 16:15
  • PSMF – Pharmacovigilance system master file

    • PSMF summary design, role of QPPV and managing audits.
    • Responsibilities of stakeholders.
    • Accessibility of PSMF and Transparency and ensuring compliance
    • Challenges in the managing data collection, audit information and documenting changes in logbooks, transferring information to license partners or third parties

      Watch Session
    Tea Babic

    Tea Babic Director, Head of PV Audits and Inspections Deputy Head of PV Compliance Global Patient Safety and Pharmacovigilance
    Teva Pharmaceuticals

  • 16:40
  • Cross-Functional Initiatives for Safety, Risk Management, and Pharmacovigilance Activities Across the Product’s Lifecycle

    • Increase transparency and improve awareness in your communication for Safety, Risk Management, and Pharmacovigilance across the product’s lifecycle
    • Bring value to cross functional approaches within safety governance (SMT and SAC), preparing aggregate reports (DSUR/ PBRER), safety surveillance and core data sheet etc.

Outsourcing & Vendor Management

  • 17:30
  • Safety-Radar: towards autonomous reasoning in investigative toxicology. Including patients' genetics data in assessments of adverse events

    • Architecture of Safety-Radar – a system for evaluating drug safety.
    • The platform will support automated reasoning and serendipitous discovery of new 'facts' or interesting and testable hypotheses
    • Strategies of how to integrate and provide high-value AI-ready data sources and how to develop (semi) autonomous reasoning agents.

      Watch Session
    Marcin Von Grotthuss

    Marcin Von Grotthuss Associate Director, Machine Learning
    Takeda

  • 17:55
  • Chairperson’s closing remarks

      Watch Session
    Michael Ramcharan

    Michael Ramcharan Managing Director
    Reumat Consulting

  • 18:05
  • Virtual Networking - Catch-up with your peers in social lounge


 

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