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

  • 17:05
  • Build Effective Metrics for Vendor Oversight

      Watch Session
    Julia Appelskog

    Julia Appelskog EU QPPV, Head of EU QPPV Office
    Novavax

  • 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


Wednesday - 23rd 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

Automation, AI & Data Management

  • 10:45
  • Impact of AI & Machine learning on Pharmacovigilance and Drug Safety

    • Ever expanding data and its safety
    • Importance and application of AI
    • Improving speed, accuracy and reliability using AI
      Watch Session   Presentation
    Robert Di Giovanni

    Robert Di Giovanni Global Project Safety Lead
    Novartis

  • 11:10
  • Patient involvement throughout the product lifecycle

    • Evolution of patient involvement 
    • Utilisation of new technologies
    • How Pharmacovigilance can support patient involvement 
    • Patient safety reporting
    • Preferred communication methods - mind the gap
      Watch Session   Presentation
    Yvonne Nanciu

    Yvonne Nanciu Country Head Pharmacovigilance Germany
    Bayer

  • 11:35
  • PV Inspections: Sharing knowledge, Increasing collaboration and engagement

    • how to structure regular gap analysis activities and how it can support inspection resdiness
    • how should PV and QPPV involved in risk based approach audits management
      Watch Session   Presentation
    Valentina Mancini

    Valentina Mancini Senior Director Pharmacovigilance, QPPV
    Shionogi

  • 12:25
  • Virtual Luncheon & Networking - Visit Exhibitor Booths & Network with your peers in our Lounge (Face to Face Video Chats)

     

                

  • 13:10
  • Use of real-world data to conduct rapid, non-protocolized signal assessment

      Watch Session   Presentation
    William Blumentals

    William Blumentals Sr. Director, Head of Pharmacoepidemiology in Specialty Care
    Sanofi

  • 13:35
  • ICH in Brazil: New PV Regulation following Incorporation of ICH Guidelines

      Watch Session   Presentation
    Raphael Elmadjian Pareschi

    Raphael Elmadjian Pareschi Head of Drug Safety Brazil / Patient Safety Lead
    Roche

  • 14:00
  • Perspectives on Benefit risk Assessment for Drugs

      Watch Session
    Siva Kumar

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

  • 14:25
  • Panel Discussion – The future of pharmacovigilance: How technology will change the way we monitor drugs

    • The future of pharmacovigilance will be more automated
    • AI will play a big role in data management and analysis
    • The use of technology will increase speed and accuracy
      Watch Session
    Michael Ramcharan

    Michael Ramcharan Managing Director
    Reumat Consulting

    Yvonne Nanciu

    Yvonne Nanciu Country Head Pharmacovigilance Germany
    Bayer

    Stephanie Tcherny-Lessenot

    Stephanie Tcherny-Lessenot Global Head of Benefit-Risk Evaluation
    Sanofi

    Ashraf Youssef

    Ashraf Youssef Senior Medical Director, Global Post Marketed Products, Global Safety Lead
    Takeda

    Christina Barker

    Christina Barker Senior Director, Product Management, Safety
    ArisGlobal

  • 15:00
  • Visit Virtual Exhibitor Booths/Speed Networking at our Exclusive Lounge (Face to Face Video chat with Exhibitors and other attendees)

     

         

Case Processing & Patient Centric Approach

  • 15:20
  • Importance of Quality Case Processing in Pharmacovigilance

      Watch Session
    Laura Arce Mora

    Laura Arce Mora Country Safety Lead
    Pfizer

  • 15:45
  • Designing a Patient Centred Pharmacovigilance System

      Watch Session
    Agustina Zilifian

    Agustina Zilifian Regional Patient Safety Head
    Boehringer Ingelheim

  • 16:10
  • Compliance, the tools to be used, the continuous oversight and need for improvement

      Watch Session   Presentation
    Marco Colombati

    Marco Colombati Corporate Pharmacovigilance Compliance Specialist
    Italfarmaco SpA

  • 16:35
  • Effectiveness of Risk Minimisation Measures

      Watch Session   Presentation
    Zeljana Margan Koletic

    Zeljana Margan Koletic Head of Pharmacovigilance and Rational Pharmacotherapy Department
    Agency for Medicinal Products and Medical Devices

  • 17:25
  • Developing Value-Based Partnerships

    • Establishing a clear understanding of the goals and objectives of the partnership
    • Defining the roles and responsibilities of each partner
    • Negotiating and formalizing agreements between partners
    • Monitoring and evaluating the partnership performance on an ongoing basis
      Watch Session   Presentation
    Cinthya Galicia Quintanar

    Cinthya Galicia Quintanar Senior Manager, Country Safety Lead
    Pfizer

  • 17:50
  • Chairperson’s closing remarks & End of Conference

      Watch Session
    Michael Ramcharan

    Michael Ramcharan Managing Director
    Reumat Consulting


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