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

  • 09:30
  • Welcome Address & Platform Orientation - Orientation will focus on how to access and navigate the virtual conference platform for Live Sessions & Interactive Networking

  • 09:40
  • Chairperson’s opening remarks

  • 09:50
  • Assessing the Quality of ICSRs & the Impact on causality assessment and signal evaluation


    Maria De Los Angeles Hernandez Loli

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

Drug Safety Strategies & Pharmacovigilance

  • 10:15
  • Women and child health care medicines and pharmacovigilance


    Carla Valeria Massironi

    Carla Valeria Massironi CHC Country Safety Head
    Sanofi

  • 10:35
  • 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

  • 11:05
  • Drug Safety Evaluation Strategies


    Nibha Mishra

    Nibha Mishra Senior Scientist
    Takeda

  • 11:25
  • ICH in Brazil: New PV Regulation following Incorporation of ICH Guidelines


    Raphael Elmadjian Pareschi

    Raphael Elmadjian Pareschi Pharmacovigilance Associate Director
    MSD

Safety Signals & Risk Management

  • 11:45
  • Innovative techniques and strategies in signal detection

    • The lacunae in existing technique
    • New strategies that have been implemented recently
    • How have implementation of new strategies benefited signal detection studies


    Booked for Aris Global (Platinum Sponsor) 

  • 12:05
  • An industrial perspective: Post-marketing Signal Detection and management

    • Present Drug safety signal detection systems and tools and what do they lack
    • Emerging techniques and tools in detection and management of signals
    • Sources for identifying safety signals

    Ajinkya Inamdar

    Ajinkya Inamdar Director, Vaccines Global Safety Strategy and Risk Management
    Janssen Pharmaceutical

  • 12:30
  • Virtual Luncheon & Networking - Visit Exhibitor Booths & Network with your peers in our Lounge (Face to Face Video Chats)

     

                

  • 13:00
  • Risk management in Mexico: challenges and opportunities


    Rodrigo Ruiz

    Rodrigo Ruiz Senior Manager, Patient Safety
    Bristol-Myers Squibb

  • 13:25
  • 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

    Klaudija Marijanovic Barac

    Klaudija Marijanovic Barac EU & UK QPPV deputy
    Teva Pharmaceuticals

  • 13:50
  • Review of aRMM effectiveness measures in Europe


    Robert Massouh

    Robert Massouh Director - Risk Management Product Lead
    Pfizer

  • 14:15
  • Signal Detection and Communications in PV


    Eman Gomaa

    Eman Gomaa MEA PV Hub Lead
    AbbVie

Quality Assurance and Regulatory Compliance

  • 14:40
  • Key steps for establishing and maintaining compliance with all applicable internal and external requirements and regulations


    Sam Bovonsombat

    Sam Bovonsombat Associate Director, Global Quality Management
    Otsuka

  • 15:05
  • What are the key steps for establishing and maintaining compliance with all applicable internal and external requirements and regulations

     

    For sponsorship opportunities please contact: [email protected] or call +44 (0) 207 096 0786

  • 15:30
  • Visit Virtual Exhibitor Booths/Speed Networking at our Exclusive Lounge (Face to Face Video chat with Exhibitors and other attendees)

     

         

  • 15:50
  • Pharmacovigilance Audit Inspection & Quality systems


    Valentina Mancini

    Valentina Mancini Director Pharmacovigilance, EU and UK QPPV
    Shionogi

  • 16:15
  • Pharmacovigilance System: Audit & Inspection Readiness

    • Sales, information and knowledge of consumers
    • Awareness, generic names, reduction of medication errors in private clinics
    • Industrial association

    Raj K Bhogal

    Raj K Bhogal Senior Director, R&D Audits & Inspections
    Jazz Pharmaceuticals

Advanced therapy medicinal products (ATMPs) and PV

  • 16:40
  • Advanced therapeutic techniques and pharmacovigilance

    • Advanced therapeutic techniques and pharmacovigilance
    • Challenges related with monitoring and safety
    • Benefit-risk assessment of ATMP

    Retesh Kumar

    Retesh Kumar Director, Global Pharmacovigilance, Therapeutic Area Lead- Cardio Renal
    Otsuka Pharmaceutical Companies (U.S)

  • 17:05
  • Hepatotoxicity of new therapies


    Ester Pena - Van Leeuwen

    Ester Pena - Van Leeuwen Ass Global Medical Safety Director
    Astellas Pharma Europe

Outsourcing & Vendor Management

  • 17:30
  • 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

    Cinthya Galicia Quintanar

    Cinthya Galicia Quintanar Senior Manager, Country Safety Lead
    Pfizer

  • 17:55
  • Build Effective Metrics for Vendor Oversight


    Julia Appelskog

    Julia Appelskog EU QPPV, Head of EU QPPV Office
    Novavax

  • 18:20
  • Chairperson’s closing remarks

  • 18:30
  • Virtual Networking - Catch-up with your peers in social lounge


Wednesday - 23rd November 2022 (Time Zone - GMT)

  • 09:30
  • Welcome Address & Platform Orientation - Orientation will focus on how to access and navigate the virtual conference platform for Live Sessions & Interactive Networking

  • 09:40
  • Chairperson’s opening remarks

  • 09:50
  • Improving the quality of your adverse event reporting system (Topic TBC)


    Santiago Schiaffino

    Santiago Schiaffino Head of PV Systems and Standards / Deputy EUQPPV
    Boehringer Ingelheim

  • 10:15
  • Service provider Presentation

     

    For sponsorship opportunities please contact: [email protected] or call +44 (0) 207 096 0786

Automation, AI & Data Management

  • 10:35
  • 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

    Robert Di Giovanni

    Robert Di Giovanni Global Project Safety Lead
    Novartis

  • 11:00
  • Automation and pharmacovigilance: identifying risk factors for AEs


    Michael Von Forstner

    Michael Von Forstner Global Head of Clinical Safety and Pharmacovigilance
    Biogen

  • 11:25
  • New developments in Safety Data Signal Detection and Evaluation


    Marianna Trani

    Marianna Trani Safety Risk Lead
    Pfizer

  • 11:50
  • Improving patient involvement and wearables

    • Role of internet/ communication techniques, advertisement
    • Post-market surveillance of devices
    • Therapeutic good administration
    • Safety management

    Yvonne Nanciu

    Yvonne Nanciu Country Head Pharmacovigilance Germany
    Bayer

  • 12:15
  • 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

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

     

                

  • 13:05
  • Leveraging Data Analytics to predict risks to a Pharmacovigilance System


    Minhaj Obeidullah

    Minhaj Obeidullah Head Compliance & Risk Management
    Novartis

  • 13:30
  • Artificial Intelligence in Medical Device

     

    Booked for Gavion Technologies

  • 13:55
  • Pharmacoepidemiology and Real-World Evidence (RWE) generation

  • 14:20
  • 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

    Yvonne Nanciu

    Yvonne Nanciu Country Head Pharmacovigilance Germany
    Bayer

Case Processing & Patient Centric Approach

  • 14:50
  • Importance of Quality Case Processing in Pharmacovigilance


    Laura Arce Mora

    Laura Arce Mora Country Safety Lead
    Pfizer

  • 15:15
  • AI & Machine Learning for Automated Case Processing in Pharmacovigilance

  • 15:40
  • Visit Virtual Exhibitor Booths/Speed Networking at our Exclusive Lounge (Face to Face Video chat with Exhibitors and other attendees)

     

         

  • 16:00
  • Partnership arrangements to speed up case processing times, improve data quality, and reduce costs are an essential part of ensuring the safety of drugs and protecting patients' health


    Victoria Bartasek

    Victoria Bartasek Senior Associate Director, Global Pharmacovigilance Operations
    Boehringer Ingelheim

  • 16:25
  • Designing a Patient Centred Pharmacovigilance System

  • 16:50
  • Chairperson’s closing remarks & End of Conference


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