Tuesday - 23rd November 2021 (Time Zone - GMT)

  • 10:00
  • Welcome Address & Platform Orientation - Orientation will focus on how to access and navigate the virtual conference platform for Live Sessions & Interactive Networking

  • 10:20
  • Chairperson’s opening remarks

    Uwe Gudat (Moderator)

    Uwe Gudat (Moderator) Head of Medical Affairs & CSPV
    Fresenius Kabi

  • 10:30
  • Applying a structured approach to benefit-risk assessment and illustrating how it can make a difference in decision making purposes and regulatory approvals of medicinal products

    Stephanie Tcherny

    Stephanie Tcherny Global Head of Benefit-Risk Evaluation

  • 11:00
  • "X-functional Drug Safety Strategy" - How to set it up and why it is important

    Andreas Osanger

    Andreas Osanger Director - Therapeutic Area Lead Nephrology
    Vifor Pharma

  • 11:20
  • The unmet need for medication adherence

    Mayada Alkhakany

    Mayada Alkhakany Senior Global NTA Manager
    Boehringer Ingelheim

  • 11:40
  • Transforming Safety with End-to-end PV Solutions

    Jen Markey

    Jen Markey Vice President, Safety Strategy, EU
    Veeva Systems

  • 12:00
  • Virtual Luncheon & Networking - Visit Exhibitor Booths & Network with your peers in our Lounge (Face to Face Video Chats)



  • 12:55
  • Novel AI for Extraction of Adverse Events and Auto Generation of Adverse Event Reports

    Jingqing Zhang

    Jingqing Zhang Head of AI
    Pangaea Data

  • 13:20
  • ICH in Brazil: New PV Regulation following Incorporation of ICH Guidelines

    Raphael Elmadjian Pareschi

    Raphael Elmadjian Pareschi Associate Director Pharmacovigilance

Safety Signals and Risk Management

  • 13:40
  • Pivoting Safety to a Strategic Center - with an End-to-end AI Enabled Data Fabric

    • Learn how technology and industry trends are creating opportunity to transform safety to a strategic driver.
    • Gain perspective on how safety systems must evolve to seize this opportunity
    • Hear about ArisGlobal's progress toward enabling the future of pharmacovigilance.

    Beena Wood

    Beena Wood VP, Safety Product Management

  • 14:10
  • Signal Management in Pharmacovigilance – What Is New?

    •  Routine signal detection methods in EudraVigilance
    • Ongoing monitoring activities for signal detection
    • Enhanced quantitative signal detection methods (data mining)
    • Qualitative vs. quantitative assessment of ICSRs

    Dimitris Zampatis

    Dimitris Zampatis Head of Pharmacovigilance EMA- EU/UK QPPV
    Lupin Europe

  • 14:30
  • Implementing a systematic approach in the area of drug safety and risk management

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

    Allison Stogdale

    Allison Stogdale Associate Director, Global Patient Safety & Risk Management
    Alnylam Pharmaceuticals

  • 14:50
  • What does a signal, signal?

    Uwe Gudat (Moderator)

    Uwe Gudat (Moderator) Head of Medical Affairs & CSPV
    Fresenius Kabi

  • 15:10
  • Visit Virtual Exhibitor Booths/Speed Networking at our Exclusive Lounge (Face to Face Video chat with Exhibitors and other attendees)



  • 15:20
  • Fireside Chat: Strengthening Risk Evaluation and Mitigation Strategies (REMS)

    • Creating a REMS Industry-Wide Standardized Risk Evaluation and Mitigation Strategy (REMS) Program
    • Global regulatory developments
    • EU GVP XVI revision – what we could expect?
    • REMS for generics
    • Effective tools and strategies to improve REMS effectiveness
    • REMS at the patient-level: improving safety and proper use of medicines
    • Evolving REMS: New opportunities for branded drugs 
    • What have we learned? Next steps toward the future 

    Uwe Gudat (Moderator)

    Uwe Gudat (Moderator) Head of Medical Affairs & CSPV
    Fresenius Kabi

    Lisa Stagi

    Lisa Stagi Drug Safety & Quality Head

    Kal Elhoregy

    Kal Elhoregy Director, Risk Evaluation and Mitigation Strategies
    Amneal Pharmaceuticals

    Lisa Benaise

    Lisa Benaise Vice President, Head of Pharmacovigilance
    Calliditas Therapeutics

    Klaudija Marijanovic Barac

    Klaudija Marijanovic Barac Sr. Director, TPC - Global PSUR & RMP Unit
    Teva Pharmaceuticals

  • 16:00
  • How PV is implemented in MENA

    What do you need to know about the rapidly evolving GVP implementation in the MENA region? Are you keeping the pace to be compliant to local authorities?

    Shahinaz Badr

    Shahinaz Badr Regional Pharmacovigilance Manager
    NewBridge Pharmaceuticals

  • 16:20
  • Post-marketing Signal Detection and management from industrial perspective

    • Sources for identifying safety signals 
    • Present Drug safety signal detection systems and tools and what do they lack 
    • How we can improve the techniques and the tools to have a more efficient signal detection and management 

    Luca Cariolato

    Luca Cariolato Head of Signal Management
    Vifor Pharma

  • 16:40
  • Pharmacovigilance in Mexico: Updates and Challenges

    • Provide the most current Local Regulatory environment in terms of Pharmacovigilance in Mexico
    • Analyze the most important changes within Pharmacovigilance Guidelines

    Rodrigo Ruiz

    Rodrigo Ruiz Head of Country Pharmacovigilance Mexico
    Bristol-Myers Squibb

  • 17:00
  • Panel discussion: PV Outsourcing: Challenges and Opportunities

    • Building partnerships
    • Identifying the key areas for outsourcing
    • The main challenges faced and impact of new legislation
    • Economy
    • PV Quality assurance
    • Post-authorization safety studies
    • Core competencies, activities-database, follow-up studies, case-studies, etc.

    Uwe Gudat (Moderator)

    Uwe Gudat (Moderator) Head of Medical Affairs & CSPV
    Fresenius Kabi

    Joan Francesc Aregall Picamal

    Joan Francesc Aregall Picamal Former Pharmacovigilance Country Head, Spain

    Sharmila Sabaratnam

    Sharmila Sabaratnam Senior Director, Vault Safety Strategy
    Veeva Systems

  • 17:30
  • Chairperson’s closing remarks

    Uwe Gudat (Moderator)

    Uwe Gudat (Moderator) Head of Medical Affairs & CSPV
    Fresenius Kabi

  • 17:40
  • Virtual Networking - Catch-up with your peers in social lounge




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