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
    Sanofi

  • 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
    MSD

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
    ArisGlobal

  • 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
    Roche

    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
    Bayer

    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

     

         


Wednesday - 24th 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


    Michael Ramcharan (Moderator)

    Michael Ramcharan (Moderator) Managing Director
    Reumat Consulting

  • 10:30
  • Globalisation of the PSMF

    • What does this mean for global MAHs?
    • How to adapt to these global requirements?
    • How could automation support?

    Maria Artolazabal Cabrerizo

    Maria Artolazabal Cabrerizo PV Governance & Policy Leader - PSMF GPO
    Roche

  • 11:00
  • Impact and Use of Digital Media in Pharmacovigilance


    Agata Catalano

    Agata Catalano Pharmacovigilance Manager
    Shionogi Europe

Patient Centric Pharmacovigilance

  • 11:20
  • Designing a Patient Centred Pharmacovigilance System


    Brian Edwards

    Brian Edwards Managing Director
    Husoteria Ltd

  • 11:40
  • Role of Pharmacovigilance in boosting market access


    Hadir Rostom

    Hadir Rostom Consultant
    WHO

Quality and Compliance

  • 12:00
  • PV Inspections – Regulatory perspective from the Health Products Regulatory Authority

    • Overview of PV inspection programmes
    • Co-operation among the European network
    • How best to support inspections as an inspectee
    • Impact of Covid-19 and use of remote inspections
    • Common inspection findings

    Peter Twomey

    Peter Twomey GCP/PV Inspection Manager
    Health Products Regulatory Authority (HPRA)

  • 12:20
  • Virtual Luncheon & Networking - Visit Exhibitor Booths & Network with your peers in our Lounge (Face to Face Video Chats)

     

                      

  • 13:10
  • Business partner GVP audits: How to apply a risk based approach and decide the partners to audit and topics to focus on?


    Tea Babic

    Tea Babic Director, PV Audits and Inspections
    Teva Pharmaceuticals

  • 13:30
  • Licence partner risk assessment in Pharmacovigilance


    Andrew Cooper

    Andrew Cooper Pharmacovigilance Auditor
    GSK

  • 13:50
  • Pharmacovigilance System: Audit & Inspection Readiness


    Ahmed Abdelrahman

    Ahmed Abdelrahman Patient Safety and Pharmacovigilance Manager GulfIP
    Boehringer Ingelheim

Data & Next-Gen Technologies

  • 14:10
  • Patient-Centric Pharmacovigilance: Building Better Outcomes through Integrated Technology to monitor quality and improve patient outcomes


    Raghda Mohamed

    Raghda Mohamed Patient Safety Cluster Lead - Middle East and Turkey / Global patient Safety Evaluation
    Takeda

  • 14:30
  • CASE STUDY: Postmarket Safety Reporting for Combination Products in the US


    Khaudeja Bano

    Khaudeja Bano Head of Combination Product and Device Safety, Executive Medical Director
    Amgen

  • 14:50
  • Visit Virtual Exhibitor Booths/Speed Networking at our Exclusive Lounge (Face to Face Video chat with Exhibitors and other attendees)

     

          

  • 15:10
  • Leveraging Data Analytics to predict risks to a Pharmacovigilance System


    Minhaj Obeidullah

    Minhaj Obeidullah Head Compliance & Risk Management
    Novartis

  • 15:40
  • Improving patient involvement with Patient Generated Health Data

    • Benefits of Patient Generated Health Data 

    • Mobile Health Technology and potential value in Pharmacovigilance

    • Legal and regulatory considerations


    Victoria Abdala

    Victoria Abdala Head of Patient Safety & Pharmacovigilance ROPU South America
    Boehringer Ingelheim

  • 16:00
  • Safety as a strategy: Some current and emerging opportunities for pharmacoepidemiology and real-world evidence (RWE) generation to inform benefit/risk decision making


    Ryan Kilpatrick

    Ryan Kilpatrick Head, Global Epidemiology
    Abbvie

  • 16:30
  • Panel Discussion: Innovation and the future of Pharmacovigilance

    • Importance of bringing patients on board
    • The need for patient database and effective communication
    • Automation, cognitive technologies, and advanced analytics
    • AI is Transforming Pharmacovigilance and Drug Safety
    • Emerging technologies, digitization and social platform
    • Benefits of digital technology and regulatory hurdles

    Michael Ramcharan (Moderator)

    Michael Ramcharan (Moderator) Managing Director
    Reumat Consulting

    Michael Glaser

    Michael Glaser Safety Innovation Technology Director
    GSK

    Yvonne Nanciu

    Yvonne Nanciu Country Head Pharmacovigilance Germany
    Bayer pharmaceuticals

    Kate Gofman

    Kate Gofman Global Safety Physician, AI & Blockchain Innovator
    AstraZeneca

    Rishi Chopra

    Rishi Chopra Senior Director, Head of International Pharmacovigilance (IPV)
    Biogen

Vendor Management and Outsourcing

  • 17:00
  • Pharmacovigilance Vendor Management

    • Procurement & Brand Teams
    • Vendor Oversight
    • Global & Local Regulations
    • Vendor Relationship Building

    Dawn Mucci

    Dawn Mucci Team Lead, Patient Safety Compliance and Enablement
    AstraZeneca

  • 17:30
  • Chair Person’s closing remarks & End of the Conference


    Michael Ramcharan (Moderator)

    Michael Ramcharan (Moderator) Managing Director
    Reumat Consulting


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