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Wednesday - 1st November 2023

  • 08:50

  • Chairperson’s opening remarks

Drug Safety Strategies, Colloboration & Regulatory updates

  • 09:00

  • Pharmacovigilance of women and child health care medicines and its challenges

    • Challenges associated with conducting clinical trials and post-marketing surveillance of drugs used in pregnant and breastfeeding women and children, including ethical and safety considerations.
    • Strategies for improving pharmacovigilance and safety monitoring in women and children, including innovative data sources and patient engagement initiatives
    • The role of regulatory agencies, healthcare providers, and the pharmaceutical industry in promoting drug safety and efficacy in women and child healthcare

     

    For sponsorship opportunities please contact: sponsor@corvusglobalevents.com or call +44 (0) 207 096 0786

  • 09:25

  • Assessing the Quality of ICSRs & the Impact on causality assessment

    • 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 
    Maria De Los Angeles Hernandez Loli

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

  • 09:50

  • Panel Discussion - Collaborative Approaches to Pharmacovigilance: Integrating Systems for Effective Safety Monitoring and Risk Management

    • The benefits and challenges of integrating pharmacovigilance systems across different organizations, including pharmaceutical companies, regulatory agencies, and healthcare providers.
    • Strategies for developing standardized processes and data sharing agreements to improve collaboration and streamline pharmacovigilance activities
    • The role of technology in facilitating collaborative approaches to pharmacovigilance, such as using AI and machine learning to automate ADR detection and analysis.
    • The importance of stakeholder engagement and communication in building trust and fostering collaboration among different organizations involved in pharmacovigilance
    • Best practices for successful implementation of collaborative pharmacovigilance initiatives
    Petar Gjorgiev

    Petar Gjorgiev Safety Risk Lead, Medical director
     Pfizer

    Dimitris Zampatis

    Dimitris Zampatis Global Program Safety Lead
     Sandoz

  • 10:20

  • Real World Evidence (RWE) in Pharmacovigilance

    Mariana Calzada Mijangos

    Mariana Calzada Mijangos CHC Country Safety Head
     Sanofi

  • 10:40

  • Business Card Exchange with Morning Coffee/Tea & Discussion

     

         

  • 11:00

  • Practical considerations for creating a proactive safety and pharmacovigilance plan

     

    For sponsorship opportunities please contact: sponsor@corvusglobalevents.com or call +44 (0) 207 096 0786

  • 11:25

  • Ensuring Drug Safety Through International Harmonization of Drug Regulatory Requirements in LATAM

    Cinthya Galicia Quintanar

    Cinthya Galicia Quintanar Senior Manager, Country Safety Lead
     Pfizer

Safety Signals & Risk Management

  • 11:50

  • 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

     

    For sponsorship opportunities please contact: sponsor@corvusglobalevents.com or call +44 (0) 207 096 0786

  • 12:10

  • Risk minimisation measures and how to implement and the impact on PBRER and Signal management

    Zina Sadeq

    Zina Sadeq Director, Regional PV & Alliance Management
     Amicus Therapeutics

  • 12:30

  • Luncheon & Networking - Visit Exhibitor Booths & Network with your peers in our Lounge

     

                

  • 13:00

  • 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

  • 13:25

  • RMP for biosimilars

    Dimitris Zampatis

    Dimitris Zampatis Global Program Safety Lead
     Sandoz

  • 13:50

  • Developmental Risk Management - Safety and Risk management Activities During Clinical Trials

    Gauri Utturkar

    Gauri Utturkar Patient Safety Physician
     UCB Pharma

  • 14:15

  • Fireside Chat - Ensuring Effective REMS Implementation: Strategies for Compliance and Inspection Readiness

    • What is the role of Quality and Compliance discipline within REMS development/operations?
    • What are some of the biggest challenges regarding stakeholders’ compliance?
    • How do you ensure internal organization REMS compliance 
    • What are some recommendations when submitting compliance and audit plan with your REMS submission?
    • Does inspection readiness help to demonstrate ensuring REMS compliance? Is there a mechanism in place for REMS specific inspection readiness?
    • How do you ensure the inspection readiness oversight of REMS administrators, contracted vendors, PMO etc.
    Zina Sadeq

    Zina Sadeq Director, Regional PV & Alliance Management
     Amicus Therapeutics

Quality & Compliance

  • 14:45

  • Pharmacovigilance System: Audit & Inspection Readiness

    • Best Practices for Ensuring Audit and Inspection Readiness
    • Collaboration and Communication with Regulatory Authorities
    • Harnessing Technology for Efficient Audit and Inspection Processes
    Tea Babic

    Tea Babic Director, PV Audits and Inspections
     Teva Pharmaceuticals

  • 15:10

  • Reason, Scope and Significance of establishing good PV system

    • The Impact of a Good Pharmacovigilance (PV) System on Patient Safety
    • Regulatory Compliance and the Importance of a Good PV System:
    • Industry Reputation and Business Sustainability

  • 15:30

  • Grab your Tea/Coffee - Visit our Exhibitor Booths & Network with your colleagues

     

         

  • 15:50

  • Pharmacovigilance Audit Inspection & Quality systems

    Julia Appelskog

    Julia Appelskog EU QPPV, Head of EU QPPV Office
     Novavax

  • 16:15

  • International harmonization and drug regulatory requirement

    Mina Awad

    Mina Awad Pharmacovigilance Senior Manager and QPPV, Middle East
     Kyowa Kirin International plc

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

     

    For sponsorship opportunities please contact: sponsor@corvusglobalevents.com or call +44 (0) 207 096 0786

  • 17:05

  • Exploring complexities of PV in new therapeutic modalities such as CAR T

    Ferdinando E. Vegni

    Ferdinando E. Vegni Head of Patient Safety Haematology and Cell Therapy
     Bristol Myers Squibb

Outsourcing & Partnerships

  • 17:30

  • Pharmacovigilance Agreements & PV language in External Service provider agreements

    Netsanet Getachew Desta

    Netsanet Getachew Desta Director, Global Pharmacovigilance Alliance Lead and International Expansion
     Swedish Orphan Biovitrum AB (publ)

  • 17:55

  • Build Effective Metrics for Vendor Oversight

  • 18:20

  • Chairperson’s Closing Remark

  • 18:30

  • Networking Drinks Session


Thursday - 2nd November 2023

  • 08:50

  • Chairperson’s opening remarks

  • 09:00

  • The Role of Patients in Pharmacovigilance: Empowering Public Participation

    Mayssa Aboughannam

    Mayssa Aboughannam Cross-Sector Country Safety Team Lead, GCC, Pakistan & Afghanistan
     Janssen Pharmaceutical

  • 09:30

  • Unintentional Adverse Events in Market Research

    Dawn Mucci

    Dawn Mucci Senior Manager, PV Alliance Management
     Jazz Pharmaceuticals

  • 10:00

  • Impact and Use of Digital Media in Pharmacovigilance

  • 10:30

  • Business Card Exchange with Morning Coffee/Tea & Discussion

     

         

Automation, AI & Data Management

  • 11:00

  • 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
    Lizanne Pistorius

    Lizanne Pistorius Senior Manager Global Patient Safety Operations, QMS & Risk Management
     Aimmune Therapeutics & Nestle Health Science

  • 11:25

  • New probabilistic algorithm to assess causality and help signal detection

    Fabio De Gregorio

    Fabio De Gregorio Vice President, Head of Drug Safety Europe
     Shionogi Europe

  • 11:50

  • Big data be used to identify Adverse Drug Events and Interactions

     

    For sponsorship opportunities please contact: sponsor@corvusglobalevents.com or call +44 (0) 207 096 0786

  • 12:15

  • Characterizing the safety profile of HSC gene therapies

    Mattia Calissano

    Mattia Calissano Head of Pharmacovigilance
     Orchard Therapeutics

  • 12:35

  • Luncheon & Networking - Visit Exhibitor Booths & Network with your peers in our Lounge

     

                

  • 13:05

  • Leveraging Data Analytics to predict risks to a Pharmacovigilance System

    Pav Rishiraj

    Pav Rishiraj Director, Head of Pharmacovigilance
     Ipsen

  • 13:30

  • Improving patient involvement and wearables

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

  • 13:55

  • Pharmacoepidemiology and Real-World Evidence (RWE) generation

     

    For sponsorship opportunities please contact: sponsor@corvusglobalevents.com or call +44 (0) 207 096 0786

  • 14:20

  • Panel Discussion – Digital Transformation in Pharmacovigilance: Leveraging Emerging Technologies for Better Patient Outcomes

    • 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
    Lizanne Pistorius

    Lizanne Pistorius Senior Manager Global Patient Safety Operations, QMS & Risk Management
     Aimmune Therapeutics & Nestle Health Science

  • 14:50

  • Artificial Intelligence in Medical Device

     

    Booked for Gavion Technologies

  • 15:15

  • Risk Management Under EU Medical Device Regulation (EU MDR)

  • 15:40

  • Grab your Tea/Coffee - Visit our Exhibitor Booths & Network with your colleagues

     

         

Case Processing & Patient Centric Approach

  • 16:00

  • Importance of Quality Case Processing in Pharmacovigilance

  • 16:25

  • AI & Machine Learning for Automated Case Processing in Pharmacovigilance

  • 16:50

  • 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

  • 17:15

  • Chairperson’s closing remarks & End of Conference

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