Conference Overview

As medical science advances, so does our understanding of drug safety and the need for vigilance when it comes to monitoring its usage. In recent years, pharmacovigilance has gained significant attention and importance due to the growing complexity of drug therapies, the emergence of new medicines, and the increased scrutiny of regulatory agencies. This has led to a greater emphasis on monitoring the safety profiles of pharmaceutical products throughout their lifecycle, from pre-marketing clinical trials to post-marketing surveillance.

 

The need for effective pharmacovigilance systems becomes even more crucial as the global population continues to expand, resulting in an increased consumption of medications. Adverse drug reactions (ADRs) can have severe consequences, leading to hospitalizations, prolonged treatments, and in some cases, even fatalities. Therefore, it is imperative to enhance our understanding of ADRs, identify potential risks, and implement appropriate risk mitigation strategies. To efficiently address these challenges, collaboration between international regulatory bodies, healthcare providers, and patients is essential. With a strong focus on patient safety as well as public health and by creating an interconnected network of experts from around the world who are dedicated to advancing our understanding of drug safety and pharmacovigilance, we can create a robust system.

This conference will serve as a knowledge-sharing and networking platform, providing a unique opportunity for researchers, pharmacists, healthcare professionals, industry representatives, and regulatory authorities to come together and discuss the latest trends, challenges, and advancements in pharmacovigilance. By sharing experiences and best practices, we aim to enhance global drug safety and improve patient outcomes. Throughout the conference, we will delve into various topics such as signal detection and management, adverse event reporting and analysis, risk assessment, benefit-risk evaluation, regulatory updates, collaboration and the integration of artificial intelligence and digital technologies in pharmacovigilance.

 

Our esteemed panel of speakers, comprising leading experts from academia, industry, and regulatory agencies, will present their research findings, share case studies, and engage in thought-provoking discussions. The conference will also feature interactive networking opportunities, fostering collaboration and enabling the exchange of ideas.

 

We are delighted to welcome you to the Pharmacovigilance World 2023, and we are confident that your active participation will contribute to the advancement of drug safety practices. Together, let us strive towards a safer and more vigilant healthcare system that prioritizes patient well-being and ensures the continued benefit of medications worldwide.
 


Conference Streams Include

 

 

Global PV & Methodologies

Data management & Analytics in PV

PV Automation, AI & Machine Learning

Safety Signals & Management

Pharmacovigilance Regulations

Risk
Management

Patient Centric Drug Safety

Case
Management

Quality &
Compliance

Pharmacovigilance Outsourcing

Medical Devices Safety

Adverse Drug Reactions

 

 

KEY DISCUSSIONS WE'LL BE EXPLORING

  • Pharmacovigilance and globalization
  • Pharmacovigilance in a pandemic world
  • Women and child health care medicines and pharmacovigilance
  • Patient-centric approaches in PV
  • Pharmacovigilance legislation and regulations
  • Harmonization and pharmacovigilance
  • Advanced therapeutic techniques and pharmacovigilance
  • Pharmacovigilance and data management and eudravigilance
  • Post-marketing surveillance in pharmacovigilance
  • PV regulations and challenges
  • Benefit-risk management strategies
  • Risk management and minimization
  • Risk Evaluation and Mitigation
  • Adverse drug reactions reporting
  • Signal detection and post authorization safety
  • Good Pharmacovigilance Practices
  • Innovative approaches to drug safety
  • Strategies to improve PV
  • Real World Evidence in PV
  • Big data and AI in pharmacovigilance
  • Pharmacovigilance Workflows with AI & Automation
  • Other emerging technologies in PV

 

 

WHO SHOULD ATTEND PHARMACOVIGILANCE 2023

 

C-level, Presidents, Senior/Global Vice Presidents, Directors, Directors, Heads & Managers, Scientific Advisors, Consultants and professionals who work for pharmaceutical, biotechnology & devices industries, CROs and service providers involved in Pharmacovigilance and Drug safety.

 

  • Pharmacovigilance
  • Safety & Risk management
  • Drug safety
  • PV Compliance
  • Safety Surveillance
  • Medical Affairs
  • Regulatory Affairs
  • Inspection and Audit
  • Pharmacoepidemiology
  • Post-market studies
  • Medical product safety assessment
  • Drug Research & Development
  • Clinical Pharmacology
  • Medical information
  • Contract outsourcing service providers
  • Health outcomes
  • Sales and Marketing

 

 

 

 

pharmaceutical companies

Speakers

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There are plenty of opportunities to position yourself as a thought leader & showcase your company.

For enquiries on speaker opportunities please e-mail to speaker@corvusglobalevents.com

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Wednesday - 1st November 2023

  • 08:50
  • Chairperson’s opening remarks


    Michael Ramcharan

    Michael Ramcharan Managing Director
    Reumat Consulting

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

    Pav Rishiraj

    Pav Rishiraj Director, Head of Pharmacovigilance, ABPI PV Expert Chair
    Ipsen

    Mayssa Aboughannam

    Mayssa Aboughannam Country Safety Team Lead, GCC, Pakistan & Afghanistan
    Johnson & Johnson

    Gauri Utturkar

    Gauri Utturkar Patient Safety Physician
    UCB Pharma

    Michael Ramcharan

    Michael Ramcharan Managing Director
    Reumat Consulting

    Chetan Shatapathy

    Chetan Shatapathy Consultant Medical Advisor, Office of the QPPV (Interim)
    The Janssen Pharmaceutical

  • 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
  • Case Study - Supporting real inspections, and establishing and adhering to corrective action plans to enhance pharmacovigilance practices


    Bertrand Sailly

    Bertrand Sailly Associate Director Safety & LOC Medical QA Lead - GVP/GCP
    Takeda

  • 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

    Nadia Hussain

    Nadia Hussain Pharmacovigilance Manager
    AbbVie

  • 13:25
  • Case Study: Development and implementation of additional risk minimisation measure


    Amit Jadhav

    Amit Jadhav Director Global Patient Safety, CVS and metabolic
    Regeneron

  • 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
  • Ethics & Compliance meets PV - best partners to join forces, especially in Third Party Business


    Christian Muehl

    Christian Muehl Head Ethics & Compliance / Member Global Leadership Team Partner & Emerging Markets
    Alnylam Pharmaceuticals

  • 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 in MENA region


    Mina Awad

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

  • 16:40
  • Auditing and Practical Aspects in PV, Hints & Tips


    Antje Baumgarten

    Antje Baumgarten Senior Global System Auditor
    Bayer Healthcare

  • 17:05
  • Exploring complexities of PV in new therapeutic modalities such as CAR T, bi-specifics, ADCs and combinations


    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


    Michael Ramcharan

    Michael Ramcharan Managing Director
    Reumat Consulting

  • 18:30
  • Networking Drinks Session


Thursday - 2nd November 2023

  • 08:50
  • Chairperson’s opening remarks


    Michael Ramcharan

    Michael Ramcharan Managing Director
    Reumat Consulting

  • 09:00
  • Unlocking Patient Potential in Pharmacovigilance


    Mayssa Aboughannam

    Mayssa Aboughannam Country Safety Team Lead, GCC, Pakistan & Afghanistan
    Johnson & Johnson

  • 09:30
  • Unintentional Adverse Events in Market Research


    Dawn Mucci

    Dawn Mucci Senior Manager, PV Alliance Management
    Jazz Pharmaceuticals

  • 10:00
  • Potential of Generative AI/ChatGPT in Pharmacovigilance


    Jordi Casanellas

    Jordi Casanellas Head of Decision Science for MAPV and R&D
    Bayer

  • 10:30
  • Business Card Exchange with Morning Coffee/Tea & Discussion

     

         

Automation, AI & Data Management

  • 11:00
  • Quality Management Systems in Pharmacovigilance: Best Practices and Compliance


    Lizanne Pistorius

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

  • 11:25
  • A new algorithmic approach to identify immune-mediated adverse events


    Fiorenza Gaudenzi

    Fiorenza Gaudenzi Senior Global Program Safety Lead
    Novartis

  • 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
  • The Future of PV - Paradigm Shifts


    Pav Rishiraj

    Pav Rishiraj Director, Head of Pharmacovigilance, ABPI PV Expert Chair
    Ipsen

  • 13:30
  • Pharmacoepidemiology and Real-World Evidence (RWE) generation

     

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

  • 13:55
  • A new probabilistic algorithm for causality assessment and its use in signal detection


    Fabio De Gregorio

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

  • 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

    Pav Rishiraj

    Pav Rishiraj Director, Head of Pharmacovigilance, ABPI PV Expert Chair
    Ipsen

    Lizanne Pistorius

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

    Michael Ramcharan

    Michael Ramcharan Managing Director
    Reumat Consulting

  • 14:50
  • Artificial Intelligence in Medical Device

     

    Booked for Gavion Technologies

  • 15:15
  • RMP for biosimilars


    Dimitris Zampatis

    Dimitris Zampatis Global Program Safety Lead
    Sandoz

  • 15:40
  • Grab your Tea/Coffee - Visit our Exhibitor Booths & Network with your colleagues

     

         

Case Processing & Patient Centric Approach

  • 16:00
  • AI & Machine Learning for Automated Case Processing in Pharmacovigilance


    Otilia Elena Hurezanu

    Otilia Elena Hurezanu Senior Manager, PV Systems
    AbbVie

  • 16:25
  • The importance of timely and accurate case processing (ICSR)


    Roberto Resende

    Roberto Resende Senior Quality Specialist
    Alexion Pharmaceuticals, Inc

  • 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


    Michael Ramcharan

    Michael Ramcharan Managing Director
    Reumat Consulting

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