• 08:50
• 

• Chairperson’s opening remarks

  ---

  

  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 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 Safety Risk Lead, Medical director
  Pfizer

  

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

  

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

  

  Gauri Utturkar Patient Safety Physician
  UCB Pharma

  

  Michael Ramcharan Managing Director
  Reumat Consulting

  

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

• 10:20
• 

• Real World Evidence (RWE) in Pharmacovigilance

  ---

  

  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 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 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 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 Pharmacovigilance Manager
  AbbVie

• 13:25
• 

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

  ---

  

  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 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 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 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 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 EU QPPV, Head of EU QPPV Office
  Novavax

• 16:15
• 

• International harmonization and drug regulatory requirement in MENA region

  ---

  

  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 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 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 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 Managing Director
  Reumat Consulting

• 18:30
• 

• Networking Drinks Session

• 08:50
• 

• Chairperson’s opening remarks

  ---

  

  Michael Ramcharan Managing Director
  Reumat Consulting

• 09:00
• 

• Unlocking Patient Potential in Pharmacovigilance

  ---

  

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

• 09:30
• 

• Unintentional Adverse Events in Market Research

  ---

  

  Dawn Mucci Senior Manager, PV Alliance Management
  Jazz Pharmaceuticals

• 10:00
• 

• Potential of Generative AI/ChatGPT in Pharmacovigilance

  ---

  

  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 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 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 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 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 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 Director, Head of Pharmacovigilance, ABPI PV Expert Chair
  Ipsen

  

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

  

  Michael Ramcharan Managing Director
  Reumat Consulting

• 14:50
• 

• Artificial Intelligence in Medical Device

   

  Booked for Gavion Technologies

• 15:15
• 

• RMP for biosimilars

  ---

  

  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 Senior Manager, PV Systems
  AbbVie

• 16:25
• 

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

  ---

  

  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 Managing Director
  Reumat Consulting