• 08:15
• 

• Registration & Refreshments

  Kick off your conference experience by checking in at our registration desk. Collect your event materials and enjoy a selection of refreshments. It's the perfect time to mingle with fellow attendees and set the tone for an engaging and informative event

• 08:50
• 

• Welcome Address & Chairperson’s opening remarks

  Begin your conference journey with a warm welcome from our esteemed Chairperson

  ---

  

  Sanjeev Srivastav Signal Management Lead
  BioNTech SE

Strengthening Pharmacovigilance Systems and Practices

• 09:00
• 

• Creating and Implementing a Global Signal Management Tool

  • Internal and regulatory challenges in managing Pfizer's extensive safety signals portfolio and the innovative system/process implemented to address them.
  • Workflow for signal collection, validation, and communication of validated/evaluated signals and risks to health authorities, including report generation for inspections and PSUR contributions.
  • Advantages and considerations of developing an in-house Signal Management system
    Presentation

  ---

  

  David Jones Director
  Pfizer

  Safety Signals & Management Regulatory Compliance

• 09:30
• 

• Failure Modes in Pharmacovigilance Systems

  ---

  

  Andrew Cooper Director, Pharmacovigilance Quality Assurance
  GSK

  Risk Management Quality Assurance

• 10:00
• 

• Vigilance of drug-device combinations (DDC)

    Presentation

  ---

  

  Ana Mendonca Sr. Vigilance Process Manager
  Novartis

  Medical Devices Safety Patient Safety

• 10:30
• 

• Business Card Exchange with Morning Coffee/Tea & Discussion

  Network over morning coffee or tea, exchanging business cards or using our app's QR code scanner for easy contact sharing. A prime moment for engaging discussions and new connections

   

       

• 11:00
• 

• Global Pharmacovigilance: 3 tips for a successful language solution program

  ---

  

  Carolina Arias Head of Sales
  Linguamatics

  AI & Automation Adverse Drug Reactions

• 11:30
• 

• Signal detection, challenges and lesson learned in the last 5 years

  • Routine signal detection
  • Qualitative and quantitative analysis
  • Differences in big and small pharma companies
  • Lesson learned from Covid pandemic
  • How will Signal detection evolve?

  ---

  

  Maria Maddalena Lino Senior Safety risk Lead Director
  Pfizer

• 11:55
• 

• Leveraging Expertise at PV Affiliates: Enhancing Decision Making through Cross-Functional Collaboration

    Presentation

  ---

  

  Begum Benli Peker Head of Patient Safety Netherlands & EU Hub
  Bristol Myers Squibb

  Global Pharmacovigilance Collaborative and Partnering Strategies

• 12:20
• 

• Impact of the Harmonisation of PV Regulations in the Post Covid-19 Pandemic Era

  ---

  

  Kinga Faulkner Drug Safety Lead
  Roche

  Global Pharmacovigilance Regulatory Compliance

• 12:45
• 

• Luncheon & Networking - Explore, Engage with Your Peers and Connect at Our Exhibitor Booths

  Enjoy a luncheon while networking with peers and exploring exhibitor booths. This is an ideal time to engage with industry leaders, delve into innovative solutions, and forge valuable connections in a collaborative atmosphere.

   

              

• 13:25
• 

• Elevating Drug Safety: The Crucial Role of Quality Case Processing in Pharmacovigilance

    Presentation

  ---

  

  Laura Arce Mora Senior Country Safety Lead Central America and Caribbean
  Pfizer

  Case Management Quality Assurance

• 13:50
• 

• Pharmacoepidemiology and Real-World Evidence (RWE) Generation

  • How pharmacoepidemiology methodologies contribute to the generation of real-world evidence, including observational studies, data analysis, and the evaluation of drug safety and effectiveness in diverse patient populations
  • The practical applications of real-world evidence in informing regulatory decisions, clinical guidelines, and healthcare policies, and its role in enhancing patient outcomes and reducing healthcare costs
  • The challenges in utilizing real-world evidence, such as data quality, bias, and standardization, and discussing emerging trends and innovations in pharmacoepidemiology and RWE generation for evidence-based healthcare
    Presentation

  ---

  

  David Gillen Chief Medical Officer
  Norgine

  Data management & Analytics Post-Marketing Surveillance

• 14:15
• 

• Panel Discussion - Integrated Drug Safety Surveillance Systems: Fostering Collaboration for Enhanced Pharmacovigilance

  • Assessing the benefits and hurdles in forming a network that includes pharmaceutical companies, healthcare providers, and regulatory bodies for improved drug safety monitoring
  • Discussing strategies for standardizing data collection, reporting, and analysis across various organizations to ensure consistent and reliable pharmacovigilance
  • Investigating how AI, blockchain, and big data are transforming ADR detection and analysis, increasing the efficiency and precision of pharmacovigilance
  • Emphasizing the need for effective communication and collaboration among patients, healthcare providers, and regulatory bodies to establish a trust-based pharmacovigilance system
  • Detailing best practices and essential factors for successful collaborative pharmacovigilance, with a focus on regulatory compliance, data privacy, and cross-sector cooperation

  ---

  

  Sanjeev Srivastav Signal Management Lead
  BioNTech SE

  

  David Gillen Chief Medical Officer
  Norgine

  

  Amit Jadhav Director Global Patient Safety, Gene therapy I General medicine
  Regeneron

  

  Gurpreet Singh Vice President, Managing Director Integrated Safety
  IQVIA

  Data management & Analytics Safety Signals & Management Patient Safety

• 14:45
• 

• Case study: Development and implementation of Additional Risk Minimisation Measures

    Presentation

  ---

  

  Amit Jadhav Director Global Patient Safety, Gene therapy I General medicine
  Regeneron

• 15:10
• 

• Recharge with Tea or Coffee While Networking

  Refresh with a tea or coffee break, using this time to continue networking. It's a perfect opportunity to discuss ideas, share experiences, and connect with fellow attendees in a relaxed setting.

   

       

• 15:30
• 

• Auditing Pharmacovigilance Automation

  AI & Automation PV Audits & Inspections

• 15:55
• 

• Diverse Approaches to Communication in Pharmacovigilance: Examining Risk Management Activities including Risk Minimisation Measures

    Presentation

  ---

  

  Nick Nikberg Senior Patient Safety Specialist
  AstraZeneca

  Risk Management Regulatory Compliance Labeling and Safety Communications

• 16:20
• 

• PV vendor oversight snags

    Presentation

  ---

  

  Marianne Banoub Regional Head, Pharmacovigilance and Quality Assurance
  NewBridge Pharmaceuticals

• 16:45
• 

• Elevating Pharmacovigilance Systems: Achieving Excellence in PV Alliance

    Presentation

  ---

  

  Valentina Mancini Senior Director Pharmacovigilance, QPPV
  Shionogi Europe

  Quality Assurance PV Audits & Inspections

• 17:10
• 

• Case Study on Emerging safety issue management

    Presentation

  ---

  

  Arun Ravindran Benefit Risk Lead
  UCB

  Safety Signals & Management Risk Management

• 17:35
• 

• Chairperson's Closing remarks

  End the conference with the Chairperson's closing remarks, summarizing key insights and leaving attendees with final thoughts to inspire ongoing engagement and action.

  ---

  

  Sanjeev Srivastav Signal Management Lead
  BioNTech SE

• 17:45
• 

• Networking Drinks Session - Unwind with Evening Drinks and Engaging Conversations

  Wrap up the day with evening drinks and lively conversations. A relaxed setting to network, share insights from the day, and enjoy the company of fellow attendees.

• 08:15
• 

• Registration & Refreshments

  Start the second day of the conference by checking in and grabbing a morning refreshment. It’s a great opportunity to re-engage with peers, discuss the previous day’s insights, and prepare for another day of learning and networking.

• 08:50
• 

• Welcome Address & Chairperson’s opening remarks

  Start the second day with insightful remarks from our Chairperson

  ---

  

  Sanjeev Srivastav Signal Management Lead
  BioNTech SE

Global Strategies and Future Directions in Drug Safety

• 09:00
• 

• Improving Drug Safety Through Adverse Event Detection with Natural Language Processing (NLP) and Generative AI

  • The transformative impact of Natural Language Processing (NLP) on the efficiency and accuracy of adverse event detection in pharmacovigilance.
  • How NLP techniques can convert unstructured textual data from sources like medical records, social media, and patient narratives into actionable insights for drug safety monitoring.
  • The challenges, such as data quality and privacy concerns, as well as the opportunities presented by NLP in improving drug safety, including early signal detection and more precise risk assessment.
    Presentation

  ---

  

  Jordi Casanellas Head of Language AI
  Bayer

  AI & Automation Adverse Drug Reactions

• 09:30
• 

• Audits and inspections in GVP: Evolving landscape

    Presentation

  ---

  

  Tea Babic Director, Global Head of PV Audits and Inspections; Deputy Head PV Compliance
  Teva Pharmaceuticals

• 10:00
• 

• How to prepare non-PV teams for a PV inspection

    Presentation

  ---

  

  Zina Sadeq Director, Regional PV & Alliance Management
  Amicus Therapeutics

• 10:30
• 

• How to approach Innovation with GenAI in Patient Safety

    Presentation

  ---

  

  Suzanne Foncin Head of Safety Analysis and Writing
  UCB

• 11:00
• 

• Business Card Exchange with Morning Coffee/Tea & Discussion

  Network over morning coffee or tea, exchanging business cards or using our app's QR code scanner for easy contact sharing. A prime moment for engaging discussions and new connections.

   

       

• 11:25
• 

• Mandatory Hospital ADR Reporting Under Protecting Canadians from Unsafe Drugs Act (Vanessa's Law): A New Era for Canadian Pharmacovigilance

  The transformative impact of the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) on Canadian pharmacovigilance. Attendees will gain a comprehensive understanding of:

  • Enhanced Accountability and Transparency
  • Historical Context and Current Implementation
  • Challenges and Opportunities for Compliance
  • Future Implications for Drug Safety

  ---

  

  Manar Hammood Founder & Director of PV Operations
  Zenith PV

  Global Pharmacovigilance Regulatory Compliance

• 11:45
• 

• The Intersection of Digital Health and Pharmacovigilance for Enhanced Drug Safety

    Presentation

  ---

  

  Daniela Bernardini Country Patient Safety Head
  Novartis Farma

  Patient Safety Digital Health Technologies

• 12:15
• 

• From Inspector to Industry: Ensuring PV Process Excellence through Collaboration

  • Introducing PV excellence to through effective change management and collaboration
  • Skills and pointers to successfully introduce and navigate process changes in any part of the PV system
  • How organisations can keep pace with changing PV landscape and technologies
    Presentation

  ---

  

  Anna Adams Senior Director, Business Excellence & Project Management
  Daiichi Sankyo

  Risk Management Regulatory Compliance

• 12:45
• 

• Elevating Pharmacovigilance Systems: Achieving Excellence in Audit and Inspection Readiness

  Quality Assurance PV Audits & Inspections

• 13:00
• 

• Luncheon & Networking - Explore, Engage with Your Peers and Connect at Our Exhibitor Booths

  Enjoy a luncheon while networking with peers and exploring exhibitor booths. This is an ideal time to engage with industry leaders, delve into innovative solutions, and forge valuable connections in a collaborative atmosphere.

   

              

• 13:30
• 

• Importance of strategy in risk management during drug development

    Presentation

  ---

  

  Mohamed Abdillahi Director, Risk Management Product Lead
  Pfizer

• 14:00
• 

• Re-designing of Pharmacovigilance system to augment patient safety

    Presentation

  ---

  

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

  Quality Assurance Patient Safety

• 14:30
• 

• What to expect in the future?

  • Sales, information and knowledge of consumers
  • Awareness, generic names, reduction of medication errors in private clinics
  • Industrial association
    Presentation

  ---

  

  Teresa Saragoca Technical Manager & Regulatory Affairs Director
  Italfarmaco

  Global Pharmacovigilance Regulatory Compliance

• 15:00
• 

• Navigating the digital fog: A case for intelligent automation in drug safety

  ---

  

  Sanjeev Srivastav Signal Management Lead
  BioNTech SE

  AI & Automation Patient Centric Drug Safety

• 15:30
• 

• Recharge with Tea or Coffee While Networking

  Refresh with a tea or coffee break, using this time to continue networking. It's a perfect opportunity to discuss ideas, share experiences, and connect with fellow attendees in a relaxed setting.

   

       

• 15:50
• 

• Panel Discussion – Unleashing the Potential: Digital Transformation in Pharmacovigilance – Opportunities, Challenges and Future Directions

  • How artificial intelligence and machine learning are reshaping pharmacovigilance by enhancing signal detection, automating adverse event processing, and predicting potential risks.
  • The utilization of real-world data from sources such as electronic health records, social media, and wearables for more comprehensive and timely adverse event monitoring.
  • The role of digital technologies in improving patient engagement and reporting of adverse events, and the impact of patient-generated data on pharmacovigilance efforts.
  • Addressing the challenges related to data privacy, security, and compliance with evolving regulations in the context of digital transformation in pharmacovigilance.
  • The emerging trends, opportunities, and best practices in the ongoing digital transformation journey within the field of pharmacovigilance.

  ---

  

  Sanjeev Srivastav Signal Management Lead
  BioNTech SE

  

  Teresa Saragoca Technical Manager & Regulatory Affairs Director
  Italfarmaco

  

  Jordi Casanellas Head of Language AI
  Bayer

  

  Anna Adams Senior Director, Business Excellence & Project Management
  Daiichi Sankyo

  Data management & Analytics AI & Automation

• 16:30
• 

• Can Pharmacovigilance be the ‘Ground Truth’ for an AI Data Centric approach in Clinical Research?

  • Model Centric vs Data Centric in AI development
  • ‘Ground Truth’ and HLP
  • ClinOps X DM x PV x Medical: are we ‘seeing’ the same patient’s data?
    Presentation

  ---

  

  Aldir Medeiros Filho Clinical Data Scientist
  Independent

• 17:00
• 

• Unveiling the good, the bad and the data-ful (GVP inspections)

  ---

  

  Erika Barbarosie Associate Director PV Compliance
  Gilead Sciences

• 17:30
• 

• High-Impact Collaborations in Pharmacovigilance: Strategies for Value-Based Partnerships

  Data management & Analytics AI & Automation Patient Safety

• 18:00
• 

• Chairperson’s Closing Remarks

  End the conference with the Chairperson's closing remarks, summarizing key insights and leaving attendees with final thoughts to inspire ongoing engagement and action.

  ---

  

  Sanjeev Srivastav Signal Management Lead
  BioNTech SE