9th Annual
Global
Pharmacovigilance
Summit
To be announced soon!
(Time Zone: CEST)
Join us In-Person or Online
2 DAYS CONFERENCE
The Event!
We are very excited to welcoming you at our upcoming 9th Annual Global Pharmacovigilance Summit that will be held in the beautiful city of Amsterdam this coming September 2024.
The summit is designed for professionals from pharma industry to keep up to date with new trends, requirements and regulations when it comes to Drug Safety and Risk Management in 2024.
Participants can explore a broad range of current and future trends via the round table discussion and interactive panel discussion, case studies etc. Offering you a strategic platform which has been crafted to enable a great opportunity for information exchange and networking with top leaders and experts from all pharma industry across the globe.
We will be looking forward to meeting you at our event!
Key Topics
– Applying data analytics in pharmacovigilance processes to increase the speed of signal detection
– Procedure and RMP governance: challenges and solutions for the PV sector
– Behind the curtains of inspections: recent advances in GVP inspections
– The future of the PV industry in the next 10 years
– Most recent regulatory changes and improving compliance
Some Of Our Keynote Speakers
“get inspired from the world’s leading experts”
Petros Mavrogenis
Head Pharmacovigilance Process Excellence
DOES REPEATED FOLLOW-UP PRODUCE BETTER QUALITY SAFETY DATA? EFFORT VS REWARD
An analysis of follow-up attempts for adverse event reports was conducted to describe the characteristics of a risk-based follow-up for Individual Case Safety Reports (ICSR).
Dimitris Zampatis
Global Program Safety Lead
POST TRIAL ACCESS AND PATIENT SAFETY
– Current regulations on PTA
– Implementation challenges
– Safety requirements -signal, risk management and benefit risk assessment with PTAs
Luvanka Hanxhari
Global RMP Lead & Deputy of Head RMP Office
DIGITAL SOLUTIONS ON THE DISTRIBUTION OF RMP EDUCATIONAL MATERIALS, GLOBAL AND LOCAL PERSPECTIVES
– Internal tools for distribution of RMP EMs
– External tools for distribution of RMP EMs
– Challenges and Opportunities using digital tools for RMP EMs
Dr. Vipin Sethi
AVP / Global Head Pharmacovigilance
PATIENT CENTRICITY AND BENEFIT-RISK EVALUATION
– Understanding the impact of risks on patients and tolerability
– Assessing patients’ preferences and trade-offs for BR Identification of patient needs and relevant endpoints for patients
– Benefit risk evaluations
Khaudeja Bano
Vice President Combination Product, Devices, Diagnostics and Software as a Medical Device Quality
IS YOUR PV ORGANIZATION FUTURE READY?
– Discuss the evolution of the regulatory framework globally
– Key challenges and best practices
– How to be best prepared for the future
Who Should Attend?
Members of board, C-level, Senior Vice Presidents, Vice Presidents, Directors, QPPVs, and Heads of departments from pharmaceutical industry / industries involved in:
- Pharmacovigilance
- Drug Safety
- Safety & Risk Management
- Signal Detection
- Benefit-Risk Assessment
- Safety Evaluation
- Regulatory Affairs,
- Safety Surveillance
- QPPV
- Pharmacovigilance Operations
- PV Inspection and Audit Readiness
- Patient Support Programs
- Market Research Programs
- Clinical Safety
- Medical Safety
- Medical Information
- Pharmacoepidemiology
- PV Governance
Companies You Will Meet
sponsors & exhibitors are welcome
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Share 3 of your Main Challenges
Sponsorship opportunities
If you are looking to build awareness of your brand in the pharma industry, it doesn’t get bigger than the “9th Annual Global Pharmacovigilance Summit” that will be held in the beautiful city of Amsterdam this coming September.
Marxo Smith Events sponsorship opportunities provide your organisation with substantial international exposure, increasing visibility of your brand and your networking capacity. We have a sponsorship package suitable for you, no matter how big or small your budget..
Download the program to see how you can get involved.
PREVIOUS EVENT SPONSORS
PV Excel
PV Excel is a premier artificial intelligence consulting company dedicated to advancing drug safety and pharmacovigilance. With specialized expertise in the implementation of the Oracle Argus Safety applications suite, data migration, E2B compliance, Argus customizations, and comprehensive consulting services, PV Excel is at the forefront of technological innovation in the pharmaceutical industry. At PV Excel, our commitment to excellence drives us to continually innovate and enhance drug safety and pharmacovigilance processes. Our AI-powered solutions and expert services empower pharma companies to achieve superior safety outcomes, regulatory compliance, and operational efficiency, ensuring the highest standards of patient safety.
Our Expertise:
- AI Solutions:
- Document Parsing and Case Intake: Advanced AI tools for parsing structured and unstructured source documents, creating and transmitting E2B files for safety system ingestion.
- Literature Search: AI solution to parse and index literature articles and sources to be utilized for literature search using Natural Language Processing to provide actionable insights.
- Case Assessment: Utilizing AI to provide comprehensive and accurate case assessments by processing and comparing similar case assessments done previously and, in the processes gaining knowledge to make better assessments over time.
- Case Follow-Up Narratives: Using AI to read through the available fields and narrative text to create a delta follow-up narrative that blends seamlessly with existing last case version narrative to produce a final version that can be reviewed and accepted with the click of a button.
- Duplicate Search with SAMDD: Implementing the Statistical Adaptive Model for Duplicate Detection (SAMDD) to efficiently identify duplicate cases.
- Auto Translation: Employing AI or customer preferred translation services for seamless and accurate translations.
- Adverse Event Capture from social media: Leveraging AI to monitor and capture adverse events from social media feeds.
- Other Products and Services:
- Oracle Argus Safety Implementation: Expert deployment of Oracle Argus Safety applications to ensure robust and compliant drug safety operations.
- Data Migration: Seamless and precise data migration services to facilitate efficient system transitions.
- E2B Compliance: Ensuring the electronic exchange of Individual Case Safety Reports (ICSRs) in full compliance with global and regional E2B standards.
- Argus Customizations: Tailored customizations to optimize the Argus Safety system according to specific client requirements.
- Reporting, Monitoring, and Quality Check (RMQC): Strategies for optimizing reporting processes and ensuring quality in pharmacovigilance activities.
- Signaling: Implement industry standard signaling algorithm and signal workflow management to detect, assess and process potential safety concerns.
Welocalize
Welocalize is driving the future of global communication. For over 25 years, Welocalize has helped some of the largest organizations in the world improve customer engagement through the power of localized content. Better engagement is proven to drive business outcomes:
- Higher Marketing Conversion Rates
- Ensure Regulatory Compliance
- Increased Customer Satisfaction & Retention
- Safeguard Intellectual Property
- Higher Adoption Rates
- Improved Data with Improved Models
Continuing a Heritage of Innovation
Since our founding in 1997, we have been at the forefront of applying advanced technology to deliver the highest quality translations quickly, efficiently and at scale. Through constant investment in these technologies and our early adoption of AI, Welocalize has earned a reputation for delivering innovative solutions.
Beyond data and AI technologies, we have also invested in quality standards certifications. Welocalize has been ISO 9001 certified for 14 years. We became one of the first translation service providers to successfully implement a new ISO virtual-site certification model, which certifies cloud-based quality processes and systems instead of locations.
Our reputation for mastering some of the most complex data science issues related to AI has made us a partner for companies developing large language models. Teams at global companies who are building AI tools and applications turn to Welocalize for data services, advice, and expertise for a variety AI-enabled use cases.