Karsten Lollike
Novo Nordisk
Corporate Vice President & QPPV Global Safety
Risk Associated with Counterfeit Medicines: Rising incidents of counterfeit drugs affecting patient safety
- Recognizing the technological barriers faced by smaller pharma and regulatory agencies in adopting advanced detection and monitoring systems
- Combating the rise of online pharmacies that operate without regulatory oversight, making it easier for counterfeit drugs to reach patients
- Enhancing patient awareness and education to empower individuals to recognize legitimate medications and understand the risks associated with counterfeit products
- Addressing the lack of global standards for drug manufacturing and distribution across EU
Dr. Mohammed Ali Kotal
Sandoz
Global Head Medical Safety and Site Head
Pharmacofuturovigilance: Shaping the Future of Drug Safety
- Leveraging AI, machine learning, and predictive analytics to anticipate and manage safety signals
- Using data from electronic health records, wearables, and social media to enhance post-marketing surveillance
- Adapting drug safety practices to align with precision medicine and individual patient profiles
- Strengthening international networks to address emerging safety challenges and pandemics
Yvonne Nanciu
Bayer
PV Country Head Germany and Deputy EU QPPV
Enhancing Collaboration and Communication in Pharmacovigilance: Breaking Down Barriers
- Identifying common communication barriers within pharmacovigilance (Jargon, lack of standardization, cultural differences etc)
- Developing Inter-Organizational Collaboration Models and transparency between departments
- Strategies for establishing trust between various stakeholders
Maria Maddalena Lino
Pfizer
Safety risk Lead Director
Advancing Post-Marketing Signal Detection and Management: Lessons and Innovations
- Shifts in methodologies over recent years and their impact on pharmacovigilance practices
- Exploring PASS, RCA, social media monitoring, and literature reviews for effective signal detection
- Insights gained from H1N1 and COVID-19 in adapting pharmacovigilance to unprecedented challenges
- How observed vs. expected analyses and innovative approaches enhanced signal evaluation
Sanjeev Shrivastav
BionTech
Signal Management Lead
Intelligent Analytics: An Integrated Approach to Signal Management
- The need for a centralized platform to streamline signal detection, evaluation, and tracking
- Utilizing interactive and actionable visual tools to enhance decision-making in pharmacovigilance
- Key components for designing a cohesive system: data integration, AI-driven insights, and user-centric design
Dr. Balaji Malla
Dr. Reddy Labs
Head of Pharmacovigilance, QPPV- EU & UK
Implementing Agile Risk Management Models (ARMMs) in Generic Pharma
- Leveraging agile tools and techniques to proactively address risks across the drug lifecycle
- Integrating ARMMs to ensure compliance, reduce deviations, and improve operational efficiency
- Encouraging seamless communication between R&D, QA, QC, and regulatory teams
- Using real-time analytics and iterative reviews to refine risk strategies and drive improvements
Over 1 million adverse drug reactions are reported each year in Europe alone, highlighting the urgent need for vigilant pharmacovigilance practices. In today’s complex landscape, pharmacovigilance has become more essential than ever, with challenges like adverse reactions, unpredictable drug interactions, and gaps in cross-border regulations creating significant risks for patient safety. Join us at Pronovea’s 4th edition of Drug Safety and Risk Management Summit as we explore transformative trends, embrace real-world evidence, navigate the latest updates in pharmacovigilance and expanding its scope to address the emerging issues in pharmacovigilance today, offering new perspectives and actionable strategies that reflect the latest industry trends and challenges.