Pharmacovigilance & Drug Safety
Ensuring the safety of medicines post-launch is a key responsibility for regulatory agencies and pharmaceutical companies. This session covers the principles of pharmacovigilance (PV), including signal detection, risk assessment, and adverse event reporting. Attendees will learn about PV systems required by ICH E2E, FDA, and EMA guidelines. Sessions will include hands-on case studies of how safety signals are detected and investigated using spontaneous reporting systems and real-world data. With the rise of social media and digital health data, the session will also explore how modern tools are augmenting PV, enabling earlier detection of safety issues. The use of AI in PV databases and automated narrative analysis will be highlighted.
Global PV harmonization challenges will be discussed, especially when dealing with multiple territories, local reporting obligations, and multilingual case processing. The role of Qualified Persons for Pharmacovigilance (QPPV) will be emphasized. This track is essential for professionals responsible for post-marketing surveillance, providing strategies to optimize safety systems and improve patient trust.
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- The Future of Pharma R&D - Future Pharma 2025 (Netherlands)
- The Role of CROs in Clinical Trial Execution - Clinical Trials-2026 (UK)
- Toxicological Impacts of Air and Water Pollution - Euro Pharmacology 2025 (France)
- Toxicology and Safety Pharmacology - Pharmacology-2025 (Spain)
- Toxicology: Mechanisms and Risk Assessment - Euro Pharmacology 2025 (France)
- Transdermal and Intradermal Delivery Systems - Drug Delivery-2025 (Netherlands)
- Translational Research - Personalizedmedicine-2025 (Switzerland)
- Trending: Digital Health and Telemedicine for Rare Care - ORPHAN DRUGS 2025 (France)
- Types of Formulations - Formulations 2025 (France)
- Vaccine Delivery Technologies - Drug Delivery-2025 (Netherlands)
- Vaccine Development Against Bacterial Pathogens - Euro Antibiotics 2025 (Netherlands)
- Vaccine Drug Delivery Systems - PHARMACEUTICA 2025 (Germany)
- Vaccines & Immunotherapy - Pharma Expo-2026 (Thailand)
- Veterinary Pharmacology - Pharmacology-2025 (Spain)
- Women in Rare Disease Leadership and Science - ORPHAN DRUGS 2025 (France)