Live Training: AI Implementation according to GVP (basic principles)

Product detailed description

The integration of AI solutions in pharmacovigilance is not just about technological innovation—it is a complex interplay of IT systems, simulated human decision-making, and operational feasibility. AI in drug safety must be carefully designed to support, rather than replace, human expertise while ensuring compliance with regulatory frameworks like the AI Act and Good Pharmacovigilance Practices (GVP). 

One of the most critical aspects of AI implementation in pharmacovigilance is the accuracy and reliability of both input and output data. Any inconsistency in data collection, processing, or interpretation can lead to misclassification of drug safety information, regulatory non-compliance, or compromised patient safety. Understanding how AI algorithms function within PV processes, ensuring transparency, and maintaining robust oversight are essential for its responsible use. 

This introductory training will provide basic knowledge on the key challenges, regulatory requirements, and best practices for AI implementation in pharmacovigilance. Participants will gain insight into the basic principles of AI-driven automation, the role of data quality and integrity, and the compliance landscape under the AI Act and GVP regulations. 

Key topics: 

1. Key regulatory requirements for AI use in drug safety under the AI Act and GVP 
2. Complexity of AI implementation 
3. Steps to implement AI in pharmacovigilance while ensuring compliance and efficiency 

Structure of the Training:  

• 1 hour of training 
• 1 hour of deep discussion on pre-defined case studies or your open discussion issues 
• Training is for up to 6 participants. The training is limited to a maximum of 6 participants.Additional sessions will be scheduled if needed.

Live Trainings are interactive online meetings where we provide valuable insights into key pharmacovigilance topics while ensuring a practical and engaging learning experience. Our goal is not just to present information but to create a dynamic space for knowledge sharing, where participants can gain a clear understanding of regulatory requirements, best practices, and real-world applications. Each session is designed to be concise, well-structured, and packed with actionable content to help attendees navigate complex industry challenge. 

Speaker: 

Richard Kodat: Pharmacovigilance auditor and strategic advisor for vendor management with more than 10 years of experience.