Live Training: AI Implementation according to GVP (challenges in integrating AI into GVP)

Product detailed description

Artificial Intelligence is transforming pharmacovigilance (PV) by enhancing efficiency, data processing, and decision-making. However, its implementation has to align with Good Pharmacovigilance Practices (GVP) to ensure regulatory compliance, data integrity, and patient safety. This live training provides a comprehensive and practical guide to integrating AI into pharmacovigilance processes while addressing the key challenges and regulatory expectations. 

Key topics: 

1. Lack of Transparency and Explainability: Many AI models, particularly machine learning (ML) algorithms, function as “black boxes,” making it difficult to justify safety decisions. 
2. Data Integrity and Bias in AI Models: AI models rely on large datasets, but poor data quality, biases, or incorrect training data can lead to misinterpretations and compliance risks. If AI algorithms learn from incomplete or biased data, they may produce inaccurate safety signals or overlook critical risks. 
3. Integration Challenges and Workforce Adaptation: AI implementation in PV often disrupts existing workflows. Resistance to change, lack of AI expertise, and integration issues can hinder the successful adoption of AI-driven solutions. 

Structure of the Training:  

• 1 hour of training 
• 1 hour of deep discussion on pre-defined case studies or your open discussion issues 
• 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.