Live Training: AI Implementation according to GVP (role of QPPV)

Product detailed description

Artificial Intelligence (AI) is transforming pharmacovigilance, bringing automation, efficiency, and advanced data processing capabilities. However, its implementation has to comply with Good Pharmacovigilance Practices (GVP) while maintaining transparency, accountability, and regulatory adherence. Qualified Persons for Pharmacovigilance (QPPVs) play a crucial role in ensuring that AI-driven processes meet compliance standards, mitigate risks, and support informed decision-making in drug safety. 

Key topics: 

1. The role of the QPPV in AI-driven pharmacovigilance: The QPPV ensures AI implementation aligns with GVP and maintains patient safety. Oversight is crucial to verify AI-generated decisions are traceable and scientifically sound. 
2. Regulatory expectations under GVP and the AI Act: Regulators demand transparency, data integrity, and accountability in AI-driven pharmacovigilance. The AI Act adds requirements for risk classification, human oversight, and auditability within GVP. 
3. Vendor management in AI: AI implementation often involves external vendors, making compliance, data security, and system validation. The QPPV must ensure that AI solutions from vendors meet GVP, AI Act, and regulatory requirements, with clear contractual agreements on data integrity, transparency, and risk management. 

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.