Dive into the intricate world of Product Information (PI) updates with our specialized AIDIFY course. In the regulatory sphere, managing Product Information is not just a procedural necessity, but a vital commitment to patient safety. This meticulously designed course sheds light on the diverse procedures for updating PI, taking into account various contexts like generic medicinal products, CCDS-based updates, referral outcomes, and PRAC recommendations. With real-world examples, learn the art of seamlessly integrating new safety or efficacy details into medicinal products, balancing both compliance and patient well-being.
Key Learning Outcomes:
- Understand the foundational principles of PI updating, while pinpointing common errors and hurdles encountered in the process
- Illustrate the protocol for PI updates concerning a generic medicinal product, considering its reference medicinal product
- Detail the mechanism for PI amendments using the CCDS as a reference
- Elucidate the process for updating PI based on both referral outcomes and PRAC recommendations
- Offer a comprehensive view of crafting national translations for PI updates, ensuring global comprehensibility and alignment
Course Highlights:
- Acquire an edge in the regulatory department by mastering one of its most essential functions
- Learn from real-world examples, bridging theory and practical application
- Equip yourself with knowledge that emphasizes both procedural compliance and the utmost patient safety
- Engage in interactive discussions and benefit from a community of learners on the AIDIFY platform
Position yourself as a PI expert, proficient in both its nuances and its larger impact on medicinal products’ regulatory landscape. Join us in this enriching learning journey, merging best practices, patient safety, and compliance into a harmonious expertise.
