Dive deep into the essence of medicinal product information with this comprehensive course. In the realm of pharmaceuticals, clarity and scientific validation are paramount. This course is designed to illuminate the processes, regulatory requirements, and best practices in creating and maintaining top-tier product information for medicinal products. Equip yourself with the tools and knowledge to ensure the safest use by patients and the most informed prescribing by healthcare professionals.
Key Learning Outcomes:
- Acquire a deep understanding of the key terms and principles surrounding product information for medicinal products
- Decode the regulatory requirements for Summary Product Characteristics (SmPC)
- Understand and explain the regulatory mandates for packaging information, focusing on Labelling and the Patient Information Leaflet (PIL). Grasp the foundational elements that must be present on both the outer and immediate package
- Master the regulatory guidelines for developing product information and effectively apply them in real-world scenarios
- Learn the criteria for preparing SmPC for multiple strengths of medicinal products
- Identify the regulatory procedures where product information is updated and understand the associated scope
Course Highlights:
- Engaging modules filled with practical examples
- Insights into the common challenges faced during product information development and strategies to overcome them
- Opportunity to interact and discuss course content with AIDIFY platform users
Embark on this enlightening journey to solidify your role as an expert in the field of medicinal product information. Equip yourself with the knowledge to make informed decisions, ensuring the safety and clarity of product use.
