Ever felt perplexed by the intricate fee structures governing regulatory procedures in the world of pharmaceuticals? This course serves as a comprehensive guide, illuminating the complex fee systems of both the EMA and Poland’s national-specific requirements. From understanding basic calculation rules to mastering fee structuring in diverse procedure scenarios, this course is tailored for regulatory specialists seeking precision and clarity.
Key Learning Outcomes:
- Gain a comprehensive understanding of the EMA fee system and the various incentives it offers
- Master the art of fee calculation for several EMA regulatory procedures for medicinal products, such as MAA, single and grouping variations, renewals, and more
- Dive deep into Poland’s specific fee system for medicinal products, tailored for specialists working with products marketed in Poland
- Accurately group and calculate fees for a spectrum of regulatory procedures in Poland, spanning from MAA to MA transfers
Course Highlights:
- Practical exercises and scenarios to apply your learning in real-time
- Insights into common challenges and misconceptions about fee calculations and strategies to address them
- Opportunity to interact and discuss course content with AIDIFY platform users
Step into a realm of clarity and precision with this course, ensuring your proficiency in navigating and calculating fees in both the EMA and Poland’s regulatory landscapes. Equip yourself with this indispensable skill set and stand out in your professional sphere.
