About course
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.
Competences covered by this course
- Fee system and calculating fees
By attending this course, you will learn
- How EMA fee system looks like and list possible incentive
- Calculating fees for various procedures in EMA
- How fee system in Poland looks like
- Calculating fees for various procedures in Poland
Few words from Course SME
Work experience:
- Regulatory Associate Manager in the multinational pharmaceutical company with over 6 years of experience in the industry.
- Managing early development oncology programs (registrational planning and strategy building, leading preparations for EMA scientific advice, ODD, EU PIP etc.).
- Pre-registrational stage: management of clinical trial documentation (substantial, non-substantial amendments of IB/Clinical Protocol/IMPD); managing Response to Questions from Health Authorities; leading preparations for transitions and new applications under EU CTR).
- Post-authorisation stage: performing and being responsible for wide array of procedures for medicinal products registered in the EU (via CP/MRP/DCP procedures) and nationally registered products in Poland, such as: MAAs, renewals, variations, referrals, notifications, gap analysis, withdrawals of medicinal products, leading Response to Questions from Health Authorities, resolving validation enquires; global project management of variations and MAH transfer.
- Providing regulatory recommendations on marketing and promotional materials.
- Maintaining effective and professional communication with Health Authorities and other relevant stakeholders.
- Speaker in multiple conferences for healthcare professionals and pharmacy students in both national and international level; delivering trainings and participant of multiple healthcare conferences, soft and hard skills trainings / workshops.
Education:
- Pharmacy, MPharm at Jagiellonian University Medical College in Cracow, Poland (2017)
- Interdisciplinary Studies in Pharmaceutical Management at Business School, Warsaw University of Technology, Poland (2019)
Achievements:
- Laureate of leadership programme of American Chamber of Commerce “30 Under 30”, 7th edition, 2021- 2022.
- Laureate of programme „Leaders of healthcare sector” of Leslaw A. Paga Fundation, Warsaw, Poland. The main aim of that educational project is to qualify and train the best and open for changes management staff in healthcare sector.
- Soft skills trainer with growing mindset who is so enthusiastic in self-development, effective communication and public speaking improving skills.
- Polish Pharmaceutical Students’ Association (PPSA) – association initiator and the first national president in 2016; EPSA Alumna since 2017.
- Toastmasters- non-profit organization that teaches public speaking and leadership skills – these both encourage me to be AIDIFY SME
Certificates HARD:
- Pharmacoeconomics, Business School, Warsaw University of Technology
- Clinical Trials and drug development, Business School, Warsaw University of Technology
- Selling and marketing of medicinal products, Business School, Warsaw University of Technology
- GMP, Business School, Warsaw University of Technology
- Regulatory Specialist – workshop
- Medical Devices in light of new regulation
- Variation documentation preparation – workshop
- Variations and renewals
- Product information for medicinal products, 2018
Certificates SOFT:
- Thinking Environment Course, 2022
- LEAN Practitioner, 2021
- Project Management Fundamentals, 2021
- Virtual Presentation Skills, 2021
- Toastmaster “Competent Communicator”, 2020
- Trainers Development Camp, 2016
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