About course
Jump right into the fascinating world of excipients with AIDIFY! Ever wondered what makes our medicines safe, effective, and top-quality? It’s excipients – those essential ingredients that play a massive role behind the scenes in drug development. Health experts around the world understand their importance. And now, through this easy-to-understand course, so can you! Discover the golden rules, the big “do’s and don’ts”, and everything else you need to know about excipients and their place in our medicines.
Key Learning Outcomes:
- Become a pro in the important rules and guidelines about excipients and how to show them on Product Labels
- Dive into simple definitions, key ideas, real-world examples, and basic principles, including a special look at excipients for kids
- Learn the easy steps to gather info about excipients and how to show them clearly in SmPC, PIL, and other labels
- Become a champ in using the European Commission’s recommendations on excipients and really get how it’s structured
Course Highlights:
- Fun and engaging lessons crafted by real experts
- Real-life examples to make complex ideas super simple
- Opportunity to interact and discuss course content with AIDIFY platform users
Ready to dive into the world of excipients and stand out in the crowd? This is your golden ticket. Join the AIDIFY family and boost your knowledge. Click enroll and let’s get started!
Competences covered by this course
By attending this course, you will learn
- Get solid understanding of key regulations and guidance in context of excipients and adding information about excipients into Product Information
- About the definition, key terms, examples, and principles including risk assessment of excipients and excipients for peadiatric population
- Demonstrate the main rules how to collect information about excipients in SmPC, PIL and labelling accordingly and its implementation and recommended nomenclature
- How to efficiently use recommendations on excipients from Annex I to the European Commission guideline on ‘Notice to Applicants. Volume 2C. Guidelines Medicinal products for human use Safety, environment and information. Excipients in the labelling and package leaflet of medicinal products for human use‘ and get knowledge about its structure
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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