About course
Welcome to this comprehensive course on the nuances of naming medicinal products. The pharmaceutical world is laden with challenges, and one of the crucial elements ensuring both patient safety and regulatory compliance is the accurate and clear naming of medicinal products. This course delves deep into this subject, equipping you with the knowledge and skills to navigate this complex terrain.
Key Learning Outcomes:
- Grasp the foundational principles behind medicinal product naming, ensuring clarity and preventing potential naming errors
- Dive deep into the rules for invented names, focusing on their safety implications
- Understand the importance and guidelines of international non-proprietary names (INNs)
- Explore the intricacies of naming for Over-The-Counter (OTC) medicinal products
- Master the technical registration procedures (CP/MRP/DCP) and their variations
- Familiarize yourself with umbrella branding in the EU, its regulations, acceptable abbreviations, qualifiers, and designators
Course Highlights:
- Real-world examples for better understanding and application
- Insights into common pitfalls and strategies to avoid them
- Opportunity to interact and discuss course content with AIDIFY platform users
Join us on this enlightening journey and equip yourself with an indispensable skill set in the pharmaceutical domain!
Competences covered by this course
- Naming of medicinal products
By attending this course, you will learn
- Demonstrate knowledge and understanding about key concepts of naming of medicinal products
- How to summarize general rules of naming of medicinal products, vaccines and provide error examples
- Deeply analyze the rules for invented name in terms of safety
- Discuss international non-proprietary names (INNs)
- Explain rules of assigning invented names for medicinal products who are available without prescription
- Explain verification process of acceptability of names for medicinal products
- Explain technical aspects of naming of medicinal products in terms of registration procedures (CP/MRP/DCP) and variations
- Define umbrella branding in EU and list countries which accept umbrella branding; summarize rules for umbrella branding together with examples; analyze verification process and list examples of commonly acceptable abbreviations / qualifiers / designators
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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