About course
Unpack the secrets of medical packaging with AIDIFY’s crash course on mock-ups! Ever wonder why medicine packages look the way they do? It’s not just about looks – it’s about safety, quality, and super important info for both patients and health pros. With this super simple and fun course, we’ll pull back the curtain on all things mock-up. From the colors, fonts, and symbols to those tiny little Braille dots – we’ll show you what’s what and why it matters big time!
Key Learning Outcomes:
- Get the low-down on the laws and need-to-know terms for making mock-ups for medicine packs
- Master the EMA’s checklist on how to jazz up your package leaflets and boxes, even if you’re dealing with multiple languages or Braille
- Know the ins and outs of the perfect font size, design, layout, and color for every kind of packaging
- Nail the dos and don’ts of symbols, pictograms, and even QR codes with real-world examples
- Discover the special rules for those teeny tiny medicine packs
- Avoid facepalms by learning common mistakes and tricks to get your mock-up game on point
Course Highlights:
- Learn from real-world examples: See the good, the bad, and the “what were they thinking?!”
- Engage in interactive sessions: Get all your burning questions answered on the AIDIFY platform
- Opportunity to interact and discuss course content with AIDIFY platform users
Ready to become a mock-up master? Join the coolest course on AIDIFY and make your mark in the world of medicine packaging. No more waiting – click enroll and dive in!
Competences covered by this course
- Mock-ups for package leaflet and packaging for medicinal products
By attending this course, you will learn
- Legal basis and key terms on mock-ups preparations for package leaflet and packaging
- Main rules and and EMA review process of mock-ups for package leaflet and packaging including multilingual packs and using Braille
- Key requirements on type size and font, design, layout of the information and print colour on outer packaging, immediate packaging and package leaflet
- Rules of including symbols and pictograms, including QR code, together with acceptable and non-acceptable examples
- Rules for mock-ups for small packs
- The most frequent errors over mock-ups preparation and recommendations how to optimize the mock-up preparations
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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