About course
Are you aware that 1 in 10 medicines in certain regions might be falsified? Frightening, right? Dive into the world of pharmaceutical authenticity with AIDIFY’s new course. We’ll take you back to 2019 when the industry got a big shake-up, and you’ll find out how the EU’s stepping up its game to stop these fakes in their tracks. Learn the who, what, why, and how behind safe and genuine medicines. Let’s make the world safer, one pill at a time!
Key Learning Outcomes:
- Dive into what makes a medicine “falsified” and the nitty-gritty of the Falsified Medicines Directive (FMD)
- Unpack the big goal of “serialization” (it’s like giving each medicine its own unique ID!)
- Get to know Anti-Tampering Devices (think of them like seals on a soda bottle) and the role of the Unique Identifier (the special ID for medicines)
- Become a pro in showcasing these safety features on medicine packaging – it’s all about trust!
Course Highlights:
- Real-world Scenarios: See what happens when things go wrong and how to prevent it
- Interactive Quizzes: Test what you’ve learned and challenge yourself
- Opportunity to interact and discuss course content with AIDIFY platform users
Wanna be a hero in the fight against fake meds? Jump into AIDIFY’s course now and help make the world a safer place, one medicine at a time. Click enroll and enjoy the course!
Competences covered by this course
- Falsified medicines – safety features
By attending this course, you will learn
- Definition, key aspects of falsified medicinal products together with main pillars of FMD
- Key principles and aim of serialization, legislation and guidance about safety features
- Anti-Tampering Device examples and role of Unique Identifier
- How to implement safety features and present them on packaging
- Roles and responsibilities of key stakeholders together with EMVO and NMVO
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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