About course
Dive deep into the essence of medicinal product information with this comprehensive course. In the realm of pharmaceuticals, clarity and scientific validation are paramount. This course is designed to illuminate the processes, regulatory requirements, and best practices in creating and maintaining top-tier product information for medicinal products. Equip yourself with the tools and knowledge to ensure the safest use by patients and the most informed prescribing by healthcare professionals.
Key Learning Outcomes:
- Acquire a deep understanding of the key terms and principles surrounding product information for medicinal products
- Decode the regulatory requirements for Summary Product Characteristics (SmPC)
- Understand and explain the regulatory mandates for packaging information, focusing on Labelling and the Patient Information Leaflet (PIL). Grasp the foundational elements that must be present on both the outer and immediate package
- Master the regulatory guidelines for developing product information and effectively apply them in real-world scenarios
- Learn the criteria for preparing SmPC for multiple strengths of medicinal products
- Identify the regulatory procedures where product information is updated and understand the associated scope
Course Highlights:
- Engaging modules filled with practical examples
- Insights into the common challenges faced during product information development and strategies to overcome them
- Opportunity to interact and discuss course content with AIDIFY platform users
Embark on this enlightening journey to solidify your role as an expert in the field of medicinal product information. Equip yourself with the knowledge to make informed decisions, ensuring the safety and clarity of product use.
Competences covered by this course
- Product information management
By attending this course, you will learn
- The key terms and principles of product information of medicinal products
- Regulatory requirements for Summary Products Characteristics (SmPC)
- Regulatory requirements for packaging information (Labelling and Patient Information Leaflet (PIL)); and to list basic principles which shall occur on the outer and immediate package
- How to use the regulatory guidelines for product information development
- The criteria of preparing SmPC for several strengths of medicinal products
- How to identify in which kind of regulatory procedure product information can be updated and within which scope
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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