About course
In the realm of pharmaceuticals, ensuring patients have clear and accessible information about their medications is paramount for their safe and appropriate use. Join us on AIDIFY’s platform to explore how regulatory professionals can uphold these principles in the package leaflet (PIL), ensuring patients are well-informed and capable of taking the necessary actions based on the provided information.
Drawing from years of experience as a pharmacist, this course addresses common challenges faced by patients in understanding PILs and offers insights into ensuring the delivery of high-quality information. Operating within a highly regulated environment, pharmaceutical companies must adhere to specific guidance to design package leaflets effectively—a process that requires continuous improvement.
By attending this course, you will:
- Understand key terms, objectives, and methods for testing PIL readability, and determine when testing is necessary.
- Learn the principles and methodologies for conducting user testing, along with success criteria for effective testing.
- Gain a solid understanding of bridging and recognize instances where a proper report can or cannot confirm PIL readability.
- Identify the main characteristics of test reports and criteria for assessment.
Course Highlights:
- Engaging modules filled with practical examples.
- Insights into the common challenges faced PIL readability testing and strategies to overcome them.
- Opportunity to interact and discuss course content with AIDIFY platform users.
Whether you’re a regulatory professional seeking to enhance your skills or a pharmaceutical company striving to improve patient communication, this course equips you with the knowledge and tools necessary to ensure clear, accessible, and informative package leaflets.
Enroll now and embark on a journey towards enhancing patient safety and empowerment through effective medication information dissemination.
Competences covered by this course
By attending this course, you will learn
- Key terms, aim, possible methods of testing PIL readability and the student would be able to define when testing is needed
- The way of conducting the user testing and its main principles and success criteria
- Main principles and solid understanding of bridging and the student would be able to list examples when a proper report can and cannot be used to confirm PIL readability
- Main characteristics of test reports and assessment criteria
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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