About course
Dive into the intricate world of Product Information (PI) updates with our specialized AIDIFY course. In the regulatory sphere, managing Product Information is not just a procedural necessity, but a vital commitment to patient safety. This meticulously designed course sheds light on the diverse procedures for updating PI, taking into account various contexts like generic medicinal products, CCDS-based updates, referral outcomes, and PRAC recommendations. With real-world examples, learn the art of seamlessly integrating new safety or efficacy details into medicinal products, balancing both compliance and patient well-being.
Key Learning Outcomes:
- Understand the foundational principles of PI updating, while pinpointing common errors and hurdles encountered in the process
- Illustrate the protocol for PI updates concerning a generic medicinal product, considering its reference medicinal product
- Detail the mechanism for PI amendments using the CCDS as a reference
- Elucidate the process for updating PI based on both referral outcomes and PRAC recommendations
- Offer a comprehensive view of crafting national translations for PI updates, ensuring global comprehensibility and alignment
Course Highlights:
- Acquire an edge in the regulatory department by mastering one of its most essential functions
- Learn from real-world examples, bridging theory and practical application
- Equip yourself with knowledge that emphasizes both procedural compliance and the utmost patient safety
- Engage in interactive discussions and benefit from a community of learners on the AIDIFY platform
Position yourself as a PI expert, proficient in both its nuances and its larger impact on medicinal products’ regulatory landscape. Join us in this enriching learning journey, merging best practices, patient safety, and compliance into a harmonious expertise.
Competences covered by this course
- Product information management
By attending this course, you will learn
- The main principles, the most common mistakes and challenges related to PI updates
- Managing the PI updates for a generic medicinal product of a reference medicinal product
- Managing the PI updates based on CCDS
- Managing the PI updates based on referral outcome
- Managing the PI updates based on PRAC recommendations
- Main principles of preparing national translations of updates in the PI
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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