Regulatory framework in Poland with key local legislations
MAH requirements based on the Pharmaceutical Act, such as notification of initial placing into the market, shortage notification (temporary/permanent), „sunset clause”, annual fees
Local regulatory requirements in line with various Regulations: MAA, variations, how to handle formal requirements in Poland, grouping „in consultations”, preparing mock ups and possibilites of MA withdrawal
The Office for Registration of Medicinal Products for human use: structure, activities and quality policy
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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