About course
Have you ever wondered about the intricate processes that govern the authorization of medicines? Look no further than AIDIFY’s immersive course on pharmaceutical regulatory affairs! This course is your gateway to understanding the vital procedures for authorizing medicines in the ever-evolving world of pharmaceuticals.
Key Learning Outcomes:
- Grasp the fundamentals of the Centralised Procedure (CP), where you’ll delve into legislation, procedure conditions, and the products that fall under its scope
- Explore the procedural milestones of the Centralised Procedure, both before and after submitting the application
- Understand the roles and responsibilities of key players in EU procedures, including the European Commission (EC), European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP), Coordination Group for Mutual Recognition and Decentralised Procedures‚ Human (CMDh), Rapporteur/Co-Rapporteur, EMA Product Team, and Reference Member State (RMS)
- Navigate the intricacies of the Decentralised Procedure (DCP), from its legislation and procedure conditions to practical insights
- Master the procedural milestones of the DCP, ensuring a solid grasp of the process
- Dive into the Mutual Recognition Procedure (MRP), covering legislation, procedure conditions, and practical considerations
- Uncover the procedural milestones of the MRP, gaining insights into its inner workings
- Discover the core principles underpinning the national authorization of medicines
Course Highlights:
- Learn through real-world case studies: Analyze successful procedures, potential pitfalls, and best practices.
- Engage in interactive sessions: Get all your burning questions answered on the AIDIFY platform.
- Opportunity to interact and discuss course content with AIDIFY platform users
This course equips you with the knowledge needed to navigate the intricacies of pharmaceutical regulatory affairs. Whether you’re planning a career in regulatory affairs or seeking a comprehensive understanding of the authorization process, this course is your go-to resource.
Ready to take the first step toward mastering procedures for authorizing medicines in the? Enroll now in the AIDIFY course and gain the expertise to make informed decisions. Don’t wait ‚ click ‘Start course’ to embark on this transformative journey!
Competences covered by this course
- EU procedures for authorizing medicines
By attending this course, you will learn
- Centralised Procedure (CP): legislation, procedure conditions, practical information and products in scope (which medicines must be authorised under CP and which might be)
- Centralised Procedure (CP) procedural milestones – phase before and after application submission
- Understanding of roles and responsibilities of key stakeholders over European procedures
- Decentralised Procedure (DCP): legislation, procedure conditions and practical information
- Decentralised Procedure (DCP) procedural milestones
- Mutual Recognition Procedure (MRP): legislation, procedure conditions and practical information
- Mutual Recognition Procedure (MRP) procedural milestones
- Main principles of National Procedure (NP)
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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