About course
Based on the EMA Annual Report from 2021, variations are definitely the most common regulatory procedure from the post authorization stage of the products lifecycle. Therefore, this course will provide you with a solid background for variation management. You will dive into the variation classification, such as variations type IA, IB and II variation categories, such as administrative, quality or safety and documentation required to be enclosed to the variation package. Each variation type is presented in more details, covering procedural timelines, principles on assessment phase and approval and/or rejection. Moreover, you will learn more about notifications, some aspects related to variation management such as best practice and importance of communication between main stakeholders.
The student after completing this course should be able to:
- Demonstrate knowledge about key regulations and guidance in terms of variations and understanding on variation definition and list possible reasons for variations
- For variations type IA/IB (foreseen and unforeseen)/II: demonstrate understanding of basic theory and have fundamental practice skills in terms of variations understand key terms, rules, and tools (variation classification / submission timelines / validation, assessment phase, approval/rejection, receiving decision / implementation date / reasons of rejection)
- List the main and supportive documentation required for variation submission
- Classify variation in terms of specific category: administrative, quality, safety and explain main principles of CEP procedure
- Explain and describe Notification Art. 61(3) procedure for medicinal product
- Manage the preparation stage of variation submission by regulatory professional
- List and explain roles and duties of various stakeholders in variation management
Competences covered by this course
By attending this course, you will learn
- Key regulations and guidance related to variations
- Definition and get to know possible rejection reasons
- Variation type IA
- Variation type IB (foreseen and unforeseen)
- Unforeseen variations type IB
- Variation type II and category “z”
- Required variation documentation
- Supportive variation documentation
- How to categorize a change
- Article 61(3) Notification
- How to manage preparations of the variation submission?
- Variation management: main stakeholders
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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