About course
An arbitration mechanism which is used to resolve disagreements and to address concerns such as safety or efficacy. This course will guide you throughout all the relevant legislation and referral types (referrals based on Article 20 and 5(3) of EC Regulation, and referrals based on Articles 30, 31, 107i of Directive). Besides that, you will delve into roles and responsibilities of various stakeholders, such as scientific committees and groups. Without successful implementation of a referral outcome, there is a high risk of facing obstacles with inspections. Therefore, to support you while managing a referral procedure, broadening understanding with regards this area is also covered in this comprehensive course.
The student after completing this course should be able to:
- Demonstrate knowledge about key regulations and guidance related to referrals and understanding on key terms, rules, methods and tools
- Present roles and responsibilities of various stakeholders involved in referrals management. Present “decision-making process” and describe organisation of work within the CHMP, PRAC and EMA secretariat
- Define under which circumstances a potential serious risk to public health can occur according to Directive 2001/83/EC (in terms of quality and safety)
- Characterize European Union referral based on Art. 20 and Art. 5(3) of EC Regulation 726/2004 and provide an example
- Characterize harmonized referral according to Art. 30 of Directive 2001/83/WE and demonstrate knowledge when this kind of procedure can be initiated, what are main characteristics of this procedure and provide an example
- Characterize safety referral (PRAC) according to Art. 31 and 107i Directive 2001/83/WE and demonstrate knowledge about main characteristics of the procedure and what are the assessment timelines for CHMP / PRAC/ CMDh and provide an example
- Summarize list of documents which are enclosed to PRAC recommendations and CMDh position
- Demonstrate basic theoretical knowledge and basic practical skills in terms of referrals
- Implement outcomes from referrals and classify variation accordingly ‚ update of product information as a result of referral procedure.
- Explain PSUSA procedure (PSUR Single Assessment Procedure)
- Explain PSUR worksharing procedure and its main characteristics, distinguish CSP documents (Core Safety Profile) and CCDS/CDS (Company Core Data Sheet/Core Data Sheet) to classify the variation to implement outcome to product
Competences covered by this course
By attending this course, you will learn
- Key regulations and guidance
- Key terms, rules, methods and tools
- Roles and responsibilities of various stakeholders
- Potential serious risk to public health
- Referral based on Article 20 and Article 5(3) (EC Reg)
- Referral based on Article 30 (Directive)
- Refeeral based on Article 31 and Article 107i (Directive)
- List of documents enclosed to referral outcomes
- Theory about referrals and getting practical skills
- How to implement referral outcome
- PSUSA procedure
- PSUR Worksharing
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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