Learning area: Clinical Trials
Study Start-Up Associate Program
Build focused knowledge of the regulatory, documentation and site-readiness activities used to prepare clinical studies and sites for activation.
BEST FORFirst job / Junior / Study Start-Up
Is this program for you?
Choose this program if you:
What will you focus on?
The curriculum concentrates on:
How the program works
A fixed focused curriculum included in the Clinical Trials learning area subscription.
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Enroll in the program
Start the program on the AIDIFY platform with a learning area subscription.
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Learn at your own pace
Complete the 10 program courses one by one and collect a certificate for each of them.
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Complete the program
Finish all 10 courses to earn the job-ready certificate.
FIXED CURRICULUM
10 courses in the program
The fixed focused curriculum of this program. Open any course to explore its content and learning outcomes.
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Navigating EU CTR 536/2014 with transitioning from CTD
PharmacovigilanceClinical TrialsRegulatory AffairsKatarzyna Kopacz-Zakrzewska
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What you get in every course
Each course combines focused content, supporting resources and a clear completion path.
PROGRAM EXPERTS
Meet the experts behind this program
Meet the specialists teaching the courses included in this program.
Ernest Szubert
Associate DirectorAbout
Excellent communicator with can-do attitude and strong desire to learn. Project Manager with line management responsibilities focused on quality. Currently fulfilling the role of an Oversight Portfolio Manager working on a governance level, responsible for several studies of one client and oversight and support a group of CTMs allocated for those projects. Client oriented and dedicated team player. Long-term goal is to have an independent and responsible position as a global project director. Experience in pharmaceutical marketing, medical affairs and clinical trials gained in pharma companies and CROs.Founder and member of Polish Pharmaceutical Students’ Association. Member and head of the training group at Polish Association for Good Clinical Practice (GCPpl). Pharmacist with strong interest in clinical pharmacy. Academic teacher delivering lectures related with clinical trials.
Certificates: Soft Skills Trainer Certificate, Prince2 Foundation Training Certificate, Barnett GCP Certificate. Laureate and winner of a 3rd place of the national competition “Leaders of Clinical Trials (2021)” in the category Project Manager. Scholar of Leslaw A. Paga Foundation in the program “Healthcare Leaders”.
Privately foodie and enthusiast of cooking, travelling and fantasy books.
Katarzyna Pieńczuk
Associate Director, Third Party Processes & OperationsAbout
She has been involved in the clinical research industry since 2015. She currently works for a global pharmaceutical company as a Manager in the Clinical Documentation team, where her main role is FSO Operations Lead.
She places high value on personal development and the quality of performed activities, which makes her a valued member of project teams. She has operational experience gained in global CROs and pharmaceutical companies. She has worked on both investigational and medical device projects in a variety of therapeutic areas.
From the very beginning of her work in clinical research, she has struggled with the complex nature of clinical trial documentation and TMF, which she continues to explore to this day.
In addition to her day job, she is actively involved in the academic community, initially as a coordinator and support to the manager of a post-graduate study in the clinical trial area. Currently, she is a lecturer at Conducting and Monitoring Clinical Trials and Associate Director in Third Party Processes & Operations.
This collaboration started after the previously completed postgraduate studies in Conducting and Monitoring Clinical Trials. Graduate of Nicolaus Copernicus University in Torun in the faculties of molecular biology and environmental protection.
Although she started her professional life at the Central Forensic Laboratory of the Police, she now finds herself perfectly at work in clinical project activities and now she is conducting other types of investigations.
Katarzyna Kopacz-Zakrzewska
Regulatory professional in pharma industryAbout
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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READY TO GET STARTED?
Build focused skills for your pharma career
Get 10 courses and a job-ready certificate in one focused program, included in the Clinical Trials learning area subscription.