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.

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

Agnieszka is graduated from Faculty of Biology, University of Warsaw, where she also had continued research study earning PhD in Molecular Biology. Mastering the knowledge in life science field and developing transferable skills helped her in clinical research field. Currently, she is a GCP Expert with over 15 years of experience in clinical research as a Contract Research Associate, Trainer and Clinical Quality Manager. Responsible for inspection readiness activities, inspection preparation, facilitation and follow up. Participated in several on-site or remote FDA, EMA and local Health Authority inspections as well as in number of audits when working for CROs or pharmaceutical companies. Actively involved in in-dept root cause analysis of the audit or inspections findings, effective CAPA plans preparation, their follow up and effectiveness check.

Agnieszka is process-oriented, especially in terms of the processes at the site level, as she believes that a good set up of the investigational site for clinical trial is indispensable to its success.

As a member Training Section of the Association for Good Clinical Practice in Poland (GCPpl), she promotes knowledge about clinical trials and ICH GCP in the medical and pharmaceutical industries and likes sharing experience with others.

Lucas is an accomplished clinical trial quality expert with nearly two decades of experience in Good Clinical Practice (GCP) across SMO and CRO environments. With a strong background in leadership and oversight, he has held senior responsibilities in Quality Assurance and Clinical Quality, ensuring that clinical trial activities meet high standards of regulatory compliance, patient safety and data integrity. quality management systems within the pharmaceutical industry. What gives me him unique perspective on this subject is his dual experience - having had the privilege of working both within the Polish Regulatory Authority and on the industry side, collaborating with organizations that plan and conduct clinical trials. This dual background allows him to understand the expectations of regulators while deeply appreciating the practical, day-to-day realities of trial operations.

His expertise includes an advanced understanding of global clinical trial regulations and practical experience overseeing, preparing for and hosting major regulatory inspections, including those conducted by the FDA, MHRA and BfArM. He has worked across multiple quality functions, including Quality Management System development, implementation and maintenance; audit and compliance activities; root cause analysis; and corrective and preventive action planning.

His specialist areas include building and maintaining robust Quality Management Systems, designing annual audit programmes, conducting vertical, horizontal, directed, routine and for-cause GCP audits, managing GCP vendor audits and oversight, and supporting inspection readiness. This breadth of experience enables him to provide practical, regulation-focused insight into clinical trial quality and compliance.