5th International Conference We! Are Clinical Research

5th International Conference
We! Are Clinical Research

We! Are Clinical Research – 5th Jubilee Conference Celebrating 5 Years of inspiring meetings, expert content, and powerful networking in clinical research.

The conferencje will take placa on October 8-10, 2025. Welcome to the most important annual clinical research event in Poland – a space where regulatory minds, innovators, investigators, and patients come together to shape the future of health research. This year’s conference brings a special Jubilee edition with three days of expert insights, multistakeholder dialogues, new workshop formats, and thought-provoking discussions. With the release of ICH GCP E6(R3), the evolution of decentralized models, and the power of real-world data, we’re entering a new era – together. But first – let’s take a look at what happened during previous editions.

Organizers:

AGENDA & SESSION DESCRIPTIONS

DAY 1:

Day 1: The Patient at the Center of Innovation – The Evolution of the Clinical Trial Model We focus on modern approaches to conducting clinical research with the participant in mind and the integration of real-world clinical data to improve quality, accessibility, and impact. 1st Session: New Horizons in Research – Decentralized Clinical Trials (DCT) in Practice  

Overview: As clinical trials evolve in the digital era, DCTs are becoming essential to improving patient access, increasing diversity, and enabling innovation.  This session will showcase real-world DCT implementations across Europe, with lessons learned on design, technology, and operational success. Topics include:
  • What DCT models actually work?
  • Measuring compliance and quality in decentralized settings
  • Do DCTs really improve inclusion and participant experience?
  • Regulatory and ethical alignment in virtual trial environments

2nd Session: The Power of Real-World Data – Leveraging RWD in Study Planning and Analysis

Overview: Real-World Data is transforming how we design protocols, choose populations, and evaluate outcomes. This session will explore how to meaningfully integrate RWD from EHRs, ePROs, registries, and more into clinical trial planning and decision-making.

Topics include:

  • Identifying high-quality and regulatory-relevant RWD sources
  • Managing variability, standardization, and data governance
  • When can RWD complement or replace randomized data?
  • Case studies on embedding RWD into traditional trials

3rd Session: Dialogue and Partnership – Patient Forum

Overview: A rare opportunity to hear directly from research participants and patient advocates. This forum shifts the focus from process to people, exploring how we can build truly participant-centered research systems. Topics include:

  • Co-designing protocols with patient involvement
  • What “participant-centric” means from a lived-experience perspective
  • Transparency, plain language, and the right to understand
  • Building long-term trust and meaningful collaboration

Biggest international meeting for clinical research market stakeholders. 3 days focused on: Patients, Regulatory&Quality, Competency Development & Motivation

DAY 2:

Day 2: Regulation and Quality – Safe Frameworks for Modern Clinical Trials A day dedicated to the legal, ethical, and quality foundations of running clinical trials in 2025 and beyond. 1st Session: CTIS in Daily Practice – New Requirements and Lessons Learned

Overview: The Clinical Trials Information System (CTIS), launched under the EU Clinical Trials Regulation, is reshaping trial governance across Europe.  

Topics include:
  • Day-to-day CTIS operations – what’s working, what’s not
  • National nuances in ethics and regulatory harmonization
  • Sponsor experience with public transparency and submission processes
  • Practical strategies for internal compliance with CTR and CTIS workflows

2nd Session: The Regulatory Landscape – Implementations, Experiences, and Recommendations

Overview: This session provides a practical review of current regulatory realities in Poland and across the EU. Are we achieving harmonization? What have recent implementations revealed? Topics include:

  • Harmonizing ethics review under CTR – success or struggle?
  • Roles of local vs. centralized bodies in new regulatory frameworks
  • Best practices from implementation in sponsor organizations
  • Legal, operational, and ethical coordination challenges

3rd Session: GCP R3 – Think Strategically, Act Responsibly Panel Highlight: GCP R3 – Think Strategically, Act Responsibly With the release of ICH GCP E6(R3) in 2025, clinical research enters a new era. For the first time since 1996, GCP is not just updated – it’s redefined. This panel explores the evolution of Good Clinical Practice over nearly three decades, challenging us to rethink compliance and ethics not as rules to follow, but as values to lead by.

Together we’ll explore:

  • How GCP has changed since 1996 – and what we’ve learned.
  • What GCP means today: a checklist, a culture, or a code of conduct?
  • What R3 offers, encourages, and demands – and what it leaves unsaid.

Thematic Focus: GCP E6(R3) redefines our understanding of research conduct. It:

  • Emphasizes risk-based, proportionate oversight
  • Redefines roles across sponsors, CROs, and investigators
  • Encourages digital transformation and adaptable documentation
  • Promotes a participant-centered, principle-driven culture

Panelists will Include:

  • An Investigator – representing ethical and operational realities at research sites
  • A Patient Advocate – reminding us who clinical trials are really for
  • A Sponsor Representative – translating high-level guidance into practical decisions
  • A Regulatory or Ethics Expert – bringing clarity to complexity

Why You Should Join: If you work in operations, quality, regulatory affairs, or ethics – this conversation is for you.  Come ready to:

  • Challenge assumptions
  • Ask the hard questions
  • Take fresh ideas back to your organization

Because the future of clinical research will not be built by rules alone – but by how we understand and live them.

Your best investment in yourself - 3 days of gaining excellent knwoledge from industry professionals

DAY 3:

Day 3: Effective Management and Competency Development in Clinical Research This final day is designed for clinical operations professionals, project managers, and those leading people and projects in clinical trials. 1st Session: Clinical Trial Management – Practical Strategies and Operational Models Overview: From strategy to execution, this session will explore how project teams can lead with clarity, agility, and purpose in today’s research environment.  

Topics include:
  • Building efficient, audit-ready study frameworks
  • Managing multi-site, hybrid, or decentralized trials
  • Trial KPIs and performance metrics that matter
  • The evolving role of the Clinical Project Manager

Panel: Time to evolve! A new chapter of project management. The world of clinical research is evolving at lightning speed! Are you ready to evolve your role as a Project Manager - or even revolutionize your approach to project management? A panel discussion on project management in clinical research will seek to answer how the Project Manager's role is evolving in the face of dynamic market changes.  In today's world, where data plays an increasingly crucial role and expectations for using modern tools, including AI, are commonplace, it's essential to acquire new skills and competencies and navigate an increasingly complex reality. We'll discuss how to adapt to significant variability and effectively leverage the latest trends to meet the challenges of modern clinical research. We will also discover how this is reflected in the recently updated project management standards. Join us and find out what new skills and perspectives are necessary to succeed in this new chapter of project management. Don't miss this unique opportunity to exchange knowledge and experiences! It's time to evolve! 2nd Session: Inspiration and Growth – Motivational Talks Inspirational keynotes by leaders from research and beyond

Overview: This session closes the event with powerful messages from individuals who have led with vision, resilience, and human impact. Topics include:

  • Finding purpose in clinical research work
  • Leading through uncertainty and complexity
  • Mental health, motivation, and leadership in a changing industry
  • Personal stories of transformation and perspective shifts

Motivational Talks: Nikolay Kirov - "When Uncertainty Reigns! How to Take Care of Yourself as Global Change Accelerates Exponentially?"

  • How can we cope in times of uncertainty?
  • What can we do on a personal level to maintain mental and professional balance?
  • How can our everyday decisions and habits support us in this process?

Why You Should Attend

  • The largest and most impactful clinical research event in Poland every fall.
  • Over 30 top-tier speakers and panelists from across the research ecosystem
  • A unique mix of regulatory updates, practical training, and human stories
  • Focus on the future: digitalization, decentralization, and participant partnership
  • New format with hands-on workshops and leadership inspiration

Speakers:

PhD Bart Lagerwaard

Bart Lagerwaard, PhD works as assistant professor at the University Medical Centre Utrecht. Trained in Molecular Nutrition and a PhD in Human Physiology in the field of muscle ageing, his current work focuses on Clinical Trial Innovation. Bart Lagerwaard ensures the scientific coordination of RADIAL trial for the IMI Trials@Home project (www.trialsathome.com), which aims to reshape clinical trial design, conduct and operations, by developing and piloting standards, recommendations and tools for the definition and operationalisation of Decentralised clinical trials in Europe. Furthermore, he is active in the Hypermarker project, focused on personalised pharmacometabolomic optimisation of treatment for hypertension using Arteficial Inteligence. Bart frequently , collaborates with industry, CROs, patient organisations, and regulatory agencies. Through these collaborations, he aims to strengthen the clinical trial ecosystem within Europe.
Bart is coordinator of the post-graduate course Clinical Epidemiology.

Viviënne van de Walle

Viviënne van de Walle is a physician specialized in clinical research (registered certified clinical pharmacology and pharmaceutical specialist). She is the owner of VivHo, a life science consultancy company, and PT&R, an independent research center both in The Netherlands. She is also involved in various professional organizations in the field of clinical research, such as CISCRP, NVFG, ACRP and the SCRS. For all her work in the field of clinical research she was awarded the prestigious Christine K. Pierre Site Impact award in 2023 . She studied medicine at the University of Maastricht and the University of Oxford, and has a PhD in Auxology . She is a registered physician in both the Netherlands and Belgium passed the  CPI exam and QM-IAOCR. As of 2025 she is appointed to serve on the Global Exam committee for the Certified Principal Investigator Program  She has a special interest in implementing and streamlining eCOA and A.I.  in clinical research . She is a mentor, speaker, leader and bridge builder always keeping the patient  in focus. Known for some memorable quotes on the day-to-day challenges at a site like: “Get me out of this bad escaperoom”. She is passionate about sharing her 25+ years of experience and looking for creative solutions: "I love it when you pick my brain".

Dr Agata Bloswick

Dr Agata Bloswick is a recognized expert in clinical trials with over two decades of international experience in the pharmaceutical and CRO sectors. She earned her PhD in pharmacology at Jagiellonian University and has since combined scientific expertise with strategic leadership, contributing to the successful delivery of innovative therapies worldwide. She has held senior global roles guiding large-scale clinical operations and has published and lectured extensively on ethics, project management, and drug development. As a faculty member and guest lecturer at institutions such as Yale University and Kozminski University, she has educated and inspired future professionals in clinical research. Known as a mentor of generations, Dr Bloswick is committed to empowering the next wave of leaders and advancing ethical, patient-centered clinical trials.

Prof Willy Kriz

Prof. Willy Christian Kriz is a professor of organizational and business psychology at the Vorarlberg University of Applied Sciences in Dornbirn, Austria. He is an expert in the psychology of organizational change, focusing on how individuals and teams adapt to transformation in complex environments. Internationally recognized for his work in simulation and gaming, he developed the SysTeamsChange simulation game, which helps organizations model change processes through experiential learning. He has been a leading figure in the simulation and gaming community, serving as president of ISAGA and co-founding SAGSAGA, as well as contributing as an editor to the journal Simulation & Gaming. His career combines psychological expertise with innovative use of simulations to drive sustainable organizational change and leadership development.

Beata Chełstowska

Graduate of medical analytics at the Medical University of Warsaw and of doctoral studies at the First Medical Faculty of WUM. Listener of postgraduate studies Conducting and Monitoring Clinical Trials at Kozminski University.  
Since the beginning of her professional path, she has been involved in the study of molecular and biochemical pathomechanisms of metabolic disorders. Currently co-managing the newly established Faculty of Medicine at UKSW, responsible for the training of future medical staff. Performer of projects in the field of education and health care organization. Interested in the possibility of developing clinical research in Poland and optimizing the management of projects and non-commercial clinical trials. 
Member of, among others, the Polish Society for Civilization Diseases and the "Clinical Research is WE!" movement. - a modern platform for sharing experience and knowledge in the field of clinical research.

Piotr Sawicki

A three-time graduate and lecturer at Kozminski University.
He has been associated with the research market since the nineties. It deals with the activities of Research Centers as well as recruitment and retention centers. Co-founder of the Osteomed Medical Center and the Lambda Clinical Research Center. An expert in planning and implementing campaigns of candidates in the recruitment with an understandable understanding of the correction and correctness of the language. In the years 2012 - 2019, the Head of Patient Engagement at Synexus and currently the Head of the Clinical Research Department at the CMP Medical Center.

Multiple speakers at international recruitment conferences.

doctor Łukasz Więch

Łukasz Wiech is a physician and public health specialist with over 15 years of experience in clinical research and extensive expertise in healthcare management. He is a graduate of the MBA for Medical Professionals at Kozminski University.
He currently serves as Medical Director at the Trialmed network of clinical research sites in Poland, where he is responsible for developing the medical team, ensuring research quality, and safeguarding patient safety. As a leader of healthcare programs at Kozminski University, he has educated more than 2,000 graduates, enhancing their competencies in healthcare management and clinical research. Being also the founder and promoter of the WE! Are Clinical Research community, he pursues the mission of building a development platform for clinical research professionals in Poland and across Europe.
He is a certified trainer of the advanced simulation game SysTeamsChange®, supporting managers and organizations in developing practical skills for implementing and managing change, particularly in the healthcare sector. His research focuses on the use of simulation games as educational tools in management processes, combining theory with practice and setting new directions for development in this field.
Łukasz Wiech believes that the future of healthcare depends on education, innovation, and collaboration, and he works at the intersection of science, business, and clinical practice to create value for patients, professionals, and organizations.

Marcin Wardaszko
PhD Marcin Wardaszko
  1. Assistant professor and Head of the Department of Quantitative Methods & Information Technology, Director of MBA for IT at Kozminski University and Adjunct Professor at University of Applied Science Vorarlberg. 2003 trainer and developer of simulation games and gamification systems for education, business, and consulting. Author of many publications on games-based learning and serious game design. Passionate game designer, author, and co-author of around 60 scientific publications. Fellow at Association for Business Simulation and Experiential Learning and President of International Simulation and Gaming Association (2019-2020) and Member of SAGSAGA. Laureate of the CEEMAN 2019 Champion in Teaching Award for innovative VR game-based learning program. He is actively teaching, researching, and publishing on the field of games and gaming for learning, teaching, and engaging people. An enthusiastic supporter of games and gamification and a member of the gamification experts network, he believes that games and gamification will change how we learn and work.

Nikolay Kirov

Practitioner with teaching experience and academic background. Since 1996, trainer, consultant, mentor, inspirational speaker, and lecturer in the fields of:
• Leadership, team building and motivation
• Negotiation, Relationship Building, and Value Creation in Business
• Strategy and implementation of organizational change
• Transformation of organizations and organizational culture based on values
• Communication and conflict resolution
• Strategic and Cross-cultural Negotiations
• Self-management, team management, and managing one’s own energy: body, emotions, and mind

Mentor, certified in diagnostic tools: Value Match, Reiss Motivation Profile®, FRIS® Thinking and Action Styles, Facet5, MasterPersonalAnalysis, LifeEnergy Barometer®, MTQ48 – mental toughness. He conducts individual and group Life & Business Coaching and Mentoring sessions.

Partner and board member of “Kirov Strategic Negotiators” Sp. z o.o. and LifeEnergy.pl, Member of the Scientific Council of the “Passion for Education and Development” Foundation, Board Member of the BARGEWORK Foundation, and member of the PNSA – Polish National Sales Awards Jury.

Specializes in consulting on strategy and organizational change, including organizational culture, as well as designing talent and development programs for managers tailored to the individual needs of organizations.

Director of Kozminski MBA for Engineers and Entrepreneurs and of the Leadership & Negotiation area – Kozminski University.

Previously: Long-term Director of Strategy and Development at Kozminski Executive Business School. For over 10 years served as a member of the editorial board of Management and Business Administration. Central Europe, member of the Program Council of Personel i Zarządzanie, and member of the Association of Professional Speakers.

His inspirational talks and lectures, delivered both to companies and at industry conferences such as: HR Congress, HR Professionals Forum, HR Excellence, National Sales Congress, Quo Vadis Training, Sales Morphology, have been highly rated for both content and delivery.

Five-time consecutive winner of the Best Inspirational Speaker award at the National Sales Congress. Achieved the highest ratings at Europe’s largest congress “IT Manager of Tomorrow” 2024. Shared the stage with Garry Kasparov and Dan Millman at “Giants of Life.” Largest audience: 8,000 people.

Four-time (2020, 2021, 2022, 2023) awardee of the “TOP100 Polish Influencers – Polish Marketing Personalities” ranking.

Decorated with the National Education Commission Medal for outstanding contributions to education and upbringing, and the Silver Medal of the President of the Republic of Poland for long service in education.

For 30 years, over 300,000 people have participated in his lectures, training, and strategic sessions within development programs for corporations and entrepreneurs, postgraduate studies, and MBA programs: Executive MBA, MBA IT, MBA HR, MBA Finance, MBA for Engineers, MBA for Healthcare Managers. Lecturer at Kozminski – Advanced Management Program – held in Warsaw and Barcelona, also taught at EADA Business School.

Author and co-author of over 10 books: Prepare for Negotiations Without Fear!, Life Energy Management. Managing Life Energy, Work Remotely and Effectively. Survival Guide in the Virtual Environment, Epigenetics – Where Science Meets Business (forthcoming), Consulting Projects as a Way of Building Knowledge, Competence and Skills of HR Managers, as well as hundreds of articles in academic journals and management press.

Teacher and Instructor of more than 10 Qigong/Tai Chi systems, including: Shi Ba Shi Taiji Qigong, Calligraphy Health System, Five Elements Qigong, Dao Yin Zang Fu Qigong, Forest Rock Monastery School Exercises, Heaven to Earth Qigong, Tian Quan Qigong, Six Healing Sounds of the Zang Fu, Sleeping Qigong, Qigong Walking: Tiger Steps Qigong, Dao Yin Walking, Knee Strings, Pot Walking – as well as ZEN Coaching practitioner, leading regular group sessions on self-management and energy management for life balance, under the LifeEnergy.pl project.

He studied Qigong, Traditional Chinese Medicine, Epigenetics, Neuroanatomy (also with students of Thomas Myers), and Neurobiology in Indonesia, Vietnam, Australia, and Europe. Certified trainer of Forest Rock Qigong Taiji School and Calligraphy Health System. Key speaker at the conference Epigenetics – Where Science Meets Business ‘24.

Founder of the “Academy of Negotiation, Relationship Building and Value Creation in Business.” Academic coordinator of Kozminski MBA for Engineers and Entrepreneurs. Designed and coordinates the postgraduate program Strategic Sales and Sales Team Management, which introduces a new approach to sales. More at kirov.pl.

Co-creator of programs: “Life & Business Management” (LifeEnergy.pl), “Strategic Leadership Program,” “Academy of Conscious Leadership and Team Collaboration,” “Organizational and Cultural Transformation Based on Values – Spiral Dynamics Value Match.”

In his courses, he demonstrates: how leadership, negotiation, and relationship-building skills in business, and value-based work, directly translate into financial benefits and mutual partner satisfaction; how to sign more favorable long-term contracts; how to respond to changes in the environment and within organizations; how to manage oneself, one’s energy, team energy and motivation, and make decisions to be a leader in times of rapid change.

He has provided consulting and training for organizations such as:
• BNP Paribas, BGK, NBP, KNF, ING Bank Śląski, BRE Bank, Cardif Insurance, Noble Bank, mBank, PKO BP, PZU, Raiffeisen POLBANK, Raiffeisen Leasing, RBS, BNP Cardif Insurance, Bankowe Towarzystwo Leasingowe, Union Investment, Krajowa Izba Rozliczeniowa, ERGO Hestia, Credit Agricole
• Amazon, Allegro, Asseco, ORANGE, T-Mobile, PLAY, Dolby, Future Processing, INFOVIDE-MATRIX, Integrated Solutions, TIM S.A., Carlson Wagonlit, JET LINE, CASINOS Poland, Q-Development, Poczta Polska, TELTECH, Canal+, Worldline
• Mercedes, Renault, Renault Truck, KIA Motors, Kongsberg Automotive, GatX, HSV Polska, PESA Bydgoszcz, SPX FLOW, Skoda, Tramwaje Warszawskie, VW, MAN
• AUCHAN, EUROCASH, METRO GROUP, Jeronimo Martins, Amplus, Leroy Merlin, Procter & Gamble, AmRest, SCM Poland, ATRIUM Poland Real Estate Management, MULTI Poland, Swede Center, Profit Development, Vantage Development
• PGNiG, NAFTA POLSKA, ORLEN Upstream, Polska Spółka Gazownictwa, Polskie Sieci Energetyczne PSE-INFO, PGE Baltica, GAZ-SYSTEM, Electra, ELECTRUM, PSB – Polskie Składy Budowlane, AirProducts, Euro-Hel
• Carlsberg, CCC, Robert BOSCH, Balluff, Balticon, Benefit Systems, Grupa AZOTY, GTV, STOCK Polska, CMC, Jabil Circuit Poland, Jabil Assembly Poland, Norcospectra Industries, Kompania Piwowarska, Krosno Glass, Reckitt Benckiser, Schneider Electric, T4B, WSK-Rzeszów, OTIS, Polmos Żyrardów (BELVEDERE), UTC-Aerospace, SPX Flow, Reynaers, Veolia, R-Bag, Panattoni, Nextbike, Bauer
• Industrial Development Agency, Supreme Audit Office, General Counsel to the Republic of Poland, Operator ARP, City of Warsaw HR and Training Office, Warsaw Chief Architect’s Office, Bogdanka Mine, Underground Mining Research and Supervision Center, Ministry of Funds and Regional Policy
• AstraZeneca, Aurovitas, Boehringer Ingelheim, Hartmann, Medicover, Molnlycke, POLFA Warsaw, POLPHARMA, Polish Pharmaceutical Group, SIEMENS Health Care, SLAWEX, Pomeranian Hospitals, Celon Pharma

Supervisor of more than 300 strategic consulting projects within MBA and Strategic Sales and Team Management programs, and supervisor of over 200 consulting projects for public administration. Between 2005–2008, regional coordinator of Europe’s largest educational project Postgraduate Studies for Managers and Enterprise Employees, implemented by the Association of Universities “Education for Entrepreneurship” under SPORZL 2.3.A.

Main research, consulting, and training interests: negotiations and building relationships with strategic business partners; strategic, team, and multilateral negotiations; self-management and energy management; leadership and the application of neuroscience in communication and team building; organizational culture transformation based on values; and implementation of strategic changes for companies in the financial, automotive, medical, pharmaceutical, FMCG, tourism, construction, publishing, logistics, and industrial sectors, as well as public institutions.

Urszula Jaworska

In 1997, Urszula Jaworska was the first patient in Poland to undergo a bone marrow transplant from an unrelated donor. This pioneering procedure in the history of Polish medicine took place at the Hematology Clinic of the Medical University of Silesia in Katowice, and the procedure was performed by Professor Jerzy Hołowiecki and his team. While still a patient, she became the Founder of the Urszula Jaworska Foundation.

It was these experiences of fighting for one's own life that determined the creation of the foundation, which since 1997 has been actively helping cancer patients, patients with leukemia, MS, hepatitis C, conducts educational and information campaigns in the media and pro-patient changes in the health care system.

For many years, the organization was also the largest in terms of the number of registered people - the Bone Marrow Donor Bank in Poland. It is thanks to the personal commitment of Urszula Jaworska and the entire foundation team that the idea of bone marrow donation has become so popular in Poland. The foundation's register currently associates over 11,000 bone marrow donors.

Despite many duties, she tries to combine her work in the foundation with supporting other patient organizations. For years, she has been actively working with the Ombudsman for Patients' Rights and the Ombudsman, and in the current term of office she is a member of the Committee of Health Experts. For her activities in 2014 she was awarded the Golden Cross of Merit by President Bronisław Komorowski. In 2019 she was ranked 14th on the "Puls Medycyny" List of One Hundred most influential people in Polish medicine. She was a member of the Social Council - the national debate on health "Together for Health". Since February 2018, she has been participating in the work of the Health Committee of the Polish Chamber of Commerce and chaired the Team for the development of proposals for statutory regulations regarding the rights and obligations of patients at the Ministry of Health.

From 2021, she is the chair of the working group on patients' needs, which operates as part of the Scientific Working Group of the Medical Research Agency. In April 2022, she was appointed a member of the Patient Organization Council at the minister responsible for health. She is a member of the Management Board of the Society for the Promotion of Quality for the years 2022-2026. As the President of the Foundation, she is active in the field of systemic pro-patient solutions. It is thanks to her efforts that the model of coordinated care in multiple sclerosis and the government project of eliminating HCV among uninsured prisoners for the years 2022-2027 have been initiated and prepared together with the National Health Fund.

Similar solutions were created with her participation in the care of a patient with diabetes and geriatric care. She was a member of the team at the Ministry of Digitization for the Stop Covid application. Since June 2023, a member of the Chief Bioethics Committee at ABM. Graduate of the State Ballet School in Warsaw, student of the Karol Szymanowski Academy of Music in Warsaw. Fryderyk Chopin in Warsaw at the Faculty of Ballet Pedagogy. Dancer and soloist, as well as the manager of many significant ballet companies, including: Syrena, Sabat, Mazowsze. In 1994, she was diagnosed with a cancer - leukemia. As a patient, who was the first in Poland to have a bone marrow transplant from an unrelated donor, she became the Founder of the Urszula Jaworska Foundation.

She actively participates in organizing activities aimed at broadly understood help for patients with leukemia, other cancers and chronic diseases. Shee attaches great importance to raising the level of knowledge in the society regarding cancer.

Karol Szczukiewicz

A highly experienced Clinical Research Leader with a passion for the field and a knack for making things happen. His successful 17+ years career includes experience in global CROs and pharmaceutical companies, focused mainly on Project, Programme and Portfolio Management.
As the Head of a Project Management Department, Karol is responsible for the strategic planning, execution, and coordination of the Project Management Functional Area, providing leadership and insight to ensure the successful implementation of company strategy.
His commitment to advancing the field extends to education and industry leadership. He is the co-founder of the "Project Management in Clinical Trials" postgraduate program at Kozminski University and a co-author of "Clinical Research. Practice, Law, Ethics." book. He also served as a former board member (2016-2022) and Head of Training at the Association for Good Clinical Practice in Poland. He is also the originator and co-leader of the "Clinical Trials Leaders" industry competition and Member of the Business Council at the Polish Clinical Trials Network.
Beyond his corporate and academic roles, as CEO of the Forge of Leaders - Leadership Excellence Centre, Karol applies his expertise in Executive Coaching, Leadership Development, Public Speaking, and Training. He is a frequent speaker at international conferences, passionate about empowering individuals and teams to achieve peak performance.

Paweł Orzeł

Graduate of the Warsaw School of Economics (Management/Business Administration) and the Warsaw University of Life Sciences (Faculty of Food Technology). For 18 years he has been involved in the field of clinical research. Thanks to many years of work in the largest pharmaceutical corporations and global CRO companies, in specialist, managerial, and director-level positions, he has an in-depth understanding of the clinical research market. He knows both the sponsor’s perspective and that of companies conducting trials on their behalf.

Since 2015, he has been professionally associated with PPD, where, in cooperation with multidisciplinary research teams, he manages global research projects. As Project Director and Oversight Director, he is responsible for managing global programs and projects, as well as building relationships with the organization’s strategic clients.

A long-time lecturer and thesis supervisor at Kozminski University, the John Paul II Catholic University of Lublin, and the Medical University of Lublin. Author and academic director of the postgraduate program Project Management in Clinical Research.

PhD Tomasz Żemojtel

Business Development Manager for the Healthcare Sector in the EMEA Region at Amazon Web Services (AWS)**, combines expertise in leveraging clinical and omics data with driving innovation in healthcare. At AWS, he supports medical organizations in utilizing cloud technologies, including AI, with a focus on advancing personalized medicine.  

Previously, he led the genomic platform at the Berlin Institute of Health at Charité - Universitätsmedizin Berlin, managing projects in oncology and rare diseases. Under his leadership, the molecular genetics unit was established at Europe’s largest hospital-based laboratory, Labor Berlin (a joint venture between Charité and Vivantes). Earlier in his career, he conducted research in human genetics at the Max Planck Institute for Molecular Genetics.  

By combining medical knowledge with business skills, Dr. Żemojtel advocates for harnessing the computational power of the cloud to unlock the potential of large clinical datasets, driving the development of personalized therapies and integrated healthcare solutions.

   

Prof. Łukasz Kołtowski

Prof. Łukasz Kołtowski, MD, PhD, FESC
He is a cardiologist and Assistant Professor at the 1st Department and Clinic of the Medical University of Warsaw. A graduate of the Medical University of Warsaw and the Foundation Programme at John Radcliffe Hospital in Oxford (UK). He was awarded for his doctoral thesis by the Council of the 1st Faculty of the Medical University of Warsaw. He holds the title of Fellow of the European Society of Cardiology (FESC) and has received the prestigious Innovator Under 35 award from MIT Technology Review.

He leads a care program for patients after myocardial infarction, heart failure, and invasive treatment of multivessel coronary artery disease, focusing on the prevention of further cardiovascular events through risk factor optimization, modern pharmacotherapy, and lifestyle modification.

His specialization includes the diagnosis and treatment of coronary artery disease using minimally invasive methods. He works on assessing myocardial ischemia caused by microvascular disease and vasospastic angina (Prinzmetal’s angina), conducting a comprehensive functional diagnostic program using advanced intravascular imaging and computed tomography techniques. He is a researcher and promoter of innovative methods for physiological assessment of coronary circulation and intravascular imaging in complex coronary angioplasty procedures. He holds the title of independent operator granted by the Cardiovascular Association of the Polish Cardiac Society.

He served as a board member of the European Association of Percutaneous Cardiovascular Interventions (EAPCI/ESC) from 2018 to 2020 and is currently a member of the Digital Cardiology and Artificial Intelligence Section of the European Society of Cardiology (2022–2026). He is a principal and co-investigator in multicenter clinical trials in invasive cardiology, including TROPICAL-ACS, OCTOBER, and FAVOR.

He is the originator and author of the Baltic Declaration – a document outlining barriers to the development of telemedicine in Poland, endorsed by the Minister of Health. He was appointed by the European Commission to an expert team developing the mHealth Guidelines and served as an expert for the Polish Ministry of Health in creating the e-Health Development Strategy for 2018–2022.

He is the author of numerous scientific publications in journals with a total impact factor of 637 and an h-index of 24.

Prof. Marcin Sobczak

Vice-Rector for Science and Technology Transfer
Medical University of Warsaw
and
Head of the Department of Pharmaceutical Chemistry and Biomaterials
Faculty of Pharmacy
Medical University of Warsaw

An academic lecturer and researcher with over 25 years of experience in research and teaching units as well as in the commercial sector. Conducts scientific research in the fields of medical and health sciences, natural and exact sciences, and engineering and technical sciences. Specializes in biomaterials engineering, nanopharmacy, pharmaceutical chemistry, polymer physicochemistry, medicinal chemistry, and drug formulation technology.

In 2001, he obtained a PhD in chemical sciences from the Warsaw University of Technology, and in 2012, a postdoctoral degree (habilitation) in pharmaceutical sciences from the Medical University of Warsaw. In 2020, by decision of the President of the Republic of Poland, he was awarded the title of Professor in medical and health sciences. He completed an MBA program as well as postgraduate studies in healthcare management, hygiene and epidemiology, biomaterials for medicine, and physics.

He has held various leadership positions, including Vice-Dean for Science and Chair of the Scientific Discipline Council for Pharmaceutical Sciences at the Medical University of Warsaw, and Director of the Military Institute of Hygiene and Epidemiology. He has also served in other scientific leadership roles (head of department, unit, and research team). He was a member of scientific councils of several research institutes and centers for science and technology transfer. He has served as an expert and reviewer for institutions such as NCN, NCBR, ABM, MNiSzW, and the Science Evaluation Commission.

Additionally, he has several years of experience in the private sector, where he worked as an R&D manager and project leader. He also ran his own business focused on research and development in the natural and technical sciences.

He is the author/co-author of approximately 130 articles published in renowned scientific journals and holds 9 patents. He was the principal investigator and key contributor in 12 externally funded projects. For his scientific achievements, he has received 25 awards, including the Team Scientific Award of the Minister of Health. He is a member of several national scientific societies.

Assoc Prof. MD, PhD Jarosław Biliński

Physician, scientist, innovator, academic teacher at the Medical University of Warsaw, accomplished specialization in hematology at the Department of Hematology, Transplantation and Internal Medicine University Clinical Center of Medical University of Warsaw. Founder and CEO of Human Biome S.A. – innovative donor microbiota bank and mainly R&D company working on biosynthetic microbiome and microbiome-based drugs, being his research commercialization. Former vice president of the Regional Medical Council in Warsaw. 
During his medical studies, he was a laureate of many competitions and a Scholarship of the Minister of Science and Higher Education. In 2013 he graduated from the Faculty of Medicine with the highest score of the year at the Collegium Medicum in Bydgoszcz of the Nicolaus Copernicus University in Toruń. He graduated, a year before the plan, of doctoral studies at the Medical University of Warsaw and in 2017 he defended his doctoral dissertation with distinction at the First Medical Faculty of the Medical University of Warsaw and habilitation in 2024. Laureate (5th place) in Supertalents in Medicine 2025. Winner of the prestigious Award of the 5th Faculty of Medicine of the Polish Academy of Sciences. In 2020, he was the winner in the prestigious polish "Golden OTIS" competition in the "scientific debut of the year" category. Also, in 2020, elected as an "Young Ambassador” of the European Society for Blood and Marrow Transplantation (EBMT).
In his research work, he deals with topics in the fields of hematology, clinical transplantology, immunology, metagenomics, genetics and cancer response, gut microbiome and its interactions with the host and longevity, healthy-ageing. Author of many full-text publications in prestigious scientific journals, conference summaries and conference reports, including at prestigious international congresses. Impact Factor> 200, Hirsch index 15, Number of citations> 1000. Leader of 7 research grants (over 3 million euro in total), co-researcher in the international clinical trials, including study within the framework of the European Society for Blood and Marrow Transplantation (EBMT). Currently fully focused on Human Biome S.A. development and providing the first human biosynthetic microbiome and derived medicines, alongside with his scientific research.

Zbigniew Kowalski

The Chairman of the Patient Motivation Section of the Polish Society for Medical Communication and an active member of the International Association for Communication in Healthcare. As a pioneer in applying social and interpersonal skills within the field of medicine, he was among the first researchers to explore the critical role of these competencies in patient care.
He holds formal education in negotiation, interpersonal communication, and psychology. Furthermore, he is a proud graduate of the postgraduate course “Patient Engagement Design” from Stanford University School of Medicine. He previously served as director of the postgraduate program in “Management of a Private Medical Facility in Aesthetic Medicine and Dentistry” and has lectured on medical communication at both the Medical University of Warsaw and Jagiellonian University, as well as within MBA programs in healthcare.
With a career spanning more than two decades, since 2000, he has delivered training courses, keynote lectures, workshops, and panel debates. His expertise has directly benefited more than 180,000 professionals to date—including over 85,000 physicians, 35,000 pharmacists, and 30,000 nurses.
He is an accredited consultant and trainer for globally recognized organizations and models including Insights Discovery (functional style typology), Oldham & Morris (personality psychology), and the Body Language Institute Washington (specializing in lie detection and interpersonal diagnostics).
He is also the author or co-author of 14 books and practical guides on communication in healthcare—resources widely recognized and utilized across the medical field.

Dr n. med. Elżbieta Bylina

Deputy Director of the Clinical Research Development Center at the Medical Research Agency.
A graduate of the University of Warsaw and postgraduate studies in clinical research management organized by the Medical University of Warsaw.
From 1995 to 2021, she was affiliated with the Maria Skłodowska-Curie National Research Institute of Oncology, where she worked as a clinical research coordinator, and from 2016 to 2021, she headed the Clinical Research Department. In 2019, she obtained a PhD in medical sciences at the same institute.
She is a lecturer in postgraduate programs and a speaker at industry conferences, specializing in the coordination and management of clinical research at research centers.

Katarzyna Myszczyszyn

Graduate of the Faculty of Pharmacy at the Medical University of Warsaw and the postgraduate programme in Project Management in Clinical Research at Kozminski University.
Winner of the Leaders of Clinical Research competition. Connected with the clinical research industry for nearly 15 years – both on the public administration side at the Department of Clinical Trials of the Office for Registration of Medicinal Products, and on the business side at Parexel (CRO). As Regulatory Lead, she is responsible for global management of regulatory activities in numerous projects – with a particular focus on planning and executing start-up strategies. She participates in the development and improvement of processes for the Regulatory & Access department (SOP Owner) as well as operational models for individual projects and partnerships. She designs and delivers internal training in project management, systems, and processes. She also takes part in planning and implementing required configuration changes for the Veeva Clinical platform and coordinates the group of Super Users supporting the R&A department in using the VC system.

Privately, a fan of symphonic metal, alpine skiing, and recreational sailing. In her rare free time, she enjoys various forms of creative handicraft. 

Monika Trawińska

Director of the National Centre for Bioethics
Expert with over 15 years of experience in clinical research, including project management in the pharmaceutical sector. Member of the MedEthicsEU group at the European Commission – bringing together national representatives of bioethics committees for medical research (CTR/MDR). Responsible for the development and strategic initiatives of the National Centre for Bioethics within the Medical Research Agency, with particular focus on the standardisation of procedures for bioethics committees, international cooperation, and the implementation of innovative solutions in the field of clinical research ethics.

 

Monique Al

Monique Al is special advisor at the Central Committee on Research Involving Human Subjects (CCMO) in The Netherlands. Since May 2023 she is the vice-chair of the Clinical Trial Coordination Group. She is also co-chair of MedtEthicsEU, a group of national representatives of Medical Research Ethics Committees in EU/EEA launched in February 2024. Her background is Clinical Nutrition with a PhD in Human Biology. She has worked for several nutritional and pharmaceutical companies in the field of clinical research before she started in 2001 as a scientific staff member at the CCMO.

Jakub Jędrzejewski

Jakub Jedrzejewski is a seasoned global project manager currently working at FutureMeds dedicated research site network since April 2023. After graduating in genetics and experimental biology, he started his clinical research journey in 2019 by joining Synexus. From then on, Jakub has successfuly managed more than 30 multi-country and multi-site projects. In his day-to-day work, he employs his understanding of the industry, site operations, and Sponsors' and CROs' challenges and combines it with his data- and culture-driven approach.

PhD Renata Śledziewska

Graduate of the University of Warsaw, Faculty of Romance Philology.
University lecturer, speaker at international academic conferences, and certified business trainer with extensive teaching experience.

She completed postgraduate studies at Lazarski University in Education Organization and Management, as well as at Kozminski University in two fields: Project Management in Clinical Research and Monitoring and Conducting Clinical Trials.

For over 9 years, she has been involved in the world of clinical research, including the past 6 years on the CRO side. Currently, as a Global Project Leader, she manages oncology research projects.

Member of the Association for Good Clinical Practice in Poland, where she coordinates the work of the Bioethics Working Group.

MSc Pharm. Klaudiusz Gajewski

Pharmaceutical Market and Medical Technology Expert | Business Development Director | Court Expert

An experienced leader with over 20 years of practice in pharmacy, drug distribution, and the implementation of innovative technological solutions in the healthcare sector. Currently serving as Commercial Director EU at CTIN – a clinical trial search platform, where he is responsible for the strategy of introducing modern tools to the European market that support sponsors, research centers, and patients.

He specializes in the development of digital products, FMD-compliant systems, traceability technologies, and solutions for pharmacies, wholesalers, and hospitals. As Director of Commercialization of the FMD system, he was responsible for education, implementation of serialization systems, and SaaS-class solutions for the pharmaceutical sector.

 

PhD Piotr Iwanowski

Medical doctor, PhD. For over 25 years continuously professionally involved in the clinical development of drugs and medical devices, within sponsor organisations and as an independent consultant. Previously engaged on the operational side (study monitoring, operational management) and quality assurance (clinical research auditor). For over a decade, has been leading the development of drugs and medical devices from the scientific and methodological perspective, also participating in strategic activities, including procedures with key market regulators (including EMA and FDA). Currently serving as Chief Medical Officer at Molecure S.A. Previously served as board member and vice-president of the Polish Association for Good Clinical Practice (GCPpl), as well as long-time head of its standing working group on ethics review. Lecturer in clinical research, including in postgraduate studies at Kozminski University. Faculty member for clinical research funding applications at the (Polish) Medical Research Agency (ABM).

Dr Przemysław Grochowski

Graduate of the Collegium Medicum at Jagiellonian University. He has been involved in the pharmaceutical industry since 1999, and since 2007 has focused specifically on clinical research. Currently, he serves as Deputy Director of Clinical Operations at a CRO company, working closely with clinical research associates, project teams, and investigative sites.

He is a lecturer in numerous postgraduate programs and training courses in the field of clinical research, as well as a co-host of all editions of the IQVIA CRA School course to date. He is the author of articles and papers dedicated to clinical research topics.

Vice President of the Management Board of the Polish Association of Employers of Contract Research Organizations "POLCRO".

Anita Sitarska Haber

Graduate of the Second Faculty of Medicine at the Medical University of Warsaw. She has been involved in the clinical research industry since 1998 and currently works as Deputy Director of Clinical Operations at a global CRO company. She is responsible for training, mentoring, and managing a team of Clinical Research Associates and Clinical Trial Managers, coordinating collaboration with research site networks, as well as educational initiatives and patient organization relations.

She is passionate about decentralized trials and innovative methods of clinical trial planning and management. Since 2000, she has been actively engaged with the Association for Good Clinical Practice in Poland (GCPpl), currently serving as Vice President of the Association. She co-organizes statutory activities such as the “Clinical Trials Ambassadors” program, cooperation with ABM and the Ministry of Health, and organizes trainings and industry meetings, including the annual conference celebrating International Clinical Trials Day.

Since 2007, she has been a lecturer in postgraduate studies and a speaker at industry conferences and symposia in the field of clinical research. She is also a co-author of publications and articles on clinical trials, including the textbook “Clinical Trials – Practice, Law, Ethics” published in 2024.

Olga Bogaczyńska

Olga Bogaczyńska – Director of Processes and Compliance in the Medical Evidence department, Oncology Business Unit, AstraZeneca.
A veterinarian by education, she has been involved in clinical research for over a dozen years, specializing in GCP, quality, and sponsor oversight—particularly in outsourced models. In her work, she combines expert knowledge with a practical approach to managing compliance and risk in clinical trials. She lectures and conducts training sessions on quality in clinical research and actively participates in initiatives related to implementing AI in research processes. A passionate advocate for simplifying what is overly complex—for the benefit of teams, patients, and research outcomes.

Łukasz Pronicki

Pharmacist with over 7 years of experience in clinical research. Head of the Sponsor Support Center at the Medical Research Agency, responsible for collaboration with the pharmaceutical and biotechnology sectors as well as operational support for research projects.

Alina Pszczółkowska

Alina Pszczółkowska – Head of Global Medical Evidence Excellence

Alina Pszczółkowska is a physician and a graduate of the Medical University of Warsaw. She also holds an MBA degree from the Polish Open University and Oxford Brookes University. Since 1997, she has been involved in clinical research. She joined AstraZeneca in 1999, working both in Poland and internationally within the company’s Research and Development division. Over the years, she has overseen portfolio development across several therapeutic areas and managed projects and organizations worldwide. Alina also serves as Vice President of AstraZeneca Pharma Poland.

Wioleta Kicman

Business Psychologist. Specialist in Change Management and Organizational Transformation with over a decade of experience gained in Poland and the United Kingdom.
She has led projects for organizations such as the NHS, Becton Dickinson, and Labcorp Drug Development (Fortrea). Currently, as a Transformation Lead Consultant, she manages strategic initiatives within a company that is one of the leaders in the pharmaceutical industry.
Academic lecturer and expert invited to speak at international conferences, including the PMI Global Summit in Berlin, the PMI Leadership Institute Meeting in Barcelona, and HR Meet in Kathmandu.
Graduate of the Medical University of Warsaw (Public Health) and SWPS University in Wrocław (Psychology, specialization: Business Psychology).

Grzegorz Szałajko

An international expert in portfolio, program, project, and change management.
Supports organizations in key strategic initiatives and transformations, as well as in developing strategies and business models. Has experience working with global companies and local market leaders in industries such as IT, telecommunications, automotive, pharmaceutical, construction, service outsourcing, finance and banking, retail, higher education, industrial manufacturing, energy, mining and processing of natural resources, and business incubation and financing.
Lead editor of the Polish edition of the PMBOK® Guide, Seventh Edition. Coauthor of The Standard for Risk Management in Portfolios, Programs, and Projects published by the Project Management Institute (PMI). Lead editor and one of the architects of the global project assessment standard Project Excellence Baseline published by the International Project Management Association (IPMA). Member of the jury for the PMI Global PMO Awards and, previously, for 18 years one of the most experienced lead assessors in the prestigious IPMA Global Project Excellence Award competition.
A founding member of the Project Management Institute Poland Chapter and cofounder of its Wrocław branch. Honorary Member of the Project Management Association of Nepal (PMAN). Recipient of the international IPMA Otto Ziegelmeier Award for promoting the idea of project excellence worldwide and the Atlas Project Management award granted by IPMA Poland for contributions to the development of project management in Poland. Multiple award winner for development programs and mentoring in project management.
Author of programs and lecturer in international MBA and Executive MBA programs. A respected speaker invited to national and international management events.

Aleksandra Kosakowska

Graduate of the Faculty of Pharmacy at the Jagiellonian University Medical College.
After several years of working as a pharmacist, she has been involved in the clinical research industry for nearly seven years, focusing on medical devices and medicinal products.
Currently, as a Clinical Project Manager at KCRI (a CRO), she is responsible for the comprehensive management of clinical trials – from collaboration with sponsors, through coordination of research sites and monitors, to oversight of CRO teams (including Safety, Regulatory, and Data Management).
In her work, she places particular emphasis on efficient and effective communication among all parties involved in the process, as well as on proactive risk management.

Conference fee

Regular price after 7th September: one day = 250 PLN, two days = 450 PLN three days = 600 PLN

Starting from October 1, 2024, parking at Kozminski University is paid. Parking for up to 30 minutes is free of charge. After this time, the following daily rates apply:

First hour: 7 PLN Second hour: 10 PLN Third and each subsequent hour (until 4:59 PM): 10 PLN Hours are cumulative From 5:00 PM to midnight, the fee is 3 PLN for the entire parking period.

If you wish to use the parking lot, please take a ticket upon entry and pay for it at the parking machine before exiting.

TERMOMODERNIZACJA

Patrons:

Czasopismo Badania Kliniczne

Partners:

Honorary Patronage:

If you have any substantive question, please contact with:
dr n. med. i n. o zdr. Beata Chełstowska
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Biuro Konferencji/ Conference Office
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