Quality is a certain degree of perfection (Plato)
When we buy a car, we expect a number of its features, certainly depending on its price, age, technical condition and class of the car. And in fact, we get a product with a list of certain attributes. Most of them testify to the quality of workmanship or the service to which the vehicle was subject before it came into our possession. However, not all of them are equally important to us. We will spend a lot of time making sure that the brakes are working properly and that the headlights are on. The statutory car diagnostician will also take care of this during the technical examination. However, it will not check, and for us it will not be crucial, how quickly the electric sunroof opens (or in the case of an old car - whether it opens at all ...).
Therefore, we can see that the concept of quality covers many non-obvious shades.
- During our meeting, we will consider what quality is in clinical trials.
- Which elements of our work are key to the correctness of the process, and which are a nice, but not necessary addition.
- We will focus on the question of what is data integrity? Why is it so important in clinical trials? What are the discussions about it among the FDA / MHRA? Data Integrity is important as the lights in the car or should we place it lower on the scale of importance?
We will talk about this and other aspects of Data Integrity at the next Webinar of We! Clinical Research movement, whose guest will be Łukasz Dzioba, Director, Global Quality Assurance at Accelerated Enrollment Solutions and Andrzej Szczęsny, Product Vigilance Policy Lead at Johnson & Johnson Poland.
Organizational matters
Time and place: Wednesday, January 26, 2022 at 6:00 p.m.
Online - Zoom Meeting
The seminar will be conducted in Polish. Technical issues will be communicated to those registered with a link to the event.
We act and support!
Every activity of the WE! Are the Clinical Research Movement is associated with the support of the Koźmiński Foundation, whose goals include activities for the development of science, education, upbringing and upbringing as well as supporting gifted youth.
The cost of participation in the Seminar is PLN 50, and the entire amount collected is allocated to the activities of the Koźmiński Foundation.
See you at the Seminar!
Łukasz Dzioba jest magistrem biologii i doktorem farmacji. Przez ostatnie 17 lat pełnił wiele funkcji w zakresie jakości GCP we wszystkich fazach badań klinicznych na ludziach po obu stronach barykady – przemysłu i regulatora.
Zaczynał jako przedstawiciel medyczny, następnie zajmował się rejestracją leków, kontrolą jakości, by ostatecznie wyspecjalizować się w zapewnianiu jakości w badaniach klinicznych.
Przeprowadził wiele rodzajów audytów w lokalizacjach na całym świecie. Na stanowiskach managerskich był odpowiedzialny za przygotowania i przebieg inspekcji prowadzonych przez krajowe i międzynarodowe organy regulacyjne, w tym FDA, EMA, MHRA, BefARM, URPL.
Dzisiaj na poziomie globalnym odpowiada za Quality Assurance w bostońskiej Care Access Research LLC.
Nasz gość ma bezpośrednie doświadczenie we wdrażaniu globalnych standardów GCP, budowaniu zgodności operacyjnej, systemach zarządzania jakością oraz różnych aspektach walidacji systemów komputerowych. Dlatego mocno wierzy we wspólne podejście do jakości. Quality Assurance jest istotnym elementem każdego systemu zarządzania jakością, ale nie może odnieść sukcesu bez partnerów operacyjnych, którzy chcą stworzyć prawdziwe środowisko jakości.
Prywatnie pasjonuje się wspinaczką i pieczeniem chleba na zakwasie.
Clinical Research Associate skills and experience from feasibility to closure of studies,
Clinical Trial Coordinator and Clinical Trial Manager skills and experience - management of the local project teams through the various stages of the clinical processes,
Clinical Research Manager experience - management of the team of CRAs and CTAs supervision and support of the team, team building, etc.
Associate Director - management of the local unit of the multinational CRO, Local Head of the Unit responsible for overall activities of the team of CTAs, CRAs, administrative staff and IT infrastructure.
International Project Manager - responsible for multinational, cross-cultural, metabolic study.
GCP Manager/Regional GCP Manager, Quality and Compliance Manager - deep understanding of the GCP processes and support for quality-oriented activities.
Specialties: negotiations, logistics, agreements, problem-solving, difficult situations, risk-based scenarios evaluation, passionate of CAPA processes