GCP R3 - what's new and how to put regulations into practice?

Clinical research expert with more than 20 years of international experience, which she has gained working in pharmaceutical companies and CROs - including Poland, the UK, Singapore and Japan. She is involved in quality strategy and implementation of innovative solutions in the field of clinical research.

He specializes in audits of all phases of clinical trials, building and improving quality culture (Culture of Quality), quality management systems (Quality Management System), ensuring process compliance (Process Compliance) and risk management (Risk Management) of clinical trials aimed at ensuring the safety of participants and improving the lives of patients, as well as ensuring the integrity and reliability of clinical trial data.

She is involved in Process Improvement (Global Process and Continuous Improvement), Operational Optimization (Operational Excellence), and is responsible for the development of operational and quality systems based on regulations concerning, among other things, the use of technology in clinical trials, decentralization of clinical trials, Good Clinical Practice (GCP), and clinical trial planning and organization.

She completed her doctoral studies in economic sciences (economics) and received a PhD in social sciences in the discipline of public policy sciences on the basis of her distinguished dissertation "Socio-economic aspects of the clinical research system in Poland."

She has earned the distinction of Fellow Member awarded by the Research Quality Association (RQA). She is an experienced university lecturer, mentor to support professional development and speaker at international conferences and meetings in Europe, Asia and the USA.

She has authored and co-authored articles in Polish and international publications on clinical trials, a book entitled "Clinical trials - challenges and perspectives. "Clinical trials - challenges and prospects for development" and "Clinical trials. Practice, Law, Ethics".

Founder and CEO of INDICRO Ltd

Trish Parry is a training and clinical research consultant with 34 years’ global experience and is also the founder and CEO of INDICRO Ltd.  She has supported sponsors with their Clinical Quality Management Systems, clinical trial design and planning, clinical trial set up, clinical project management for all stages of clinical trials, Research Ethics Committee and regulatory submissions, vendor management and oversight, medical writing, monitoring and co-monitoring. She has experience of all phases of clinical trials and in international roles ranging from CRA to Director of Clinical Operations. Trish was a Clinical Subject Matter Expert for 2.5 years in the UK Government Vaccines Taskforce during the COVID-19 pandemic.

She has developed and delivered many Transcelerate accredited courses and workshops on Good Clinical Practice to sponsors, investigators and universities internationally.

More recently, in May 2023, she founded INDICRO Ltd., a digital hub connecting Life Science R&D Freelancers, Companies and Service Providers.

Trish is author of Statistics in Clinical Research (The Institute of Clinical Research, 2004) and was on the Editorial Board of the Institute of Clinical Research’s Journal, CRFocus from 2005-2014. Trish is one of the founders of the UK Institute of Clinical Research Trainers Forum, is Co-Chair of the Institute of Clinical Research Ethics and GCP Forum and a Sub-Leader for the UK Clinical Trials Talent Taskforce (CTTT). She is a Chartered Scientist and a member of Research Quality Assurance (RQA), Bioindustry Association (BIA), Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI) and the UK based Independent Clinical Research Freelance Network (ICRFN).  Trish founded Otus Clinical Services Limited in 2004, and has provided consulting services to the clinical research community through Otus for the last 20 years.  
 

Mr Kosieradzki leads the company KOSIERADZKI.com which organizes and performs all types of audits of clinical trials, implements, improves and maintains Quality Assurance Systems (QMS-GCP) for its clients. He is anesthesiologist, a GCP auditor of clinical trials with experience from CRO (Kendle->INC) and pharmaceutical companies (Janssen, Polpharma Biologics). The fan of process mapping, meaningful procedures and effective quality assurance systems. As a trainer and mock inspector, he prepares clinical trial sponsors and trial sites for EMEA, MHRA and FDA inspections. Mr Kosieradzki conducts original training courses at www.AcademyGCP.com and  takes part at international conferences and industry training courses like a speaker. He also trains auditors in audit methodology. Tomasz Kosieradzki headed the training group at the Association for Good Clinical Practice in Poland (GCPpl) and is a member of the Research Quality Association (RQA). He writes for the journal Clinical Research, blogs about clinical trials at www.BlogGCP.pl and is the author of the chapter "Quality, Audit and Inspections in Clinical Trials" in the book "Clinical Trials, Practice, Law, Ethics", CeDEW 2024.

Prof. Edward Czerwinski, MD, is a retired Jagiellonian University professor with 52 years of professional experience as an orthopedist and traumatologist. He worked for 36 years at the Department of Orthopedics of the Jagiellonian University Medical College, including six years as its head. Founder (1995) and director of Krakow Medical Center (until 2020), currently Senior Medical Director of Futuremeds. At KCM, he completed 180 clinical trials, and was principal investigator in 58 projects. Almost all drugs introduced for the treatment of osteoporosis were studied at KCM.

He has been involved in bone and joint diseases for 41 years, first in fluorosis (habilitation) and for 31 years in osteoporosis. Since 2007, together with the National Specialist and President of PTOiTr, he has been developing “Principles of prevention, diagnosis and treatment of osteoporotic bone fractures” every 2 years. Founder of the Polish Society of Osteopathology, creator and animator of the Polish Osteoporosis Portal. 

Prof. E. Czerwinski collaborated with Prof. John Kanis in the development of the FRAX® calculator for the Polish population. He was appointed to the panel of experts working on international standards concerning, among others: management after osteoporotic fracture EULAR/ EFORT and recommended level of Vitamin D3 IOF. Since 1994, Prof. E. Czerwinski has organized 27 symposia and congresses in the field of orthopedics and osteoporosis, with about 14,000 participants. Since 1996, he has organized the Central European Congresses on Osteoporosis and Osteoarthrosis. In 2002, he organized Poland's first international curricula.

In his free time, Professor Czerwiński enjoys solitary mountain hikes, especially in the Tatra and Bieszczady Mountains, skiing, Polish rivers and lakes, and exotic travel. His greatest passions are photography and music. More www.eczerwinski.pl.