The QARP is an international team of coaching trainers, experts, and auditors in Clinical Trials
Of experience in the international clinical trials market (since 2015)
completed Russian and English trainings and workshops in Clinical Trial area
audits in various GxP areas worldwide (including site quality control visit)
pre-inspection audits and FDA, EMA and Federal Service for Surveillance in Healthcare (Roszdravnadzor) inspections hosting
Our goals |
The QARP goal is to develop an interactive platform for an open discussion regarding Clinical Trials and quality management aspects for experts. We perform trainings, workshops, and develop new educational techniques
We have teamed up to improve educational principles and paradigms for experts
Consulting in development and maintenance of Quality Management System and Regulatory Affairs
Independent international GCP auditor
Maxim Bunimovich is an International GCP auditor, QA consultant, trainer with a considerable experience in audits and inspections of study sites in various countries worldwide (EU, CIS, Africa), as well as practical experience in development of quality management systems for CRO and sites (over 10 years of experience).
Expert, independent auditor and trainer in Good Clinical Practice, The QARP
Alena Kulikova is a clinical trial expert who has a vast knowledge and practical experience in organisation, coordination, monitoring, quality verification, and audit of clinical trials, as well as training of all involved parties. She has significant experience in organisation and performance of trainings at the international level for hundreds of CT specialists throughout Europe and the Middle East.
The QARP Expert in Good Clinical Laboratory Practice
Polina Gremyakova is highly proficient in performance of laboratory audits, development and generation of quality management systems of laboratories performing analyses in clinical trials (GCLP). She is experienced in laboratory certification for conformity with GLP and ISO 9001:2015 requirements.
Dr. Hanna PreuS, MRQA
Director, Clinical Quality Assurance (Global Process and Continuous Improvement Lead), Astellas Pharma
Global Quality & Compliance Expert, Auditor and Business Strategist
Quality Culture & Quality Management System
Operational Excellence, Process Compliance and Agile Project Management
Clinical Operations and Quality Strategy
Business Integration and Process Improvement
Broad experience in regulatory and GxP standards
Paul MacMahon, RQA
Experienced Quality Assurance (QA) auditor since 2007 with experience in GLP/GCP CRO organisations working to both UK/EU and international regulatory requirements.
Is an experienced Quality Assurance professional covering both GCP and CSV
Sabrina Dey is an experienced Quality Assurance professional, being highly proficient both in GCP and CSV. She has significant experience in the management of numerous QA activities including but not limited to: the conduct of GxP audits, training, and SOPs oversight and management.