19 - 27 September 2022, Online Course
Joint Project
"New Clinical Stars"
Course for clinical trials professionals (basic level)
The peculiarity of the course
- ExpertsInstructors have a breadth of experience in the field of clinical trials: be it the operations or the quality assurance. Some of them work for international giants such as British consulting firms, Global pharmaceutical companies Astellas Pharma, Roche, and Astra Zeneca as well
as independent auditors. - ExperienceThe QARP has conducted many instances of different trainings all around the world.
- GoalThe goal of The QARP is to create a platform which can train an individual without
any relevant experience into a adequate professional, all done online and in engaging manner. - Interactive Technologies and GamificationThe course is constructed with several webinars, with interactive and practical assignments filling
in the gaps. The approach of The QARP is to deliver engaging and thought-provoking content while also offering stellar education on the matter. - Educational PlaltformEach of THEQARP's students gets access to our platform, allowing students
to slightly deviate from the in-class path and better create a plan to tailor to their needs. - CertificateAfter the adequate completion of the course, individuals will receive a Trancelerate certificate, which holds real-world application in terms of finding employment.
Who is this course for?
Course was constructed to be a guidebook for the newer members of this industry, as well as acting as refresher for the seasoned individuals.
Experts
- Dr. Hanna PreuS, MRQADirector, 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
- Maxim BunimovichIndependent international GCP auditorMaxim 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). - Sabrina DeyIs an experienced Quality Assurance professional covering both GCP and CSVSabrina 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.
- Alena KulikovaExpert, independent auditor and trainer in Good Clinical Practice, The QARPAlena 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. - Alexandra SazonovaTalent Acquisition specialist, 10+ years of experience working in major Global CRO (IQVIA), 2000+ filled roles across Europe region from entry level to senior leadership roles
Course program
09:00 - 10:15
Glossary and GCP principles
10:15 - 10:25
Break
10:25 - 12:00
Regulatory authorities and Ethics committee communication. Quiz.
12:00 - 12:15
Break
12:15 - 13:00
Informed Consent (Sponsor responsibilities). Electronical ICF
13:00 - 14:15
Informed Consent (Sites responsibilities). Workshop and Quiz.
Glossary and GCP principles
10:15 - 10:25
Break
10:25 - 12:00
Regulatory authorities and Ethics committee communication. Quiz.
12:00 - 12:15
Break
12:15 - 13:00
Informed Consent (Sponsor responsibilities). Electronical ICF
13:00 - 14:15
Informed Consent (Sites responsibilities). Workshop and Quiz.
13:00 - 14:15
Investigational product (Sponsor responsibilities)
14:15 - 15:30
Investigational product (Investigator responsibilities). Quiz.
15:30-15:45
Break
15:45-17:00
Source documents
Investigational product (Sponsor responsibilities)
14:15 - 15:30
Investigational product (Investigator responsibilities). Quiz.
15:30-15:45
Break
15:45-17:00
Source documents
12:00-13:00
Case Report Form.
13:00-14:00
Safety management (Investigator responsibilities)
14:00-14:15
Break
14:15-15:00
Safety management (Sponsor responsibilities). Quiz.
15:00-16:00
Investigator and trial site responsibilities. Quiz.
16:00-16:15
Break
17:00-17:45
Essential documents. Quiz.
Case Report Form.
13:00-14:00
Safety management (Investigator responsibilities)
14:00-14:15
Break
14:15-15:00
Safety management (Sponsor responsibilities). Quiz.
15:00-16:00
Investigator and trial site responsibilities. Quiz.
16:00-16:15
Break
17:00-17:45
Essential documents. Quiz.
09:00-11:00
Site selection visit. Workshop. Quiz.
11:00-11:15
Break
11:15-12:15
Monitoring, audit, inspection. Quiz.
12:15-12:30
Break
12:30-14:00
Site initiation visit. Workshop. Quiz.
14:00-15:30
Site monitoring visit. Theoretical aspects.
15:30-15:45
Break
15:45-17:15
Site monitoring visit. Workshop.
Site selection visit. Workshop. Quiz.
11:00-11:15
Break
11:15-12:15
Monitoring, audit, inspection. Quiz.
12:15-12:30
Break
12:30-14:00
Site initiation visit. Workshop. Quiz.
14:00-15:30
Site monitoring visit. Theoretical aspects.
15:30-15:45
Break
15:45-17:15
Site monitoring visit. Workshop.
10:00-11:30
Presentation skills. Workshop.
11:30-11:45
Break
11:45-12:30
Communication skills. Workshop.
Homework
Presentation skills. Workshop.
11:30-11:45
Break
11:45-12:30
Communication skills. Workshop.
Homework
09:30-10:15
Risk based monitoring. Remote and centralized visit.
10:15-10:30
Break
10:30-12:00
Close-out visit. Workshop. Quiz.
12:00-12:15
Break
12:15-13:15
Site visit report. Workshop.
13:15-13:45
Homework discussion
Risk based monitoring. Remote and centralized visit.
10:15-10:30
Break
10:30-12:00
Close-out visit. Workshop. Quiz.
12:00-12:15
Break
12:15-13:15
Site visit report. Workshop.
13:15-13:45
Homework discussion
09:00-10:30
Quality management system in clinical trials. Quiz.
10:30-10:40
Break
10:40-12:10
Standard Operating Procedures. Workshop.
12:10-12:20
Break
12:20-13:50
Noncompliance management. CAPA.
13:50-14:30
Break
14:30-15:30
Audit at the clinical trial.
15:30-15:45
Break
15:45-16:30
Regulatory inspection. Workshop.
Quality management system in clinical trials. Quiz.
10:30-10:40
Break
10:40-12:10
Standard Operating Procedures. Workshop.
12:10-12:20
Break
12:20-13:50
Noncompliance management. CAPA.
13:50-14:30
Break
14:30-15:30
Audit at the clinical trial.
15:30-15:45
Break
15:45-16:30
Regulatory inspection. Workshop.
09:00-10:00
English language in clinical trials.
10:00-10:15
Break
10:15-12:00
Job interview and Curriculum vitae.
12:00-15:00
Homework discussion
English language in clinical trials.
10:00-10:15
Break
10:15-12:00
Job interview and Curriculum vitae.
12:00-15:00
Homework discussion
09:00-11:00
Homework
11:00-14:00
The final test.
15:00-17:00
Closing round table and discussion
Homework
11:00-14:00
The final test.
15:00-17:00
Closing round table and discussion
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