19 - 27 September 2022, Online Course

Joint Project
"New Clinical Stars"
Course for clinical trials professionals (basic level)

The peculiarity of the course
Experts
Instructors 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.
Experience
The QARP has conducted many instances of different trainings all around the world.
Goal
The 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.
Webinars & Practical Assignments
Course is constructed with several webinars, with interactive and practical assignments filling
in the gaps. Approach of The QARP is to deliver engaging and thought-provoking content while also offering stellar education on the matter.
Interactive Technologies and Gamification
The 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 Plaltform
Each 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.
Certificate
After the adequate competition 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, 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
Maxim Bunimovich
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).
Sabrina Dey
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.
Alena Kulikova
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.
Alexandra Sazonova
Talent 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
Day 1

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

Inform consent (Sponsor responsibilities). Electronical ICF


13:00 - 14:15

Inform consent (Sites responsibilities). Workshop and Quiz.

Day 2

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
Day 3
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.
Day 4
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.
Day 5
10:00-11:30
Presentation skills. Workshop.

11:30-11:45
Break

11:45-12:30
Communication skills. Workshop.

Homework
Day 6
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
Day 7
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.
Day 8
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
Day 9
09:00-11:00
Homework

11:00-14:00
The final test.

15:00-17:00
Closing round table and discussion
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