Postgraduates for Project Management in clinical trials
The post-graduates course for project management in clinical trials covers all ICH Efficacy Guidelines (E1-E8). This training is face to face and online with weekends module.
The program provides a structured approach to developing knowledge and skills which will enable you to develop your research portfolio or, more commonly, assist in the management of an existing portfolio.
This course provides knowledge and understanding of key topics including clinical trial design, the critical pathway for drug development, statistics, good clinical practice and critical appraisal.
You will be equipped with management and communication skills, including problem-solving, project design, decision process, teamwork, written and oral reports as well as become familiar with scientific publications.
- Introduction in clinical research
- Drug Development Process and Clinical Development Plan
- Cooperation of Medical Affairs, Clinical Development and Clinical Operations
- Regulatory Affairs from Plan to Labeling
- General Project Team Management
- Ethics in Clinical Research & Studies in Vulnerable Subjects
- Principles of Conducting Clinical Research
- Designing Clinical Trials
- Statistics in Clinical Research
- Data Processing & Management in Clinical Research
- Project Management in Clinical Research
- Monitoring in Clinical Research
- External Providers (Vendors) in Clinical Research
- Patients recruitment and retention
- Legal aspects
- Risk management
- Pharmacovigilance and Drug Safety in Clinical Research
- Quality Management Systems in Clinical Research
- Audits
- Financial Aspects in Clinical Research
- Medical writing
- Bioequivalence and Phase 1 Clinical Trials
- Clinical Research in Pediatric
- Clinical Research in Medical Devices
- Health Care Services and Community Economical Benefits of Clinical Research
- Clinical Research in Romania (facultative)
- Clinical Trials Utilization
- Wrap-up and Final Test
Come back soon for more information about this course!
If you would like to be placed on a waiting list for the next course or you need something else, please let us know at info@avantyo.com. Do not forget to mention your specific education needs in clinical trials.
The post-graduates course for project management in clinical trials is dedicated to Clinical Research Associates (CRA), Senior Clinical Research Associates (CRA), Junior Clinical Associates, Clinical Research Assistants (CTA), Investigators, Nurses, Monitors or any other professionals with at least one year experience in clinical research.
For previous events, please access one of the following links.
