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Next: Clinical Trials Symposium on 18th November, 2022

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 is a one year course with 12 modules.

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.

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