ICH GCP TRAINING FOR SPONSORS
- Principles and background of ICH Good Clinical Practice (GCP)
- Responsibilities of the Sponsor according to section 5 of ICH GCP in all stages of the trial
- Ethical and scientific quality standards that lead to reliable trial results
- Quality management, internal quality controls, and quality assurance during the trial set-up
- Sponsor’s involvement in gathering data and preparing documents to submit to the IRB/IEC, the reviewing committee
- Ethical review that happens prior to the first subject entering a trial
- Sponsor’s role during the trial including monitoring the quality of the conduct of the trial, IP Management, Safety, and quality controls
- Requirements for closing the trial and archiving
EU CTR FOUNDATION
- Goal EU CTR and difference between a Directive and Regulation
- Scope of EU CTR: to which type of research is the EU CTR applicable?
- High-level contents of the EU CTR
- Opportunities, benefits, and challenges of the EU CTRand submissions via the CTIS portal
- When will the EU CTR be implemented and what does the transition period look like?
- Timelines of the submission- and review process according to the EU CTR regulation
- Differences in the submission of a national trial and an international trial
- Results of the validation phase, Assessment part I and assessment part II
- Differences in the submission of investigator-initiated trials and sponsor (pharma/biotech) initiated trials
ICH GCP for Sponsors. The self-paced online training gives you a practical understanding of ICH GCP guidelines for Sponsors. It is a solution for clinical research professionals who initiate and monitor international clinical trials in ICH regions. It is specifically for those who need to be aware of the sponsor responsibilities as laid down in Chapter 5 of the Good Clinical Practice guidelines applicable to clinical research with human subjects. This training is applicable for CRA’s, research coordinators, and sponsor’s. It allows you to initiate clinical research in ICH. The online training translates the GCP framework to practice and gives you the tools to directly implement the knowledge in your daily practice. The training consist in a logical order: from the design to the close-out of a clinical trial. The training modules are divided into chapters of 10 minutes and consist of the guidelines which apply to international clinical trials, including the Declaration of Helsinki, and ICH GCP E6 Addendum R2. After you have completed all components of the ICH GCP e-learning course, you will receive a GCP Certificate. EU CTR FOUNDATION. The EU CTR Foundation course for clinical trials in Europe explains the principles of the new regulation, clarifies the critical timelines, and helps you understand the changes that are applicable since January 31st 2022. After completion of all the training modules, you will receive an online EU CTR certificate. The EU CTR training is intended for anyone who is responsible for product development and management, drug research design, and/ or strategic decisions. This course is perfect for research and science coordinators, principal investigators (investigator-initiated research), sponsors, medical directors, head of ClinOps, study directors, project managers, CRAs, monitors, and people responsible for submitting dossiers. Both training courses include one year of access to online training. With our continuous learning model, we will keep you up-to-date with changing regulations and guidelines. • Acknowledged GCP and EU CTR certificate • Efficient and interactive learning • Optimal mix: online modular training and daily GCP practice in an instructor-led classroom session The program of the classroom session is tailored to the needs of the attendees (maximum 20) and allows interaction. You are challenged to apply your GCP knowledge to solve practical case studies. You will exchange knowledge and experiences with your peers and have in-depth discussions with the trainer to maximize your learning experience.