REGISTRATION FORM – pivot park – 2 June 2023
BLENDED ICH GCP AND EU CTR training for Sponsors
Blended GMP Quality Oversight training for Sponsors
Training objectives ICH GCP 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
TRAINING OBJECTIVES 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
BLENDED TRAINING: ONLINE & CLASSROOM
Classroom: Friday 2nd June from 09:00 to 12:30h.
The blended ICH GCP and EU CTR training for Sponsors is the optimal mix: learn online about GCP guidelines and EU CTR, at your own pace, and apply the GCP rules to practical situations in an instructor-led classroom session at our training facility at the inspiring life sciences campus Pivot Park in Oss (The Netherlands). For more information check our webpage.
Address for visitors
Pivot Park – site organisation (Building RK)
5349 AB Oss
The campus is situated in Oss, conveniently close to the motorway network. The campus has its own car park for visitors, with a number of EV charging points. Oss railway station is a 7-minute walk from us.
ICH GCP and EU CTR TRAINER
Marieke Meulemans Marieke Meulemans speaks routinely across Europe at industry events and professional organisations. Her expertise and passion for making GCP training accessible for busy professionals and her desire to move beyond the endless powerpoints for training makes her an engaging and passionate trainer.
TRAINING FOR sponsors
This training is applicable for the Quality department, the QMS team, management of pharmaceutical and biotech companies, drug product development leaders, clinical study supply leaders, CMC leaders, and all others involved in quality oversight.
More information or questions call: 085 130 54 89 | Mail: firstname.lastname@example.org
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