Refresh GCP
The revision of the ICH-GCP Guideline has come into force on the 14th of June 2017. In fact, the revision maintains the original text from 1996 but adds definitions, clarifications on the existing text and especially adds a comprehensive section on risk-based quality management responsibilities of the sponsor.
In this Interactive GCP Workshop, you will learn about the changes and get an opportunity to better understand the implications of these additions for the quality management system of the sponsor and its suitability for investigator sites in practical terms.
Applying the principles of quality risk management will be the topic of an exercise.
The participants will have to pass a test to get the Certificate of Completion.
- Location: Bucharest, Romania
- Date: 23rd November, 2023
- Trainer : Catalina Sarbu
- This course was tailored for Arensia Exploratory Medicine Bucharest to train his employees and collaborators and suited Arensia’s specific needs, delivered face to face & online.
Booking available after registering on this site.
For discounts and assistance please contact us:
info@avantyo.com
diana.lupu@avantyo.com (0726 840 456)
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
Internationally recognized certification from TransCelerate
This training is for professionals working in clinical trials (Investigators, clinical study teams or referrals, i.e. clinicians, GPs, study coordinators, study nurses), Clinical Research Coordinators, Clinical Research Organizations (CROs), members of Ethics Committees or Competent Authorities, researchers or other research staff.
Dr. Catalina SARBU Secretary General of the Romanian Association of CROs (ACCSCR) Romania
- 2004-2022 GMBA and Director Clinical Operations - PAREXEL International Romania S.R.L.
- 2000-2022 Director of the Romanian Representative office of PAREXEL Nederland BV
- Former President of the CRO Association in Romania (ASSCRC)
- General Practitioner – Center of Hematology, Ploiesti, Romania
- Saint Antoine University, Paris, France - Hematology and Blood Transfusion, 1-year courses
- University of Medicine and Pharmacy, Bucharest, Romania -Medical Doctor Degree
For previous events, please access one of the following links.
