06.Dec.2012

OCT conducts GCP training for a large Pharmaceutical Company

OCT is pleased to announce that we are conducting GCP trainings for a large top ten Pharmaceutical Company this autumn. A training has already been conducted in Moscow, Russia.

OCT is pleased to announce that we are conducting GCP trainings for a large top ten Pharmaceutical Company this autumn. A training has already been conducted in Moscow, Russia. The second training will be carried out in Almaty, Kazakhstan. The training in Moscow was performed for 30 principal investigators. In the upcoming training in Kazakhstan there will be 25 principal investigators participating. The person who will be administering the training for this company from OCT will be a very experienced Quality Assurance specialist who has obtained multiple confirming certificates over the years, and is a member of international organizations which subscribe to the GCP standards (e.g., BARQA, etc.)

At OCT, all employees are required to not only be familiar with the GCP but pass an examination with a sufficient score once every year in order to keep the clinical practices fresh in their memory. This goes for everybody at OCT from the legal advisor to the IT and logistics department, not to mention the clinical team who have a much tougher and more thorough understanding and examination when it comes to the test and application. As for the training that OCT provides it is broken down in multiple days and many different parts since there is so much information to obtain when it comes to the GCP. The OCT Quality Assurance Manager does a wonderful job in breaking down the key points when it comes to the GCP. At the beginning of the training there is an assessment test to see how much the people already know about the GCP whether it is the bare minimum or a substantial amount. This first test is not graded it is merely an assessment to find out the participants levels of the GCP knowledge. Then the Quality Assurance (QA) Manager starts with the core of the GCP with the history first, phases and types of clinical trials next, the structure of the GCP along with principals of clinical trials following that, ethical aspects of clinical trials, responsibilities of the researcher, responsibilities of the sponsor, and rules for filling out Case Report Form (CRF) finish out the first day training session. The second day picks up on clinical trial protocol, investigator’s brochure, and adverse events, main stages of clinical research, audit of clinical research, and then the final test with presentation of certificates for those who passed at the required level. The training to a large extent covers the core of the GCP fundamentals.

OCT has had substantial experience in GCP training conducting the required training in house for all of our employees annually. This is also not the first time that a large Pharmaceutical company has asked for our services to conduct GCP training in this department for the investigators with whom they are working in clinical trials. OCT has a very high level Quality Assurance department which conducts all of our in house and external GCP training.

At OCT we hope that the performed trainings will become a useful way of refreshing the existing GCP knowledge, making new interesting contacts, as well as assisting the pharmaceutical company in sustaining excellent quality assurance standards.