Astra Nova is happy to announce the release of an updated Good Clinical Practice online course. This ICH-GCP training is compliant to the latest regulations in the clinical research space and is already available online to the people worldwide. The course is aimed at staff involved in clinical studies and is suitable for people conducting CTIMP (Clinical Trial of an Investigational Medicine Product) and non-CTIMP courses. It is designed to meet all criteria and regulatory requirements of the international regulatory bodies – EMA, FDA and MHRA. Upon successful completion of a test in the end, users get an individual GCP certificate accredited with 6 CPD points by the Faculty of Pharmaceutical Medicine (FPM) in the UK.
What is New in the GCP Training?
We updated the training to cover the latest amendments proposed in the EU Directive 2005/28/EC, as well as all the changes proposed in the Clinical Trial Regulation (CTR) (Regulation (EU) No 536/2014). It aims to train the participants on the International Conference on Harmonization (ICH) E6 Good Clinical Practice – Addendum R2 Guidelines and enable people to effectively apply them in the conduct and monitoring of clinical research in humans.
The training material is divided into 8 different modules that contain topics such as Key Changes brought about by ICH GCP E6 R2 Addendum, Roles and Responsibilities according to ICH-GCP, Drug Compliance and Accountability, Adverse & Serious Adverse Events, etc. In addition, the course includes various exercises, case studies, valuable documents, links, videos and a detailed glossary.
What Will You Learn?
During the GCP Course, the trainees will have the opportunity to receive world-class training in the field of clinical trials and good practices. Principles of ICH-GCP, Risk Assessment, Roles and Responsibilities according to ICH-GCP and The Purpose of Ethics Committee are only a few of the themes included in the course.
The interactive online GCP course aims to ensure that:
- the rights, safety, and well-being of human subjects are protected
- clinical trials are conducted following approved plans with rigour and integrity
- data derived from clinical trials is reliable
Get a Certification
Upon successful course and test completion, you will receive an individual ICH-GCP (International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) certificate. Pharmaceutical and biotech companies, as well as Contract Research Organizations, recommend that their employees possess a valid certificate. With an Advanced ICH-GCP Certification (AGCPC), you get the training you need in a convenient and interactive way!