Training

The EMEACR Academy has been developed with an emphasis on providing training to individuals with or without clinical trial experience who would benefit from basic or supplementary training or refresher courses.

The training focuses on the fundamentals of clinical research, based on ICH/GCP guidelines, EU Directives, and FDA/EMEA or regional regulations. Course materials have been designed for the training of naïve and experienced investigator site personnel, new monitors, and experienced monitors in need of formal training.

The training program format is flexible and customizable. It can be conducted at the client's place of business, thereby offering a significant savings of both time and expense. If a more formal or larger training venue is appropriate, our trainers can host the training at venues worldwide. We also provide online training facilities which may prove more convenient for your organisation, please see below for details.

The EMEACR Academy training covers a wide spectrum of organisations - local Health Authority accreditation is being sought where appropriate.

 

EMEACR e-Learning Modules

In addition to our Face-to-Face training services we also provide the following online training modules:

ICH GCP Certificate
This module is designed for those individuals who require a documented knowledge of ICH GCP. The Course Manual guides you through ICH GCP in preparation for the examination - bookNow_inline1

Introduction to Clinical Research
The module introduces the pharmaceutical industry and provides an informative overview of the stages of developing a new pharmaceutical product, with particular emphasis on clinical trials - EMEACR Training Course

GCP and Essential Guidelines
This module introduces the background and history to clinical research guidelines and regulations. The module progresses by looking at the relevant guidelines and regulations (ICH GCP, EU and US legislation) and provides an essential foundation for anyone involved or wanting to be involved in clinical research - EMEACR e-learning training modules

Clinical Trial Designs
This online module goes through the various components of clinical design and details the various aspects and considerations of each one. The module explains among other matters the difference between parallel group and cross over trials, single, double and triple blinding, sample size considerations, and difference vs non-inferiority - EMEACR Clinical Trial Designs

Monitoring
The module is designed for anyone who is new to the role of a monitor or is seeking a position as a CRA/Monitor. The module provides the essential foundation to monitoring and contains a practical monitoring exercise to put what you have learned from the module into practice - EMEACR Clinical Trial Designs

Essential Documents
This module details the guidelines and regulations governing essential documents required in GCP, explains what they are and why they are needed as well as providing information about where these should be filed - EMEACR Clinical Trial Designs

Pharmacovigilance for Clinical Trials
This module provides information and guidance on collection, review and reporting requirements in accordance with ICH, EMA and FDA legislation and guidance. The module covers reporting for clinical trials, annual safety updates during drug development and also post-marketing pharmacovigilance requirements -  EMEACR Clinical Trial Designs