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The new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC). Key aims of the new Regulation are to harmonise procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submitting clinical trial information through a single point of entry. The go-live of the centralised clinical trial portal is scheduled for December 2021.
This course is ideal for anyone requiring an overview of the EU Clinical Trial Regulation and changes for EU trials. It will provide essential understanding to help with compliance with the new Regulation and associated implementing acts and other texts for carrying out clinical trials in the EU.Find out more »
The aim of this training workshop is to ensure you gain a comprehensive understanding of the tools and techniques of project management and clinical trial management and how they can be applied straight away to your own clinical research projects in the workplace.
It is specifically designed for Clinical Trials Professionals including Clinical Trial Coordinators who want to develop effective clinical trial management and clinical trial project management skills.Find out more »
In modern global pharmaceutical companies it is becoming increasingly important for non-statisticians to understand the value and application of statistics in order to maximise the value of the data. This course is designed for professionals working in the pharmaceutical industry with no or little previous knowledge of statistics.
The objective of the course is not to teach how to become a statistician, but to help to work with statisticians, ask them the right questions and get the maximum value when reviewing statistical output.Find out more »
This course offers a perfect introduction to understanding the complex process of drug development and most relevant tasks and responsibilities within the clinical research setting.
It is designed for those new to or with little experience in clinical research, those in supporting roles and departments or those seeking an overview or needing basic training of the clinical research process, regulations, terminology, acronyms, roles and responsibilities within clinical research.Find out more »
This interactive two-day course provides the perfect introduction to the different phases of drug development, clinical trials and complexity of these fields. The combination of trainer interaction, information sharing, exercises and quizzes guarantee a solid introductory understanding of the topic.
The course is designed for newcomers to the industry, clinical research personnel with up to 2 years experience, those returning to “the sharp edge” of Clinical Operations, scientists working in related areas.Find out more »