Past Training Courses
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This course is designed for those working/interacting with vendors to deliver your clinical trials. How do you ensure you manage them to optimise your clinical trial delivery? What is required for compliant vendor oversight? What could put you at risk of inspection findings? Do you require a governance system with your vendors? How should you implement this for your outsourcing model and how will it add value? What is the best approach to maintain healthy business relationships when outsourcing? How do you drive performance transparency through use of metrics?
It is aimed at Clinical Development Staff, including those working in Clinical Outsourcing, Contracts and Outsourcing, Clinical Quality Assurance, Clinical Quality Control, Clinical Operations, Vendor Management, Global QA/Compliance and Regulatory Affairs.Find out more »
This highly interactive course with a balance of information, workshops, exercises and quizzes offers a general overview of the drug development process.
It is addressed to 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 »
ICH GCP Refresher including Inspections, Current Issues and Hot Topics – date in 2020 to be confirmed
This course offers practical guidance/advice on how to ensure readiness for Health Authority inspections, both of Sponsor and Investigator sites, an update and refresh of ICH-GCP, including E6R2 as well as current issues and hot topics.Find out more »
The new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC). It was originally due to come into effect in 2016, however implementation has been delayed until the new portal and clinical trial database have been completed and audited. 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.
This course is ideal for anyone requiring an overview of the EU Clinical Trial Regulation and changes for EU trials.Find out more »