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These days, both clinical effectiveness and 'value for money' are essential and pharma companies must navigate an increasingly complex re-imbursement landscape to make sure the product reaches the patients for whom it is intended. This course provides an introduction to the dynamics and challenges of Market Access in assuring pharmaceutical brands reach the patients.
It will provide those active in, or working with the Healthcare Industry, an introduction to the Market Access dynamics and challenges.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 »
The aim of this 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 work place.
This leading Project Management and Clinical Trial Management course is specifically designed for the Clinical Trials Professionals including Clinical Trial Coordinators who want to develop effective clinical trial management and clinical trial project management skills.Find out more »
This course offers a thorough update of the current understanding and interpretation of Good Clinical Practice including the changes to ICH-GCP E6 R2, current issues and hot topics as well as practical guidance/advice on how to ensure readiness for Health Authority inspections, both of Sponsor and Investigator sites.Find out more »
This course is designed for those with little or no experience in clinical research or those seeking an overview of the clinical research process, regulations, terminology, acronyms, roles and responsibilities within clinical research.
It is aimed at Clinical Research Assistants, support staff and persons with related functions (eg. IT Support Staff).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 »
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 as we start right at the beginning with the basics. It will be non-software focused, but rather understanding the basic statistical concepts, interpreting output and discussing how the knowledge can be…Find out more »
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? Who should attend? This course is designed for anyone involved in or those seeking a better understanding of vendor management and vendor oversight: Clinical Development Staff, including those…Find out more »