The aim of this virtual 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.

The definition of Market Access is the process to ensure that the right patients who would benefit from a medication, get rapid and maintained access to the medication, at the right time. 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 and is especially useful to those who want to know what Market Access really is! It has been designed for professionals working in the pharmaceutical industry, particularly those in Drug Development, Regulatory Affairs, Medical Affairs who want to learn about the role Market Access plays in providing access of pharmaceutical brands to patients.

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.

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.

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.