Recent changes to the EU clinical trials directive have impacted on the time taken to gain regulatory approval in early clinical development. It is important to submit the relevant data and documentation in the correct format in order to proceed to the next Phase. The time taken for a drug to move on to the next clinical development phase can have a profound impact on the company’s market share. Ensuring regulatory compliance will minimise the time taken to gain approval.

This course to the presents delegates with in-depth knowledge of regulatory affairs strategies in this area in order to expedite Phase I clinical trials and subsequent licensing. This course will equip the participant with the knowledge and confidence to manage all regulatory affairs throughout a Phase I clinical trial.

> Understand the changes to the EU directive for Phase I clinical trials to ensure compliance
> Gain the knowledge necessary to reduce the likelihood of your product being withdrawn after going to market
> Identify the factors which influence approval by the regulatory bodies
> Understand the role of all the regulatory bodies
> Investigate the advantages and disadvantages of using a CRO
> Traverse the mine field of documentation necessary for submission for approval of your Phase I clinical trial
> Explore successful strategies to ensure compliance with current regulatory affairs
> Optimise and maintain your regulatory procedures for Phase I clinical trials within the EEA