GoingToMeet

You will learn about:

* The current regulatory system and efforts towards creating a harmonised European framework
* Understanding your role in the context of drug development and clinical affairs
* Ensuring that clinical trials meet with regulatory approval in Europe
* Routes to obtaining Scientific Advice in Europe
* Submission formats and building successful dossiers for Europe, including the eCTD
* Key benefits and drawbacks of the centralised, decentralised and mutual recognition procedures
* What the regulators look for in Readability Testing
* Regulatory requirements for orphan drugs and paediatric research
* The importance of on-going pharmacovigilance and risk management