European Regulatory Affairs School

This practical 3-day course is designed to provide you with essential regulatory affairs information that is necessary for your role. The objective is for you to understand the importance of the regulations and broaden your knowledge of the field.With ever-changing regulations and tighter standards you need to be aware of  the very latest developments to ensure you and your company remain compliant.

Our expert panel will take you through all the regulatory stages from drug discovery to receiving regulatory approval. By the end of day 3 you will have a firm understanding of the pharmaceutical regulatory framework. You will learn what the authorisations and submission process involves, the impact and challenges of the Clinical Trials Directive, how to manage legal issues and how to prepare for inspections.

You will confidently walk away with a clear picture of how different departments and functions fit together and what your role is within this complex environment.

• Understanding the role of the national regulators and the European Medicines Agency (EMA)
• Electronic submissions in regulatory affairs, including the eCTD
• Building a successful dossier for submission

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