Introduction to European Regulatory Affairs

Optimising “time-to-market” is an increasingly critical requirement for pharmaceutical companies who arechallenged by shrinking pipelines. Tighter standards imposed by regulatory authorities have almost certainly
contributed to a drop in the number of products being launched globally each year.

Are you looking for ways to improve your regulatory affairs activities and optimise drug submission procedures?

This course will provide you with a clear understanding of the EU regulatory structure and ensure that your
submissions meet the standards required by the regulators. The course will focus on understanding the European legal & regulatory environment; the registration procedures that are available, and the structure of the registration dossier. The course will adopt a practical and interactive approach that will enable you to apply what you have learned to your daily work.

The ‘Introduction to European Regulatory Affairs’ course provides an overview of current EU regulatory requirements and procedures for human pharmaceuticals. The emphasis is on procedural, practical and general requirements. Interactive exercises and discussion are an integral part of the programme.

Those new to regulatory affairs, returning after a career break or requiring an overview of all aspects the European regulatory environment will find the course useful. It will also be of value to personnel requiring knowledge of how regulatory affairs influences the pharmaceutical industry, including those involved in development, manufacturing, project management or business planning.

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