Introductory Course: Current EU Regulatory Practices

The Regulatory Affairs function within the pharmaceutical industry is absolutely pivotal to the successful development and licensing of safe and effective medicines, to the benefit of patients' health worldwide. The TOPRA Introductory Course is chosen by Regulatory Affairs Managers who wish to get their people up-to-speed on current EU regulatory practices.

The Course looks at the bigger picture, focusing not only on EU legislation and regulatory procedures, but also on the central role that Regulatory Affairs plays in a modern pharmaceutical company and in the development of new drugs. The Course will also include the valuable insight from experienced speakers who grapple daily with the challenges of working in a constantly changing regulatory environment.

Overview

The TOPRA Introductory Courses cover all aspects of the regulatory framework for a product’s development, from early non-clinical investigations, through human clinical trials, via manufacturing, testing and supply, to post-approval maintenance and promotional activities. The Course is presented by over 50 speakers and facilitators, all respected authorities in their fields. No other course of its kind enables delegates to interact with so many leading regulatory professionals.

The Spring Introductory Course has been running successfully for 30 years. The Autumn Introductory Course is already in its 14th year. This experience, combined with the feedback we receive from our presenters and delegates, ensures that the TOPRA Introductory Course is always up-to-date and in tune with the needs of the pharmaceutical industry.

• Most comprehensive course available of its kind
• 30 years of experience
• Over 50 speakers and facilitators
• Detailed course notes
• Industry and Regulatory Agency specialists
• European perspective

Who should attend?

Delegates should ideally have a minimum of six months professional regulatory experience to gain maximum benefit from the Course. The Course is also suitable for those wishing to refresh their regulatory knowledge and for allied professionals who want to understand drug development and its interface with Regulatory Affairs.

• People new to Regulatory Affairs who want to acquire a comprehensive foundation
• Regulatory Professionals wishing to update their knowledge
• Allied Professionals wishing to understand the role of Regulatory Affairs

For more information, please visit: www.topra.org/conferences-and-training/introductory-course.