European Regulatory Procedures-EMA & National Requirements

Whether you are refreshing your knowledge of regulatory procedures in the drug industry, or are brand new to the field, the European Regulatory Procedures course is designed for you. If you work in a field that requires you to have a thorough knowledge of EMA and other national requirements in European countries (such as CP), this course also contains training that will get you started. What is this course exactly, and what can you expect from it?

Brief Course Description

This is a two-day course that provides a basic overview of regulatory procedures in Europe pertaining to the drug industry, pharmaceutical industry, and biopharmaceutical industry. The course covers topics such as:

• European Medicines Agency (EMA) procedures
• Centralised Procedure (CP)
• Mutual Recognition Procedure (MRP)
• Decentralised Procedure (DCP)
• How to choose the right procedure
• Procedure management
• Variations in authorization
• Transparency of regulations
• Emerging trends that will impact these regulations in the future

Day one of the course takes you through the various procedures, while day two includes interactive workshops and a deeper look into the differences between EU regulatory procedures and other regulatory procedures from outside Europe.

What You Need to Know

The course is held over two days, both of which run from 9:00 to 5:00. Breakfast and lunch are included on both days.

You do not need to have any past experience in any of the subject matter. Everything is presented in an easy-to-understand format for beginners. Real-life examples are used to explain complex legal topics.

The course is taught by an experienced ex-regulator. Both detailed explanations and answers to all your questions are offered during the two-day course, and the presenter is regularly commended for offering hands-on instruction that helps all attendees leave with a great understanding of the information.

Is This Course Right for You?

The course is perfect for the following:

• A professional working in the regulatory affairs field who wants to deepen their understanding of how to choose the right regulatory submission standards
   
• Any person that is new to the regulatory affairs career field
   
• Any person, regardless of career, who wants to understand the basics of European regulatory affairs better
   
• Project managers who regularly need to manage submissions to any of these agencies
   
• Clinical and Non-Clinical medical professionals
   
• Anyone working in pharmaceutical or generic drug manufacturing or quality control

What Will You Come Away With?

After taking this course, you will come away with a thorough understanding of the EU regulations environment, as well as:

• The legal complexities that govern authorization
• How all the national health agencies work together
• The key features and benefits of each major regulatory procedure
• The way changes and variations to authorization are handled
• How to properly use the EU regulatory online tools
• The avenues for regulation for things such as pediatric and orphan therapies
• The differences between EU regulatory authority procedures, and those from elsewhere

Register Online for Early Bird Savings

If you register at least one month before the next available course, you will get a discounted tuition rate. Find out more and register online.