Comprehensive Overview of European Regulatory Procedures - EU and Member State Submission Requirements™

Course Description

This course will give participants the necessary overview of the applications and procedures used within Europe to grant marketing authorizations for medicinal products, as well as, the agencies and institutions which control the regulatory process. While special focus will be given to the European Medicines Agency (EMA) and it’s centralized procedure, the role of localized national health authorities and other EU bodies will be discussed in depth. The course will also cover topics relating to registration of specific groups of products such as orphan and pediatric medicines, as well as, advanced therapy and herbal product requirements.

The current regulatory climate will be discussed in depth and, from a regulatory agency’s perspective, will include examples of common filing deficiencies to avoid. Additionally, key differences between US and EU application dossiers will be examined in detail. This will also include an examination of emerging trends which are already affecting, or are likely to impact, future regulatory filing requirements.

Who Should Attend

This topics delivered in this two-day course provide both a comprehensive overview of regulatory filing requirements in Europe for new Regulatory Affairs professionals in the pharmaceutical, biopharmaceutical and generic drug industries, as well as, benefiting experienced staff who need to be aware of changes and trends in regulatory procedures.

Personnel whose responsibilities require knowledge of the EU and European country regulatory environment, such as Project Managers and those in Clinical, Non-Clinical, Manufacturing and Quality areas will also find this training highly relevant.

Learning Objectives

This course is designed to provide an overview of the regulatory environment throughout Europe and will provide training in:

• The key EU Directives and Regulations governing the pharmaceutical, biopharmaceutical and generic drug industries
• The various legal types of authorization under which products are marketed in Europe
• How the EU institutions and individual countries within Europe interact
• The scope, operation and management of the centralized procedure
• Practical issues in the decision to use MRP and DCP regulatory application routes
• How changes (variations) to the EU marketing authorization are handled
• Transparency in regulatory decision making
• Requirements for specific product types such as orphan, pediatric and advanced therapies
• Challenges for global companies in generating a common set of registration documents
• Understanding the concerns and issues of European Regulatory Personnel
• How emerging trends in EU healthcare are likely to impact regulatory procedures

Past Participants' Comments

"The course was well structured and documented, but what made it outstanding was the presentation by the instructor. The knowledge and experience of the Course Director was quite evident and her presentation and communication skills helped to effectively deliver the complex topic to an audience with different background. She was very attentive to questions and used many real-life examples to illustrate the regulations." Gregor D., Regulatory Affairs Manager, NxStage Medical 

"The Course Director is very knowledgeable in EU regulations and current expectations for submissions.  I appreciated the detailed course and follow up to questions I had." Synthia L., Manager, R&D, Watson Labs 

"Director did an excellent job of presenting an otherwise very dry topic and maintaining class attention and interest. I think this is particularly due to the fact that she is hands on and highly experienced. Very nice and interesting presenter." John B., Mgr, Operations Engineering, Promega