European Regulatory Procedures - Comprehensive Overview of EMA and National Requirements™

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COURSE DETAILS

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, and of the agencies and institutions that control the regulatory process.  Special focus will be on the European Medicines Agency and the centralised procedure, with the role of the national health authorities and other EU bodies in the mutual recognition and decentralized procedures explained also.  The course will cover topics relating to registration of specific groups of products such as orphan and paediatric medicinal products, as well as advanced therapy and herbal product requirements. 

The current regulatory climate will be discussed in depth with examples of common filing deficiencies and how to avoid them, provided from the regulator’s perspective, as well as highlighting key differences between US and EU application dossiers.  The impact of key emerging trends already affecting or likely to impact on regulatory filing requirements in the future will be discussed.

Who Should Attend

 

An experienced ex-regulator will deliver this course and provide a comprehensive overview of the regulatory filing requirements in Europe. The course will be of value to both those who are new Regulatory Affairs in the pharmaceutical, biopharmaceutical and generic drug industries, as well as experienced professionals wishing to refresh their regulatory knowledge. 

Personnel whose responsibilities require knowledge of the EMA 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:

  • What are the key EU Directives and Regulations governing regulation of pharmaceuticals
  • The various legal types of authorisation 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, paediatric & advanced therapies
  • Challenges for global companies in generating a common set of registration documents
  • Understanding the concerns and issues of European Regulatory Personnel
  • What emerging trends in EU healthcare are likely to impact upon regulatory procedures

Past Participants' Comments

"The Course Director was very knowledgeable about the subject. She had many insights into real-life experiences and examples which provided enhancements to the material provided. She was very approachable to questions, queries and information on websites. This was a great class!" Tasneem A., QS Auditor, NDC (Nitinol Devices & Components)
"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
"The 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

Frequently Asked Questions

I am a regulatory affairs professional but would like to gain a better understanding of the various European regulatory procedures, in order to assist in regulatory strategy decisions and improve regulatory submission standards. Is this course suitable for me?

The level of information in this course is pitched to provide both a comprehensive overview of regulatory filing requirements in Europe for those relatively new to regulatory affairs as well as benefiting experienced staff who need to be aware of the key roles of the EMA and the various other local health authorities, and understand the advantages and disadvantages of the various European regulatory procedures.

I do not work in a regulatory role but I would like to gain a better understanding of the European regulatory environment and the requirements and procedures used – is this course suitable for me?

This course provides an ideal basis also for non-regulatory professionals whose role would benefit from an understanding of the EU and European regulatory environment for pharmaceuticals, biopharmaceuticals and generics. No prior regulatory experience is required as the legal background to regulations and the structures and functions of the various European institutions is handled in a user-friendly manner. Past participants from roles as diverse as operations for medical devices and clinical project managers have all been very positive about the benefits of attending this course.

Will this course cover European clinical trial submission requirements?

This course is focused on the regulatory procedures leading to the granting of a Marketing Authorisation, either by the European Medicines Agency or a national agency. A separate system, under the responsibility of the national agencies, deals with Clinical Trial Authorisation. See the CfPIE course , 'the EU Clinical Trial Directive'.

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