Pharma / Biotech
This course will give participants the necessary overview of the application procedures and regulatory filing pathways used within Europe to grant marketing authorisations for medicinal products, and of the agencies and institutions that control the regulatory process. Special focus will be given to the European Medicines Agency (EMA) and the Centralised Procedure (CP), with the role of the national health authorities and other EU bodies in the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) explained also. Factors affecting the choice of procedure will be discussed, as well as best practice in the management of the procedures. A workshop session will engage participants in a case study evaluating the options for submission of a marketing authorization application.
The course will also outline how variations to the marketing authorisation, as well as authorisation of specific groups of products such as orphan, paediatric, advanced therapy and herbal medicinal products are handled in the EU. The transparency of EU regulatory decision making will be demonstrated via review and navigation of EU regulatory websites. The impact of key emerging trends already affecting or likely to impact on European pharmaceutical registrations in the future will be discussed.
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.
Legal Basis for the European Regulation of Medicinal Products
Understand the EU Institutions for Pharmaceutical Regulation and How they Interact
Regulatory Pathways – the Centralized Procedure
Review and Navigation of the European Medicines Agency Website
Decentralized and Mutual Recognition Procedures-Practical Considerations
Variations to the EU Marketing Authorization (Post-Approval Changes)
EU Regulatory Innovations for Specific Groups
Workshop on developing an EU Regulatory Filing Strategy
Challenges to Global Submissions Management: EU versus US Key Differences
Emerging Trends Impacting on EU Pharmaceutical Registration, including
Participants will gain an overview of regulatory submission requirements for marketing authorisations in Europe by an understanding of:
"I would like especially to commend Course Director, her systematic approach, professionalism, great communication and useful recommendations for many topics and practical dilemmas that I occasionally meet at work. Thanks in advance!" Svetlana M., Medicines and Medical Devices Agency of Serbia
"The Course Director has thorough knowledge, experience and expertise in the topics she taught. She has both industry and regulatory agency views which made her comments objective." Jian C., Regulatory Affairs Manager, Glaxo SmithKline
"The Course Director is an excellent instructor. She was well-organized, very easy to follow and understand, and enthusiastically answered all of our questions that many times extended past course hours. She really knew the subject matter and often gave current examples and trends, which greatly helped us understand. I would definitely attend another training course taught by her." Diane H., Associate Director, Acorda Therapeutics
"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
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.
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.
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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*Valid up to 30 days prior to course date(s). Cannot be combined with other discounts or offers.
The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
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