European Regulatory Procedures - EMA & National Requirements

Participants will gain an overview of regulatory submission requirements for marketing authorisations in Europe by an understanding of:

• The EU legislative environment and the key EU Directives and Regulations relating to human medicines
• The legal basis and main features of the various types of authorisation – full, well-established use, hybrids, generics, biosimilars, etc.
• How the EMA, EU institutions and individual national health authorities interact
• The scope, operation and management of the Centralised Procedure
• Key features of the Mutual Recognition (MRP) and Decentralised Procedure (DCP) and factors influencing the choice of procedure
• How changes (variations) to the EU marketing authorization are handled
• Review and navigation of key EU regulatory websites
• Regulatory pathways for specific product types such as orphan, paediatric and advanced therapies
• Challenges to global submissions management presented by EU versus US key differences

Legal Basis for the European Regulation of Medicinal Products

• Historical perspective
• EU Pharmaceutical Legislation Overview
• Review of the key EU Directives and Regulations governing medicinal products
• Legal basis of marketing authorization applications and how data requirements are met
• Main features of the EU Marketing Authorisation (MA)

Understand the EU Institutions for Pharmaceutical Regulation and How they Interact

• European Commission (EC)
• European Medicines Agency (EMA)
• European Directorate for the Quality Of Medicines (EDQM)
• National Competent Authorities and interactions via Heads of Medicines' Agencies/CMDh
• EU Agreements and Co-operation-International, Tripartite, Bilateral and Regional

Regulatory Pathways – the Centralized Procedure

• Overview of the Centralised Procedure (CP)
• Mandatory versus Optional Scope
• Consultations with EMA and Pre-submission activities
• Managing procedural phases up to adoption of the final CHMP opinion, including written and oral presentations
• The CHMP opinion and post-opinion activities – possible outcomes and their implications

Review and Navigation of the European Medicines Agency Website

• This interactive session will give ample opportunity to ensure participants are familiar with locating available guidances and procedural documentation on the EMA website as well as exploiting the publicly available product-specific information to view the decision-making procedures used by the EMA in assessing and reaching its opinion

Decentralized and Mutual Recognition Procedures-Practical Considerations

• Key features and differences of DCP and MRP
• Role of the Reference Member State (RMS) and booking your RMS slot
• The role of the Co-ordination Group – CMD(h)
• Planning and managing MRP and DCP
• Referrals (Article 30 and 31)

Variations to the EU Marketing Authorization (Post-Approval Changes)

• Background and key elements of the variations procedure
• Implementing texts and guidelines
• Options for filing “unforeseen” changes
• Grouping and Worksharing
• Role of the CMDh

EU Regulatory Innovations for Specific Groups

• Orphan medicinal product incentives
• Paediatric development incentives – the PUMA and extension to patent protection
• Traditional Herbal Medicinal Products Certification– a simplified registration scheme
• Advanced Therapy Medicinal Products (ATMPs)-additional provisions governing these
• Conditional Marketing Authorisation, Exceptional Circumstances and Accelerated Review

Workshop on developing an EU Regulatory Filing Strategy

• This interactive workshop session will engage participants in a case study, to evaluate the various options for the submission of a marketing authorization application, in order to inform the corporate regulatory strategy for the compound in the EU

Challenges to Global Submissions Management: EU versus US Key Differences

• Regional differences in Common Technical Document Administrative information
• Role of Module 2 summaries
• Incorporation of additional EU technical requirements, use of CEPs
• Presenting EU Product Information: SmPC, Package Leaflet, Labeling
• Managing divergence in EU procedures, e.g. national MAs, MRP/DCP referrals

Emerging Trends Impacting on EU Pharmaceutical Registration, including

• Emerging topics presented are updated continually e.g. Health Technology Assessment, Prescription to non-prescription switches, EMA Reflection papers, etc.

"Very well organized and a very engaged course director. This was a very comprehensive course and its focus was adapted to the audience."

Kelly H., Medical Writer, Galapagos NV

"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