European Regulatory Procedures: European Medicines Agency (EMA) and National Requirements

Participants will gain an overview of regulatory submission requirements for marketing authorizations (MAs) in Europe. This course covers:

• The EU legislative environment and the key EU directives and regulations that relate to human medicines.
• The legal basis and main features of the various types of authorisation, including the full, well-established use, hybrids, generics and biosimilars.
• How the EMA, EU institutions and individual national health authorities interact.
• The scope, operation and management of the CP, which allows pharmaceutical companies to submit a single application to the EMA.
• The MRP and DCP regulatory pathways for authorizing medicines across multiple EU Member States or European Economic Area (EEA) countries simultaneously. 
• How changes or 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.
• Key difference in the EU and the United States' challenges with global submissions management.

Learn what to expect throughout this European Common Technical Document (CTD) submission training.

Section 1: Legal Basis for the European Regulation of Medicinal Products

At the start of this course, we'll cover:

• Historical perspectives
• EU Pharmaceutical Legislation overviews
• Review of the key EU Directives and Regulations that govern medicinal products
• The legal basis of marketing authorization applications and how data requirements are met
• The main features of the EU MAs

Section 2: Understand the EU Institutions for Pharmaceutical Regulation and How They Interact

We'll review the following:

• European Commission (EC)
• EMA
• European Directorate for the Quality Of Medicines (EDQM)
• NCA and interactions via Heads of Medicines' Agencies/CMDh
• EU Agreements and co-operation that's international, tripartite, bilateral or regional

Section 3: CPs for Regulatory Pathways

The next section will cover:

• An overview of CPs
• Mandatory versus optional scopes
• Consultations with EMAs and pre-submission activities
• Managing procedural phases up to the adoption of the final Committee for Medicinal Products for Human Use (CHMP) opinion, including written and oral presentations
• The CHMP opinion and post-opinion activities, including the possible outcomes and their implications

Section 4: Review and Navigation of the EMA Website

This interactive session will give ample opportunity to ensure participants are familiar with locating available guidance 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.

Section 5: Practical Considerations for DCPs and MRPs

Our EU pharmaceutical submission workshop covers:

• Key features and differences of DCPs and MRPs
• Role of the Reference Member State (RMS) and booking your RMS slot
• The role of the Co-ordination Group, or CMD(h)
• Planning and managing MRPs and DCPs
• Referrals (Articles 30 and 31)

Section 6: Variations to the EU Marketing Authorization (Post-Approval Changes)

Course attendees will review:

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

Section 7: EU Regulatory Innovations for Specific Groups

Special considerations must be made for patients and consumers who meet certain criteria. Our training covers:

• Orphan medicinal product incentives
• Paediatric development incentives, including the PUMA and extension to patent protection
• The Traditional Herbal Medicinal Products Certification, which is a simplified registration scheme
• Advanced Therapy Medicinal Products (ATMPs) and the additional provisions governing these
• Conditional MAs, exceptional circumstances and accelerated review processes

Section 8: 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. This hands-on activity helps inform attendees about the corporate regulatory strategy for the compound in the EU.

Section 9: Challenges to Global Submissions Management: EU versus U.S. Key Differences

We'll discuss:

• Regional differences in Certification of Suitability (CTD) administrative information
• Role of Module 2 summaries
• Incorporation of additional EU technical requirements and the use of CEPs
• Presenting EU Product Information via SmPCs, package leaflets and labeling
• Managing divergence in EU procedures, such as national MAs or MRP and DCP referrals

Section 10:Emerging Trends That Impact the EU Pharmaceutical Registration

We'll discuss relevant topics, such as:

• Health technology assessments.
• Prescription to non-prescription switches.
• EMA Reflection papers.

See what attendees say about this training program. 

"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