Marketing Authorisation Procedures in the EU
A complete guide to EU drug approval procedures
- Comprehensive EU regulatory insights
- Detailed coverage of MRP, DCP and CP
- Expert-led practical guidance
- Certified to ISO 9001 and ISO 21001 standard
Online-Seminar
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
from 09:00 -17:00 CET
Buchungsdetails
Online-Seminar
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
from 09:00 -17:00 CET
This seminar provides an in-depth exploration of EU drug marketing authorisation, focusing on regulatory frameworks, application types and procedures. It covers mutual recognition, decentralised and centralised procedures (MRP, DCP, CP) in detail, providing essential insights for successful EU drug approval.
Your speakers
Gabriele Eibenstein M.A.
-requested-
Senior Expert in Regulatory Affairs, Bonn, GERMANY
Senior Expert in Regulatory Affairs
Ms Eibenstein has extensive expertise in European procedural management, heads the specialist field…
Your speaker
Gabriele Eibenstein M.A.
-requested-
Senior Expert in Regulatory Affairs, Bonn, GERMANY
Senior Expert in Regulatory Affairs
Ms Eibenstein has extensive expertise in European procedural management, heads the specialist field "RAS, AM counterfeiting, supply shortages" at BfArM, is the German member of the SPOC Working Party, and is actively involved in shortage management at both national and European levels.
Dr. Christian M. Moers
Sträter Lawyers, GERMANY
Lawyer
His prime interests are the interdisciplinary challenges of medicinal product law. His focal advisory areas are as follows:
- European and German medicinal product law
-…
Your speaker
Dr. Christian M. Moers
Sträter Lawyers, GERMANY
Lawyer
His prime interests are the interdisciplinary challenges of medicinal product law. His focal advisory areas are as follows:
- European and German medicinal product law
- Marketing authorisation law & regulatory affairs
- Pharmacovigilance
- Wholesale trade with medicinal products, distribution of medicinal products
- Manufacture of medicinal products
What to Expect
- EU regulatory framework and legal basis
- Mutual recognition and decentralised procedures (MRP and DCP)
- Centralised procedure (CP)
- Specifics for generic drug approvals
Who Should Attend
This seminar is intended for professionals involved in the drug approval process needing in-depth knowledge of European approval procedures. It is specifically tailored for beginners and career changers.
Objective of the Event
This seminar provides a practical overview of the EU regulatory framework and the marketing authorisation procedures for medicinal products.
Participants will examine the different regulatory pathways and application types, including the mutual recognition, decentralised and centralised procedures. They will also gain insights into the roles and responsibilities of the relevant national and European authorities, scientific committees and other regulatory bodies.
The seminar further covers the scientific advice process and key procedural requirements for bringing medicinal products to the European market.
In addition, participants will learn about data exclusivity, innovation protection and the requirements for generic medicinal products.
Your Benefit
- In-depth knowledge of EU regulatory framework and marketing authorisation procedures
- Insights into the roles and functions of relevant authorities and committees
- Strategies for mutual recognition and decentralised procedures
- Detailed understanding of the centralised procedure and scientific advice process
- Specific information on data exclusivity, innovation protection and requirements for generics
Programme
from 09:00 -17:00
You may dial-in 30 minutes before
09:00
09:15
Dr Christian M. Moers
- The regulatory framework: regulations, directives and guidelines
- Involved authorities
- The available marketing authorisation procedures: centralised, decentralised and national
- Role of the coordination group (CMDh)
10:30
10:45
Dr Christian M. Moers
- Full application, bibliographic application, mixed application, and informed consent
- Generic application, hybrid application and biosimilars
- Specifics for generics
- European reference product
- Data exclusivity and innovation protection
- Registration
12:45
13:45
Gabriele Eibenstein M.A.
- Common principles
- Submission strategy
- Deadlines and clock stops
15:00
15:15
Gabriele Eibenstein M.A.
- Scope and mandatory products
- Role of the EMA and committees, e.g. CHMP
- The procedure in detail
- Scientific advice
- Challenges for innovative products
16:45
17:00
Welcoming and introduction round
09:15
Basic principles and terminology
Basic principles and terminology
Dr Christian M. Moers
- The regulatory framework: regulations, directives and guidelines
- Involved authorities
- The available marketing authorisation procedures: centralised, decentralised and national
- Role of the coordination group (CMDh)
Coffee break
10:45
Legal basis for marketing authorisation procedures in Europe
Legal basis for marketing authorisation procedures in Europe
Dr Christian M. Moers
- Full application, bibliographic application, mixed application, and informed consent
- Generic application, hybrid application and biosimilars
- Specifics for generics
- European reference product
- Data exclusivity and innovation protection
- Registration
Lunch break
13:45
Mutual recognition and decentralised procedures
Mutual recognition and decentralised procedures
Gabriele Eibenstein M.A.
- Common principles
- Submission strategy
- Deadlines and clock stops
Coffee break
15:15
Centralised procedure
Centralised procedure
Gabriele Eibenstein M.A.
- Scope and mandatory products
- Role of the EMA and committees, e.g. CHMP
- The procedure in detail
- Scientific advice
- Challenges for innovative products
Questions and answers
End of the seminar
More Options
This will familiarise you with the regulatory affairs principles involved in applying for a marketing authorisation in Europe. It addresses the EU marketing authorisation procedures for the various products. It will also introduce you to post-authorisation duties.
Simply add the seminar to your cart by clicking 'Add to Cart'. In the shopping cart, you can add the e-learning in the bundle options. You will receive a €100 discount if you also book the e-learning (€290 + local VAT rather than €390 + local VAT).
Search for the webcode 60012501 on our website for more information and registration or simply click on the link below:
Qualification Course Regulatory Affairs Manager
By booking the qualification course you will save up to 30% compared to individual bookings.
Downloads
Request the documents using our form.
List of abbreviations "Drug Regulatory Affairs and CMC"
Further Informations
Access to and procedure for online events
Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.
All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.
On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.
Learn more about our online events here.
Technical requirements
You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.
We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.
Free pre-meeting and technology check
You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.
The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.
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Further Information
Qualification Course Regulatory Affairs Manager
Expand your competencies in drug regulatory affairs in a practice-oriented manner with up to 30% price advantage.
e-Learning - Click and learn
We provide flexible education and training with high-quality e-Learning programmes for several topics.
We guarantee the highest quality
We are now officially certified to ISO 9001 and ISO 21001 standard.
Your Contact Person
We are happy to advise you personally and individually.
Jean-Marie Bayhurst
Conference Manager
+49 6221 500-685
j.bayhurst@forum-institut.de