2024-11-09 2024-11-09 , online online, 1,590 € zzgl. MwSt. Dr.ssa Ida Caramazza https://www.forum-institut.de/seminar/25052610-marketing-authorisation-documents-in-the-eu/referenten/25/25_05/25052610-course-marketing-authorisation-documents-in-the-eu_caramazza-ida.jpg Marketing Authorisation Documents in the EU

This seminar provides an in-depth exploration of the marketing authorisation dossier and the electronic submission process, focusing on the CTD structure and modules 1-5. Participants will gain practical knowledge and strategies for successful drug approval applications in the EU.

Topics
  • Module 1 and 2 of the marketing authorisation dossier
  • The SmPC and package leaflet
  • Chemistry, manufacturing and controls (CMC) - Module 3
  • Compilation of nonclinical and clinical data in Modules 4 and 5
  • eCTD and electronic submission requirements


Who should attend
This seminar is ideal for professionals involved in the drug approval process needing in-depth knowledge of marketing authorisation documents and submission. Basic knowledge of European marketing authorisation procedures is recommended. We recommend that absolute beginners first complete the introductory e-learning programme (webcode: 25122642) or the seminar on MA procedures (webcode: 25042610).
Aims and objectives
This seminar aims to provide participants with a comprehensive understanding of the marketing authorisation dossier and its components.

By focusing on the Common Technical Document (CTD) structure and the electronic submission process, participants will gain essential insights into compiling and submitting drug approval documents in the EU.

The seminar also addresses common errors and authority findings to ensure successful applications.
Your benefit

  • Detailed knowledge of the CTD structure and specifications for Modules 1-5
  • Key elements and structure of the SmPC and package leaflet
  • Practical insights into compiling nonclinical and clinical data
  • An understanding of eCTD principles, document requirements and submission
  • Strategies to avoid common errors and align with authority expectations

Course Marketing Authorisation Documents in the EU

Marketing Authorisation Documents in the EU

Benefits
  • A guide to CTD and dossier compilation
  • Practical insights into eCTD and electronic submission processes
  • Alignment with regulatory expectations
  • Certified to ISO 9001 and ISO 21001 standard

Webcode 25052610

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Termin

08-09/05/2025

08-09/05/2025

Zeitraum

Day 1 from 09:00 - 17:00
Day 2 from 09:00 - 12:45

Day 1 from 09:00 - 17:00
Day 2 from 09:00 - 12:45
Veranstaltungsort

online

online

Downloads
Gebühr
Your contact

Dr. Rebekka Bitsch
Conference Manager

+49 6221 500-565
r.bitsch@forum-institut.de

Details

This seminar provides an in-depth exploration of the marketing authorisation dossier and the electronic submission process, focusing on the CTD structure and modules 1-5. Participants will gain practical knowledge and strategies for successful drug approval applications in the EU.

Topics

  • Module 1 and 2 of the marketing authorisation dossier
  • The SmPC and package leaflet
  • Chemistry, manufacturing and controls (CMC) - Module 3
  • Compilation of nonclinical and clinical data in Modules 4 and 5
  • eCTD and electronic submission requirements


Who should attend
This seminar is ideal for professionals involved in the drug approval process needing in-depth knowledge of marketing authorisation documents and submission. Basic knowledge of European marketing authorisation procedures is recommended. We recommend that absolute beginners first complete the introductory e-learning programme (webcode: 25122642) or the seminar on MA procedures (webcode: 25042610).

Aims and objectives

This seminar aims to provide participants with a comprehensive understanding of the marketing authorisation dossier and its components.

By focusing on the Common Technical Document (CTD) structure and the electronic submission process, participants will gain essential insights into compiling and submitting drug approval documents in the EU.

The seminar also addresses common errors and authority findings to ensure successful applications.

Your benefit

  • Detailed knowledge of the CTD structure and specifications for Modules 1-5
  • Key elements and structure of the SmPC and package leaflet
  • Practical insights into compiling nonclinical and clinical data
  • An understanding of eCTD principles, document requirements and submission
  • Strategies to avoid common errors and align with authority expectations

Detailed programme

Day 1 from 09:00 - 17:00
Day 2 from 09:00 - 12:45

Welcoming and introduction round


Émanuela Negri

Marketing authorisation dossier - Module 1
  • Overview of the CTD: purpose and structure
  • Module 1 Specification
  • Focus on the cover letter and application form
  • National peculiarities

Émanuela Negri

SmPC and the package leaflet
  • Key elements and structure of the SmPC and the package leaflet
  • QRD templates

Coffee break


Émanuela Negri

Module 2
  • Common principles for overviews and summaries

Lunch break


Dr.ssa Ida Caramazza

Nonclinical data: Module 4, nonclinical summaries and nonclinical overview
  • Compilation of preclinical data: Pharmacology, Pharmacokinetics, ToxicologySmPC consistency with nonclinical data
  • Common errors and authority findings

Coffee break


Dr.ssa Ida Caramazza

Clinical data: Module 5, clinical summaries and clinical overview
  • Compilation of clinical data: Biopharmaceutics, Clinical pharmacology, Efficacy, Safety
  • Benefit and risk conclusions
  • SmPC consistency with clinical data
  • Common errors and authority findings

Questions and answers


End of day 1


Welcoming and introduction round


Karl-Heinz Loebel

eCTD/electronic submission of application documentation
  • eCTD basic principles: Structure, document requirements and dossier lifecycle
  • EU Module 1 eCTD requirements
  • eCTD specifics for centralised, decentralised and purely national applications
  • CESP Portal and EMA axway/syncplicity gateway
  • Outlook: eCTD 4.0/Next Major Version

Coffee break


Karl-Heinz Loebel

Data submission and technology changes
  • Unstructured - semi-structured - structured information
  • EMA IT Product Portfolio
  • EMA access and user account management
  • electronic Application Forms - PLM portal
  • from XEVMPD to SPOR
  • IRIS and CTIS

Questions and answers


End of the seminar


More Information

E-Learning: Introduction to EU Marketing Authorisation

Do you lack basic marketing authorisation expertise? Then, we would recommend the e-Learning 'Introduction to EU Marketing Authorisation' e-learning.
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.

Upon completion, you will be conversant with the key principles of regulatory affairs and have a good starting basis to work in this field.

Please register for the seminar "Marketing Authorisation Documents in the EU" by clicking '"Register"'. You will receive a €100 discount if you also book the e-learning (you will be billed €290 + local VAT rather than €390 + local VAT).

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.

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.

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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