Marketing Authorisation Documents in the EU
Dossier compilation and electronic submission
- 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
Online-Seminar
From
1.590,00 €
plus VAT
Services & Process
Veranstaltung - 1.590,-€ zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
Day 1 from 09:00 - 17:00 CET
Day 2 from 09:00 - 12:45 CET
Booking details
Online-Seminar
From
1.590,00 €
plus VAT
Services & Process
Veranstaltung - 1.590,-€ zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
Day 1 from 09:00 - 17:00 CET
Day 2 from 09:00 - 12:45 CET
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.
Your speakers
Dr Laura Bisi
ACARPIA Farmaceutici S.r.l., Milan, ITALY
Head of Quality
Your speaker
Dr Laura Bisi
ACARPIA Farmaceutici S.r.l., Milan, ITALY
Head of Quality
Dr Ida Caramazza
Ida Caramazza has a Degree in Pharmaceutical Technology and Chemistry and a Diploma as Specialist in Toxicology . She has been working in the Pharmaceutical field since the '80s.
Her experience started…
Your speaker
Dr Ida Caramazza
Ida Caramazza has a Degree in Pharmaceutical Technology and Chemistry and a Diploma as Specialist in Toxicology . She has been working in the Pharmaceutical field since the '80s.
Her experience started with preclinical research activity in Pharmaceutical Companies and then continued in the regulatory affairs sector, working for Regulatory Consultancy Firms and for international Pharmaceutical Companies, being involved in Regulatory Affairs activities mainly on medicinal products, but also on other healthcare products, such as medical devices, food supplements and cosmetics.
She currently works as a Senior Regulatory Affairs Consultant on regulatory strategy projects, regulatory activities and regulatory training. She is also involved in teaching activities at the University Master in Regulatory Sciences.
Karl-Heinz Loebel
PharmaLex GmbH, Mannheim
Director, Principal Consultant Regulatory Operations
After completing his studies, K.H. Loebel worked at Heidelberg University for several years before joining a biotechnology…
Your speaker
Karl-Heinz Loebel
PharmaLex GmbH, Mannheim
Director, Principal Consultant Regulatory Operations
After completing his studies, K.H. Loebel worked at Heidelberg University for several years before joining a biotechnology start-up company in 2000. K.H. Loebel has been with PharmaLex GmbH in Mannheim since 2005. He initially headed the Regulatory Operations department and has been Director and Principal Consultant Regulatory Operations Industry/Agency Liaisons since 2015. His responsibilities include managing electronic submissions, planning projects, and providing strategic advice to pharmaceutical companies.
What to Expect
- Module 1 and 2 of the Marketing authorisation dossier
- The SmPC and package leaflet
- Chemistry, manufacturing and controls (CMC) - Module 3
- Compilation of non-clinical 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.
Objective of the Event
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 non-clinical and clinical data
- An understanding of eCTD principles, document requirements and submission
- Strategies to avoid common errors and align with authority expectations
Programme
Day 1 from 09:00 - 17:00 CET
Day 2 from 09:00 - 12:30 CET
Day 1
08:59
09:00
09:15
Dr Laura Bisi
- Overview of the CTD: purpose and structure
- Module 1 specification
- Focus on the cover letter and application form
- National peculiarities
10:00
Dr Laura Bisi
- Key elements and structure of the SmPC and the package leaflet
- QRD templates
10:45
11:00
Dr Laura Bisi
- Common principles for overviews and summaries
11:30
Dr Laura Bisi
- Core documents and data
- Related section in the Module 2
- Common errors and authority findings
- Practical Exercises
13:00
14:00
Dr Ida Caramazza
- Compilation of preclinical data: Pharmacology, Pharmacokinetics, Toxicology, SmPC consistency with non-clinical data
- Common errors and authority findings
15:15
15:30
Dr Ida Caramazza
- Compilation of clinical data: Biopharmaceutics, Clinical Pharmacology, Efficacy, Safety
- Benefit and risk conclusions
- SmPC consistency with clinical data
- Common errors and authority findings
17:00
Day 1 from 09:00 - 17:00
Welcoming and introduction round
09:15
MA dossier - Module 1
MA dossier - Module 1
Dr Laura Bisi
- Overview of the CTD: purpose and structure
- Module 1 specification
- Focus on the cover letter and application form
- National peculiarities
10:00
SmPC and the package leaflet
SmPC and the package leaflet
Dr Laura Bisi
- Key elements and structure of the SmPC and the package leaflet
- QRD templates
Coffee break
11:00
Module 2
Module 2
Dr Laura Bisi
- Common principles for overviews and summaries
11:30
CMC Module 3
CMC Module 3
Dr Laura Bisi
- Core documents and data
- Related section in the Module 2
- Common errors and authority findings
- Practical Exercises
Lunch break
14:00
Non-clinical data: Module 4, non-clinical summaries and overview
Non-clinical data: Module 4, non-clinical summaries and overview
Dr Ida Caramazza
- Compilation of preclinical data: Pharmacology, Pharmacokinetics, Toxicology, SmPC consistency with non-clinical data
- Common errors and authority findings
Coffee break
15:30
Clinical data: Module 5, clinical summaries and clinical overview
Clinical data: Module 5, clinical summaries and clinical overview
Dr Ida Caramazza
- Compilation of clinical data: Biopharmaceutics, Clinical Pharmacology, Efficacy, Safety
- Benefit and risk conclusions
- SmPC consistency with clinical data
- Common errors and authority findings
End of day 1
Day 2
08:59
09:00
09:15
Karl-Heinz Loebel
- 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
10:45
11:00
Karl-Heinz Loebel
- Unstructured - semi-structured - structured information
- EMA IT Product Portfolio
- EMA access and user account management
- eApplication Forms - PLM portal
- from XEVMPD to SPOR
- IRIS and CTIS
12:45
Day 2 from 09:00 - 12.30
Welcoming and introduction round
09:15
eCTD/electronic submission of application documentation
eCTD/electronic submission of application documentation
Karl-Heinz Loebel
- 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
11:00
Data submission and technology changes
Data submission and technology changes
Karl-Heinz Loebel
- Unstructured - semi-structured - structured information
- EMA IT Product Portfolio
- EMA access and user account management
- eApplication Forms - PLM portal
- from XEVMPD to SPOR
- IRIS and CTIS
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 register for the seminar by clicking 'Register'. You will receive a €100 discount if you also book the e-learning (€290 + local VAT rather than €390 + local VAT).
It will address full as well as abridged dossier application formats, enabling participants to select the data necessary for each application type. Module 3 requirements will be addressed in depth (drug substance and drug product data requirements).
Simply register for the seminar by clicking 'Register'. You will receive a €100 discount if you also book the e-learning (€490 + local VAT rather than €590 + 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.
Weitere Informationen
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.
Our Recommendations
Further Information
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