Webcode 25052610
Dr.ssa Ida Caramazza
Senior Expert Regulatory Affairs
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. Currently she works as Senior Regulatory Affairs Consultant on regulatory strategy projects, regulatory activities, training in regulatory field. She is also involved in teaching activities at University masters in Regulatory Sciences.
Émanuela Negri
Regulatory Affairs, Compliance and Pharmacovigilance Consultant, ITALY
Regulatory Affairs, Compliance and Pharmacovigilance Consultant, ITALY
Karl-Heinz Loebel
CENCORA PharmaLex, Mannheim, GERMANY
Director, Principal Consultant Regulatory Operations
More information please click here.
08-09/05/2025
08-09/05/2025
Day 1 from 09:00 - 17:00
Day 2 from 09:00 - 12:45
online
online
Event - 1,590 € plus tax
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Event - 1,590 € plus tax
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Dr. Rebekka Bitsch
Conference Manager
+49 6221 500-565
r.bitsch@forum-institut.de
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.
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.
Welcoming and introduction round
Émanuela Negri
Émanuela Negri
Coffee break
Émanuela Negri
Lunch break
Dr.ssa Ida Caramazza
Coffee break
Dr.ssa Ida Caramazza
Questions and answers
End of day 1
Welcoming and introduction round
Karl-Heinz Loebel
Coffee break
Karl-Heinz Loebel
Questions and answers
End of the seminar
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).
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.
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.
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