eCTD Life Cycle Management - National and Global
Integration of national requirements in global life cycle management
- eCTD requirements in Europe, the US and the ICH region
- Electronic submission requirements in LATAM, ASEAN, the Middle East and Africa
- Life cycle management: dealing with line extensions, new manufacturers, etc.
- Challenges of parallel submissions and splitting procedures
- Master data concept and core dossier
Aims and objectivesThis seminar will address peculiarities both in developing and submitting an eCTD within the ICH region and in global eSubmission requirements. It will make you aware of the duties involved in applying for a marketing authorisation in the ICH region and in LATAM, ASEAN, the Middle East and Africa.
It will also make you especially knowledgeable of your life cycle management duties and provide best-practice tips on how to integrate national requirements in your global life cycle management.
Ultimately, it will show you how to optimise your regulatory operations and IT support.
Prior knowledge of the ICH eCTD is required.
(from 08:30 registration)
- The FDA
- The ICH region
- The Middle East
- Change management and variation submissions
- How to deal with extensions of indications, new formulations, etc.?
- How to integrate national requirements into global life cycle management?
- Changing manufacturer
- Parallel submissions
- EU splitting procedures
- Adaptation of new eSubmission structures
- Case study: Brazil and China
Business Consultant Regulatory Competence Center
Regulatory Affairs Associate Director
Phone: +49 89 411090-0
Fax: +49 89 411090-1000
- Two industry experts with technical and practical expertise in eCTD projects
- Best-practice tips for your dossier life cycle management
- Preparation for data-driven submissions
Do you lack CTD/eCTD expertise (including CMC know how for CTD module 3)? Then, we would recommend the 'Common Technical Document & eCTD' e-learning programme.
This e-learning programme will provide you with detailed knowledge on the structure and content of the (electronic) common technical document - the only valid dossier format for marketing authorisation applications for human pharmaceuticals in the ICH region.
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).
The e-learning programme 'Common Technical Document & eCTD' comprises four didactic modules that include videos in which the experts Lidia Cánovas and Michael Schaub shares their expertise with you. You can also download and print the corresponding presentation documents.
Each module comprises additional documents (links, guideline texts, etc.) as well as interactive exercises and questions, which help you practise and apply your newly gained knowledge.
Once you have completed the four modules and passed a final multiple-choice test, you will be awarded a certificate, which you can print out directly. The e-learning programme should be completed within three months. Try our e-learning programme for free and familiarise yourself with our learning environment.
Please register for the seminar "eCTD Life Cycle Management - National and Global" by clicking '"Register"'. You will receive a €100 discount if you also book the e-learning programme (you will be billed €490 + local VAT rather than €590 + local VAT).
After completing this seminar, participants will be aware of the key regulatory requirements when preparing texts, with a greater awareness of the importance of proper English writing, reviewing and proofreading processes.
17. - 18.02.2020 in Frankfurt
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17.03.2020 in Frankfurt
CTD Dossier and submission in Asia, the ASEAN countries and especially China discussed in detail at this seminar
18.03.2020 in Frankfurt