e-Learning: Common Technical Document & eCTD
including CMC requirements for marketing authorisation applications
- CTD principles and structure
- Format and content of Module 1 - 5 CTD
- CMC data required for Module 3 (drug substance and drug product)
- Dossier requirements for generics and further abridged procedures
- Dossier requirements for ASMF and CEP submissions
This distinguishes our event
Aims and objectivesThis 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).
This e-Learning was developed in July 2018.
- EU legislation
- CTD Modules 1-5
- Regional and Administrative documents (EU focus)
- Overviews and Summaries
- Study Report
- Data Exclusivity
- Full Application
- Generic, Hybrid or Similar Biological Applications
- Well Established Use Applications & Fixed Dose Combinations
- Traditional Use Registration for herbal medicinal product
- Modul 4a: IntroductionCTD Module 3 structure and guidelines
- Modul 4b: Drug Substance CTD Module 3 drug substance data requirements
- Modul 4c: ASMP & CEP
- Modul 4d: Drug Product CTD Module 3 - drug product data requirements
Director Munich Office Michael holds a degree in biology from the University of Konstanz, Germany. His scientific experience includes molecular biology research projects at the Oregon State University and Florida Atlantic University in the USA, as well as the Centre for Genomic Regulation in Barcelona. He began his career as a Regulatory Affairs consultant when he joined Asphalion, S.L. in 2007. Over the years he gathered wide experience in European, FDA, and RoW registration procedures. He acquired particular knowledge in the implementation of eSubmission standards, regulatory support for innovative products, such as Biologicals, Biosimilars and ATMPs, as well as the strategic preparation of paediatric investigation plans. Nowadays, his responsibilities include support for Asphalion's customers in Central Europe, strategy and management of international drug registration procedures, evaluation of the respective dossiers, as well as the conduct of scientific advice procedures and pre-submission meetings with international regulatory authorities. http://de.linkedin.com/in/mcschaub/
Nähere Informationen finden Sie hier.
The e-learning programme 'Common Technical Document & eCTD' comprises four didactic modules that include videos in which the experts share 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 the multiple-choice tests, 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.
1. Register for an e-learning programme on our website.
2. You will receive an email with your login data for our learning platform.
3. Log in to start your e-learning programme.
4. Complete your e-learning modules at your own pace.
5. Finalise the modules with a multiple-choice test.
6. Once you have successfully completed the test, you will be awarded a certificate, which you can print out.
Please try out the demo versions of our e-learning programmes free of charge to get an idea of our learning environment.
This e-learning will familiarise you with the regulatory affairs principles outside the ICH region and show you how to categorise the various regions in terms of regulatory requirements. Dossier requirements in Australia, Hong Kong, India, South Korea, Taiwan, Saudi Arabia, GCC, Jordan, Turkey, Thailand, China, South Africa, Russia, Kazakhstan, Eqypt, Brazil, Mexico & Argentina will be addressed
31.12.2018 in Online
This e-learning programme will familiarise you with the regulatory affairs principles involved in applying for a marketing authorisation in Europe (MRP, DCP, CP) . It will also introduce you to post-authorisation duties (renewal, variation...).
31.12.2018 in Online
Dieses e-Learning hilft Ihnen, Änderungstatbestände korrekt zu klassifizieren und als Variations mittels eAF einzureichen.
31.12.2018 in Online
Dieses Seminar vermittelt Ihnen die neuen Anforderungen an die Qualitätsdokumentation zu Monoklonalen Antikörpern und rekombinanten Proteinen im Investigational Medicinal Product Dossier (IMPD).
31.01. - 01.02.2019 in Bonn
Dieser Kurs bietet einen umfassenden Überblick über den regulatorischen Rahmen der Kennzeichnung, Verpackung und des Marketings kosmetischer Mittel.
09.04.2019 in Frankfurt