e-Learning
Webcode 25122646
Lidia Cánovas
ASPHALION S.L., Barcelona, Spain
General Manager, Regulatory Affairs Director; Lidia Cánovas has over 25 years of global drug development and regulatory affairs experience in the biopharmaceutical industry. She received her degree in Pharmacy from the University of Barcelona, and has a Master in Business Administration in the Pharmaceutical Industry. She is currently the General Manager - Regulatory Affairs of Asphalion, S.L., a consulting company specialized in drug development and regulatory affairs; which she joined in 2003. With over 80 employees with backgrounds in all areas of life science, Asphalion's consultants are experts in their fields and are in direct contact with European agencies for the implementation of new regulatory standards.Her main activities focuses on consulting and strategic management of projects in the area of Regulatory Affairs and Development for Europe and USA, actively participating in Scientific Advice, Pediatric Plans, Orphan Drug Designations, Development Plans, Centralized Procedures, Decentralized and Mutual Recognition in permanent contact with the regulatory authorities. She has extensive regulatory and development experience in innovative, biological, biotech, biosimilars and advanced therapy products.
Michael Schaub
ASPHALION S.L., Munich, GERMANY
Director Munich Office
Michael has broad experience in European, FDA and RoW registration procedures. He has acquired specialist knowledge in the implementation of eSubmission standards, the regulatory support for innovative products such as biologicals, biosimilars and ATMPs, as well as the preparation of paediatric investigation plans. Nowadays, his responsibilities include the strategy and the management of international drug registration procedures, evaluation of the respective dossiers as well as carrying out scientific advice procedures and presubmission meetings with international regulatory authorities.
More information please click here.
anytime
anytime
online
online
Veranstaltung - 590 € zzgl. MwSt.
The fee for a single account that is valid for 90 days is €590 (excluding German VAT). You can access the modules as often as you want during this time. You will be awarded a certificate of completion at the end.
Veranstaltung - 590 € zzgl. MwSt.
The fee for a single account that is valid for 90 days is €590 (excluding German VAT). You can access the modules as often as you want during this time. You will be awarded a certificate of completion at the end.
Jean-Marie Bayhurst
Conference Manager
+49 6221 500-685
j.bayhurst@forum-institut.de
Do you need know how regarding CTD/eCTD & CMC? Then this e-learning programme is the fast track to becoming knowledgeable in this field. No prior dossier experience is required.
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).
This e-Learning was developed in July 2018 and was completely revised in August 2025.
Lidia Cánovas, Michael Schaub
Lidia Cánovas, Michael Schaub
Lidia Cánovas, Michael Schaub
Lidia Cánovas, Michael Schaub
Here you can get a brief insight into the e-Learning Common Technical Document & eCTD.
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.
Modules
Hours of learning content
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