e-Learning
Webcode 24122641
Lidia Cánovas
ASPHALION S.L., Barcelona, SPAIN
General Manager
Michael Schaub
ASPHALION S.L., Munich, GERMANY
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/
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.
Dr. Rebekka Bitsch
Conference Manager
+49 6221 500-565
r.bitsch@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 2022.
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
Die Good Pharmacovigilance Practices Module (GVP-Module) von der European Medicines Agency (EMA) stellt in der Pharmakov...
DAS Jahresupdate für Informationsbeauftragte!
Outsourcing of activities, tasks or positions in regulatory affairs and pharmacovigilance is often standard practice. In...
This e-Learning programme will provide you with detailed knowledge on the classification, grouping and submission of var...
This e-learning programme will familiarise you with the regulatory affairs principles involved in applying for a marketi...
This learning model suited me really well. I could study the material in advance and stop the video at any time to make notes or to repeat sections which I didn't understand directly.
28.04.2023
