eCTD Training

27-28 September 2017


This hands-on training delivered by EXTEDO’s Regulatory Experts will be based on the eCTD format and the
relevant associated common business processes.

27 September 2017 – Level 1

You will gain basic understanding of what eCTD is about and the practical experience on how to build and compile a valid submission. Join this course if you are affected by these Drug Regulatory Requirements!

28 September 2017 – Level 2

Level 2 is an advanced level where we will analyze the eCTD format in detail, check the validation rules, create our own test submissions, including errors and how to validate them. You will be explained the technical files and what these are about. In addition, you will get hands on experience with real and complex test submissions with the opportunity to analyze them, find errors and correct with guided help from our experts. We believe Practical hands on experience is the best way to learn. Ultimately this course will give you a solid understanding and practical guidance and overview of eCTD to allow you to put it into practice.

Please note: Delegates can register to attend either Level independently and is not a prerequisite to attend both. The decision should be based on knowledge and your attendance of previous Extedo trainings.

Speakers:

Maren Mueller, Senior Business Consultant EXTEDO
Sophia Vraka, Business Consultant Regulatory Competence Center (RCC), EXTEDO