Pharmaceutical Education, University Education , other training, experience in the pharmaceutical industry and relevant skills are the main determinants of a successful career in regulatory affairs. Careful plan is required in acquiring the right blend of these elements . It’s possible to waste a lot of time not doing things that add value to competence […]
ECTD publishing jobs in Canada are not as many as in USA although there are many qualified personnel around. Most of these jobs are found in Ontario and Quebec. Activities related to eCTD publishing in Canada are usually taken up by regulatory affairs personnel than designated eCTD publishers.
Education and Training for eCTD Publishing
Generally a Bachelor’s […]
Regulatory agencies employ different eCTD validation rules to to ensure that all dossiers meet the same regulatory standards. In this article I will discuss some eCTD validation rules used by Health Canada in relation to PDF documents , hyperlinks and bookmarks.
Validation Software and eCTD Validation Rules
There are several types of eCTD Validation software. They may […]
The sequence folder contain all the ectd information. When you submit an application for market authorization Regulatory agencies such as Health Canada apply certain validation rules to determine compliance with the eCTD guidelines. Your submission will not be accepted unless it complies with the guidelines. Submitting an eCTD dossier is team work. Several people will […]
