In recent times, Health Canada published several new regulations related to eCTD and SPL, which will affect your submissions to the Canadian Authority. We decided to summarize these updates in a webinar and invite you to join.
The topics will be:
- Mandatory use of the Electronic Common Technical Document (eCTD) format for Master File submissions I, II, III abd IV.
- Product Monographs, Canada's version of labels which go in M1.3.1 section, will have to be submitted in SPL format
- Implementation of eCTD for clinical trial regulatory activities in Canada
Our regulatory expert Susan Paisley will highlight the new regulations and expain the affects on your submissions to Health Canada.
Our product manager Maren Müller will show you how theses submission types are managed in EXTEDO's eCTDmanager, the most advanced submission management software solution which is supporting nearly all global standards for electronic submissions.
1. EXTEDO company overview (Thomas Kessler, EXTEDO)
2. eCTD Becomes Mandatory for Specific Submission Types and Use of SPL (Susan Paisley, EXTEDO)
a) Master file submissions I, II, III and IV
b) Product Monographs
c) Clinical Trial (CTA) Submissions
3. Managing the new regulations with EXTEDO eCTDmanager - live demo (Maren Müller, EXTEDO)
4. Questions & Answers
- Susan Paisley, Senior Application Manager, EXTEDO Inc
- Maren Müller, Product Manager, EXTEDO GmbH
Event Details and Registration
Date: Tuesday, 28 April 2020
07:00 h PDT (San Francisco, Vancouver)
10:00 h EDT (New York, Toronto)
15:00 h BST (London, Lisbon)
16:00 h CEST (Madrid, Berlin)
Duration: 60 Minutes
Participation is free of charge.
Useful Links regarding Health Canada Submissions
Request for the Submission descriptions for different regulatory types:
The document is available upon request by visiting this link under Regulatory Transaction Descriptions (available upon request via email at: email@example.com):
There is a conversion section in the master file guidance document and all information related regarding the baseline
In addition there are also information on baseline/conversion in the recently released eCTD guidance document
Guidance Document - Preparation of Regulatory Activities in eCTD Format (available upon request via email at: firstname.lastname@example.org)
Mandatory use of eCTD format:
Implementation of eCTD for clinical trial regulatory activities:
Clinical Trial Applications in eCTD Format (available upon request via email at: email@example.com)
Product Monograph links:
Product Monograph Implementation plans: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-product-monograph-implementation-plans.html
Links to Product Monograph guidance’s: https://github.com/HealthCanada/HPFB/tree/master/product-monograph/guidance
Link to Product Monograph SPL samples: https://github.com/HealthCanada/HPFB/tree/master/product-monograph/samples