BWG Publications, Registration, Presentations and Publicity
http://journal.emwa.org/post-approval-regulatory-writing/the-emwa-budapest-working-group-a-2-year-collaboration-to-make-recommendations-for-aligning-the-ich-e3-guideline-with-current-practice-and-developing-clinical-study-protocol-guidance/ and http://dx.doi.org/10.1179/2047480614Z.000000000254
Critical Review T/Cel CSR Template [Slide Deck]
Docket # FDA-2019-N-2012 [Slide Deck]
CORE Reference - Three Years On [Slide Deck]
CORE Reference - One Year On [Slide Deck]CORE Reference - One Year On [Symposium Report and Utility Survey Results]
“CORE Reference: ICH E3 for Dummies: A Users Guide to ICH E3, privacy, disclosure, transparency, and applied value in the preparation of clinical study reports”
In order to view the video, an AMWA login will need to be created. This is a free registration process for those who are not, or do not wish to become, AMWA members.
Regulatory Public Disclosure Special Interest Group - First "Meet and Share"
Join the discussion at the EMWA RPD SIG "Meet and Share"
Topics for discussion include two new requirements once the European Clinical Trials Regulation EU No 536/2014 becomes fully applicable: 1) lay person summaries of clinical trial results and 2) redaction of key clinical trial documents which will be made publicly available, e.g., protocol IB, CSR.
Where: Online (save the date for now; link will be shared when available)
When: Friday 02 July 2021, 13.30-14.30 CET/12.30-13.30 BST
Third-party Publications and Presentations
The BWG, the developers of CORE Reference are pleased to share the following third-party materials about CORE Reference. The BWG does not accept responsibility for the accuracy of third-party materials. If you have a third-party publication to share, please email: email@example.com
The TransCelerate Biopharma Clinical Study Report template (December 2019 release) is available on the TransCelerate website under:Clinical Content and Reuse Assets
ICH E3 and CORE Reference are the two “well-known standards” used in TransCelerate’s CSR template development in this TransCelerate slide deck.
Note: The developers of CORE Reference were not involved in TransCelerate’s CSR template development.
CORE Reference-related updates are now available in Japanese on a dedicated blog. Thank you to Yukie Uchiyama (responsible for Japanese writing of the blog) and Hiroko Ebina (responsible for quality assurance of the blog) for making this initiative possible.
Note: The opinions expressed in Yukie Uchiyama’s blog, and the interpretations of CORE Reference are solely those of the blogger, and are not necessarily those of the CORE Reference authors.
Ebina H, Homma Y, Woolley KL. Poster P-11 (English translation from the Japanese): CORE Reference: New guidelines of preparing clinical study reports for Japanese biopharmaceutical companies seeking international regulatory approvals. Presented at the 6th General Meeting for the Society of Regulatory Science of Medical Products. 9-10 September 2016, Tokyo, Japan.
Radkova E. Slide presentation. Clarity and Openness in Reporting: E3-based (CORE) Reference. OCT IV Annual Conference - Clinical Trials in and Outside Russia. 19 September 2016, Moscow, Russia.