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.
EMWA Webinar Wed 21 June 2023, 11.00 CET (10.00 BST, 17.00 China Standard Time)
The CORE Reference Team - Chair, Sam Hamilton (Freelance);
Committee - Alison McIntosh (Freelance), Vivien Fagan (IQVIA), Zuo
Yen Lee (Caidya) will present a Webinar and Q&A session on CORE
Reference and the CPD resources.
Title: The CORE Reference Project - Value for the Global Regulatory
Target Audience: Regulatory medical writers (MWs) with an interest
in CSR writing and transparency and disclosure (T&D) of clinical
documents. The content of this session will be similar to that presented
in Prague in May 2023 with additional content on T&D in Asia.
Abstract: The CORE Reference EMWA Special Project provides
Continuous Professional Development (CPD) for regulatory MWs
through open access resources and intelligence dissemination on
clinical study reporting and public disclosure of clinical-regulatory
documents. The team will present a 60-minute session including a full
web tour; demonstration of the CPD resources, including the RPD
content published monthly; a PDF open-book demonstration of CORE
Reference and its practical utility; an update on T&D in Asia; and we
will take questions from the audience.
You may submit questions in advance to firstname.lastname@example.org.
Email email@example.com to register.
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: firstname.lastname@example.org
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.