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 Conference Prague May 2023
The CORE Reference Team will host a face-to-face open introductory and Q&A session on CORE Reference and the CPD resources during the EMWA May 2023 conference in Prague. See you on Friday 12 May 2023 at 17.15-18.15.
Title: The CORE Reference Project - Value for the Global Regulatory MW Community
Abstract: The CORE Reference EMWA Special Project provides Continuous Professional Development (CPD) for regulatory medical writers 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 open session including a full web tour, demonstration of the CPD resources, including the RPD content published monthly, insights on the ICH M11 Step 2 draft protocol template, an RPD update from Asia, and we will take questions from the audience.
Presenters names (with affiliations): Chair, Sam Hamilton (Freelance); Committee - Alison McIntosh (Freelance), Vivien Fagan (IQVIA), Zuo Yen Lee (Caidya)
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.