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Submission: On November 15 via manual from NL — Scanned from NL
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* Home * About ISDB * What is ISDB? * Committee * Constitution * How to join * COI-forms * Criteria for membership * Application forms * Members * Bulletin index * Full members * Associated members * Publications * Newsletters * ISDB Publications * Press releases * Documents of interest * Campaigns * Working groups * Petitions * Future meetings * Past meetings * Intranet * * * Search for: INTERNATIONAL SOCIETY OF DRUG BULLETINS * Home * About ISDB * What is ISDB? * Committee * Constitution * How to join * COI-forms * Criteria for membership * Application forms * Members * Bulletin index * Full members * Associated members * Publications * Newsletters * ISDB Publications * Press releases * Documents of interest * Campaigns * Working groups * Petitions * Future meetings * Past meetings * Intranet * Menu RECENT ACTIVITIES ISDB Newsletter October 2023 A new ISDB Newsletter issue has just been released. Please, enjoy reading at: https://www.isdbweb.org/wp-content/uploads/ISDB_October2023.pdf ISDB response to the public consultation on the transparency rules for the operation of the Clinical Trials Regulation (CTR) and its Clinical Trials Information System (CTIS) The ISDB has recently responded to a public consultation from EMA, the Heads of Medicines Agencies and the European Commission on the Clinical Trials Regulation and its information system. You can consult the whole content of this statement at: https://www.isdbweb.org/publication/documents-of-interest/isdb-response-to-the-public-consultation-on-the-clinical-trials-regulation-and-its-information-system Access to regulatory documents Dr. Juan Erviti, former DTB Navarre coordinator and ISDB secretary, has recently presented a webinar at Therapeutics Initiative on “The need for access to regulatory documents for better drug assessment“. The video is freely available at https://www.youtube.com/watch?v=LTk4bbQnBX0 ISDB Strategic Plan As part of a strategic plan for ISDB, the executive committee has launched two subgroups to reflect ISDB’s membership and on its mission and activities. On-line meetings will take place during 2023. The groups are expected to make recommendations by end 2023. Stay tuned! Interesting publications The international network RIAT – Restoring Invisible and Abandoned Trials – recently published a re-analysis of the FOURIER trial (evolocumab vs placebo in secondary cardiovascular prevention). Authors, also belonging to ISDB members in Canada and Spain, assessed regulatory data and observed inconsistencies between the information in the Clinical Study Report and that in the 2017 primary trial results publication. A second RIAT re-analysis led by Spanish ISDB members has also been published recently, focused on a misreported trial on Plasma Rich in Growth Factors for knee osteoarthritis. ______________________________________________________________________________________________ RECENT PUBLICATIONS * ISDB Newsletter October 2023 * ISDB response to the public consultation on the Clinical Trials Regulation and its information system * ISDB Newsletter April 2023 * Information on Covid-19 * Response letter of the Australian Health Minister in follow-up of ISDB mobilization in support of Australian Prescriber NEWSLETTER SIGN UP FOR OUR NEWSLETTER Full Name Email address: Leave this field empty if you're human: RECENT CAMPAIGNS * Letter to the Australian Health Minister in support of Australian Prescriber * Letter to Charles Michel on transparency in EU institutions * A letter to the Prime Minister of India * ISDB General Assembly Paris 2019 * News from working groups: Clinical Study Reports? CONTACT President Rita Kessler president@isdbweb.org Webmaster deToon tjvandort@gmail.com Sign up to receive our newsletter. PRESS RELEASES * Statement: COVID-19 [EN] * ISDB General Assembly Paris 2019 * Cochrane’s sinking ship and conflicts of interest * No to EMA’s provision of confidential scientific advice to drug companies (November 2017) * Supplementary protection certificates (SPCs) delay access to affordable medicines (September 2017) NEWSLETTERS * ISDB Newsletter October 2023 * ISDB Newsletter April 2023 * ISDB Newsletter September 2022 * ISDB Newsletter December 2021 * ISDB Newsletter August 2021 © 2023 ISDB – International Society of Drug Bulletins.