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INTERNATIONAL SOCIETY OF DRUG BULLETINS

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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


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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

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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.