Murilo Freitas - 16:50, 1 de December de 20172,403
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The ICH Assembly announced the acceptance of Invima as the new observer of the ICH in an official communication.
The International Council for the Harmonization of Technical Requirements for Pharmaceutical Products (ICH) is an initiative with 25 years of existence, unique in bringing together regulatory authorities and the pharmaceutical industry to work on regulatory convergence and development processes of International guidelines of reference on the scientific and technical aspects of the registration of medicines.
A comment form on hepatitis E vaccines is downloadable from the website next to the document until 12 February 2018.
The current draft recommendations was prepared based on the discussion and consensus reached by the experts from regulators, industry and academia, in the working group meeting in May 2017 and subsequent review and comments of a initial draft by the working group participants over past months.
WHO are seeking for your critical review and comments/suggestions on this document for further development and improvement. Please would you send your comments or comments from your colleagues who are involved in regulation or responsible for manufacturing and quality control of hepatitis E vaccines by using the “comment form” on the web by 12 February 2018 to leid@who.int . Your comments will be reviewed by an informal consultation and incorporated into next version of the Recommendations as appropriate. Finally the Recommendations will be submitted to ECBS for review and adoption in its meeting in October 2018.
Source: Dianliang LEI PhD, Scientist Technologies, Standards and Norms, Essential Medicines and Health Products, World Health Organization. Email: leid@who.int
Murilo Freitas - 15:41, 22 de November de 20172,917
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Better safety monitoring for patients across Europe
The European Medicines Agency (EMA) has launched today a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA). The new system makes it easier for marketing authorisation holders and sponsors of clinical trials to report suspected adverse reactions and allows for better analysis of this information for the benefit of patient safety in Europe.
Murilo Freitas - 13:37, 21 de November de 20171,871
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RedETSA and the Pan-American Health Organization (PAHO) are launching the Regional Base of Health Technology Assessment Reports of the Americas – BRISA. This tool will allow the search of Health Technologies Assessment (HTA) bibliography produced by 33 member organizations of the Network. Initially, the base will include around 600 reports in Spanish, Portuguese, French, and English
This initiative, pioneer in Americas, was made in partnership with BIREME (Centro Latino-Americano e do Caribe de InformaçãoemCiência da Saúde), through BVS (Bibioteca Virtual emSaúde). BVS will host the database, which enables crossing- searching the researched subject with other available databases, such as LILACS and Medline.
With the launching of BRISA, PAHO and RedETSA aim to promote the use of HTA to improve the decision making process for the incorporation of technologies in the health systems.
