Rift-lines within european regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Rift-lines within european regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account write by Malik Osmane. This book was released on 2014-02-01. Rift-lines within european regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account available in PDF, EPUB and Kindle. Biopharmaceutical medicinal products (biologics) represent a huge financial market. Thus upon patent protection expiry of the innovator (reference) biologic there is interest from industry to gain a portion of this market by launching a 'similar' biologic at a reduced development cost, thus boosting potential gains. The EMA responded to this desire and lead the guidance process with industry on the topic of biosimilars. Based on the experience gained with biosimilars in the past, the EMA started to introduce a second generation series of guidance documents, which take into account the past, current and possibly future challenges of biosimilars. Those proposals were evaluated by EMA and partially incorporated into new guidance documents. This work highlights the challenges and risks associated with biosimilar submissions for large and complex bio-molecules such antibodies. Results: There are unaddressed questions for the regulator with regard to the unsolved dynamic of heterogeneity and variations of the quality profile, which have potential implications on safety and efficacy. This is neglected and not taken into account seriously enough by the stakeholders. Solution: Further, the only (in my view) progressive way to deal with such foreseeable situations from the biosimilar developer’s point of view is to incorporate a design space.
Rift-lines Within European Regulatory Framework for Biosimilars when Taking Heterogeneity and Variation During Lifecycle of the Reference Biologic and the Biosimilar Into Account
Rift-lines Within European Regulatory Framework for Biosimilars when Taking Heterogeneity and Variation During Lifecycle of the Reference Biologic and the Biosimilar Into Account - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Rift-lines Within European Regulatory Framework for Biosimilars when Taking Heterogeneity and Variation During Lifecycle of the Reference Biologic and the Biosimilar Into Account write by Malik Osmane. This book was released on 2014. Rift-lines Within European Regulatory Framework for Biosimilars when Taking Heterogeneity and Variation During Lifecycle of the Reference Biologic and the Biosimilar Into Account available in PDF, EPUB and Kindle. Biopharmaceutical medicinal products (biologics) represent a huge financial market. Thus upon patent protection expiry of the innovator (reference) biologic there is interest from industry to gain a portion of this market by launching a 'similar' biologic at a reduced development cost, thus boosting potential gains. The EMA responded to this desire and lead the guidance process with industry on the topic of biosimilars. Based on the experience gained with biosimilars in the past, the EMA started to introduce a second generation series of guidance documents, which take into account the past, current and possibly future challenges of biosimilars. Those proposals were evaluated by EMA and partially incorporated into new guidance documents. This work highlights the challenges and risks associated with biosimilar submissions for large and complex bio-molecules such antibodies. Results: There are unaddressed questions for the regulator with regard to the unsolved dynamic of heterogeneity and variations of the quality profile, which have potential implications on safety and efficacy. This is neglected and not taken into account seriously enough by the stakeholders. Solution: Further, the only (in my view) progressive way to deal with such foreseeable situations from the biosimilar developer’s point of view is to incorporate a design space.
UNESCO science report
UNESCO science report - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook UNESCO science report write by UNESCO. This book was released on 2015-11-09. UNESCO science report available in PDF, EPUB and Kindle. There are fewer grounds today than in the past to deplore a North‑South divide in research and innovation. This is one of the key findings of the UNESCO Science Report: towards 2030. A large number of countries are now incorporating science, technology and innovation in their national development agenda, in order to make their economies less reliant on raw materials and more rooted in knowledge. Most research and development (R&D) is taking place in high-income countries, but innovation of some kind is now occurring across the full spectrum of income levels according to the first survey of manufacturing companies in 65 countries conducted by the UNESCO Institute for Statistics and summarized in this report. For many lower-income countries, sustainable development has become an integral part of their national development plans for the next 10–20 years. Among higher-income countries, a firm commitment to sustainable development is often coupled with the desire to maintain competitiveness in global markets that are increasingly leaning towards ‘green’ technologies. The quest for clean energy and greater energy efficiency now figures among the research priorities of numerous countries. Written by more than 50 experts who are each covering the country or region from which they hail, the UNESCO Science Report: towards 2030 provides more country-level information than ever before. The trends and developments in science, technology and innovation policy and governance between 2009 and mid-2015 described here provide essential baseline information on the concerns and priorities of countries that could orient the implementation and drive the assessment of the 2030 Agenda for Sustainable Development in the years to come.
WHO Expert Committee on Biological Standardization
WHO Expert Committee on Biological Standardization - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook WHO Expert Committee on Biological Standardization write by World Health Organization. This book was released on 2017. WHO Expert Committee on Biological Standardization available in PDF, EPUB and Kindle. This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biological substances, and the establishment of international biological reference materials. Following a brief introduction, the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report, of particular relevance to manufacturers and national regulatory authorities, outlines the discussions held on the development and revision of WHO Guidelines for a number of vaccines, blood products and related substances. Specific discussion areas included WHO guidance on the production and evaluation of the quality, safety and efficacy of monoclonal antibodies as similar biotherapeutic products (SBPs); blood and blood components as essential medicines; estimation of residual risk of HIV, HBV or HCV infections via cellular blood components and plasma; snake antivenom immunoglobulins; human pandemic influenza vaccines in non-vaccine-producing countries; and clinical evaluation of vaccines: regulatory expectations. In addition, the following WHO guidance documents were also adopted: WHO manual for the preparation of secondary reference materials for in vitro diagnostic assays designed for infectious disease nucleic acid or antigen detection: calibration to WHO International Standards; and Human challenge trials for vaccine development: regulatory considerations. One WHO addendum document "Labeling information of inactivated influenza vaccines for use in pregnant women" was also adopted. Subsequent sections of the report provide information on the current status, proposed development and establishment of international reference materials in the areas of: biotherapeutics other than blood products; blood products and related substances; cellular and gene therapies; in vitro diagnostics; and vaccines and related substances. A series of annexes are then presented which include an updated list of all WHO Recommendations, Guidelines and other documents on biological substances used in medicine (Annex 1). The above nine WHO documents adopted on the advice of the Committee are then published as part of this report (Annexes 2-10). Finally, all additions and discontinuations made during the 2016 meeting to the list of International Standards, Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 11. The updated full catalog of WHO International Reference Preparations is available at: http://www.who.int/bloodproducts/catalogue/en/.
Building a New Future
Building a New Future - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Building a New Future write by United Nations. This book was released on 2021-05-31. Building a New Future available in PDF, EPUB and Kindle. This publication argues that Latin America and the Caribbean are in a position to move towards a "big push for sustainability" through a combination of economic, industrial, social and environmental policies capable of driving an equal and sustainable recovery and relaunching development in the region. Comprised of five chapters, the publication studies the three crises (slow growth, growing inequality and the environmental emergency) affecting economies and societies around the world, placing particular focus on those of Latin America and the Caribbean. It goes on to present a framework for analysing these crises in an integrated manner and measuring their magnitude in the specified regions. It then examines the quantitative impacts on growth, emissions, income distribution and the external sector under different policy scenarios, highlighting the potential of various policy combinations to forge a more dynamic growth path, with lower emissions and greater equality. Further identifying seven sectors that can drive sustainable development and proposing policies to foster these sectors, the publication concludes with an analysis that links up macroeconomic, industrial, social and environmental policies and the role of the State in building consensus for their implementation.
