The Regulatory Environment for Science
Author | : |
Publisher | : |
Total Pages | : 184 |
Release | : 1986 |
Genre | : Research |
ISBN | : |
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Author | : |
Publisher | : |
Total Pages | : 184 |
Release | : 1986 |
Genre | : Research |
ISBN | : |
Author | : United States. Congress. Office of Technology Assessment |
Publisher | : DIANE Publishing |
Total Pages | : 139 |
Release | : 1986 |
Genre | : |
ISBN | : 1428923136 |
Author | : National Research Council |
Publisher | : National Academies Press |
Total Pages | : 164 |
Release | : 2004-03-02 |
Genre | : Technology & Engineering |
ISBN | : 0309089778 |
In recent years much has happened to justify an examination of biological research in light of national security concerns. The destructive application of biotechnology research includes activities such as spreading common pathogens or transforming them into even more lethal forms. Policymakers and the scientific community at large must put forth a vigorous and immediate response to this challenge. This new book by the National Research Council recommends that the government expand existing regulations and rely on self-governance by scientists rather than adopt intrusive new policies. One key recommendation of the report is that the government should not attempt to regulate scientific publishing but should trust scientists and journals to screen their papers for security risks, a task some journals have already taken up. With biological information and tools widely distributed, regulating only U.S. researchers would have little effect. A new International Forum on Biosecurity should encourage the adoption of similar measures around the world. Seven types of risky studies would require approval by the Institutional Biosafety Committees that already oversee recombinant DNA research at some 400 U.S. institutions. These "experiments of concern" include making an infectious agent more lethal and rendering vaccines powerless.
Author | : United States. Congress. House. Committee on Science and Technology. Task Force on Science Policy |
Publisher | : |
Total Pages | : 182 |
Release | : 1986 |
Genre | : Science |
ISBN | : |
Author | : |
Publisher | : |
Total Pages | : 0 |
Release | : 1986 |
Genre | : Research |
ISBN | : |
Author | : Stephen J. Heinig |
Publisher | : |
Total Pages | : 56 |
Release | : 1990 |
Genre | : Research |
ISBN | : |
Author | : National Academies of Sciences, Engineering, and Medicine |
Publisher | : National Academies Press |
Total Pages | : 169 |
Release | : 2020-04-25 |
Genre | : Medical |
ISBN | : 0309498635 |
Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Author | : UNITED STATES. CONGRESS. HOUSE. COMMITTEE ON SCIENCE AND TECHNOLOGY. |
Publisher | : |
Total Pages | : 100 |
Release | : 1986 |
Genre | : |
ISBN | : |
Author | : |
Publisher | : |
Total Pages | : |
Release | : 1986 |
Genre | : |
ISBN | : |
Author | : Reem K. Al-Essa |
Publisher | : Springer |
Total Pages | : 246 |
Release | : 2015-05-06 |
Genre | : Medical |
ISBN | : 3319175904 |
This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified, which, if fully implemented, could have a significant impact on patients’ access to new medicines. The Persian Gulf represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is considered critical to the future regulatory environment in this region. Pharmaceutical Regulatory Environment: Challenges & Opportunities in the Gulf Region is a must read for those interested in pharmaceutical regulation in the Gulf region.