Council Recommendation of 9 February 1987 concerning the testing of medicinal products for placing on the market (87/176/E)

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Recommendation of the Council of the European Union of 9 February 1987 . concerning the testing of medicines for placing on the market (87/176/E)”, created by the team of authors, is an important document that has become fundamental in the field of pharmaceutical regulation and development of new drugs in Europe. This work not only reflects the historical context in which it was written, but also continues to be relevant for professionals in the field of medicine, pharmaceuticals and legislation. The book focuses on recommendations regarding drug testing before they enter the market. With the ever-increasing number of new drugs and increasing requirements for their safety and efficacy, this guide serves as an important guide for researchers, manufacturers and regulators. The authors consider in detail the main stages and methodologies that must be observed during clinical trials, and also emphasize the importance of ethical standards and the protection of patients’ rights. This book will be of interest not only to specialists in the field of pharmaceuticals and medicine, but also to students studying these disciplines, as well as lawyers working in the field of medical law. It can attract the attention of researchers involved in the development of new drugs, as well as representatives of government bodies responsible for control and supervision in the field of health care. Readers interested in the safety and effectiveness of medicines will find in it a lot of useful recommendations and practical advice. The topics raised in the book cover a wide range of issues, including the ethics of clinical trials, the need to comply with quality standards, and the importance of transparency in the testing process. The authors emphasize that successful drug testing requires an integrated approach that includes both scientific and social aspects. This makes the book particularly valuable for those seeking to understand not only the technical details but also the broader contexts in which pharmaceutical innovation is evolving. The style of presentation of the authors is clear and accessible, which allows readers to easily assimilate complex concepts and apply them in practice. The team of authors who worked on this document includes experts with extensive experience in the field of medicine and pharmaceuticals, which gives the book special value. Their previous work and research in the field of clinical trials and regulatory norms make this book a reliable source of information for anyone interested in modern approaches to drug testing. Recommendation of the Council of the European Union of 9 February 1987 . regarding the testing of medicines for placing on the market (87/176/E)" is not only an important historical document, but also a relevant guide for all those who work in the field of development and testing of new drugs. It will help readers better understand how to control the quality and safety of medicines, as well as what steps need to be taken to successfully enter the market for a new product. If you are looking for a deep and informative reading that will help you understand the complex issues of drug testing and pharmaceutical regulation, this book will be an excellent choice. It will not only expand your knowledge, but also provide an opportunity to look at problems from a new perspective, which is especially important in the rapidly changing world of medicine and pharmaceutics.
LF/103090206/R
Data sheet
- Name of the Author
- Collective of authors
- Language
- Russian
- Release date
- 2017