Year of publication
Type of media
Source
Subject
Type of material
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Ketamine and international regulations
Taylor & Francis Verlag | 2017|the nonmedical use of ketamine in selected countries and its regulatory control. Methods: We conducted a review of literature ...Keywords: regulatory status -
Regulatory and operational challenges in conducting Asian International Academic Trial for expanding the indications of cancer drugs
Free accessWiley | 2021|faster and obtain new drug approval in wider areas. However, pharmaceutical regulatory differences hinder the efficient conduct of international ... -
Exploring Best Practices on Development Regulatory Affairs and Clinical Development Related to Multiregional Clinical Trials (MRCTs) in China, Korea, and Taiwan
Online Contents | 2013|practices for development regulatory affairs and clinical development related to multiregional clinical trials (MRCTs) in China, Korea and Taiwan. I ...Publisher: Springer International Publishing, Springer Nature, [New York] -
Experts’ Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care
Online Contents | 2022|evidence. Main Measures Principal themes in 3 domains: expedited regulatory pathways, physician and patient understanding of and reliance on FDA ...Publisher: Springer International Publishing, Springer, New York, NY -
The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation
British Library Online Contents | 2011| -
Statistics and Statisticians in European Drug Regulatory Agencies
Online Contents | 1998|and statistical review procedures was sent to the director of the national drug regulatory agency in each of 18 European countries (current ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Regulatory and Quality Aspects of Herbal Drugs
Bentham Science Publishers | 2017|interaction, side effects, toxicity and adverse effects. The International Drug Monitoring Program of World Health Organization (WHO) has made certain ...Keywords: regulatory authority, drug interactions., Clinical Trials&Regulatory Affairs -
Comparison of Drug Approvals in Europe Versus the United States
Online Contents | 2014|Background Regulators from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) do not always agree on ...Publisher: Springer International Publishing, Springer Nature, [New York]Keywords: drug approval, regulatory affairs -
International Conference on Harmonization-Keeping International Drug Development in Harmony?
Online Contents | 2001|Abstract Back in the beginning of the 1990s the International Conference on Harmonization (ICH) was born with the objective of achieving ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Medical Affairs and Drug Information Practices Within the Pharmaceutical Industry: Results of a Benchmarking Survey
Online Contents | 1999|party devised and conducted a medical affairs drug information benchmarking survey over a two-month period beginning in December of 1997. This ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Regulatory Concerns at Various Phases of Drug Development
British Library Conference Proceedings | 1998| -
The Development of a Regulatory Affairs and Quality Assurance Policy for a Hospital Supply Company
Emerald Group Publishing | 1987|relevant regulatory standards. This article describes a regulatory affairs and quality assurance programme instituted and operated by a major ...Keywords: Drug Industry -
An Overview of the US Regulatory Environment for Drug-Device and Biologic-Device Combination Products
Online Contents | 2006|initiatives and regulations that try to clarify the issues and regulatory status of this growing class of medical products. ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Second IFPMA Asian Regulatory Conference: Harmonisation between Asian regulatory authorities and industry
British Library Conference Proceedings | 1999|Publisher: Regulatory Affairs Journal Ltd -
Organization and Responsibilities of the Chemistry, Manufacturing, and Controls Function within Regulatory Affairs: A Survey of 17 Companies
Online Contents | 1998|Abstract To facilitate management of the technical and regulatory Chemistry Manufacturing and Controls (CMC) issues within core dossiers ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Clinical Development of Biologics Approved by the US Food and Drug Administration, 2003-2016
Online Contents | 2019|Center for Drug Evaluation and Research (FDA CDER) between 2003 and 2016. Methods We conducted a retrospective analysis of publicly available ...Publisher: Springer International Publishing, Springer Nature, [New York]Keywords: drug approval, regulatory Affairs -
EU pharmacovigilance regulatory requirements of anticancer biosimilar monoclonal antibodies
Free accessOnline Contents | 2018|Abstract An increasing number of innovative oncology monoclonal antibodies (mAbs) have been introduced into the global market, and ...Publisher: Springer International Publishing, Springer, Dordrecht [u.a.]Keywords: Adverse drug reaction -
Roles of Regulatory Project Managers in the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research
Online Contents | 2000|Research’s new drug review process was clearly the springboard for the evolution of the regulatory project manager position. This role represents a ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Technical expertise and public decisions : proceedings : 1996 International Symposium on Technology and Society : June 21-22, the Woodrow Wilson School of Public and International Affairs, Princeton University, Princeton, New Jersey
TIBKAT | 2011|Table of contents: Experts and the Crisis of the London Ambulance Service p. 506 Esperanto, To Enhance International Collaboration on Technology in the Broader -
Energy efficiency and decarbonization for container fleet in international shipping based on IMO regulatory frameworks: A case study for South Korea
Free accessTaylor & Francis Verlag | 2023|This study investigates the impact and potential of ship’s energy efficiency and decarbonization in
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