title: Regulatory affairs issues and legal ontologies in drug development.
abstract: It usually can take more than ten years from the time a new drug is discovered, until can be launched on the market. Regulatory requirements are part of the process of drug discovery and drug development. It acts at every developmental stage. Regulatory affairs works to establish an effective and uniform balance between voluntary and regulatory compliance and agency responsiveness to consumer needs. It evaluates and coordinates all proposed legal actions to ascertain compliance with regulatory policy. The ontology presented for regulatory affairs and drug research and development gives us the possibility to correlate information from different levels and to discover new relationships between the legal aspects. In addition, the transparency of the information is affected by the inability of existing integration strategies to organize and apply the available knowledge to the range of real scientific and business issue in critical safety and regulatory applications. Therefore, the semantic technologies based on ontologies make the knowledge reusable by several applications across business, from discovery to corporate affairs.
authors.affiliation: Computer Science Faculty, University of A Coruna, Campus de Elvina, 15071 A Coruna. muntisa@gmail.com
authors.forename: Cristian Robert
authors.initials: CR
authors.lastname: Munteanu
authors.forename: Julian
authors.initials: J
authors.lastname: Dorado
authors.forename: Ion
authors.initials: I
authors.lastname: Matei-Ilfoveanu
authors.forename: Silvia Ana
authors.initials: SA
authors.lastname: Nita
mesh_terms: D060326:Chemistry Techniques, Synthetic / Q000379:methods*; D016208:Databases, Factual; D055808:Drug Discovery / Q000331:legislation & jurisprudence* / Q000379:methods*; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D033161:Government Regulation; D033181:Information Dissemination / Q000331:legislation & jurisprudence / Q000379:methods*; D020407:Internet; D012984:Software