Authier Simon, Curtis Michael J, Soloviev Maxim, Redfern Will S, Kallman Mary Jeanne, Hamlin Robert L, Leishman Derek J, Valentin Jean-Pierre, Koerner John E, Vargas Hugo M, Botchway Alfred, Correll Krystle, Pugsley Michael K
CiToxLAB North America, 445 Armand-Frappier Boul., Laval, QC H7V 4B3, Canada; Safety Pharmacology Society, 1821 Michael Faraday Drive, Reston, VA 20190, USA.
Cardiovascular Division, Faculty of Life Sciences & Medicine, Rayne Institutez, King's College London, London SE17EH, UK.
J Pharmacol Toxicol Methods. 2015 Sep-Oct;75:1-4. doi: 10.1016/j.vascn.2015.04.008. Epub 2015 May 8.
As with other professional disciplines there is a growing need from within industry as well as global regulatory authorities for implementation of a certification process in order to assure that appropriate expertise is developed and quality standards are identified for professionals involved in the practice of Safety Pharmacology (SP). In order to meet this need, the Safety Pharmacology Society (SPS) has developed the Diplomate in Safety Pharmacology (DSP) certification process. There are many benefits to certification including authentication of the discipline within the overall pharmaceutical community and with regulatory authorities. It also encourages participation in SPS activities by other professionals (toxicologists, clinicians, academics) who wish to broaden their professional expertise. It provides an opportunity for candidates to strengthen their fundamental scientific knowledge, and stimulates the sharing of data, methods and model development in the form of publications and presentations on relevant topics in SP. Accreditation in SP occurs after candidates successfully complete a written certification examination conducted at the annual SPS meeting. The DSP exam consists primarily of material pertinent to the conduct of SP vital function core battery studies (i.e., cardiovascular, respiratory and central nervous systems), supplemental SP studies (i.e., renal/urinary, gastrointestinal, immunology, and hematology), Regulatory Guidelines (ICH Guidelines) as well as relevant cross-functional knowledge (e.g., physiology, pharmacology, toxicology, biochemistry, pathology, pharmacokinetics, dosing formulation, analytical methods, and statistics). Maintenance of the DSP certification results from the accrual of credits which are gained from a range of educational and scientific contributions. Eligibility requirements include a combination of at least a bachelor degree in science and two years of relevant professional SP experience and one poster presentation on a SP topic as first author at a recognized major scientific meeting.
与其他专业领域一样,行业内部以及全球监管机构对实施认证流程的需求日益增长,以确保培养出适当的专业知识,并为从事安全药理学(SP)实践的专业人员确定质量标准。为满足这一需求,安全药理学协会(SPS)制定了安全药理学文凭(DSP)认证流程。认证有诸多益处,包括在整个制药界和监管机构中对该学科进行认证。它还鼓励其他希望拓宽专业知识的专业人员(毒理学家、临床医生、学者)参与SPS活动。它为考生提供了一个强化其基础科学知识的机会,并以关于SP相关主题的出版物和演讲的形式促进数据、方法和模型开发的共享。在考生成功完成在SPS年会举行的书面认证考试后,即可获得SP认证。DSP考试主要包括与进行SP重要功能核心组研究(即心血管、呼吸和中枢神经系统)、补充SP研究(即肾脏/泌尿系统、胃肠道、免疫学和血液学)、监管指南(ICH指南)以及相关跨职能知识(如生理学、药理学、毒理学、生物化学、病理学、药代动力学、给药制剂、分析方法和统计学)相关的内容。DSP认证的维持取决于从一系列教育和科学贡献中获得的学分累积。资格要求包括至少拥有科学学士学位以及两年相关专业SP经验,并且作为第一作者在认可的主要科学会议上发表一篇关于SP主题的海报展示。