药品标识、广告和促销证书 

的 药品标识、广告和促销证书 in the 药学院 at 威尼斯赌场网站 focuses specifically on the complex regulations associated with federal and global regulations governing labeling, 广告和促销. 这个证书是学校颁发的 法规事务(RA)和质量保证(QA)研究生课程 程序，并可在网上获得. 获得此证书不需要硕士学位.

在制药行业, labeling refers to more than a prescription label or a cardboard container enclosing prescription or over-the-counter (OTC) products. 标签也指处方信息(PI), 哪一个是详细复杂的产品参考表, often folded in multiple accordion pleats and included with prescription or OTC products. 在美国.S.，每个PI都由美国管理.S. 联邦法规, 标题21, 部分200, 哪条规定产品的每一个方面都要用书面形式描述. 这包括以下内容. 

• 药物剂型及其物理性质的说明  

• 有效成分和赋形剂的清单 

• 每种化合物的分子结构

• 药物的药代动力学和毒理学 

• 目标患者人群  

• 潜在的副作用和安全问题

• 独特的存储要求 

的 PI must accompany any print ads about prescription drugs that appear in journals and magazines. 附于每个广告, PI必须是唯一编码, 因为公司被要求准确记录广告出现的地点. 

联邦法规还规定了处方产品的广告方式. 每年, 制药公司在全国范围内花费数十亿美元用于直接面向消费者的电视广告, 是什么让许多产品家喻户晓. 的 complexity of creating these ad campaigns while complying with federal regulations continues to be a challenging task that combines industry knowledge, 监管专业知识和市场营销. Advertising companies alone cannot create the ads; regulatory professionals must be included. 除了直接面向消费者的广告, 关于医药产品的网站呈指数增长, 尤其是那些专注于一种产品的公司, 作为“患者参考页面”.” In some cases, innovator companies even sell products directly to consumers from websites.  

Countries often have unique regulatory requirements for labeling and advertising. 例如, some require labels to display the price of a product the day it was granted approval by the governing regulatory authority. 在其他情况下，产品纸箱必须设计清楚地显示价格.  

As the types and global reach of product advertising continue to expand—thereby crossing the boundaries of regulatory authorities and patient populations—the need for more global regulatory oversight is increasing. 招聘公司的招聘人员经常给坦普尔的RA和QA办公室打电话, seeking candidates with a demonstrated knowledge of the regulations governing advertising and labeling.  

药品标识证书, Advertising and Promotions provides students with credentials from Temple’s well respected RA和QA graduate program, giving them a solid grounding in the key federal and global regulations that affect the advertising and labeling of pharmaceutical products. 证书对双方都有效 硕士申请者和硕士毕业生有了这个新证书，他们可以扩大自己的职业机会. 

学习目标 

Upon completion of the Labeling, 广告及促销 Certificate, students will be able to  

• 理解你.S. 以及全球监管和行业要求的创造, 更新或维护产品标签;  

• 解释药品市场的性质和国会的作用, 法院和食品和药物管理局在标签上, 广告和促销活动;  

• evaluate specific advertising and promotion communications for regulatory compliance; and

• identify the latest trends and issues posed by internet advertisements and product websites. 

邮政局长的证书

Students have the option to complete a post-master’s curriculum in pharmaceutical labeling, 广告和促销. 申请这个12学分的课程, applicants must hold a master’s degree in a pharmacy-related field and a bachelor of science degree in bio化学, 生物学, 化学, 物理或与健康相关的学科. 另外, applicants who did not earn their master’s degree from 威尼斯赌场网站’s 药学院 must have sufficient industry experience and familiarity with the basic tenets of regulatory affairs and quality assurance to pursue the post-master’s certificate.

Learn more about the Post-master’s 研究生 Certificate in Pharmaceutical Labeling, 广告及促销.

程序的格式 & 课程

的 药品标识、广告和促销证书 may be earned on its own or on the way to the 在RA和QA部门担任硕士.  

要获得证书, the following four courses must be completed within a three-year period with an overall B (3.0)平均.  

• 食品及药物法(5592)  

• 产品标签和广告要求(5533)  

• 全球标签法规:原则和实践(5532)  

• 广告及标签规例(5611)  

学生应该参加 食品及药物法 在攻读证书的其他课程之前. 有人建议 产品标签和广告要求 下一个完成. 其余课程可按任何顺序修习.  

All courses must be completed from 威尼斯赌场网站’s RA和QA graduate program. 不接受其他院校的转学分. 如果学生已经在美国认可的大学完成了相同的课程.S. 研究生院, the student may petition the RA和QA program to waive that course and take another approved elective in its place. This request must be made in writing and approved before the student pursues the certificate. 

Learn more about the 药品标识、广告和促销证书. 

参见课程设置. 

需求 

• 考生必须在完成课程后正式申请，并遵循 申请程序 (申请表格、成绩单影印本及完成通知书).

• 在学生获得硕士学位之前，只能完成一个证书课程.

• 证书必须在三年内完成. Students must apply for the certificate no more than one year after completing the course requirements. 

• Students interested in pursuing the RA和QA MS degree may apply all credits earned in the Pharmaceutical Labeling, 获得研究生学位所需的广告和促销证书, provided they formally apply for admission to the MS program and are accepted by 威尼斯赌场网站’s 研究生院. 

了解更多有关申请流程的信息.

相关研究生学位

• 法规事务和质量保证硕士