Biologics and Biosimilars: Regulatory Aspects Certificate

The Certificate in Biologics and Biosimilars: Regulatory Aspects in the School of Pharmacy PG电子试玩平台的mba课程帮助学生获得在美国工作所需的知识和证书.S and global regulations governing biologics and biosimilar drugs. This certificate is part of the School of Pharmacy’s regulatory affairs (RA) and quality assurance (QA) graduate program.

生物制剂和生物类似药:监管方面的证书探讨以下主题. 

  • 生物制剂和生物类似药生产商特有的监管问题
  • 目前在主要的国际人用药品技术要求协调理事会(ICH)区域开发生物制品所涉及的监管和技术/科学问题
  • The clinical, manufacturing, 挑战生物产品全球商业化道路的监管和战略问题 
  • The principles that guide the development of biosimilar drugs 
  • How biosimilar development differs from innovator drug development 
  • How biologics and biosimilars differ from chemically synthesized drugs 
  • 用于表征生物制剂的分析方法以及分析测试与小分子测试的区别 
  • 与生物制剂的开发、生产和试验有关的质量设计原则 

本专业课程深入研究了主要ICH市场对生物制剂和生物仿制药产品的要求. 该证书为生物制剂和生物仿制药监管领域奠定了坚实的基础. Through the courses, 学生将接触到生物制剂和生物类似药行业面临的主要趋势和争议.  

生物制剂和生物仿制药证书:监管方面使学生能够在不致力于整个硕士学位的情况下提高他们对这个行业利基的知识. 该证书提供了工具和信息来了解生物制剂和生物仿制药是如何在全国范围内进行监管的, regionally and globally.  

高管招聘人员经常打电话给天普的RA和QA办公室，寻找对这一学科的规定有充分了解的候选人. 生物制剂和生物类似药证书:监管方面为学生提供坦普尔备受尊敬的RA和QA研究生课程的证书, giving them a solid grounding in key U.S. and global regulations that affect biologic and biosimilar products. The certificate is open to both MS in RA and QA 申请人和硕士毕业生，他们可以通过这个新的证书扩大他们的职业机会. 

Learning Objectives 

完成生物制剂和生物仿制药证书:监管方面, students will better understand the following.  

  • U.S. and global regulatory landscape for biologics and biosimilars

  • The differences between biologics and small molecules

  • The complexities and challenges in drug development across disciplines, e.g., toxicology; clinical; and chemistry, manufacturing and controls (CMC)

  • 应用于生物制剂和生物仿制药产品的临床前和临床研究策略 

  • The basics of biologics and biosimilar CMC strategies

Post-master’s Certificate

学生可以选择完成生物制剂和生物仿制药的硕士后课程:监管方面. This post-master’s certificate explores the regulatory, strategic, 生物制剂和生物类似药生产商特有的技术和科学问题. To apply for this 15-credit program, 申请人必须持有药学相关领域的硕士学位和生物学学士学位, chemistry, engineering, pharmacy, physics or related fields.

了解更多关于生物制剂和生物类似物硕士后证书:监管方面的信息.

Regulatory Affairs and Quality Assurance at the School of Pharmacy 

For over five decades, Temple University’s School of Pharmacy has provided outstanding graduate-level coursework in RA and QA. 

The School of Pharmacy  

  • pioneered RA and QA graduate education in 1968, 开设第一个RA和QA在线学位课程，并提供最全面的RA和QA课程;   

  • has outstanding expert faculty from industry and the U.S. 美国食品和药物管理局(FDA)，确保教授最新的发展和实践; 

  • attracts students from the biopharmaceutical, medical device, pharmaceutical and related industries (cosmetics, food and healthcare); 

  • 安排现场课程，在晚上和周末进行互动讨论和研讨会; 

  • has hundreds of students from across the country, facilitating great networking opportunities; and 

  • provides individualized services to students.    

证书提供坦普尔备受尊敬的RA和QA研究生课程的证书, which can be applied to the RA and QA master’s degree. 

Program Format & Curriculum

To earn the Biologics and Biosimilars: Regulatory Aspects Certificate, it is strongly suggested that students have a bachelor’s degree in biology, chemistry, engineering, pharmacy, physics or related fields, from an accredited institution of higher learning.  

The certificate may be earned on its own or on the way to the MS in RA and QA. To earn the certificate, 以下五门课程必须在四年内完成，总成绩为B (3).0) average. 

Students must complete three required courses. 

  • Drug Development (RAQA 5459) 

  • Biologics/Biosimilars: A Regulatory Overview (RAQA 5515) 

  • Global CMCs—Biologics (RAQA 5577) 

Students must complete two electives from the following courses. 

  • Production of Sterile Products (RAQA 5492) 

  • Regulatory Submissions (RAQA 5514) 

  • Clinical Drug Safety and Pharmacovigilance (RAQA 5538) or 5571* 

  • Special Topics in RAQA — Current Trends in Clinical Trials (RAQA 5560) 

  • Post-Marketing Safety Surveillance (RAQA 5571) or 5538*  

  • Vaccines: RA and QA Issues (RAQA 5572)  

*Students may take 5571 or 5538, but not both.

所有课程必须完成PG电子试玩平台的RA和QA研究生课程. No transfer credits from other institutions are accepted. If a student has completed an identical course at an accredited U.S. graduate school, 学生可以申请RA和QA项目放弃该课程，并选修另一门经批准的选修课程. 这一要求必须以书面形式提出，并在学生攻读证书之前获得批准. 

了解更多关于生物制剂和生物类似药:监管方面的证书. 

See the curriculum.

Requirements 

  • Candidates must formally apply and follow the application procedures (application form, photocopies of transcripts and Notice of Completion).  

  • 在学生获得硕士学位之前，只能完成一个证书课程.  

  • The certificate must be completed within four years.  

  • 学生必须在完成课程要求后不超过一年的时间内申请证书. 

  • 有兴趣攻读RA和QA硕士学位的学生可以将证书中获得的所有学分用于研究生学位, 前提是他们正式申请硕士课程并被PG电子试玩平台录取 graduate school. 

Learn more about the application process.

Related Graduate Degrees

Tuition & Fees

In keeping with Temple’s commitment to access and affordability, 该项目提供有竞争力的学费水平，并提供多种经济支持机会.

Tuition rates are the same, whether courses are online, on-campus, 证书课程的一部分或药学院另一个硕士课程的一部分.

Per course for Pennsylvania residents: $3,393
Per course for nonresidents: $4,218

PG电子试玩平台的学费每年由学校设定，并受多种因素影响, including program degree level (undergraduate or graduate), course load (full- or part-time), in-state or out-of-state residency, and more.

You can view the full Cost of Attendance breakdown on the Student Financial Services website.

Accreditation

Temple University’s departments and programs are accredited by the Middle States Commission on Higher Education.

PH-BBRA-GRAD

Additional Program Information

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