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Biologics and Biosimilars: Regulatory Aspects Certificate

The Certificate in Biologics and Biosimilars: Regulatory Aspects in the  at 51¶¯Âþ helps students gain the knowledge and credentials needed to work in the U.S and global regulations governing biologics and biosimilar drugs. This certificate is part of the School of Pharmacy’s .

The Biologics and Biosimilars: Regulatory Aspects Certificate explores the following topics.Ìý

• Regulatory issues that are unique to biologics and biosimilar drug manufacturers
• The current regulatory and technical/scientific issues involved in developing biological products in major International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) regions
• The clinical, manufacturing, regulatory and strategic issues that challenge the path to global commercialization of a biological product 
• 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 
• The analytical methods used to characterize biologics and how analytical testing differs from small molecule testing 
• The quality by design principles related to the development, manufacturing and testing of biologics 

This specialized curriculum delves into the requirements of major ICH markets for biologics and biosimilar products. The certificate builds a strong foundation in the biologics and biosimilar regulatory landscape. Through the courses, students are exposed to key trends and controversies facing the biologics and biosimilar industry.  

The Certificate in Biologics and Biosimilars: Regulatory Aspects enables students to sharpen their knowledge of this industry niche without committing to the entire master’s degree. This certificate provides the tools and information to understand how biologics and biosimilars are regulated nationally, regionally and globally.  

Executive recruiters often call 51¶¯Âþ’s RA and QA office seeking candidates with demonstrated knowledge of the regulations governing this discipline. The Certificate in Biologics and Biosimilars: Regulatory Aspects provides students with credentials from 51¶¯Âþ’s well-respected RA and QA graduate program, 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 applicants and MS graduates, who can expand their career opportunities with this new credential.Ìý

Learning Objectives 

Upon completion of the Certificate in Biologics and Biosimilars: Regulatory Aspects, 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)

• The strategy for preclinical and clinical studies as applied to biologics and biosimilar products 

• The basics of biologics and biosimilar CMC strategies

Post-master’s Certificate

Students have the option to complete a post-master’s curriculum in biologics and biosimilars: regulatory aspects. This post-master’s certificate explores the regulatory, strategic, technical and scientific issues that are unique to biologics and biosimilar drug manufacturers. To apply for this 15-credit program, applicants must hold a master’s degree in a pharmacy-related field and a bachelor of science degree in biology, chemistry, engineering, pharmacy, physics or related fields.

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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, five of the following courses must be completed within a four-year period with an overall B (3.0) average.Ìý

Students must complete three required courses.Ìý

• 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.Ìý

• 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.

All courses must be completed from 51¶¯Âþ’s RA and QA graduate program. No transfer credits from other institutions are accepted. If a student has completed an identical course at an accredited U.S. graduate school, the student may petition the RA and 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.Ìý

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

• Only one certificate program may be completed before students receive the MS.  

• The certificate must be completed within four years.  

• Students must apply for the certificate no more than one year after completing the course requirements.Ìý

• Students interested in pursuing the RA and QA MS degree may apply all credits earned in the certificate towards their graduate degree, provided they formally apply for admission to the MS program and are accepted by 51¶¯Âþ’s .Ìý

Learn more about the application process.

Related Graduate Degrees

• Regulatory Affairs and Quality Assurance MS