Nonclinical Regulation of Biomedical Products

Degree:
  • Certificate
Location: Boston
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Why Global Nonclinical Regulation of Biomedical Products?

The Graduate Certificate in Nonclinical Biomedical Products provides a comprehensive understanding of evolving nonclinical global biomedical product regulatory standards and processes.

The Graduate Certificate in Nonclinical Biomedical Products provides students with an opportunity to understand, develop, and apply global compliance standards in areas that are separate and distinct from direct clinical patient care. This includes, but is not limited to, design and preclinical development processes, including in vitro and in vivo animal testing, in silico testing, small scale/large scale manufacturing process development and validation, development and maintenance of supply chains, as well as product handling and distribution.

In this program, students will have the opportunity to achieve the following learning outcomes:

  • Differentiate between the nonclinical vs. clinical aspects of the global biomedical product commercialization process from a regulatory compliance perspective
  • Explain the compliance associated requirements needed to successfully practice professional nonclinical work within the global biomedical products industry
  • Describe the nonclinical regulatory standards utilized by the United States Food and Drug Administration (FDA) and other global regulatory agencies to evaluate the safety and efficacy of new and existing biomedical products employed by healthcare practitioners in various patient settings
  • Apply fundamental global nonclinical regulations to the biomedical product commercialization process, including therapy design, manufacturing process development and validation, cybersecurity and supply chain risk management

Unique Features

  • Choose from elective courses that cover a broad range of practical and relevant issues in the field
  • The BTC4450 Quality Control and Validation Issues course was developed in collaboration with quality assurance professionals from Vertex Pharmaceuticals, and other external pharmaceutical industry partners
  • Courses from this certificate can be applied toward the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices

What you'll study

General Requirements

Graduate Certificate in Nonclinical Regulation of Biomedical Products General Requirements
RGA 6405 - Nonclinical Regulations in Biomedical Product Commercialization
4.00
RGA 6410 - Fundamentals of CMC Regulations and Methods
4.00

Electives

Complete a minimum of 8 quarter hours from the following:

RGA 6000 - Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation
2.00
RGA 6001 - Introduction to Food and Drug Administration Medical Device Regulation
2.00
RGA 6112 - Biomedical Intellectual Property Management Strategy: Patents and Trade Secrets
4.00
RGA 6210 - Strategic Planning and Project Management for Regulatory Affairs
4.00
RGA 6233 - Application of Quality System Regulation in Medical Device Design and Manufacturing
4.00
RGA 6234 - Drug and Device Supplier Risk Management: Compliance and Processes
4.00
RGA 6248 - Global Regulatory Operations
2.00
RGA 6310 - Regulatory Documentation Processes
4.00
RGA 6420 - Global IVD Regulations and Submissions
4.00
RGA 6460 - Intellectual Property in the Life Sciences
2.00
RGA 6463 - Regulatory Strategy for Product Development and Life-Cycle Management
4.00

Did You Know?

A graduate certificate can boost your earnings by an average of 25% (Washington Post, 2012).

Did You Know?

137,000 new regulatory affairs jobs will need to be filled by 2018.

Average Time to Completion

1 year

Commitment

Part-Time

Entry Terms

Fall
Spring
Summer
Winter

Meets F-1 Visa Requirements

No