Program Overview

This course is designed to provide individuals with specialized knowledge and skills related to the regulatory requirements governing pharmaceutical Industry. It covers a range of topics including regulatory compliance, product registration, clinical trials, and post-market surveillance ICH GUIDELINES & US-FDA GUIDELINES

Why Choose Keck Graduate Institute?

KGI is a professional school dedicated to educating scientists for careers in industry. KGI has developed a wide portfolio of professional courses aimed at life science professionals, including extensive offerings in the management of bioscience companies.

Who Should Apply

Scientists interested in pursuing careers in the bioscience industry, want to learn about the process for commercial development of new therapies, or industry professionals who want to move into a management position.

What will you learn?

  • Introduction to Regulatory Affairs
  • Overview of Pharmaceutical Markets and Regulations
  • Regulatory Framework and Guidelines
  • Intellectual Property Rights
  • ICH Guidelines
  • US-FDA Guidelines
  • Pharmaceutical Product Registration
  • Documentation and Regulatory Approvals
  • Regulatory Compliance Audits
  • Product Life Cycle
  • Emerging Trends and Challenges

Program Requirements

  • Earned bachelor degree by the start of the program (science major recommended)
  • Work experience in applied life science or additional education
  • Application – An online application form is required that contains questions about your personal and educational background.
  • Transcripts – Unofficial transcripts verifying a bachelor degree may be submitted for evaluation purposes. If admitted and you choose to complete the certificate, official transcripts will be required. Translated copies must be submitted for international students.
  • CV or Resume – To verify work experience or additional education.
The Admissions Committee is made up of faculty and senior administrators who will thoroughly and conscientiously review each application. Applications will be considered in the context of the total applicant pool, as well as in relationship to our general admissions standards. We do not use arbitrary grade point or test score cutoffs.
All admissions decisions are final for the academic year in which they are rendered.

Eligibility

  • Earned bachelor degree by the start of the program (science major recommended)
  • Work experience in applied life science or additional education

Admission Requirements

  • Application – An online application form is required that contains questions about your personal and educational background.
  • Transcripts – Unofficial transcripts verifying a bachelor degree may be submitted for evaluation purposes. If admitted and you choose to complete the certificate, official transcripts will be required. Translated copies must be submitted for international students.
  • CV or Resume – To verify work experience or additional education.

Application Review

The Admissions Committee is made up of faculty and senior administrators who will thoroughly and conscientiously review each application. Applications will be considered in the context of the total applicant pool, as well as in relationship to our general admissions standards. We do not use arbitrary grade point or test score cutoffs.
All admissions decisions are final for the academic year in which they are rendered.