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eCourse: Regulatory Compliance


Interested in having a better understanding of the regulatory requirements for developing and marketing pharmaceutical products?  This eCourse brings together the experts and thought leaders with expertise in the regulatory affairs that affect Pharmaceutical Scientists. 

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The regulatory landscape is rapidly evolving and the pharmaceutical industry is targeting global markets for drug application submissions and approvals more and more. The objective of this course is to provide an overview as well as cross-functional training in regulatory affairs from the perspective of a pharmaceutical scientist to better understand the current regulatory processes from discovery to commercialization of pharmaceutical products.

This course will focus on three key areas:
  1. Good Laboratory Practices (GLPs)
  2. Good Clinical Practice (GCP)
  3. Current Good Manufacturing Practices (cGMPs)

Course Objectives

  • Introduce the statute, regulation and guidance relationships.
  • Review positioning the quality pillars (GLP, cGMP, and GCP) in eCTD submissions.
  • Compare and contrast critical GLP roles and responsibilities from the perspectives of the Sponsor, Study Director, Principal Investigator and Quality Assurance.
  • Provide a detailed understanding of the relevant GLP formulation nuances.
  • Review ICH Q10 in-depth.
  • Gain insight into the value of linking development knowledge to manufacturing, and knowledge management to continuous improvement.
  • Differentiate how to perform appropriate quality investigations during development and commercial batch manufacturing, and when managing investigations of external vendors such as suppliers and CROs.
  • Discuss pertinent models for conducting clinical research, focusing on new drug development and approval.
  • Understand how to put GCP into action from obtaining Informed Consent, to composing a Protocol, to selecting Clinical Sites and ending with describing the Data Review Committee.
AAPS members, students, and academicians enjoy special pricing. Previews of each of the lectures are available. Participants have access to the course content for a 6 month period following purchase.

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