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Pharmaceutical Regulatory Affairs Certification

PROGRAM OVERVIEW

This program provides with knowledge and insight into the current U.S. Professional Regulatory Affair pathways for prescription and over-the-counter drugs, biologics, medical devices, as well as combination products.
At the end of this program, students will have a good understanding of the regulatory framework around drug development, regulatory submissions, CTD, IND, NDA &
ANDA, FDA regulatory submission requirements, Chemistry and Manufacturing Control and Post approval compliance and regulatory requirementds, current Good Manufacturing Practices (cGMP) and quality concepts.

Drug Labelling

Marketed pharmaceutical drug products for human use in the U.S. must comply with the FDA labeling and promotional requirements as well as be accompanied by labeling that supports their safe and effective use.

Our Professional Regulatory Affairs program addresses all labeling regulatory requirements and industry standards in order to develop a compliance drug label. The program provides among others hands-on training on topics such as Product Monographs, Prescribing Information, Carton and Container Labeling Characteristics and Global Labeling guidelines.

Regulatory Submissions

Regulatory Affairs Professionals are required to develop strategies for and manage several types of applications and their submissions to regulatory bodies, such as the FDA, Health Canada and the European Medicines Agency.

Throughout the lifecycle of a pharmaceutical product development, these professionals are responsible for maintaining Investigational New Drug Applications, New Drug Applications, Abbreviated New Drug Applications and/or their international equivalents when seeking approval to sell a pharmaceutical drug product in the States and/or around the world.

Post-approval Compliance

Compliance activities for pharmaceutical drug products do not stop once the drug is approved and marketed in the U.S. and/or other international markets. Regulatory bodies require to be notified in the event of product changes, such as labeling or manufacturing changes, as well as adverse events from product use.

NAI’s Professional Regulatory Affairs program helps students understand the current post-marketing regulatory climate and provides hands-on training on post-approval requirements, including supplement and annual reporting, adverse event reporting and overall compliance with regulatory surveillance, investigations and inspections.

Admission Requirement:

Course Length

  • Document Control
  • Regulatory Affairs Associate
  • Regulatory Affairs Assistant
  • Project Coordinator
  • QA Associate
  • QA Assistant
  • Manufacturing Auditor
  • Quality Auditor

We developed strong partnerships with industry-leading companies in pharmaceutical and clinical field. We work directly with these organizations to provide opportunities to our graduates.

Our online learning environment gives students the option to learn completely at their own pace, anywhere and at any time of the day. Learners will have access to our subject matter experts who are there to provide support and answer any subject related questions.

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