Pharmaceutical Regulatory Affairs

The Regulatory Affairs (RA) is a department in pharmaceutical organizations which acquires approval for marketing new pharmaceutical products from relevant regulatory authorities. It also ensures that the approval is maintained for as long as the firm wants to keep the approved product on the market. Together, regulatory authorities and regulatory affairs division work towards a common goal of ensuring that patients get new and better medical treatments while demonstrating the highest level of safety and efficacy.

In this online course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum:

Introduction

• What is regulatory affairs ?

Lesson 1: The importance of regulatory affairs

Lesson 2: Understanding the drug development process

Lesson 3: What are the National and International Regulatory Authorities?

Lesson 4: Regulatory Process for Drug Approval & Registration

• Regulatory Affairs in the US
• Applications for Regulatory Approval in the US
• New drug application
• Regulatory Affairs in the EU
• Regulatory Approval Process in the EU
• Dossier Submission Application

Conclusion

Glossary

Quiz