Regulatory Affairs for Pharma: Introductory course

This is the Regulatory Affairs course everyone working in the pharmaceutical industry should take. The reason that a pharmaceutical company exists is to devlop and/or sell medicines. To make that happen the company must follow the rules and regulations that apply. They must pass assessments and inspections by regulatory authorities and have systems in place to keep a drug on the market. This course will give an overview of process necessary to achieve regulatory compliance and stay in compliance.

Course description:

This course does not aim to give the participants an in-depth knowledge in Regulatory affairs. Instead it is an introductory course that will benefit anyone new to the industry or lacking the overview. The course will start in the biggest of pictures, defining what a pharmaceutical product is. You will learn the fundamentals about the proof required by regulators to get market access, and how the drug development process aims to gather and collect that proof.
You will learn about the content and format of a regulatory submission, the Common Technical Document (CTD).
The approval processes in the EU (EMA) and the US (FDA) will be explained as well as the  obligations for keeping the product on the market.
The course will go through the Good Practices and Inspections of these practices.
Throughout the course many abbreviations commonly used will be explained. You will learn about MAH, CMC, GVP, ICH and many of the other acronyms used in the industry.

Course outline 

• Medicinal product, Medical Device or a Combination of both?
• Efficacy, Safety and Quality
• The Common Technical Document
• Overview of the Drug developmet process
• Regulatory authority interactions in the EU (EMA)
• Regulatory authority interactions in the US (FDA)
• The Good practices (GxP)
• Regulatory Inspections

Learning objectives:

After attending the course you will have a basic understanding of the drug development process, how to register a new drug in the EU and the US and how to keep it on the market. The knowledge will be useful for every role in the company as understanding the big picture will be an important piece of puzzle creating a company-wide quality culture.

Who should attend:

Anyone working in the Pharmaceutical industry wanting to understand the way their own contribution adds value to getting or keeping a drug on the market

Prerequisites:
None

#5160