Fundamentals of Regulatory Affairs in Human Drugs
Why you should attend:
- To understand and become familiar with the Fundamentals of Regulatory Affairs in Drugs
Are you considering transitioning your interest and career in drug regulatory affairs? If you are in other healthcare and medical industry (devices and dietary supplements), are you interested in learning more about regulatory affairs in drugs?
This seminar is intended to help industry professionals better understand regulatory affairs applicable for human drugs.
As regulatory professionals, understanding applicable regulatory requirements is of paramount importance so that we can better help the industry to make informed decisions.
This seminar will discuss various topics including US laws and regulations governing human drugs including important FDA guidance documents. This seminar will further discuss drug development process, good laboratory practice (GLP), good clinical practice (GCP), investigational new drug application (IND) as well as new drug application (NDA).
This seminar will provide great opportunities to become familiar with the regulatory requirements applicable for human drug development and subsequent regulatory approvals.
At the end of this seminar, you will become well aware of and familiar wih regulatory affairs matters applicable for human drugs.
Objectives of the Presentation:
- To understand and become familiar with regulatory affairs in drugs
- US Laws and Regulations Governing Drugs
- FDA Guidance Documents and FDA-(Non)-Recognized Standards
- Drug Development
- Good Laboratory Practice (GLP)
- Good Clinical Practice (GCP)
- Investigational New Drug Application (IND): Content and Format
- New Drug Application (NDA): Content and Format
Who will benefit:
- R&D Scientists
- Healthcare Professionals
- Regulatory Affairs
- Quality Professionals
- Compliance Staff and Officers
- Clinical Affairs
- Anyone Interested in the Topic