Biopharmaceuticals, known colloquially as biopharma, are the point at which biotechnology and pharmaceutical manufacturing meet. Biopharma is the application of living organisms or extractions, by-products or components of living organisms, to prevent, relieve, or treat diseases.
IPI Academy’s biopharma training courses provide an extensive series of training opportunities covering a variety of topics, including the development of biopharmaceuticals, clinical trial requirements, manufacture, regulations and applicable standards. Our courses also provide insight into the use of emerging technologies and state-of-the-art processes.
Training format
Topic
A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.
An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.
The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance. This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.
This course has been designed to provide an essential overview of the critical factors when working with the FDA (Food and Drug Administration). For those short on time this course is for you, as you will receive a focused and comprehensive overview of the key strategic considerations when making applications to the FDA.
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