The Drug Development
The Drug Development Process from Concept to Market 2020
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About The Drug Development
The goal of pharmaceutical development is to design a manufacturing process that can produce a drug product to a consistently high quality. This webinar sets out regulatory expectations for pharmaceutical development, taking account of the risk-based approach set out in ICH guidance documents (Q8, Q9, Q10 and draft Q12). It covers some examples of problems encountered during drug development.
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Pharmaceutical development is a costly and time-consuming process. A science-led, risk-based approach can save time and money.
Successful pharmaceutical development requires effective collaboration between formulation scientists, analytical chemists and, during late-stage development, production staff at the commercial manufacturing site. This webinar focuses on regulatory expectations, techniques for managing risk and the importance of reliable analytical data to support the development process. It emphasizes the importance of effective collaboration between teams and the importance of setting product performance goals at the start. You will gain an improved understanding of the drug development process, the importance of knowledge management throughout the project, and how to evaluate and mitigate risks.
- Regulatory expectations for pharmaceutical development
- An introduction to quality risk management (ICH Q9)
- Quality management of development projects
- Proposed lifecycle approach to pharmaceutical products (ICH Q12)
- Overview of the development process
- Setting product performance goals
- Analytical methods to support product development
- Examples and case studies
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