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Process Management Framework: Guidance to Successful Implementation of Processes in Clinical Development.
Michael Edward Husovich1, Ruzica Zadro2, Lora Lee Zoller-Neuner3
11 Global Quality, Amgen, Thousand Oaks, CA, USA.
Therapeutic Innovation & Regulatory Science
|February 22, 2019
Summary
Effective process management is crucial for developing medicines. This framework guides process mapping, documentation, and continuous improvement in clinical development, benefiting patients.
Area of Science:
- Clinical Quality Management
- Pharmaceutical Development
- Regulatory Compliance
Background:
- Defined processes are essential for effective medicine development and patient care.
- Process management is a core element of quality management systems (QMS), as highlighted by TransCelerate's clinical quality management system (CQMS) framework.
- ICH GCP E6 (R2) emphasizes the importance of process identification and management within quality management.
Purpose of the Study:
- To present a conceptual process management framework for the pharmaceutical industry.
- To guide organizations in effective process mapping and documentation.
- To support the implementation of learning methods and continuous improvement in clinical development.
Main Methods:
- Conceptual framework development.
- Guidance on process mapping and documentation.
- Integration of learning methods and performance evaluation.
Main Results:
- A structured approach to process management in clinical development.
- Enhanced ability to ensure quality and productivity.
- Improved delivery of treatments to patients.
Conclusions:
- An effective process management framework is fundamental for efficient and high-quality clinical development.
- This framework supports continuous improvement and optimal learning.
- Implementing robust process management ultimately benefits patient access to novel treatments.
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