Navigating the Formality Spectrum in ICH Q9(R1): The degree of formality in a risk management process should be customized to the organization's particular needs and the risks involved.
- Resource Type
- Article
- Authors
- Haddad, Ghada; Patel, Darshana
- Source
- Pharmaceutical Technology Europe; Jul2023, Vol. 35 Issue 7, p22-29, 6p
- Subject
- STAKEHOLDER analysis
UNCERTAINTY
RISK assessment
DECISION making
RISK management in business
PHARMACEUTICAL industry
NEEDS assessment
CORPORATE culture
REFLECTION (Philosophy)
- Language
- ISSN
- 17537967
The article focuses on the degree of formality that should be used in a risk management process. It emphasizes that the level of formality should be commensurate with the potential risks involved, the complexity of the process, and the unique needs of the organization. It further presents examples of both formal and informal risk management processes and stresses the importance of tailoring the level of formality to the specific situation.