Regulation of health products – pharmaceuticals, biotherapeutics, advanced therapies and medical technology - is controlled by standards, .. Read more guidelines and legal frameworks. The interactions among the stakeholders – industry, regulatory authorities, healthcare professionals and patients – are required for the effective governance for safe, quality and efficacious health products and timely access for patients. This fundamental module provides the understanding of the contributions of the various stakeholders, functions and guidelines that shape the regulatory environment and impact the healthcare management scene. The concept of product lifecycle will be also be explored among other contemporary regulatory approaches.
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