Glossary
Product Lifecycle Management (PLM)
What is Product Lifecycle Management (PLM)?
Product Lifecycle Management (PLM) in the pharmaceutical industry is a strategic approach to managing the entire lifecycle of a drug product, from initial conception through development, manufacturing, regulatory approval, market introduction, and eventual discontinuation.
How does Product Lifecycle Management (PLM) benefit pharma?
Product Lifecycle Management (PLM) ensures consistent product quality and regulatory compliance through robust data management and traceability. PLM improves coordination across departments, facilitating better decision-making and resource allocation. It aids in managing product improvements and adaptations based on market feedback and new research. By optimizing supply chain management, PLM ensures timely production and distribution. Overall, it maximizes product value while minimizing costs and risks throughout the lifecycle.
What are the key stages of the pharmaceutical product lifecycle?
The key stages include:
- Discovery and Research: Identifying potential drug candidates
- Preclinical Development: Laboratory and animal testing to assess safety and efficacy
- Clinical Development: Human trials to further evaluate safety and efficacy
- Regulatory Review and Approval: Submission to regulatory bodies for market approval
- Manufacturing and Scale-Up: Production of the drug at commercial scale
- Market Launch and Post-Marketing Surveillance: Launching the drug and monitoring its performance and safety
- Maturity and Decline: Managing the product as it matures in the market and eventually declines, potentially leading to discontinuation