Managed care cycle

To more fully understand the impact of managed care on the pharmaceutical industry, a look at managed care s cost-containment strategies and continued movement toward multiple payers will be presented first, followed by the influential market dynamics of increased competition and changing demographics. Concluding the section will be a discussion of how these factors have impacted the pharmaceutical industry s research and development priorities and product life cycles. 

Figure 55.2 Impact of managed care on pharmaceutical product life cycle...

Nanocomposite materials used in energy harvesting in electronics can be managed carefully because they have many environmental and health effects. Nanomaterials can aggregate and interact with biochemical compounds. Nanomaterials can also penetrate membranes, which indicates that toxicologists should be involved in studying these nanoproducts. The Ufe cycle and chemical fate for the current and developed nanomaterials are not estabUshed yet therefore, environmental guidelines should be developed. 

The project manager has to take care that an overall project life cycle is defined and properly described. The project management life cycle, engineering life cycle and safety life cycle have to be integrated into an overall project life cycle model. This life cycle has to specify the order in which the management, engineering and safety tasks are to be carried out. Involvement and commitment of the project team and relevant stakeholders is absolutely necessary. 

Regardless of which route, or combination, is appropriate, most projects would benefit from carefully managed iterations (see Pattern 13.3, Short-Cycle Development) and from concurrent development work (see Pattern 13.4, Parallel Work). 

Contractors, contract manufacturers, transporters, warehouses, and end users of reactive chemicals should be informed not only of chemical reactivity hazards, but provided information or training on how to control them. This should be done as part of product life-cycle management and Responsible Care/Product Stewardship. Specific issues needing to be addressed may include but probably are not limited to those that are highlighted during the hazard/risk analyses (Section 4.5), including ... 

Oral mucositis/stomatitis can be relieved by the administration of mouth care products such as antiseptic and local analgesic preparations. Severe manifestations may have to be managed by delay and/or dose modification of the patient s next cycle of chemotherapy. 

In conclusion, while RAD projects offer many advantages, they also pose certain risks, and thus require careful, competent, realistic management to ensure that they deliver validated computer systems. RAD must not be used as an excuse to circumvent necessary life-cycle controls and documentation. 

Going live with the system requires careful management and close support to achieve full audit readiness and business benefit from the day the system is operational. For replacement or upgrade projects, cutover occurs following completion of PQ and confirms that all elements of the life cycle are in place before the system is allowed to go into production. 

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