Future Trends

Computer and electronic media, originally employed for databases and statistical analysis, have now expanded to include remote data entry at investigator sites and transfer of documentation of NDA submissions. This has prompted the development of regulatory guidelines to ensure that software systems are properly designed, tested, validated, and upgraded, that they include adequate security measures and provisions for documenting changes to data (an audit trail), and that the individuals who use the systems receive adequate training. Auditors will require training to keep pace with the development of these systems and to effectively audit them in the future.

The globalization of pharmaceutical research and development is expected to shorten the time required for product approval and registration, by increasing the number of subjects available for research studies and broadening an investigational product's exposure to ethnic intrinsic factors (genetic and physiological) and extrinsic factors (cultural and environmental).

The pharmaceutical industry is already establishing a presence in Central and Eastern Europe and is aggressively moving towards South America and

China. Japan remains focused on possible genetic differences, and continues to insist upon studies conducted in its own population as a condition for registration and approval. Regional variations, such as diet, alcohol and tobacco consumption, climate, exposure to pollution and other environmental factors, socioeconomic status, and differences in technology and health care standards, require creative planning for multinational trials.

As nations adopt more open trading policies throughout the world and form economic alliances, the trend toward multinational studies will require increased cooperation between governments and a greater degree of harmonization to level the playing field in drug development. In addition to the ICH Guideline for good clinical practice (GCP) already published, unified GMP and GLP guidelines have been drafted and some portions are already approved. Efforts such as these will hopefully pave the way for mutual acceptance of all research and development data by the regulatory authorities of these and other nations.

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