In the new era of patents, pharmaceutical companies have changed their strategy for marketing their products. They are launching products in multiple markets with a shot in their share of the catch. In order to obtain approval for the marketing of its product, regulators are insisting on clinical trials of land by people in your region security concerns and suspect, and questioned the efficacy of the product. In this situation, one has to go with global thinking with local regulatory process awareness.
Initially, there are obstacles in the design of the trials of multiple centers due to regional differences in practice medica.En this case, number of sites to identify you, number of patients to be recruited for each site, lack of homology between these sites, the duration and the length of the trial to be carried out, varies so regulators and IRB/IEC approvals are compulsory.
In a study at the global level, another important issue is the translation of documents in various made idiomas.De, if we want to carry out a multicentre trial, we need to translate all IBs, ICF and protocols in 14 languages, and we must seek the approval of the respective IEC. This creates considerable delay in the commencement of the study and if any adverse, inform the regulatory body event.
Another important aspect is the respective domain researcher rating and region to carry out the estudio.Hay reciprocity in qualification of researcher in the EU, Canada, Australia New Zealand, Japan and Switzerland, even of heritage E6 intangible cultural does not speak much about qualifications researcher. For India GCP guidelines, only said that the researcher must be a physician qualified and registered with the medical society of the India. Thus, there are several rules of eligibility to be a researcher in the realization of a global view.
In relation to Windows Firewall and patient recruitment, there are regional differences, language and cultural barriers to recruit patients in the study. Issues that need to be educated about the pros and cons of study at different places and different languages.Sometimes if the study be carried out in remote areas, vernacular form of Windows Firewall must be prepared to governance study.
Training of staff in compliance with the standards of good clinical practice and security reporting are another important aspect of the study at the global level.Personal Na?ve needs much intensive training on good clinical practice and specific regulations of country and seguridad.Todos reporting training content should be translated into the respective languages and must be geographic and specific in nature. Serious and unexpected adverse events to the regulatory authorities shall indicate in each participating country, regardless of the country of origin, is another important task in the Studio at the global level.
In the case of clinical power for the initiation of the study, which should follow the specific labelling requirements of the country of origin.Certified translations, the types of information labelling, chemical named outer packaging, the Declaration of use of research, name/address of the sponsor (in country), lot number, lot number, conditions storage, expiration date, name of Protocol, dose, form the number of units, route of administration, the number of matter, instructions, manufacturing "keep out of reach of children" and "Research use".These details should be translated by the country regulatory requirements and devoid of this can lead to the failure to obtain the imported product.
The product must undergo an analytical process to proceed to consider.The fact that it is harmonizing different the pharmacopoeia standards is another barrier tecnica.Por example, originating from United States drug products should be re-analyzed in EU and accredited for by "Qualified person" for the clinic of the EU directive.EMEA did not recognize American manufacturing GMP data as the EU has different rules of GMP.Pero there is light at the end of this process recently; USFDA and EMEA reached agreement to respect the other processes, simplifying the process of adoption of clinical trials for the desire of pharmaceutical companies to carry out the study.
The last and most important factor is deadlines for approval regulatory, which are different in several countries where the study must be carried cabo.Esto can lead to a delay in the marketing of the producto.Por therefore, it is necessary to think strategically and act locally by the rules in force to obtain approval of different regulators soft study conduct.
A very informative article that explains the regulatory aspects and concerns going on in the pharmaceutical companies excelled by an employee of MakroCare.com.MakroCare consulting services offers a complete portfolio of services regulation, which consists of best practices and solutions.
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