Conduct clinical trials on humans, the subjects that are protected by the application of biology and the protection of human rights.
GOOD CLINICAL PRACTICES AND GOOD MANUFACTURING PRACTICES FOR INVESTIGATIONAL MEDICINAL PRODUCTS
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Conducting clinical trials is an expensive and a time consuming process not forgetting the risk it possess to the human trial subjects. In regulating pharmaceutical requirements, ethical behaviour cannot be overlooked. Several guidelines have been put in place to ensure that good practises are followed during clinical trials and manufacture of investigational medicinal products. Among the guidelines are the International Conference Harmonization (ICH) GCP, European Union Directive 2001/20/EC, European Union Directive 2005/28/EC, Food and Drug Administration (FDA) GCP and the European Union Good Manufacturing Practices guidelines. The guidelines generally have the same outlines but differ very little in the principles. The essay is going to outline each guideline and look at some of the differences between them.
Good Clinical Practice
According to the European Medicines Agency (2002), a good Clinical Practice are guidelines that set the standards for design, conduct, performance, monitoring, auditing , recording, analysing and reporting of clinical trials providing that the data collected and the results are credible and accurate while maintaining integrity and confidentiality of trial subjects. Many countries have specified guidelines they adhere to when conducting clinical trials to ensure integrity of human subjects. Most guidelines ensure that an informed consent is obtained from the participating trial subjects and that the person conducting the trials is qualified and well conversant with the guidelines and all procedures to ensure that the scientific interests do not surpass human rights and well being. It is within the provisions that the investigator should have alternative methods of treatment if the investigational medicinal product brings adverse effects that had not been predicted or if the subject decides to quit the trial before he is completely cured. Participants should be compensated if a clinical trial leads to health destruction to an individual who was otherwise healthy, (European Commission Enterprise Directorate-general, July 2002).
Directive 2005/28/EC
Good Clinical practices according to the Directive 2005/28/EC states that the rights, well being and safety of trial subjects should be held paramount to other societal interests of the researcher, (Commission Directive 2005/28/EC, April 2005). This is to mean that if the subjects will not be safe, then the clinical trials should stop. It is required for those conducting the research to be qualified by education in their specialty in the role they play during the trials and proper guidelines should be set up and defined to ensure that this takes place. If the drug is being administered through injection, it is important that only those who know how to use syringes will conduct the exercise. Ethical principles are supposed to be used during the entire clinical process to ensure that the safety of the trial subjects is maintained. The quality of the clinical trials aspects procedures should also be followed. Proposals for clinical trials are supposed to be accompanied by non-clinical and clinical information on concerning the investigational medicinal product. This information is supposed to be adequate. Declaration of Helsinki on Ethical Principles for Medicinal Research Involving Human Subjects should be followed for good clinical practices. Article four of this directive refers to article 2 point h in directive 2001/20/EC which provides a definition on who can be included or omitted from participating in clinical trials, monitoring of the trials and public policy. Guidance on commencing and conducting clinical trail is supposed to be followed by the investigator and sponsor. Article five puts emphasis on the recording of all data collected during the clinical trial. The recording, handling and storage should be done in a manner that it can be reported accurately, properly interpreted and verified while maintaining the confidentiality of trial subjects. To ensure that unnecessary clinical trails do not take place, it is important for the member state to come up with clear guidelines stipulating when a clinical trail can be accepted, (European Medicines Agency,
. .
The post Conduct clinical trials on humans, the subjects that
are protected by the application of biology and the protection of
human rights. appeared first on allaplusessays.com. GOOD CLINICAL PRACTICES AND GOOD MANUFACTURING PRACTICES FOR
INVESTIGATIONAL MEDICINAL PRODUCTS Name: Instructor: Course: Date: Conducting clinical trials is an expensive and a time consuming
process not forgetting the risk it possess to the human trial
subjects. In regulating pharmaceutical requirements, ethical
behaviour cannot be overlooked. Several guidelines have been put in
place to ensure that good practises are followed during clinical
trials and manufacture of investigational medicinal products. Among
the guidelines are the International Conference Harmonization (ICH)
GCP, European Union Directive 2001/20/EC, European Union Directive
2005/28/EC, Food and Drug Administration (FDA) GCP and the European
Union Good Manufacturing Practices guidelines. The guidelines
generally have the same outlines but differ very little in the
principles. The essay is going to outline each guideline and look
at some of the differences between them. Good Clinical Practice According to the European Medicines Agency (2002), a good
Clinical Practice are guidelines that set the standards for design,
conduct, performance, monitoring, auditing , recording, analysing
and reporting of clinical trials providing that the data collected
and the results are credible and accurate while maintaining
integrity and confidentiality of trial subjects. Many countries
have specified guidelines they adhere to when conducting clinical
trials to ensure integrity of human subjects. Most guidelines
ensure that an informed consent is obtained from the participating
trial subjects and that the person conducting the trials is
qualified and well conversant with the guidelines and all
procedures to ensure that the scientific interests do not surpass
human rights and well being. It is within the provisions that the
investigator should have alternative methods of treatment if the
investigational medicinal product brings adverse effects that had
not been predicted or if the subject decides to quit the trial
before he is completely cured. Participants should be compensated
if a clinical trial leads to health destruction to an individual
who was otherwise healthy, (European Commission Enterprise
Directorate-general, July 2002). Directive 2005/28/EC Good Clinical practices according to the Directive 2005/28/EC
states that the rights, well being and safety of trial subjects
should be held paramount to other societal interests of the
researcher, (Commission Directive 2005/28/EC, April 2005). This is
to mean that if the subjects will not be safe, then the clinical
trials should stop. It is required for those conducting the
research to be qualified by education in their specialty in the
role they play during the trials and proper guidelines should be
set up and defined to ensure that this takes place. If the drug is
being administered through injection, it is important that only
those who know how to use syringes will conduct the exercise.
Ethical principles are supposed to be used during the entire
clinical process to ensure that the safety of the trial subjects is
maintained. The quality of the clinical trials aspects procedures
should also be followed. Proposals for clinical trials are supposed
to be accompanied by non-clinical and clinical information on
concerning the investigational medicinal product. This information
is supposed to be adequate. Declaration of Helsinki on Ethical
Principles for Medicinal Research Involving Human Subjects should
be followed for good clinical practices. Article four of this
directive refers to article 2 point h in directive 2001/20/EC which
provides a definition on who can be included or omitted from
participating in clinical trials, monitoring of the trials and
public policy. Guidance on commencing and conducting clinical trail
is supposed to be followed by the investigator and sponsor. Article
five puts emphasis on the recording of all data collected during
the clinical trial. The recording, handling and storage should be
done in a manner that it can be reported accurately, properly
interpreted and verified while maintaining the confidentiality of
trial subjects. To ensure that unnecessary clinical trails do not
take place, it is important for the member state to come up with
clear guidelines stipulating when a clinical trail can be accepted,
(European Medicines Agency,
. .
The post Conduct clinical trials on humans, the subjects that
are protected by the application of biology and the protection of
human rights. appeared first on allaplusessays.com. GOOD CLINICAL PRACTICES AND GOOD MANUFACTURING PRACTICES FOR
INVESTIGATIONAL MEDICINAL PRODUCTS Name: Instructor: Course: Date: Conducting clinical trials is an expensive and a time consuming
process not forgetting the risk it possess to the human trial
subjects. In regulating pharmaceutical requirements, ethical
behaviour cannot be overlooked. Several guidelines have been put in
place to ensure that good practises are followed during clinical
trials and manufacture of investigational medicinal products. Among
the guidelines are the International Conference Harmonization (ICH)
GCP, European Union Directive 2001/20/EC, European Union Directive
2005/28/EC, Food and Drug Administration (FDA) GCP and the European
Union Good Manufacturing Practices guidelines. The guidelines
generally have the same outlines but differ very little in the
principles. The essay is going to outline each guideline and look
at some of the differences between them. Good Clinical Practice According to the European Medicines Agency (2002), a good
Clinical Practice are guidelines that set the standards for design,
conduct, performance, monitoring, auditing , recording, analysing
and reporting of clinical trials providing that the data collected
and the results are credible and accurate while maintaining
integrity and confidentiality of trial subjects. Many countries
have specified guidelines they adhere to when conducting clinical
trials to ensure integrity of human subjects. Most guidelines
ensure that an informed consent is obtained from the participating
trial subjects and that the person conducting the trials is
qualified and well conversant with the guidelines and all
procedures to ensure that the scientific interests do not surpass
human rights and well being. It is within the provisions that the
investigator should have alternative methods of treatment if the
investigational medicinal product brings adverse effects that had
not been predicted or if the subject decides to quit the trial
before he is completely cured. Participants should be compensated
if a clinical trial leads to health destruction to an individual
who was otherwise healthy, (European Commission Enterprise
Directorate-general, July 2002). Directive 2005/28/EC Good Clinical practices according to the Directive 2005/28/EC
states that the rights, well being and safety of trial subjects
should be held paramount to other societal interests of the
researcher, (Commission Directive 2005/28/EC, April 2005). This is
to mean that if the subjects will not be safe, then the clinical
trials should stop. It is required for those conducting the
research to be qualified by education in their specialty in the
role they play during the trials and proper guidelines should be
set up and defined to ensure that this takes place. If the drug is
being administered through injection, it is important that only
those who know how to use syringes will conduct the exercise.
Ethical principles are supposed to be used during the entire
clinical process to ensure that the safety of the trial subjects is
maintained. The quality of the clinical trials aspects procedures
should also be followed. Proposals for clinical trials are supposed
to be accompanied by non-clinical and clinical information on
concerning the investigational medicinal product. This information
is supposed to be adequate. Declaration of Helsinki on Ethical
Principles for Medicinal Research Involving Human Subjects should
be followed for good clinical practices. Article four of this
directive refers to article 2 point h in directive 2001/20/EC which
provides a definition on who can be included or omitted from
participating in clinical trials, monitoring of the trials and
public policy. Guidance on commencing and conducting clinical trail
is supposed to be followed by the investigator and sponsor. Article
five puts emphasis on the recording of all data collected during
the clinical trial. The recording, handling and storage should be
done in a manner that it can be reported accurately, properly
interpreted and verified while maintaining the confidentiality of
trial subjects. To ensure that unnecessary clinical trails do not
take place, it is important for the member state to come up with
clear guidelines stipulating when a clinical trail can be accepted,
(European Medicines Agency,
. .
The post Conduct clinical trials on humans, the subjects that
are protected by the application of biology and the protection of
human rights. appeared first on allaplusessays.com. GOOD CLINICAL PRACTICES AND GOOD MANUFACTURING PRACTICES FOR
INVESTIGATIONAL MEDICINAL PRODUCTS Name: Instructor: Course: Date: Conducting clinical trials is an expensive and a time consuming
process not forgetting the risk it possess to the human trial
subjects. In regulating pharmaceutical requirements, ethical
behaviour cannot be overlooked. Several guidelines have been put in
place to ensure that good practises are followed during clinical
trials and manufacture of investigational medicinal products. Among
the guidelines are the International Conference Harmonization (ICH)
GCP, European Union Directive 2001/20/EC, European Union Directive
2005/28/EC, Food and Drug Administration (FDA) GCP and the European
Union Good Manufacturing Practices guidelines. The guidelines
generally have the same outlines but differ very little in the
principles. The essay is going to outline each guideline and look
at some of the differences between them. Good Clinical Practice According to the European Medicines Agency (2002), a good
Clinical Practice are guidelines that set the standards for design,
conduct, performance, monitoring, auditing , recording, analysing
and reporting of clinical trials providing that the data collected
and the results are credible and accurate while maintaining
integrity and confidentiality of trial subjects. Many countries
have specified guidelines they adhere to when conducting clinical
trials to ensure integrity of human subjects. Most guidelines
ensure that an informed consent is obtained from the participating
trial subjects and that the person conducting the trials is
qualified and well conversant with the guidelines and all
procedures to ensure that the scientific interests do not surpass
human rights and well being. It is within the provisions that the
investigator should have alternative methods of treatment if the
investigational medicinal product brings adverse effects that had
not been predicted or if the subject decides to quit the trial
before he is completely cured. Participants should be compensated
if a clinical trial leads to health destruction to an individual
who was otherwise healthy, (European Commission Enterprise
Directorate-general, July 2002). Directive 2005/28/EC Good Clinical practices according to the Directive 2005/28/EC
states that the rights, well being and safety of trial subjects
should be held paramount to other societal interests of the
researcher, (Commission Directive 2005/28/EC, April 2005). This is
to mean that if the subjects will not be safe, then the clinical
trials should stop. It is required for those conducting the
research to be qualified by education in their specialty in the
role they play during the trials and proper guidelines should be
set up and defined to ensure that this takes place. If the drug is
being administered through injection, it is important that only
those who know how to use syringes will conduct the exercise.
Ethical principles are supposed to be used during the entire
clinical process to ensure that the safety of the trial subjects is
maintained. The quality of the clinical trials aspects procedures
should also be followed. Proposals for clinical trials are supposed
to be accompanied by non-clinical and clinical information on
concerning the investigational medicinal product. This information
is supposed to be adequate. Declaration of Helsinki on Ethical
Principles for Medicinal Research Involving Human Subjects should
be followed for good clinical practices. Article four of this
directive refers to article 2 point h in directive 2001/20/EC which
provides a definition on who can be included or omitted from
participating in clinical trials, monitoring of the trials and
public policy. Guidance on commencing and conducting clinical trail
is supposed to be followed by the investigator and sponsor. Article
five puts emphasis on the recording of all data collected during
the clinical trial. The recording, handling and storage should be
done in a manner that it can be reported accurately, properly
interpreted and verified while maintaining the confidentiality of
trial subjects. To ensure that unnecessary clinical trails do not
take place, it is important for the member state to come up with
clear guidelines stipulating when a clinical trail can be accepted,
(European Medicines Agency,
. .
. .
The post Conduct clinical trials on humans, the subjects that
are protected by the application of biology and the protection of
human rights. appeared first on allaplusessays.com.
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Conduct clinical trials on humans, the subjects that are
protected by the application of biology and the protection of human
rights.
"Do you need a similar assignment
done for you from scratch? We have qualified writers to help you
with a guaranteed plagiarism-free A+ quality paper. Discount Code:
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Conduct clinical trials on humans, the subjects that are
protected by the application of biology and the protection of human
rights.
"Do you need a similar assignment
done for you from scratch? We have qualified writers to help you
with a guaranteed plagiarism-free A+ quality paper. Discount Code:
SUPER50!"
Conduct clinical trials on humans, the subjects that are
protected by the application of biology and the protection of human
rights.
"Do you need a similar assignment
done for you from scratch? We have qualified writers to help you
with a guaranteed plagiarism-free A+ quality paper. Discount Code:
SUPER50!"
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