November 6, 2021
Commencement Of a Clinical Trial
Clinical Trial To start a Clinical Trial, an application submitted by the sponsor and approval by the competent authority in the Member State where the trial will take place are required, in which a 60-day system is proposed. In any case where the authority does not accept the request, the sponsor is given one opportunity…
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October 29, 2021
Protection of Clinical Trial Subjects
Subject Protection in Clinical Trials The application of GCP requirements, including human subject protection (HSP), is widely accepted as one of the primary conditions for conducting research involving humans in an ethically correct manner. 1) The Directive shall be applied without prejudice to the national provisions concerning the protection of clinical trial subjects, if these…
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October 14, 2021
Legal Duties Of The Qualified Person
Legal Duties Of The Qualified Person Qualified Person The legal duties of the Qualified Person are defined in Directive 2001/83/EC for marketed human medicines; Directive 2001/82/EC for marketed veterinary medicines; and Directive 2001/20/EC for investigational human medicinal products. The legal duties of the Qualified Person, as defined in Directives 2001/83/EC (human medicines) and 2001/82/EC (veterinary medicines), are…
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October 12, 2021
Clinical Trial Manufacture
Clinical Trial Manufacture This story and the thinking behind that statement can be traced back to war crimes. During the Second World War, the Nuremberg Code was the most influential and widely quoted code, which originated in the so-called medical research carried out in the concentration camps. Part of the judgment at the “Doctors’ trial”…
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October 5, 2021
Overview Of EU Law
Overview of EU law Europe as a society and union The European Union as an institution is neither a State nor an organisation. It is a union of states based on the rule of law and democracy. Each Member State delegates sovereignty over specific activities to common institutions that represent the interests of the Union…
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September 29, 2021
Pharmaceutical Law and Administration
Pharmaceutical Law and Administration Medicine Laws have been introduced around the world to protect the patient. Many of these were the result of disasters that caused harm to patients. Two examples of this were the following: USA 1937 – Sulphanilamide Tragedy, where over 100 children died when a company sold a syrup of sulphanilamide that included…
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June 30, 2021
Coronavirus Impact on the Tourism Industry Worldwide
Coronavirus Impact on the Tourism Industry Worldwide The coronavirus pandemic has had a profound impact on the global tourism industry. Here is a summary of its effects: Travel Restrictions Travel Restrictions: Governments implemented strict travel restrictions, including border closures and mandatory quarantines, which severely limited international and domestic travel. These measures resulted in a significant…
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June 29, 2021
Design of an Efficient Stability Programme -Bracketing and Matrixing
Design of an Efficient Stability Programme -Bracketing and Matrixing Design of an Efficient Stability Evaluating the quality and shelf life of pharmaceutical items involves an effective stability program. Two strategies that are commonly utilized to create such programs are bracketing and matrixing. Testing sample representations, such as the highest and lowest strengths, at all designated…
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June 29, 2021
QP Declaration
QP Declaration Qualified Person (QP) declaration The Declaration of a Qualified Person (QP) is a very important part of the process of quality assurance in the pharmaceutical industry. In the EU, a QP is the one who makes sure that each batch of the medicinal product meets all the necessary regulatory requirements prior to being…
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June 27, 2021
NHS study finds that CT scan gets 70% of Lung Cancer
NHS study finds that CT scan gets 70% of Lung Cancer A significant NHS study has found that a massive number of lives could be saved if individuals at risk of developing Britain’s deadliest cancer were screened to detect it before it becomes serious. Around 48,000 individuals a year are determined to have the infection…
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