December 1, 2021
Clinical Trial on Minors
Clinical Trial on Minors The protection of clinical trial subjects, the directive shall apply without prejudice to the national provisions on the protection of clinical trial subjects if they are more comprehensive than the provisions of this Directive and consistent with the procedures and time-scales specified therein. Member states shall, insofar as they have not…
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November 24, 2021
Manufacture and Import of Investigational Medicinal Product
Manufacture and Import of Investigational Medicinal Product The authorisation shall be required for both total and partial manufacture and for the various processes of dividing up, packaging, and presentation. To obtain this authorisation, the applicant must meet at least the following requirements: Specify the types of products to be manufactured or imported and the manufacturing…
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November 6, 2021
Commencement Of a Clinical Trial
Commencement Of A Clinical Trial In starting a Clinical Trial, an application submitted by the sponsor and approval by the competent authority in Member State where the trial will take place is required, in which a 60-day system is proposed. In any case where the authority does not accept the request, the sponsor is given…
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October 29, 2021
Protection of Clinical Trial Subjects
Protection of Clinical Trial Subjects Adherence to the principles of good clinical practice (GCP), including human subject protection (HSP), is universally recognised as a critical requirement for the ethical conduct of research involving human subjects. 1) The Directive shall apply without prejudice to the national provisions on the protection of clinical trial subjects if they…
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October 14, 2021
Legal Duties Of The Qualified Person
LEGAL DUTIES OF THE 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 the same; to…
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October 12, 2021
Clinical Trial Manufacture
Clinical Trial Manufacture This story and 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” at…
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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: Governments implemented strict travel restrictions, including border closures and mandatory quarantines, which severely limited international and domestic travel. These measures resulted in a significant decline in…
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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 An efficient stability program is essential for assessing the quality and shelf life of pharmaceutical products. Bracketing and matrixing are two strategies commonly used to design such programs. Bracketing involves testing representative samples, such as the highest and lowest strengths, at all specified time points. This…
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