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Erstellt / Aktualisiert 04.02.2022 / 07.02.2022
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What is the CTD?

The Common Technical Document (CTD) is a set of specifications for a dossier for the registration of medicines. The CTD was developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and adopted by the Therapeutic Goods Administration (TGA) in 2004.

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What is the organisation of the common technical document?

The Common Technical Document is organised into five modules. Module 1 is region specific. Modules 2, 3, 4, and 5 are intended to be common for all regions. Conformance with this guideline should ensure that these four modules are provided in a format acceptable to the regulatory authorities.

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5. What are the pertinent Quality Management Systems required in the production of medicinal products (drugs) with the intention to authorize the medicinal product (drug)? Please name three regulatory controlled Quality Management Systems and allocate the required QMS to the phase in medicinal product (drug) development.

 

Good Laboratory Practice (GLP) for early-stage drug development, the pre-clinical studies, Good Manufacturing Practice (GMP) for the manufacture of medicinal product throughout the medicinal product (drug) production, and Good Clinical Practice during the clinical trials. 

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What does DIR stand for?

= DIRECTIVE (GMP/GLP/GCP)

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What does REG stand for?

REG = REGULATION (GMP/GCP)

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What does ICH stand for?

= international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (GMP/GLP/GCP/CTD)

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What does OECD stand for?

= The Organisation for Economic Cooperation and Development (GLP)

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8. The currently applicable three medical device directives have been revised and in the near future two regulations will come into effect to regulate the medical devices. Name/number the three medical device directives and explain what medical products are regulated and also name/number the new two Regulations and explain which directives are covered in which regulation.

 

Directive 98/79/EC for In Vitro diagnostic medical devices, will become the Regulation 2017/746 for In Vitro diagnostic medical devices. The directive 93/42/EC for medical devices and the directive 90/385/EEC for active implantable medical devices will become the regulation 2017/745 for medical devices.