Regulatory Affairs
Based on the Lecture "Regulatory Affairs" by Prof. Spitzenberger, FH-Lübeck Germany. Lecture is part of the M.sc. BME. The cards are based on the learning outcomes of each slide.
Based on the Lecture "Regulatory Affairs" by Prof. Spitzenberger, FH-Lübeck Germany. Lecture is part of the M.sc. BME. The cards are based on the learning outcomes of each slide.
Kartei Details
| Karten | 55 |
|---|---|
| Sprache | English |
| Kategorie | Marketing |
| Stufe | Universität |
| Erstellt / Aktualisiert | 02.09.2017 / 05.02.2022 |
| Lizenzierung | Keine Angabe |
| Weblink |
https://card2brain.ch/box/20170902_regulatory_affairs
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| Einbinden |
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Who or what is a Regulatory Affairs Professional?
describe his tasks and responsibilities.
- The regulatory function is vital in making safe and effective healthcare products available worldwide.
- Regulatory professionals are those who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance.
- The responsibilities of a regulatory professional reach from the r&d phases, clinical trials, premarket approvals, manufacturing, labeling, advertising and postmarket surveillance.
- Regulatory professionals are employed in industry, government and academia and are involved with a wide range of products.
What defines a "medical device" according to European Directive 93/42/EC?
- any instrument, appliance, software or material intended by its manufacturer to be used specifically for diagnostic or therapeutic purposes
- necessary intended to be used for human beings
- does not achieve its intended action by pharmacological, immunological or metabolic means, but may be assisted in its function by such means.
- "articles" used in combination are also defined as medical devices
What defines a "in vitro diagnostiv medical device" according to European Directive 98/79/EC?
- a medical device with the difference that it is intended to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body for the purpose of providing information.
- provided information concerns a physiological or pathological state, a congenital abnormality or monitoring therapeutic measures
What defines a "medicinal device" according to Directive 2001/83/EC?
A medicinal product is any substance presented as having properties for treating or preventing disease in human beings
Or
any substance which may be used in human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmalogical.
What defines a "cosmetic product" according to Regulation (EC) No. 1223/2009?
Cosmetic product means any substance to be placed in contact with the external parts of the human body or with the teeth with a view to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.
List a selection of European and US American legal documents (at least 2) for the regulation of medical devices and explain their basic purpose.
- German: Medizin Produkte Gesetz
- European Directives (90/43/EC according medical devices - 98/79/EC according in vitro diagnostic medical devices)
- European Regulations -> MDR and IVDR entry into force during 2nd quarter of 2017
- FDC Act
=> Each is responsible for protecting the public health by ensuring the safety, efficancy and security of medical devices. While EU directives also focus on supporting innovation.
Which of the following products are Medical Devices?
Explain the regulatory challenge for so called combination products.
Products which for example combine a medicinal product and a medical device are regulated either under the one regulation or under the other.
Both acts should ensure appropriate interaction in terms of consultations during pre-market assessment.
