HVQM - Quality assurance and compliance audits
GCP compliance audits are indirectly required by ICH GCP. These audits provide insight in the quality of clinical research processes and the level of compliance with ICH GCP. In addition, the integrity and reliability of the study data are assessed. HVQM offers you independent auditing and specialized training to increase the knowledge of your clinical research staff.
Medicines Evaluation Board
The Medicines Evaluation Board in the Netherlands
NovaXon (EDC datamanagement)
NovaXon offers a range of products and services related to the collection, processing and analysis of clinical data.
European Competent Authorities:
Norway:
*
Ministry of Health
in English
* The
Norwegian Board of Health including good (English) information on the Norwegian
Regulations concerning Medical Devices. The Board of Health is an independent
technical agency, and is administratively part of the Norwegian Ministry of Health.
The Board of Health provides the Ministry with technical advice and information
Sweden:
* Medical
Product Agency in English
* The
National Board of Health and Welfare with all English documents on their website
Finland:
*
Ministry of Social Affairs
and Health in English
* The
National Agency for medicines (and medical devices) in English
Denmark:
*
The Danish Research
Agency in English. This Danish Research Agency is an independent institution
under the Ministry of Research. The agency houses amongst others the secretariats
for the Central Scientific Ethical Committee (CVK) and the Danish Committees on
Scientific Dishonesty (UVVU).
Ireland:
*
Irish Medicines Board Medical
Device Website. This site has been developed by the Medical Devices Department
of the Irish Medicines Board (IMB) to illustrate the services that are in operation
with regard to Medical Devices. It is also to facilitate the registration of medical
devices used within Ireland.
UK:
*
Medical Device Agency
of the Department of Health. Very informative website of the MDA, the UK's
Competent Authority for Medical Devices
Netherlands:
*
The
Central Committee on Research Involving Human Subjects (known by its Dutch
initials, CCMO) oversees medical research involving human subjects in the Netherlands.
Informative site including a list of certified Medical Ethics Committees (in English).
*
Ministry of Health only in
Dutch
Belgium:
*
Directorate
General of Health Protection: Medicines
Germany:
*
Bfarm in
English
* DIMDI
(=German Institute of Medical Information and Documentation) on medical devices
France:
*
The French
Health Products Safety Agency (AFSSAPS) with a couple documents in english.
The majority is in French
Austria:
*
Ministry of Social Security
only in German
Portugal:
*
The National Pharmacy
and Medicines Institute is a Government agency accountable to the Health Ministry.
The objective is to monitor, assess and regulate all activities relating to human
medicines and health products for the protection of Public Health. Summary in
English, majority of website in Portuguese.
Spain:
*
Ministry
of Health and Consumers only in Spanish
Italy:
*
Department of Italian Health
Ministry only in Italian
Greece:
*
The National Organization
for Medicines (EOF) is a public entity of the Greece Ministry of Health. EOF
mission is to ensure public health and safety with regard to (amongst others)
medicinal products for human and medical devices, marketed in Greece. In English.
Hungary:
*
Authority for Medical
Devices in English
Switzerland:
*
SwissMedic,
the Swiss Agency for Therapeutic Products on medical devices in English
Czech
Republic:
* Ministry
of Health of the Czech Republic in English
Standardization
Bodies:
* ISO:
A network of national standards institutes from 145 countries working in partnership
with international organizations, governments, industry, business and consumer
representatives. A bridge between public and private sectors.
* International
Conference on Harmonization (ICH) of Technical Requirements