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Q of the week

Q: Do clinical trials ever go wrong?

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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

Clinical Research Government and Regulatory Bodies
ICHInternational Conference on Harmonisation
WHOWorld Health Organization
PAHO
Pan American Health Organization
WHOWorld Health Organization Regional Office for Europe
WHOWorld Health Organization Regional Office for Africa
WHOWorld Health Organization Regional Office for Eatern Mediterranean
WHOWorld Health Organization Regional Office for South East Asia
WHOWorld Health Organization Regional Office for Western Pacific
WTO
World Trade Organization
ArgentinaNational Administration of Drugs, Food & Medical Technology
Armenia
Drug and Medical Technology Agency
AustraliaAustralia's Department of Health and Aged Care
AustraliaTherapeutic Goods Administration
AustriaHealth & Social Affairs
Bahrain
Ministry of Health
Bangladesh
Directorate of Drug Administration
BelgiumMinistry of Social Affairs, Public Health & Environment
Bolivia
Ministry of Health and Social Welfare
Botswana
Ministry of Health
BrazilMinistry of Health
BrazilNational Health Surveillance Agency (ANVISA)
Brunei
Ministry of Health
Bulgaria
Ministry of Health
Bulgaria
Drug Agency
CanadaHealth Canada
CanadaCanadian Institutes of Health Research(CIHR)
CanadaHealth Products and Food Branch [HPFB]
CanadaTherapeutic Products Directorate [CDD]
China
Ministry of Health
China
State Food and Drug Administration
China
National Institute for the Control of Pharmaceutical and Biological Products
ChileMinistry of Health
Chile
Institute of Public Health
ColombiaMinistry of Health
Colombia
INVIMA
Costa RicaMinistry of Health
Croatia
Ministry of Health
CzechState Institute for Drug Control
DenmarkDanish Medicines Agency
Ecuador
Ministry of Public Health
EstoniaState Agency of Medicines, Estonia
EuropeEMEA - The European Agency for the Evaluation of Medicinal Products
EuropeCommittee for Medicinal Products for Human Use [CHMP-EMEA]
Fiji
Ministry of Health
FinlandNational Agency for Medicines (NAM)
FranceAgence du Medicament
France
Ministry of Health
GermanyFederal Institute for Drugs and Medical Devices (BfArM)
GermanyMinistry of Health
GermanyPaul-Ehrlich-Instituts in Langen (PEI)
GuamDepartment of Public Health and Social Services
Hong KongDepartment of Health: Pharmaceutical Services
Hungary
Ministry of Health, Social and Family Affairs
HungaryNational Institute for Pharmacy
Iceland
Medicines Control Agency
IcelandMinistry of Health & Social Security
India
Central Drugs Standard Control Organization
India Indian Council of Medical research
India
Ministry of Health & Family Welfare
India
Department of Ayurveda,Yoga,Naturopathy,Unani,Siddha & Homeopathy
IndonesiaMinistry of Health
IrelnadDepartment of Health and Children
IrelnadIrish Medicines Board
IsraelMinistry of Health
ItalyMinistry of Health
Italy 
National Institute of Health
Jamaica
Ministry of Health
JapanMinistry of Health and Welfare
Japan
Pharmaceuticals and Medical Devices Agency
JapanNational Institute of Infectious Diseases
JapanNational Institute of Health Sciences
JordanMinistry of Health
KenyaMinistry of Health
Korea
Korea Food and Drug Administration
LatviaState Agency of Medicines
Lebanon
Ministry of Public Health
LithuaniaState Medicines Control Agency
LuxembourgMinistry of Health
MalaysiaMinistry of Health
Malaysia
National Pharmaceutical Control Bureau
Maldives
Ministry of Health
MaltaMedicines Regulatory Unit
MaltaMinistry of Health
Mauritius
Ministry of Health and Quality of Life
MexicoMinistry of Health
MoroccoMinistry of Health
NetherlandsMedicines Evaluation Board
New ZealandMedsafe - Medicines and Medical Devices Safety Authority
New ZealandNew Zealand Ministry of Health
New ZealandPHARMAC
Nicaragua
Ministry of Health
NordicNordic Council on Medicines
NorwayMinistry of Health and Social Affairs
Norway
Board of Health Supervision
Norway
Norwegian Medicines Agency
Panama
Ministry of Health

P.NewGuinea

Department of Health
Peru
Ministry of Health
PhilippinesPhilippine Council for Health Research and Development (PCHRD)
Philippines
Department of Health
PolandMinistry of Health & Social Welfare
PortugalThe National Institute of Pharmacy and Medicines (Infarmed)
Romania
Ministry of Health and the Family
RussiaPublic Health Institute
Singapore
Ministry of Health
Singapore
Health Sciences Authority
Senegal
Ministry of Health, Hygiene and Prevention
SlovakMinistry of Health
SlovakState Institute for Drug Control (SIDC)
SloveniaMinistry of Health Agency for Medicinal Products
SpainMinistry of Health
Srilanka
Ministry of Health
SwedenMedical Products Agency (MPA)
SwitzerlandSwiss Agency for Therapeutic Products
TaiwanDepartment of Health
TaiwanBureau of Food and Drug Analysis
ThailandMinistry of Public Health
Thailand
Food and Drug Administration
Trinidad
Trinidad and Tobago Ministry of Health
Tunisia
Office of Pharmacy and Medicines
TurkeyMinistry of Health
UAEMinistry of Health
Uganda
Ministry of Health
UK
Committee on Safety of Medicines (CSM)
UKDepartment of Health
UKMedicines and Healthcare Products Regulatory Agency (MHRA)
UKNational Health Service (NHS)
UKNational Institute for Biological Standards and Control (NIBSC)
Ukraine
Ministry of Health
Uruguay
Ministry of Public Health
USAAgency for Healthcare Research and Quality(AHRQ)
USAAmerican National Standards Institute(ANSI)
USACancer Centers Program [CCP]
USACenter for Biologics Evaluation and Research(CBER)
USACenter for Devices and Radiological Health [CDRH]
USACenter for Drug Evaluation and Research [CDER]
USACenter for Scientific Review [CSR]
USACenter for Veterinary Medicine [CVM]
USACenters for Disease Control and Prevention(CDC)
USACenters for Medicare & Medicaid Services [CMS]
USACompliance Program [CP]
USADepartment of Health and Human Services(HHS)
USADrug Enforcement Administration [DEA]
USAEnvironmental Protection Agency(EPA)
USAFood and Drug Administration(FDA)
USAMedical Literature, Analysis, and Retrieval System Online (MEDLINE)
USANational Cancer Institute [NCI]
USANational Center for Biotechnology Information [NCBI]
USANational Center for Complementary and Alternative Medicine [NCCAM]
USANational Center for Health Statistics [NCHS]
USANational Center for Research Resources [NCRR]
USANational Center for Toxicological Research [NCTR]
USANational Center on Minority Health and Health Disparities [NCMHD]
USANational Eye Institute [NEI]
USANational Heart, Lung, and Blood Institute [NHLBI]
USANational Institute of Allergy and Infectious Diseases [NIAID]
USANational Institute of Arthritis and Musculoskeletal and Skin Diseases [NIAMS]
USANational Institute of Biomedical Imaging and Bioengineering [NIBIB]
USANational Institute of Child Health and Human Development [NICHD]
USANational Institute of Dental and Craniofacial Research [NIDCR]
USANational Institute of Diabetes and Digestive and Kidney Diseases [NIDDK]
USANational Institute of Environmental Health Sciences [NIEHS]
USANational Institute of Mental Health [NIMH]
USANational Institute of Neurological Disorders and Stroke [NINDS]
USANational Institute on Aging [NIA]
USANational Institute on Alcohol Abuse and Alcoholism [NIAAA]
USANational Institute on Deafness and Other Communication Disorders [NIDCD]
USANational Institute on Drug Abuse [NIDA]
USANational Institutes of Health [NIH]
USANational Science Foundation(NSF)
USANIH Clinical Center [NIH-CC]
USAOffice for Human Research Protections [OHRP]
USAPatent and Trademark Office [DOC]
USAThe President's Council on Bioethics
USAPublic Health Service

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Opinion Poll

Which one of the following do you think is the most common reason for participating in clinical trials?
 
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.
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