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Useful Links

 

NATIONAL BODIES-ASSOCIATIONS:

 

Hellenic Association of CROs (HACRO)

Ministry of Health 

Ministry of Rural Development and Food

Hellenic Association of Pharmaceutical Companies (SFEE)

Hellenic Society of Pharmaceutical Medicine (ELEFI)

National Ethics Committee

Panhellenic Association of Pharmaceutical Industries (PEF)

Hellenic Data Protection Authority (HDPA) 

 

MEDICAL DICTIONARIES/CODING:

 

Medical Dictionary for Regulatory Activities (MedDRA)

WHO Collaborating Centre for Drug Statistics Methodology, ATC/DDD Index

 

CRO & CRA ASSOCIATIONS:

 

Association of Clinical Research Organizations (ACRO)

European CRO Federation(EUCROF)

Hellenic Association of CROs (HACRO)

Society of Clinical Research Associates (SoCRA)

 

REGULATORY AGENCIES FOR THE EVALUATION OF MEDICINAL & COSMETIC PRODUCTS,

OTCs, MEDICAL DEVICES, FOOD SUPPLEMENTS AND BIOCIDES:

 

National Organization for Medicines (EOF)

Cypriot Pharmaceutical Services of the Ministry of Health

European Medicines Agency (EMA)

Heads of Medicines Agencies (HMA)

US Food and Drug Administration (US FDA)

 

REGULATIONS & GUIDELINES:

 

National Gazette

Codex Alimentarius (Food standards, guidelines and related texts such as codes of practices)

European Legislation

Council for International Organizations of Medical Sciences (CIOMS)

Declaration of Helsinki, World Medical Association

Eudravigilance

European Commission, Directorate  General Health and Food Safety, Public Health, Medicinal Products for Human Use

European Directorate for the Quality of Medicines & Healthcare

European Federation of Pharmaceutical Industries and Associations (EFPIA)

European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)

Good Clinical Practices (GCP) ICH Guidelines

Good Distribution Practices (GDP) EU Guidelines

Good Laboratory Practice (GLP) OECD Guidelines

Good Manufacturing Practice (GMP) EU Guidelines

Good Pharmacoepidemiology Practices (GPP) ISPE Guidelines

Good Pharmacovigilance Practices (GVP) EU Guidelines

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

Post-Authorisation Safety Studies (PASS)

World Health Organization

World Medical Association 

 

CLINICAL TRIAL REGISTRIES:

 

EU Clinical Trials Register

EU Post-Authorisation Studies (EU-PAS) Register

National Institutes of Health Clinical Trials Database

 

REPORTING OF CLINICAL STUDIES:

 

Enhancing the QUAlity and Transparency Of health Research (EQUATOR)

Committee on Publication Ethics (COPE)

Consolidated Standards of Reporting Trials (CONSORT)

International Committee of Medical Journal Editors (ICMJE)

STrengthening the Reporting of OBservational studies in Epidemiology (STROBE)