NLGeneralInformation object

Applied regulatory conventions

Declaration of Helsinki
Other ethical principles for medical research (other than Declaration of Helsinki)
ICH-GCP Guidelines
International regulatory requirements
European regulatory requirements - European Directive 2001/20/EC, 2005/28/EC
National regulatory requirements
Institutional regulatory requirements

Applicable national laws

The Serbian Law of Food Protection and Quality

National regulations for volunteers exist for

Nutrition intervention in healthy people
Pharmaceuticals/drug trials
Invasive procedures
Catheters
Isotopes
Tissue samples

Network providing information on regulations and ethical requirements in studies

ECRIN Serbian Medical Society

Network Email

sld@bvcom.net

Network contact person

Dragana Maca A. Kastratovic, Srdjan Djani Z. Markovic, Suzana Bjelogrlic

Personal Email

drmaca.kastratovic@gmail.com

Official website providing relevant national legislation

Further Contacts: Tel:+381113234450 ; +381600326170 ; +38162323411
sld@bvcom.net ; drmaca.kastratovic@gmail.com ; srdjan0302@gmail.com

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395