State registration of drugs in Eastern Europe

On-site or on-line training

 

AGENDA:

1) Legal framework for registration of drugs

2) Organizational structure of the of the Ministry of

 

3) Procedure of state registration

4) Questions of registration applications for state registration

5) Examination of materials of registration dossier

6) Structure and completeness of the registration dossier for drugs

7) Registration dossier of materials – methods of quality control , instructions for medical use

8) Identification of drugs – mandatory text, font sizes, Braille, graphic design packages

9) Practice of conducting pre-clinical and clinical trials

10) Proof of the equivalence of generics – regulatory requirements, design reporting documentation

11) Statutory insurance issues of patients in clinical trials

12) Questions of patent protection for trade marks

13) Procedure for making changes to the drugs – types of changes of necessary documents, amendment procedure

14) Organization of pharmacovigilance – requirements, reporting.

15) Inspection of manufacturing ( GMP recognition ) for drugs submitted for state registration

16) Review of standard errors of the Applicants for work with Ministry of Health . Comments of the Experts

17) Organization of state control drug quality, imported and located in the pharmaceutical market

18) Suspension, prohibition, and the resumption of drugs in the pharmaceutical market

19) Post-registration surveillance over medicinal products registered in collaboration with the State Inspectorate for Quality Control of Medicinal Products

 

Detalles – REG@nbscience.com