Ultima actualizare: august 17, 2026
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
Detalii – [email protected]
Analiza științifică a cazului
Doriți să înțelegeți dacă programele clinice actuale, evoluții recente ale cercetării, sau abordări emergente pot fi relevante pentru situația dumneavoastră individuală?
Distribuiți întrebarea dvs. echipei noastre de cercetare științifică și primiți informaţii concentrate pe domeniile de cercetare curentă care pot fi relevante pentru cazul dvs.
- Revizuirea informațiilor pe care le furnizați
- Informații relevante de cercetare și program clinic
- Un răspuns clar concentrat pe situația dvs
Fără obligație. Întrebarea dvs. va fi examinată în mod confidențial.
Doar informații educaționale și de cercetare. Acest serviciu nu constituie un sfat medical, diagnostic, prescripție medicală, sau personalizat recomandare de tratament.
0 Comments