BASIC PRINCIPLES OF DRUG APPROVALS IN EU COUNTRIES: how to obtain Marketing Аuthorization in Europe
30-31 October, Kyiv, hotel Khreschatyk
Training course is organized and performed in partnership with European consultation company, with support of Association «Drugs manufacturers of Ukraine», and with participation of State Medicines Control Agency of Lithuania.
Highlights
- EU Pharmaceutical legislation Medicinal Products for Human Use: Directives, Regulations and Guidelines
- Drug approvals in the EU countries: prerequisites, procedures and timelines Different types of application
- Structure of the CTD: Module 1-5
- Relevant GMP documents for a marketing authorization application
- e-CTD – key endpoints of successful management of marketing authorization procedures
- Workshop
Application form
Contact information
- Address: 10a, Velyka Kytayivska vul., off. 4, Kyiv, UA
- Phone: +380 044 5694842
- E-mail: info@deya.kiev.ua
- Work hours: 09:00 (AM) - 6:00 (PM) (Mo-Fr)