| Title |
Pažangiosios terapijos vaistinių preparatų teisinis reglamentasvimas Europos Sąjungoje ir Lietuvoje |
| Translation of Title |
The legal regulation of advanced therapy medicinal products in European Union and Lithuania. |
| Authors |
Uogintienė, Agnė |
| Full Text |
|
| Pages |
71 |
| Keywords [eng] |
advanced therapy ; somatic cells ; gene therapy ; tissue engeneering ; stem cells |
| Abstract [eng] |
The master thesis analyses the current legal regulation of advanced therapy medical product in the EU and Lithuania. Until now, this topic hasn‘t been researched in Lithuanian language. In the first part of the thesis the problem of different advanced therapy medicinal products definitions are introduced. The second part analyses non-clinical and clinical requirements for advanced therapy medicinal products and current problems related with established requirements. The third part reveals the basis of the regulation of advanced therapy medicinal products in the EU and Lithuania. The thesis extensively analyses the legal acts of European Union and Lithuania law and specific legal literature. |
| Type |
Master thesis |
| Language |
Lithuanian |
| Publication date |
2014 |
