|
Lecturer(s)
|
-
Pavlát Petr, Ing. Ph.D.
-
Hradil Pavel, prof. Ing. CSc.
|
|
Course content
|
Life cycle of medicals Law about drugs and legislation in CR and EU Registration Accessible information systems (AISLP, IDRAC, Medline,Toxline?) Patent law Patent practice I- in patent office and court Patent practice II- in pharmaceutic firm Structure of registration forms Quality of preparation ( quality aasuarance, stability..) Effective compound- structure and administration of registration (DMF,CEP) Safety ( TSE/BSE,GMO, PSUR?.) Effectivity (BES, clinical examination..) DMS- administration and control of documentation Registration of preparations produced by biotechnology
|
|
Learning activities and teaching methods
|
|
Lecture
|
|
Learning outcomes
|
To inform students about new method used in organic chemistry.
The knowledge of methods of drug registration and drug patent protection.
|
|
Prerequisites
|
unspecified
|
|
Assessment methods and criteria
|
Oral exam, Written exam
Attend lectures, write a test minimally on 70 % .
|
|
Recommended literature
|
-
Notice to applicants (The rules governing medicinal products in the European Union).
-
Prováděcí pokyny DRA.
-
Zákon o léčivech č. 129/2003 Sb.
-
Zákon o návykových látkách č.167/1998 Sb.
-
Zákon o zdravotnických prostředcích č. 130/2003 Sb.
|