FaF:FDALR_FAF Regulatory Affairs - Course Information

FDALR_FAF Regulatory Affairs

Extent and Intensity

1/1/0. 25 credit(s). Type of Completion: zk (examination).

Guaranteed by

doc. Ing. Jiří Dohnal, CSc., MBA
Faculty of Pharmacy

Course Enrolment Limitations

The course is also offered to the students of the fields other than those the course is directly associated with.

fields of study / plans the course is directly associated with

• Safety and Quality of Drugs (programme FaF, D-BKL) (2)

Course objectives

After completing this subject, students should be well oriented in the field of creating, evaluating and updating documentation related to drug regulation, or they should be able to actively intervene in the processes in the field of harmonization. Attention is paid to the means of preventing the entry of counterfeit medicines into the market due to the timeliness of this measure.

Syllabus

• Regulatory Affairs
  The aim of the course is to extend the knowledge of students in the fields of registration documentation creation, registration procedures and post-authorization drug monitoring.
  A great attention is paid to the Regulatory Intelligence.
  The key theme of this subject is the harmonization of standards and regulations to ensure the safety, efficacy and quality of medicines.
  In this context a large space is dedicated to the issue of counterfeit medicines and to so called the FMD (Falsified Medicines Directive).
  The role of regulators in this area with respect to the EU and the US is discussed and compared.
  

Literature

required literature
• The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). URL URL info
• Zákon č. 378/2007 Sb., o léčivech a o změnách některých souvisejících zákonů (zákon o léčivech). info

recommended literature
• EudraLex ? Volume 1 ? Pharmaceutical legislation for medicinal products for human use. URL info
• Official Journal of the European Union: COMMISSION DELEGATED REGULATION (EU) 2016/161. info
• Vyhláška č. 228/2008 Sb., o registraci léčivých přípravků. info

Teaching methods (in Czech)

Dialogická (diskuze, rozhovor, brainstorming)
Metody práce s textem (učebnicí, knihou)

Assessment methods (in Czech)

Ústní zkouška

Language of instruction

Czech

Further comments (probably available only in Czech)

The course can also be completed outside the examination period.

Teacher's information

Teaching takes place through personal consultations and other educational activities recommended by the guarantor of the subject.

Activity	Difficulty [h]
Domácí příprava na výuku	25
Domácí příprava na výuku	25
Summary	50

• Enrolment Statistics (Spring 2020, recent)
  
• Permalink: https://is.muni.cz/course/pharm/spring2020/FDALR_FAF