Drug Discovery and Drug Development - CCOCA0095

• Title: Drug Discovery and Drug Development
• Guaranteed by: Department of Pharmacology 3FM CU (12-FARM)
• Faculty: Third Faculty of Medicine
• Actual: from 2017
• Semester: winter
• Points: 1
• E-Credits: 1
• Examination process: winter s.:
• Hours per week, examination: winter s.:0/15, C [HS]
• Capacity: unknown / unknown (4)
• Min. number of students: unlimited
• 4EU+: no
• Virtual mobility / capacity: no
• State of the course: not taught
• Language: English
• Teaching methods: full-time
• Teaching methods: full-time
• Note: course can be enrolled in outside the study plan; enabled for web enrollment
• Guarantor: doc. MUDr. Jiří Slíva, Ph.D.
• Pre-requisite : CVSE1M0001

Annotation

Last update: doc. MUDr. Jiří Slíva, Ph.D. (21.06.2017)

The fundamental principles of the process of drugs development in EU and other countries will be comprehensively described and discussed.

Aim of the course

Last update: doc. MUDr. Jiří Slíva, Ph.D. (21.06.2017)

To understand the way of the process of registration/approval of any medicinal products, so that the student get better knowledge about drugs policy.

Course completion requirements

Last update: doc. MUDr. Jiří Slíva, Ph.D. (21.06.2017)

attendance

Literature

Last update: doc. MUDr. Jiří Slíva, Ph.D. (21.06.2017)

1. British National Formulary No.70 [or higher] - BMJ Books, September 2015 [or more recent editions].
2. Pharmacology - H. P. Rang, et al. - Elsevier, Churchill Livingstone, 8th ed. 2015 or 6th, 7th ed.
3. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/landing/human_medicines_regulatory.jsp&mid=
4. https://www.fda.gov/Drugs/

Teaching methods

Last update: doc. MUDr. Jiří Slíva, Ph.D. (21.06.2017)

The subject is organised in form of seminars (see the syllabus)

Requirements to the exam

Last update: doc. MUDr. Jiří Slíva, Ph.D. (21.06.2017)

Not applicable

Syllabus

Last update: doc. MUDr. Jiří Slíva, Ph.D. (21.06.2017)

1. Establishing bio-equivalence between generic and innovator products
2. Clinical development of locally applied products
3. Clinical development of respiratory products
4. Product Development of peptides, biosimilars and vaccines
5. Clinical Development of injectable products
6. Good Clinical Practices
7. Drug Safety (Pharmacovigilance) - Regulatory Challenges with key differences between EU, US and ROW

Entry requirements

Last update: doc. MUDr. Jiří Slíva, Ph.D. (21.06.2017)

Not specified.

Course completion requirements

Last update: doc. MUDr. Jiří Slíva, Ph.D. (21.06.2017)

attendance