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
• Note: course can be enrolled in outside the study plan; enabled for web enrollment
• Guarantor: doc. MUDr. Jiří Slíva, Ph.D., MBA
• Pre-requisite : CVSE1M0001

Annotation

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

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

Aim of the course

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

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

Course completion requirements

attendance

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

Literature

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/

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

Teaching methods

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

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

Requirements to the exam

Not applicable

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

Syllabus

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

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

Entry requirements

Not specified.

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