Pharma II - Drug Development and Regulation
Course content
The topics taught are:
- Preclinical efficacy tests in animal models
- Clinical trials
- Regulatory affairs
- Quality assurance
- Production and marketing
BRIDGE - Translational Excellence Programme
On completion of the course, the participants should be able to:
Knowledge
• Give a comprehensive overview of the
preclinical efficacy tests in animals and clinical phase of
development of medicines
• Identify correct professional terms in clinical
development of medicines
• List major steps and elements of the
preclinical efficacy tests in animals and clinical drug development
process
• Outline definitions of key concepts and the
fundamentals of the major disciplines in clinical development
• Identify the important transition points that
require involvement of authorities
Skills
• Appraise the integration of the various basic
disciplines into the process of preclinical efficacy tests in
animals and clinical development of medicines
• Analyse the sequence and flow of the various
steps in the process of clinical drug discovery and development
• Plan a development process within the
regulatory framework
Competences
• Liaise with all steps of clinical drug
development
• Identify critical factors and bottlenecks that
influence the preclinical efficacy tests in animals and clinical
drug development process
• Promote and state milestones for the progress
of the clinical development of a medical product
• Communicate professionally with the various
specialist groups within the area of development of
medicines
The course is organized as an intensive 5-day course and comprises lectures, group discussions, case studies, presentations and discussions
The syllabus comprises collections of review papers, textbook
chapters and case stories and updated lecture slides.
Participants are expected to purchase: Drug Discovery and
Development. Technology in Transition, 2nd edition
Humphrey P. Rang, Churchill Livingstone, 978-0443064203. Avalable
also as E-Book.
The Textbook of Pharmaceutical Medicine, 7th edition,
2013. John P. Griffin (Editor), John Posner (Editor), Geoffrey R.
Barker (Editor) Blackwell BMJ Books serves as “nice to
know”.
Participants must meet the admission criteria in BRIDGE - Translational Excellence Programme
Automatic registration upon appointment in the Translational Excellence Programme
- ECTS
- 0 ECTS
- Type of assessment
-
Continuous assessmentCourse participationAttendance and active participation
- Aid
- All aids allowed
- Marking scale
- passed/not passed
- Censorship form
- No external censorship
Criteria for exam assessment
Attendance and active participation
Part time Master and Diploma courses
- Category
- Hours
- Lectures
- 20
- Theory exercises
- 15
- English
- 35
Kursusinformation
- Language
- English
- Course number
- SBRI19009U
- ECTS
- 0 ECTS
- Programme level
- Part Time Master
Ph.D.
- Duration
- Schedulegroup
-
See course dates and course programme in Absalon
- Capacity
- 15 participants
- Studyboard
- Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
- Department of Biomedical Sciences
Contracting faculty
- Faculty of Health and Medical Sciences
Course Coordinators
- Mette Rosenkilde (10-75727668716e6c6f67684376787167316e7831676e)
- wbf943 wbf943 (4-636a75774275777066306d7730666d)
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Courseinformation of students