DFU: B-8111 Clinical Pharmacology: Phase I-III

Main > The part-time master's programmes > Master of Industrial Drug Development - MIND > MIND Programme and
courses > B-8111 Clinical Pharmacology: Phase I-III

Preliminary course descriptions.
B-8111 Clinical Pharmacology: Phase I-III
Klinisk Farmakologi: Fase I-III
Course objectives
The objective of this course is to give the participants a thorough understanding of
clinical pharmacological considerations during drug development.
General contents
Regulatory aspects/Ethical considerations/GCP Clinical trial designs including considerations of
PK/PD, endpoints, sample size, and power Transition from preclinical to clinical phase
Operational aspects of study conduct Fraud and misconduct
Outcome
On completion of the course the participants will have a broad knowledge of the
essential elements involved in clinical drug development.
Prerequisites:
Basic knowledge of GCP: ICH Harmonised Tripartite Guideline for Good Clinical Practice. ISBN
1-874409-74-9 (to be ordered at http://www.brookwoodbooklets.com/) Griffin JP, OGrady J:
The textbook of Pharmaceutical Medicine, 4th Ed 2002; BMJ Books, London ISBN 0-7279-
1523-1
Practical Information
Date

21-25 November 2005
Course structure

The course will consist of 20 lectures over a 5-day period. Each lecture will leave time
for extensive discussions facilitating active participation by the participant. Workshops
Master of Industrial
Drug Development -
MIND
MIND Programme and
courses
B-8101 Discovery and
Development of Medicines
B-8104 Pharmacology
B-8105 Non-clinical Safety and
Toxicology
B-8111 Clinical Pharmacology:
Phase I-III
F-8103 Drug Design and Discovery
F-8106 Formulation and quality
aspects of drug dosage forms
F-8107 Drug Delivery
F-8108 Drug Regulatory Affairs in
Drug Development
F-8110 QA, QC, GXP for
pharmaceutical production
M-8102 Target Identification and
validation
MIND Practical information
News
For Participants
Master i Kvalitetssikret
Lgemiddelanvendelse
- MKL
Elective Courses
Master's project

file:///G|/stf/Master%20&%20specialist/MIND/Dagsordene...20B-8111%20Clinical%20Pharmacology%20Phase%20I-III.htm (1 of 2)25-04-2005 10:02:17
DFU: B-8111 Clinical Pharmacology: Phase I-III
will form an important part of this course.

Evaluation

2 hours written examination. Assessment with external examiners follows the 13-point
grading scale.
Course weight

2.5 ECTS-points (European Credit Transfer System) = 1/24 year full time study.
Course fee

Master students DKK 5.175, freelance students DKK 7.500.
An additional fee will be added for lunch, coffee and course materials.
Application

1 September 2005
Course capacity

30 participants.
Language

English.
Course director
Lone Harild Ottesen MD PhD, AstraZeneca A/S Contact person at the university:
Professor Ole Bjerrum, Department of Pharmacology.
Lecturers
External lecturers



Denne side er sidst blevet opdateret:
15:16 20/04 2005




file:///G|/stf/Master%20&%20specialist/MIND/Dagsordene...20B-8111%20Clinical%20Pharmacology%20Phase%20I-III.htm (2 of 2)25-04-2005 10:02:17