Clinical Evaluation of Drug Products
Provider: Faculty of Health and Medical Sciences

Activity no.: 3142-14-00-00 
Enrollment deadline: 09/10/2014
Date and time08.12.2014, at: 09:00 - 12.12.2014, at: 16:00
Regular seats20
Course fee5,520.00 kr.
LecturersLona Louring Christrup
ECTS credits4.00
Contact personMarianne Wieslander Jørgensen    E-mail address: marianne.joergensen@sund.ku.dk
Enrolment Handling/Course OrganiserPhD administration     E-mail address: phdkursus@sund.ku.dk
Aim and content
Learning objectives
A student who has met the objectives of the course have a broad knowledge:

a. of the various phases involved in development of new drugs
b. of methodological and statistical aspects of clinical trials in humans
c. of the regulatory aspects of clinical trials and approval of drug products
d. of ethical aspects in clinical trials
e. of pharmacovigilance and evidence based medicine.


Content
The clinical development phases will be presented, along with non-clinical studies that are a direct prerequisite for clinical trials. Other topics, which will be covered, include:
- Clinical trial protocol.
- Clinical trial methodology.
- Randomised clinical trial.
- Pharmacovigilance.
- Statitics in clinical trials.
- Quality assurance.
- Regulatory guidelines.
- Regulatory drug approval process.
- Evidence-based medicine and ethics in clinical drug trials.

Participants
The target group will be PhD students within pharmaceutical sciences. Other graduates holding degrees in health/life sciences at university level, but who have no in-depth knowledge of clinical drug trials, are also welcome to attend.

Language
English

Form
Lectures followed by discussions

Course director
Lona Christrup Professor PhD; ILF; llc@sund.ku.dk

Teachers
Karin Friis Bach PostDoc ILF.
Experts in the field of Clinical Research

Course secretary
Marianne W Jørgensen Marianne.Joergesensund.ku.dk

Course location
PharmaSchool UP2

Dates
8-12 December 2014 from 8.30 to 16.30