PHARMATRAIN News Contact

King's College London

Clinical Drug Development

Practical Information

Commencing Date:
tba
Language:
English
Location:
London United Kingdom


Teaching Methodology:
Blended Learning
Credits :
Short courses (CPD): 15 CATS


European Fees:
1550 GBP
Non European Fees:
2450 GBP
Scholarship Possibilities:
No

Course Contact

Programme Officer

+44 (0)20 7848 4684

pharm-med@kcl.ac.uk


Website

Fees Information

Office Link

King's College London

University Accreditation: Yes

Centre of Excellence

Description

This module covers the development of a new medicine from early exploratory clinical development right through to the stage of applying for a licence for marketing. We will highlight practical issues associated with running clinical trials, including large-scale multinational projects. Key topics include: Clinical trial design, clinical end points, writing a protocol, project management, ethical and legal aspects of clinical research, logistics issues in clinical trials, clinical trials in children, data gathering for phase 2-4 studies, adverse events in clinical trials. You will take part in workshop sessions and practical exercises to “develop” a new molecule and learn how to apply the principles of statistics to clinical trial design.

IMI Standards

  • A predefined set of teaching objectives, leading to defined learning outcomes
  • Assessment of the students' achievement in accordance with the agreed learning outcomes of the training offered
  • A system for collecting, assessing and addressing feedback from learners, teachers, technical / administrative staff and programme / course / module managers
  • Availability of appropriate and regularly reviewed reference material (e.g. published articles, links, book chapters, scripts, etc)
  • Defined and transparent admission criteria
  • Quality assurance of teaching staff
  • Regular review of the QA/QC process and demonstration that the training is further developed in light of this review
  • The facilities, infrastructure, leadership and competences available for the support of student learning
  • University accreditation OR a system for approving, monitoring and reviewing the training offered