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University of Aveiro

Clinical Development

Practical Information

Commencing Date:
tba
Language:
Portuguese
Location:
Lisbon Portugal


Teaching Methodology:
Blended Learning


European Fees:
300 EUR
Scholarship Possibilities:
No

Course Contact

Bruno Gago

(+351) 234 247 247

bmgago@ua.pt


Website

Office Link

University of Aveiro

University Accreditation: Yes

Centre of Excellence

Description

This is a 3-day stand-alone short course. It consists in a series of learning events, namely lectures, seminars, presentations, discussion panels and case studies. Pre-course activities will also be available for the interested participants.

Outcomes

On successful completion of this Module the student should be able to: Describe the various types of clinical studies and the methods used to choose the appropriate design. Describe the main statistical methods used in clinical research. Identify the key issues involved in the conduct of a clinical study including investigator and site recruitment, investigative site management and conflict resolution. Discuss the collection, evaluation and reporting of adverse event data in clinical trials. Outline the various quality management issues in clinical trials. Describe the impact of emerging results on the drug development plan. Outline the key operational and strategic issues in the clinical development plan. Explain the evaluation of the outcome of drug development: final therapeutic profile/usage of a medicine. Describe the role of the Target Product Profile (TPP) and Target Product Claims (TPC). Explain the role of the Drug Safety Monitoring Board (DSMB) and other relevant study committees. Discuss the statistical issues in statistical report writing. Describe the evaluation and interpretation of clinical trial results. Illustrate the principles and practical application of critical appraisal.

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