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CEMDC, Semmelweis University

Module 3: Clinical Development of Medicines: Exploratory and Confirmatory

Practical Information

Commencing Date:
tba
Language:
English
Location:
Budapest Hungary


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


European Fees:
1000 EUR
Scholarship Possibilities:
Yes

Course Contact

CEMDC, Semmelweis University

University Accreditation: Yes

Centre of Excellence

Description

Module Leaders: R. Maciulaitis, Lithuania and D. Niese, Germany - under discussion In this module the early clinical development of medicines from non-clinical to phase II clinical evaluation will be reviewed. The definition and the functional significance of the Proof of Concept in medicnes development will be discussed in detail.

Outcomes

Early studies in patients: dose-finding / proof of concept studies and their impact on drug development plan Clinical trial design (including legal, regulatory, ethical and practical aspects): international differences Principles and application of statistics in clinical trials Procedures for clinical trial data collection (paper and electronic) and data management (including validation processes) to ensure optimal quality data Key strategic issues in the clinical trial process, in terms of legislative requirements and Good Clinical Practice (GCP) The role of the investigator drug brochure (IDB) Principles and practical relevance of ethical issues in biomedical research.8. Legal and ethical provisions for protection of clinical trial subjects

Covered Areas

Scientific Areas

PK/PD modelling

Methodology

Quality - GMP, GCP, GLP

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