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CEMDC, Semmelweis University

Module 2: Non-Clinical Testing, Pharmaceutical and Early Clinical Development

Practical Information

Commencing Date:
tba
Language:
English
Location:
Ljubljana or Budapest, Slovenia Slovenia


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: I. Mlinaric-Rascan, University of Ljubljana, Slovenia and Beatriz Silva Lima, University of Lisbon, Portugal Cooperative European Medicine Development Course (CEMDC) Base Course. Module 2. Date: under discussion Place Ljubljana, Slovenia

Outcomes

Choice and predictive value of the non-clinical testing programme as part of the overall drug development plan for chemical and biological compounds Integration of non-clinical tests into the overall drug development plan (including scheduling of toxicology tests with respect to clinical trials) Steps in the pharmaceutical development of a drug substance and final drug product (including chemical and biological compounds) Planning of clinical trial supplies for test substance and comparators (active and placebo) Overview of non-study requirements prior to First-into-Man studies Molecular and cellular basis of toxic reactions Principles and practical application of pharmacokinetics and toxicokinetics Early exploratory development in man Principles of clinical pharmacology and their application to clinical development Influence of genetic factors in drug development and drug response

Covered Areas

Scientific Areas

+ PK/PD modelling - Target discovery and lead selection

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