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CEMDC, Semmelweis University

Module 1a (Int): Introductory Programme, Module 1b: Principles of Discovery of Medicines and Development Planning

Practical Information

Commencing Date:
tba
Language:
English
Location:
Budapest Hungary


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


European Fees:
1000 Euro (EUR)
Scholarship Possibilities:
Yes

Course Contact

CEMDC, Semmelweis University

University Accreditation: Yes

Centre of Excellence

Description

INTRODUCTORY MODULE - under discussion The introductory module section provides an introductory overview of medicine development in general and its place in healthcare PRINCIPLES OF DISCOVERY OF MEDICINE AND DEVELOPMENT PLANING Module Leaders: P. Arányi, Hungary and M. Gottwald, Germany The general introductory section is followed by the detailed discussion of the drug discovery process.

Outcomes

INTRODUCTORY PROGRAMME Process of drug development and identity of critical factors and decision points Importance of the patient in drug development Background to the development of the regulation of medicines and the role of the competent authorities Monitoring of drug safety PRINCIPLES OF DISCOVERY OF MEDICINES AND DEVELOPMENT PLANNING Principles and practice of medical marketing Role of pathophysiology and molecular biology-based pharmacology in drug development Principal steps in discovering, modifying, assessing and patenting new chemical and biological compounds (including advanced therapies) according to their therapeutic indication Resource planning (in terms of project management, budgeting and cost-control) involved in the management of a drug development programme Principles of translational research and its role in drug development Functions and elements (including business aspects) involved in the integrated development of a new drug

Covered Areas

Scientific Areas

- PK/PD modelling - Stem cells and regenerative medicine - Target discovery and lead selection

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