Overview

The professional development programme offers the participants in-depth knowledge in drug discovery and development processes, and understanding on procedures applied in drug regulatory science and the role of drug regulatory authorities during the life-span of a drug. Participants learn to understand:

  • Up-to-date methods applied to identify and validate new drug targets, and to generate lead drug molecules,
  • Technological innovations made in lead optimisation process,
  • How new drug candidates are investigated during the non-clinical drug development phase,
  • Methods of clinical drug research, clinical drug development phases, clinical trial design and biostatistical study planning,
  • Various aspects of the drug regulatory science and pharmacovigilance.

 

Programme consists of 4 Academic Modules, that can run also independently

  1. Drug regulatory science
  2. Bioinformatics in drug discovery
  3. Computer-aided drug design
  4. Clinical trial design and clinical drug development 

Schedules and organisation of the Programme can be tailored to the customers needs.

  • Role and activities of drug regulatory authorities in the EU and in the US,
  • Regulatory toxicological and safety evaluation studies,
  • Cases in drug regulatory science.
  • Biological databases,
  • Bioinformatics tools in drug development and commonly used graphical software and computing environments,
  • Analysis of microchip, protein inhibitor and sequence data,
  • Relational databases,
  • Bioinformatics tools in drug development and commonly used command-line-based software,
  • Analysis of microchip, protein inhibitor and sequence data,
  • Introduction to graphical user interface design and development.
  • Interaction of drugs and micro-molecules ,
  • Ligand-based and structure-based drug design,
  • Drug-protein interactions,
  • Ligand docking,
  • Conformational analysis
  • Pharmacophore hypothesis
  • Quantitative structure-activity relationship
  • Phases and types of clinical drug trials
  • Ethical and regulatory evaluation of trials,
  • GCP regulations and legislation regarding clinical drug research
  • Data collection and management in clinical drug trials
  • Composing trial protocols
  • Monitoring and auditing of clinical trials
  • Statistical planning, reporting and interpretation of results
  • Clinical studies for new chemical entities

Contact us for more information

TARGET GROUP

The professional development programme is targeted to experts working in the field of drug development, pharmaceutical industry, biotechnology, contract research organisations (CRO) or regulatory authorities.

AVAILABILITY

On request

Modules can also be provided independently