Institute for Biocomputation and Physics of Complex Systems of the University of Zaragoza

  • Topic 1. Introduction and overview of CC application in Biotechnology. Key concepts: accreditation, certification, regulation, others. National and international organizations highlighted by their regulatory activity in Biotechnology. Comprehensive view of regulation and quality control.
  • Topic 2. Importance of Validation Parameters in Quantitative Biotechnology. (GLPs, etc). Protocol. Report. Certificate  Standard Procedures of Work. Validation of quantitative measurement methods (biochemical, immunochemical). Biological matrices. Standardization and harmonization of biological patterns. Reasons to validate. Specific examples.
  • Topic 3. Importance of Patents in R & D & I. Technology transfer. Need to patent: the researcher's vision, company vision. Priority. Via EPO or via OPEM. Alternative options to the patent.
  • Topic  4. Regulation and Quality Control in the Preclinical Phase trials. Experimentation with animals (different types). Production of sera and antisera. Experimentation with cell cultures. Collections of cell lines (ATCC). GMOs.
  • Topic 5. Biobanks, The Law of Biomedical Research. Bioethical committees. Informed Consent.
  • Topic 6. Clinical Trials. Pharmacovigilance. Specific examples: Vaccines and other biological medicines (different levels of regulation Phase I, Phase II, Phase III). AEMPS and EMA.  Patents and Generics.
  • Topic 7. Biosecurity. Laboratory Types - Recent examples. Future needs for biotechnology quality control and regulation. Consequences of the Human Genome Project. Gene therapy. Cloning for discussion. Stem cells. Tissue therapy. (These topics will be discussed in more depth by the students in the seminars).