A medium sized Australian biotechnology company is undertaking a new project in the development of a humanized monoclonal antibody for the treatment of cancer. The company current plan is to license or co-partner with a bigger biotechnology or pharmaceutical company at the conclusion of pre-clinical studies. To this end, management wish to generate a high quality data package to enhance the value of their technology and to meet regulatory requirements for a biological cancer therapy. They intend the research work to be carried out as far as possible in Australia.
You are asked to outline for senior management the significant quality management and competency issues relating to the quality of data for regulatory compliance from discovery phase to the conclusion of preclinical studies.
Your report should contain an Executive Summary A Table of Contents is optional but the report should have sufficient headings and subheadings to allow easy navigation of the information presented. Information sources cited in text should be fully referenced. Any consistent reference method is acceptable.
The report should not exceed 3000 words.
"please follow Australian/New Zealand Standard: Quality management systems-requirements (AS/NHS ISO 9001:2000);
and Australian Standard: General requirements for the competence of testing and calibration laboratories (AS ISO/ICE 17025-2005) and Preclinical studies FDA Guidance for Industry S6 Preclinical safety evaluations http://www.fda.gov/cider/guidance/1859fnl.pdf"---Kevin
0 comments:
Post a Comment