Biotech Regulatory Affairs

The biotechnology regulatory affairs course helps the candidates in understanding the regulatory and policy issues in the field of biotechnology. The course covers the impact of regulatory issues on domestic and international affairs, clinical trials and various aspects of a product's life cycle, GLP & GMP, quality control and assurance, bioethics etc. The course will provide with the skills to comply with biotech/biosimilar submissions. It will also enhance the understanding of global regulations and regulatory procedures. This course addresses the risks associated with biotech products and the consequent interpretations of biotech regulations, exhibiting the critical steps to compliance.