Bücher von Niti Mittal

· Comprehensive content covering all aspects of clinical research.· Evolving paradigms in clinical research, e.g. modelling and simulation, artificial intelligence, etc.· Milestones in the evolution of drug regulations in India· Drug regulatory framework in India and key ICH countries.· Evolution of drug pricing mechanisms and IPRs in India.· Updated text incorporating the New Drugs and Clinical Trials Rules 2019; Guidelines on BA/BE studies; ICMR National Ethical Guidelines 2017; National Guidelines for Stem Cell Research 2017; Medical Devices Rules 2017.· Latest amendments and guidelines on ethics committees, informed consent, electronic informed consent, compensation and ICMR Policy on Research Integrity and Publication Ethics 2019.· Templates for various documents like patient information sheet, assent document, case report form, adverse event reporting form etc.