Advanced good clinical Practice About this course  ICH-GCP Guidelines are international standards of ethical and scientific consistency for the preparation, implementation, monitoring, evaluation, analysis, review and reporting of biomedical and behavioral research in the human population. Good clinical practice provides a framework of principles aimed at ensuring the safety of research participants and the integrity [...]

Drug Regulatory Affairs About this course Certification in Drug Regulatory Affairs-Drug Regulatory Affairs is the result of a government’s desire to protect public health by controlling the safety and efficacy of products in areas such as pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. The worldwide outsourcing market for regulatory affairs is [...]

Pharmacovigilance About this course Pharmacovigilance is the identification, evaluation, awareness and prevention of adverse reactions, especially the long-term and short-term side effects of therapeutic drugs, devices and biologics. There are common guidelines and principles that regulate the globalization of the health and pharmaceutical industries. Therefore, the implementation of a global systemic structure for pharmacovigilance requires [...]