ComplianceOnline training

This JAPAN Regulatory compliance training is designed to provide an overview of the regulatory environment in Japan with respect to regulatory filings and registrations. With the 2005 revisions to the Japanese Pharmaceutical Affairs Law (PAL), foreign life science companies are eyeing on the opportunities created in Japanese market for them. It becomes imperative to understand the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. ComplianceOnline brings to you a pack of 2 modules which will give you an indepth understanding of topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.