Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
October 2 - 3, 2014 - Malvern PA USCenter for Professional Innovation and Education, Inc.
info@cfpie.com
Phone:(610) 688-1708
This course focuses on the regulatory and procedural requirements required for Pharmaceuticals, Medical Devices, Biologics and Combination products in Japan. The two-day program will cover topics relating to CMC, pre-clinical and clinical requirements, as well as, addressing the structure of regulatory agencies in Japan. Also included will be detailed descriptions of the methods by which regulators within various agencies process filings and registrations and what is expected in the authorization and dossier maintenance of all licensed products. The course will also discuss strategies to bridge development work done in other regions into the Japanese market. These bridging strategies are also valuable in helping to increase the value of products prior to licensing with Japanese Pharmaceutical and Biotechnology companies. The current regulatory climate will be discussed in depth and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues that have caused difficulties for Life Sciences firms will also be discussed. Course content will also explain how Japan interacts with and utilizes ICH standards and how they relate with other national regulatory agencies. In particular, the course will help with the understanding of the unique situation within Japan and why implementation and interpretation of ICH guidelines sometimes differs from Europe and the United States. The program also discusses how personnel can best address conflicts that sometimes arise and the best approach for rapid resolution. This course will also be useful for marketing, sales and general management personnel who need an overview of regulatory compliance requirements within Japan and how best to consider the country into one’s Business Strategy.