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.

Richard Lowenthal

Specialties: International

Richard Lowenthal is President of Pacific-Link Consulting – with offices in San Diego and Tokyo. He has over 20 years of regulatory affairs and QA experience with pharmaceutical and biotechnology companies both large and small – as well as extensive experience in strategic global development and product registration in both the United States and Japan.

Previously, Mr. Lowenthal served as VP of Regulatory Affairs and Quality Assurance for Cadence Pharmaceuticals; Head of Worldwide Regulatory Affairs, Quality Assurance and Drug Safety for Maxim Pharmaceuticals, Inc. and VP of Regulatory Affairs and Quality Assurance for AnGes, MG, Inc. – a Japanese gene-therapy company. In addition, he has been a reviewer with the FDA in the divisions of both Neuropharmacology and Pulmonary/Oncology Drug Products.

Mr. Lowenthal received his M.S. in Organic Chemistry from Florida State University and his Masters in Business Science from the University of San Diego.

He has served as Chair of the San Diego-region AAPS (2005/2006), member of the USP Biotechnology Expert Committee (2005/2006), Chair of the Virology Working Group (2005/2006) and member of the National Organization for Rare Disorders corporate council (2002-Present). In addition, he has served on several PhRMA and ICH working groups.