DUBLIN–(BUSINESS WIRE)– The « China
& Pacific Rim Markets: Compliance Processes for Life Science Products –
Company Establishment, Clinical Trials, Registrations, Renewals and
Supply Chain Considerations » conference has been added to ResearchAndMarkets.com’s
This China & Pacific Rim life science compliance-based seminar will
discuss the regulatory structure and requirements for compliance with
in-country regulations for Pharmaceuticals, Medical Devices, Biologics
and Combination Products.
This course is designed to provide a detailed overview of the regulatory
requirements, local challenges and important cultural aspects of working
with the lifecycle of Life Science Products (pharmaceuticals, medical
devices, biologics, combination products) as an importer into China &
the Pacific Rim.
China has been improving its regulatory regime governing the food and
pharmaceutical industry in recent years. In 2010, by promulgating the
amended GMP and amending GLP, GCP, GSP and other regulations, China will
further align the country with international standards of practice. For
manufacturers and distributors of drugs and medical devices in China, it
is important to pay close attention to the pace at which SFDA implements
these changes and to make changes to their standard operating procedures
when necessary to ensure compliance with the evolving regime.
Other Pacific Rim markets are also growing in importance and interest in
access to innovative products. In-country Regulatory Agencies are
progressing in their sophistication, process development and regulatory
This course specifically focuses on the overall regulatory compliance
requirements and procedures for Pharmaceuticals, Medical Devices,
Biologics and Combination Products in China and the listed Pacific Rim
Countries* (Taiwan, Hong Kong, Singapore, Malaysia, Vietnam & Thailand).
The course will cover topics relating to pre-clinical and clinical
requirements, as well as, addressing the structure of the regulatory
agencies. Content will also include descriptions of the methods by which
regulators process filings and registrations and what is expected in the
authorization and dossier maintenance of licensed products.
It will provide training on:
For more information about this conference visit https://www.researchandmarkets.com/research/jgjmd7/two_day_course?w=4
Source: Research and Markets