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China & Pacific Rim Markets : Compliance Processes for Life Science Products - Seminar By ComplianceOnline

 
  July 24, 2012  
     
 
ComplianceOnline, Grand Hyatt San Francisco 345 Stockton Street, San Francisco, CA
2012-09-13


Course Description:

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 requirements.

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.

Learning Objectives:

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. It will provide training on:

  • The current Regulatory Structure.
  • Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products.
  • How to begin your company’s involvement in-country: local licenses, personnel and facilities required.
  • Clinical Trials: Why consider Country X? CTA requirements, the Application Process, CRO Selection and Start-up.
  • The current key regulations effecting product development and your company's product pipeline.
  • Pricing establishment.
  • Understanding the local concerns and specific challenges in working with Local Regulatory Personnel.

 

 
 
Organized by: ComplianceOnline
Invited Speakers:

Robert J. Russell

President of RJR Consulting, Inc

Robert J. Russell, (Bob) is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry. Bob has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process.

 
Deadline for Abstracts: 2012-09-12
 
Registration:
For Registration:
 
E-mail: referral@complianceonline.com
 
   
 
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