Compliance Processes for Life Science Products in Brazil, Russia, India, China markets - Company Establishment, Clinical Trials, Registrations, Renewa

This seminar will help you understand the regulatory, quality and import / export requirements for Life Science Products in emerging markets - Brazil, Russia, India and China.

Improved alignment to global standards was an important step forward toward foreign access, because it eliminated the conflicting standards that prevailed among provincial government agencies. Healthcare Authorities and regulatory systems have now made their requirements and procedures more transparent to industry partners. Clinical Trials can be conducted at a fraction of the expense.

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 and combination products) as an importer or producer in these emerging markets. It will provide training on:

The Nation's Regulatory Structure.

Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products

How to begin your company's involvement in each country (Brazil, Russia, India, China): local licenses, in-country personnel required and facilities required or contracted

Clinical Trials: When are Clinical Trials needed? When are they not? Healthcare Authority requirements, the Application Process, Ethics Committee approval, CRO Selection and Start-up

The current key regulations effecting product development and your company's product pipeline

Who will Benefit:

This course will be beneficial to the following personnel whose responsibilities require knowledge of these Emerging Markets' regulatory requirements for Life Science products:

Regulatory Affairs

Quality

Clinical

Manufacturing

Supply Chain

Note:

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/processes-for-pharmaceuticals-medical-devices-biologics-life-science-products-in-brazil-russia-india-china-markets-seminar-training-80029SEM-prdsm?channel=sciencedz