Satisfying Regulatory and Quality Requirements in Key Emerging Markets

Wednesday, December 11 – Thursday, December 12 2013
8:00 am – 5:00 pm

This event was posted by NSF Pharmalytica Services

Location: NSF-DBA Boston Office - 129 South Street, Boston MA 02111

Unprecedented growth in the BRIC markets (Brazil, Russia, India and China) has pharmaceutical companies rapidly aligning their strategies to understand what it takes to do business in these markets.

This course will provide an overview of the regulatory history, climate, and cultural drivers in the BRIC countries and other locations such as Turkey, Mexico and key Middle Eastern states. For instance, China (SFDA) and Brazil (Anvisa) regulatory bodies were only established in 1999; however agencies are changing rapidly and collaborating with other well established regulatory bodies. The pace of change and the regulatory trends driven by actions in the BRIC states must be appreciated. These countries are issuing GMP guidances with clear national compliance expectations and are increasingly demanding pre-approval inspections of export markets to gain access.

What You Will Learn

You will review and appreciate the regulatory history of key emerging markets including Brazil, Russia, India, China and Turkey and Russia. The course will cover the regulatory structure in these key emerging markets and highlight approval processes for clinical and commercial product.

You will gain insight to common issues encountered relating to regulatory and product quality. In- country testing requirements and technology transfer issues will be reviewed for each country. Inspection trends and expectations will be covered along with the role of PIC/S and ICH in guiding these agencies towards current quality managment expectations.

In addition, cultural drivers within the key emerging markets will be reviewed, including advice on business conduct based on our experience with both industry and agency leaders in these markets.

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