Pharmaceutical Regulatory and Quality Management for Emerging Markets

About this course

The pharmaceutical market in the emerging markets is anticipated to continue to grow at a rate of 7-10% over the next 3-5 years. Therefore, understanding BRIC markets Brazil, Russia, India and China is of fundamental importance to managers and leaders in pharma companies today.

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. The pace of change in these regions is impressive. Regulatory requirements for conducting clinical studies and commercializing drug products in these regions continue to shift frequently with unique local requirements. Being informed is being prepared and this course is designed to keep you informed.

What You Will Learn

You will review and appreciate the regulatory history of key emerging markets including China, India, Brazil, 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. Inspection trends and expectations will be covered along with the role of PIC/S and ICH in guiding these agencies towards current quality management expectations.

Course outline

• Regulatory history
• Regulatory structure
• Clinical supply approval processes
• Product approval processes
• In-country testing requirements
• Product quality considerations
• Inspection trend and tendencies
• The backdrop of ICH - history, structure and role
• The backdrop of PIC/S - history, structure and role
• Pharmacopoeia compliance
• Cultural sensitivities

This course is for Regulatory, Quality and Technical Managers doing business or planning to do business outside the USA and in key emerging markets.

Venue

JW Marriott Washington, Washington, DC USA

The Washington Marriott hotel near Dupont Circle and Georgetown is just 5 miles from Reagan Airport.

Conveniently located near Foggy Bottom and Dupont Circle Metro Lines, our hotel provides easy access to the Nation’s Capital

Venue Address and Contact Details

1221 22nd Street NW,
Washington DC, DC 20037
Phone: 1-866-576-5456

Tutors

We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.

Both presenters have worked and lived extensively outside their ‘home’ base and will relate their experiences in the context of global regulatory affairs and quality assurance to help delegates appreciate the key elements to operating successfully on a global scale.

Our expert for this course is:

• 

  Mr Jim Morris
  Executive Director
  BA Biol, MSc, MBA

  • [email protected]
  • + 1 857 277 0060
• 

  Mrs Luba Skibo
  Executive Director
  M.S. Agricultural Chemistry, M.S. Analytical Chemistry

  • [email protected]
  • + 1 857 277 0060

What you've said

What previous delegates have said about other of our NSF-DBA courses:

“Great instructors, excellent materials and references.”

Kate Silva, AMAG

“The class was terrific…comprehensive and well executed.”

Jessica Norman, MPI