ICH Q8 Pharmaceutical Development Guideline: From regulatory principles to practical experience

Program Overview

This 1-day ICH Recognised Training Programme from King's College London covers the ICH Q8 guideline on pharmaceutical development. The program includes lectures, discussions, and case studies, with no formal assessment but a certificate of attendance upon completion.

Program Outline

• Discuss the main aspects of ICH Q8 guideline, including the concept of QbD, with case studies covering various types of products.
• Explain the advantages of implementing the Q8 guideline.
• Discuss common regulatory issues associated with the Q8 guideline.
• Discuss how the guideline may be implemented in practice.

Other program details:

• The program includes live and pre-recorded lectures, Q&A/discussion sessions, and online access to pre-recorded materials.
• **Limited discounted places are available for certain groups, including regulatory bodies, King's Staff & Alumni, and King's students.

Assessment:

Teaching:

The program is delivered by a team of speakers, including:

• Dr Dave Elder (Consultant)
• Dr Karin Boon (Senior assessor, MHRA)
• Dr Mustafa Zaman (Senior assessor, MHRA)
• Dr Terry Ernest (GSK)
• Dr Ray Nims (MC Pharma)

Careers:

Other:

• **The course fee is £300, with discounts available for specific groups.

• The program is organized by the Faculty of Life Sciences & Medicine, King's College London.
• The program is currently closed, but future dates will be confirmed soon.