ICH Q6A: How to write a successful specification for new chemical drug substance and products draft

نظرة عامة على البرنامج

It includes discussions, case studies, and an outlook on the future of ICH Q6A. The program is designed for regulators, R&D scientists, and other professionals in the pharmaceutical industry. The cost is £325, with discounts available for certain groups.

مخطط البرنامج

King's College London: ICH Q6A Specifications for New Chemical Drug Substance and Products

Degree Overview:

• Course type: Continuing Professional Development (CPD)
• Credit level: Not for credit
• Duration: 1 day
• Dates: To be confirmed
It includes discussions, case studies, and an outlook on the future of ICH Q6A.
• Objectives:
• Facilitate regulatory and practical pharmaceutical discussions.
• Offer networking opportunities.
• Discuss common regulatory issues associated with ICH Q6A.

Outline:

• Content: ICH Q6A guideline
• Structure:
• Live and pre-recorded lectures
• Case studies
• Q&A discussions
• Course schedule:
• Four pre-recorded lectures (40 minutes each) provided before the meeting.
• Live meeting with focused Q&A/discussion sessions (10 minutes summary + 20 minutes Q&A).
• Modules:
• Overview of ICH Q6A
• Advantages of adaptation and implementation
• Regulatory issues
• Practical implementation

Assessment:

• Assessment method: Attendance and completion of a feedback survey.
• Criteria: Completion of the training program.

Teaching:

• Teaching methods:
• Live and pre-recorded lectures
• Case studies
• Q&A discussions
• Faculty:
• Andrew Chan, Reader
• Karin Boon, Senior Assessor, MHRA
• Mustafa Zaman, Senior Assessor, MHRA
• Terry Ernest, GSK
• Dave Elder, Consultant
• Mark Parry, Intertek
• Matt Popkin, GSK

Careers:

• Target audience: Regulators, R&D scientists, pharmaceutical analysts, formulation scientists, QA/QC, regulatory affairs specialists, and postgraduate students.
• Career paths: Pharmaceutical industry, regulatory agencies.

Other:

• Cost: £325 (full fee)
• Discounts:
• Regulatory body participants (£162.50)
• NHS/Academic/Student/King’s Alumni (£162.50)
• Contact: ka_lung.chan@kcl.ac.uk
• Offered by: Faculty of Life Sciences & Medicine