ICH Q8 Pharmaceutical Development Guideline: From regulatory principles to practical experience
Course overview
This 1-day course will be the first International Council for Harmonisation (ICH) Recognised Training Programme delivered by King’s College London to cover guidelines on pharmaceutical manufacturing standards produced by the ICH, which are applied by a growing number of regulatory authorities around the World.
This course will be delivered by speakers from the MHRA and leading pharmaceutical industry to specifically cover the topic of pharmaceutical development (Q8) guideline. We will discuss the regulatory principles of the Q8 guideline, including the concept of QbD, and illustrated with case studies covering solid, liquid dosage formulation and biotech products.
Please note that bookings for this course will close at 14.00 on 3 November.
What does this course cover?
The overall aim is to provide training to pharmaceutical industrialists and regulatory authorities on ICH guidelines to ensure wider implementation of the guidelines. A secondary aim is to provide an opportunity for in-depth discussion on regulatory and practical pharmaceutical issues and offering opportunities for collaborations and networking. The course will cover ICH Q8 guideline mainly, with some references to other guidelines to describe how it fits in the bigger picture namely e.g., ICH Q9-Q12 and the ICH Q-IWG training material.
What will I achieve?
At the end of the training, delegates should be able to: describe the overview concept of the Q8 guideline and how does it fit in the bigger picture of the ICH Quality guidelines, explain the advantages of the implementation of the Q8 guideline, discuss common regulatory issues associated with the ICH Q8 guideline, discuss how the guideline may be implemented in practice.
Who is this for?
Regulators, R&D scientists, Pharmaceutical analysts, Formulation scientists, QA/QC, Regulatory affairs specialists and postgraduate students looking for a career in the pharmaceutical industry or with an agency.
How will I be assessed?
There is no formal assessment, but attendance and completion of the training programme assessment (a feedback survey) is required for a certificate of attendance.
What is the teaching schedule?
The online meeting schedule will include a hybrid of live and pre-recorded lectures, with pre-recorded lectures made available to the delegates online prior to the meeting. There will also be focused Q&A/discussion sessions where speakers will provide a short 10 min summary of their lecture and a 20 min Q&A.
Who will I learn with?
Course Organiser
Dr Andrew Chan
Guest Lecturers
- 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)
Read the profiles for the guest lecturers and programme for the course.
Fees and discounts
The full cost of this course is £300.
There are limited discounted places available for:
- Regulatory body participants (MHRA/EMA/FDA etc): £150
- King's Staff & Alumni & KHP staff: £150
- King’s students: £75