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

This 1-day course will be the second 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 Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (Q6A) guideline. We will discuss the regulatory principles of the Q6A guideline and illustrated with case studies covering solid and semi solid dosage forms, APIs, inhaled and nasal products. A member of the ICH-QDG will also provide an outlook on the future of ICH Q6A.

The overall aim is to provide training to pharmaceutical industrialists and emerging regulatory authorities on ICH guidelines to ensure wider implementation of the guidelines. A secondary aim is to provide an opportunity for an in-depth discussion on regulatory and practical pharmaceutical issues and offering opportunities for collaborations and networking. The course will cover ICH Q6A guideline.

At the end of the training, delegates should be able to: describe the overview concept of the Q6A guideline and how does it fit in the bigger picture of the ICH Quality guidelines, explain the advantages of the adaptation and implementation of the Q6A guideline, discuss common regulatory issues associated with the ICH Q6A guideline, discuss how the guideline may be implemented in practice.

Regulator, R&D scientists, Pharmaceutical analysts, formulation scientist, QA/QC, Regulatory affairs specialists and post-graduate students looking for a career in the pharmaceutical industry or with an agency.

There is no formal assessment, but attendance and completion of the training programme assessment (a feedback survey) is required for a certificate of attendance.

The online meeting schedule will include one live and four pre-recorded lectures. The four pre-recorded lectures (approximately 40 min each) will be made available to the delegate online prior to the meeting. Delegates are required to review the materials provided before the meeting. There will be focused Q&A/discussion sessions where speakers will provide a 10 min summary followed by a 20 min Q&A.

• Final Programme and Speaker Profiles 0.38 MB

The full cost of this course is £325.

There are limited discounted places available for:

• Regulatory body participants (MHRA/EMA/FDA etc): £162.50
• NHS/Academic/Student/King’s Alumni: £162.50