Course Outline

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A Short Course on Regulatory Affairs with emphasis on the

Pharmaceutical Development and Registration of Solid Oral Dosage Forms

This Course will be a comprehensive course that blends EU pharmaceutical legislation, official guidelines and pharmacopoeia requirements with pharmaceutical science in order to create understanding of the issues important in gaining Marketing Authorisation (MA) approvals for oral solids.

Using relevant chemistry and pharmacy building blocks, delegates will learn from our experts about the importance of solid state properties such as amorphous or crystalline materials, particle size distribution and the biopharmaceutical classification. Many important aspects of formulation and pharmaceutical development, manufacturing, control and batch consistency of the dosage forms, the achievement and measurement of required performance, stability and storage conditions for the end product will be addressed.

This course is suitable for people (likely to be from analytical, formulation, pharmaceutical development, manufacturing and regulatory/registration departments) needing to understand how to submit successful applications to the Competent Authorities.

Further course coverage, dates, venue and details on how to book will be published soon. Please sign up for future announcements

EXCEPTIONAL VALUE: £995.00 + 17.5% VAT
Your delegate package includes training from experts over two days, training materials, certificate of attendance, daytime food and drinks, a conference dinner and one night’s accommodation*
* extra night(s) bookable if required, subject to availability

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