Chances and challenges in the development of topical products against the background of the European “Draft guideline on quality and equivalence of topical products“ (10635)

The “Draft guideline on quality and equivalence of topical products“ (CHMP/QWP/708282/2018) was issued to both define quality requirements for topical products and to propose several ways for the demonstration of equivalence of topical products in order to reduce or replace clinical endpoint studies. 

However, due to the long-standing draft stadium of the guideline and a huge amount of comments provided e.g. by industry associations, there are uncertainties which are challenging for product development for the European market. Therefore, applications based on a biowaiver are rather seldom – which is not in the sense of the draft guideline. 

The webinar focuses on the development of generic topical products (hybrid applications) according to European requirements and addresses – amongst other things – the following topics:

• Short overview of the draft guideline 
• Selected critical points of the draft guideline from the development perspective  
• Assessment of similarity of topical formulations 
• Demonstration of equivalence of topical products with a focus on biowaivers and decision tree for the development of topical products according to literature 
• Practical challenges and issues illustrated by case studies 

Duration of the recording: approx. 90 minutes
Lecture language: English | Slides: English

...your speaker Dr. Michael Felkel...

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