Dissolution testing - EU edition MasterClass
07-08 March, 2023
A number of aspects in the paper are also relevant for sustained and extended release dosage forms.
This topic is not only of central importance in the context of generic drug development, but also in particular in the case of changes in the physicochemical properties of the active substance, in the manufacture and/or composition of products, and in the case of site transfers.
07-08 March, 2023, Virtual
Time Zone: UTC/GMT+1 /CET
Changes in manufacturing or even a “site transfer” are imminent and the authority expects you to justify why you do not need a new biostudy as part of the submission of the change. This can only be done based on comparative drug release data with a process that meets the current requirements. Immediate release products in Europe are now expected to follow the guidance in the EMA paper “Reflection paper on the dissolution specification for generic solid oral immediate release products with systemic action” (EMA/CHMP/CVMP/QWP/336031/2017) when developing methods and setting release specifications for market release. The paper sets out, fromtheperspectiveofEUregulators, thestateof theart inthedevelopmentofappropriate drug release procedures in quality control for rapid-release generic oral solid dosage forms and how specifications for release and duration should be set and justified. An important area of tension that arises is the different approach to demonstrating pharmaceutical equivalence for biosolids and routine batch release testing. A number of aspects in the paper are also relevant for sustained and extended release dosage forms. This applies equally to human and veterinary medicinal products. The topic is not only of central importance in the context of generic drug development, but also in particular in the case of changes in the physicochemical properties of the active substance, in the manufacture and/or composition of products, and in the case of site transfers. The latter points also apply to innovator products. Production and site transfers.
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Who should attend?
• Persons involved in dissolution method development
• QC laboratory staff for testing of solid oral dosage forms
• RA-CMC teams implementing analytical, validation and release testing data into the dossier
• Quality assurance staff with focus on analytical laboratory
• Head of quality control
• EU Qualified Persons
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USP PD Team Manager
"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"
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MT Sword Laboratories (BMS)
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