PLIVA explores EU Guidelines for modified release drugs
SMi Group has announced that Pavel Farkas, Senior Director for Biopharmaceutics Clinical Development at PLIVA, will be joining the speaker line-up for the 15th annual Controlled Release Delivery conference in London next March.
With recent reports predicting the oral release drug delivery technology market to reach $50B by 2027, as well as a surge of new controlled-release technologies in phase to be commercialized in next few years, the need to understand the regulations surrounding drug delivery systems has become more significant than ever.
Speaking on Day 1 of the conference, Pavel’s presentation will focus on the impact of the current EU Guidelines EMA/CPMP/EWP/280/96/Corr 1 on the pharmacokinetic and clinical evaluation of modified release dosage forms of generic drug products. This not-to-be-missed Keynote Address will explore
- purposes of the guideline and general considerations
- types of oral modified release products from the biopharmaceutics perspective
- general rules for types of required bioequivalence studies
- primary PK parameters for demonstration of bioequivalence and their evaluation in single-dose and multiple-dose studies
- a case-by-case approach
More details about the presentation as well as the full speaker line-up for the conference can be found on www.controlledreleasedelivery.com/pharmaphorum.
Now running for 15 years, Controlled Release Delivery 2018 aims to explore and to understand innovations in oral-lipid based and abuse deterrent formulations, nanoparticles and nanotechnologies, taste-masking and controlled release approaches, 3D printed dosage forms and functional film coats.
For those interested to attend, registration is now live on the event website and there is currently an Early Bird Discount of £400 which expires on 30 November 2017.
15th Controlled Release Delivery Conference
21-22 March 2018
Copthorne Tara Hotel, London, UK
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