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Exclusive Interviews with the MHRA and the US FDA Released Ahead of Controlled Release 2016

SMi's 13th annual Controlled Release conference, taking place on 18th - 19th April 2016 in London, will feature an array of case studies and project updates from major global pharmaceutical companies and leading regulatory bodies.

London, United Kingdom, February 14, 2016 --( SMi's 13th annual Controlled Release conference will provide the ideal platform to receive updates on the latest innovations to accelerate commercialisation, as well as developments in the regulatory landscape to ensure strict compliance. The two-day programme is packed with unmissable case studies and project updates provided by GlaxoSmithKline, Ipsen, Novo Nordisk, MedImmune, AstraZeneca, Lundbeck, Merck, UCB Pharma, Critical Pharmaceuticals, Kashiv Pharma, Diurnal and more.

Furthermore, the MHRA and the US FDA will be sharing case studies at the 13th annual Controlled Release conference:

MHRA's Pharmaceutical Assessor, Marion Westwood, will share an opening address on Day One titled, 'Supporting innovation in controlled release and combination products'. Her presentation will cover the following key points:
• Discuss the latest innovations surrounding controlled release
• Gain key regulatory updates from leading competent authorities talking specifically on grey areas such as the regulatory environment surrounding combination products
• Case study on work with OxSonics

US FDA's Pharmacologist, Mohammad Absar, will be delivering a presentation at 13:50 on Day One titled 'Regulatory perspective on innovative systems for controlled release'. His presentation will cover the following key points:
• An overview of current innovative controlled release systems in the US market
• Scientific and regulatory challenges in developing generic controlled release systems
• FDA/OGD's ongoing research program

Against this backdrop, SMi is delighted to announce the release of two exclusive interviews with the MHRA and the US FDA which can be read online at

Speaker Panel includes:
• David Elder, Due Diligence Director, GlaxoSmithKline
• Andy Lewis, Director Novel Drug Delivery Technologies, Ipsen
• Sachin Mittal, Senior Principal Scientist, Merck
• Marianne Ashford, Principal Scientist Drug Targeting, AstraZeneca
• Sune Andersen, Principal Scientist, Novo Nordisk

Plus, don't miss two interactive post-conference workshops taking place on 20th April 2016:
A: QbD/PAT Driven Controlled Release Design and Development | Led by Cristiana Campa, Head, Quality by Design Integration, GlaxoSmithKline and Jerome Mantanus, Senior Scientist QbD/PAT Drug Product Formulation, UCB Pharma

B: Exploring Controlled Release Drug Delivery Methods | Led by Rene Holm, Senior Director, Lundbeck; Clive Wilson, Professor of Pharmaceutics, University of Strathclyde; Ijeoma Uchegbu, Scientific Secretary CRS, Chair in Pharmaceutical Nanoscience, University of London and CEO, Nanometrics
Contact Information
SMi Group
Vinh Trinh
+44 (0) 20 7827 6140

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