MHRA and US FDA to Discuss Innovation in Controlled Release

London, United Kingdom, March 31, 2016 --(PR.com)-- Could you benefit from hearing exclusive presentations and briefings from 11 global pharma companies covering, in detail, their own experiences in driving Controlled Release innovation?

If the answer is yes, book now to learn from your industry peers and gain valuable insight into their current strategies and future outlook to improve CR formulation and delivery for next generation drugs.

In addition to the array of pharma case studies, SMi is proud to announce that the MHRA and US FDA will be sharing their own unique perspectives at the 13th annual Controlled Release conference, taking place on 18th - 19th April 2016 in London, highlighting scientific and regulatory challenges, along with how these have been overcome:
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'. Key points covered include:
• 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 programme
Additionally, the two-day programme also promises to bring you the cutting-edge developments highlighting:
• New platforms in Controlled Release delivery
CriticalMix platform technology: A novel platform technology for sustained delivery of small and large APIs by Critical Pharmaceuticals
Diurnal on optimising drug delivery systems to mimic the human circadian rhythm
• Innovations in Controlled Release
MedImmune talks about controlling peptide stability to unlock therapeutic potential
AstraZeneca presents nanomedicine design for controlled release
• The importance of QbD
GSK examines how Quality by Design (QbD) can aid formulation and controlled release delivery
Novo Nordisk demonstrates application of QbD during spray drying scale-up
• Product Design
Parenteral controlled release: Revival for increased adherence – case study by Merck
Lundbeck showcases how to formulate poorly soluble drugs

To view the full speaker line-up and conference programme, visit http://www.controlledrelease.co.uk/prcom

Plus, don't forget to extend your stay to join the 2 post-conference interactive workshops taking place on Wednesday 20th April 2016:
Workshop A: QbD/PAT Driven Controlled Release Design and Development
Hosted by by Daniela Stranges, Senior Scientist, Quality by Design Integration, GlaxoSmithKline and Jerome Mantanus, Senior Scientist QbD/PAT Drug Product Formulation, UCB Pharma
Enhance understanding on the adoption of core principles of Quality by Design (QbD) for controlled release development and manufacturing. This workshop defines how QbD tools (DoEs, PAT) can be applied to support formulation and process development.
Workshop B: Exploring Controlled Release Drug Delivery Methods
Hosted 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
This workshop will explore drug delivery technologies that can be utilised in controlled release drug delivery and will consider some of the newer concepts in the drug delivery world including nanotechnology.