Thursday 23rd June 2016Practical implementation of ICH Q3D; challenges and solutionsRoyal Society of Chemistry, London
This symposium will critically examine the practical challenges associated with effective implementation of ICH Q3D. Finalised in December 2014, the implementation date in Europe for new products is June 2016. This symposium will provide those faced with the challenges some clear and affective guidance on how Q3D can be implemented. It will examine how to apply a risk based approach and how this can be used to identify those areas critical to implementation. It will also examine consider important areas of uncertainty, such as alternative routes of administration and how these may be practically managed.
Dr John Kauffman, FDA
Sven-Erik Hillver, Swedish MPA
Dr Andrew Teasdale, AstraZeneca
Dr Laurence Harris, Pfizer
Samuel Powell, Pfizer
Rob Sharp, GSK
Kevin Hughes, Colorcon
Registration at 9.30 a.m. Symposium starts at 10.00 a.m.
JPAG gratefully acknowledges the Gold support of Butterworth Laboratories, and the Silver support of RSSL and PerkinElmer, for this symposium
are leaders in pharmaceutical quality control analysis. Experts in pharmacopoeial methods, they also bring together both expert understanding and practical working knowledge to provide successful development and validation of methods used to confirm key quality attributes of excipients, API and drug products. In particular, expertise covers complex wet chemistry, as well as instrumental techniques such as HPLC, IC, GC, GC-MS, ICP-OES, ICP-MS and ICP-MS-MS. RSSL
is a global leader at the forefront of scientific analysis, research, consultancy and training. We provide services to the life sciences and food industry. Our multi-disciplinary teams provide rapid results, expert interpretation and sound advice to support clients. We are regularly inspected by the MHRA, FDA and UKAS which ensures that our analytical support is of the highest standard. We provide a comprehensive range of services from early phase characterisation to finished product testing, including method development & validation, stability studies, contamination identification and training. Our elemental impurities capability utilizes the latest technology to ensure compliance to ICH Q3D and other regulatory guidance. PerkinElmer
is a market leading provider of analytical techniques including inorganic spectroscopy, molecular spectroscopy, thermal analysis and gas chromatography.
Our best-selling ICP-MS system, the NexION 350, in combination with our Microwave Digestion system, the Titan, offers a perfect solution for the analysis of elemental impurities for regulatory compliance.
Not only do we provide the required hardware and software we also provide a USP <232>/<233> and ICH Q3D Toolkit comprising everything you will need to ensure your system is up and running and fully validated in as short a time as possible to maximise your return on investment.