JPAG - PAST MEETINGS
Thursday 6th December 2018
Regulatory Hot Topics III
Royal Society of Chemistry, London
This one-day symposium will address issues and challenges associated with the implementation of new and emerging guidelines.
It will provide an excellent opportunity for dialogue, discussion and debate with speakers - several of whom have been actively involved in shaping the guidance - and the peer group in an open forum.
Delegates will be able to understand, interpret and translate into day-to-day practice the guidance on topics including:
* Impurities in New Drug Substances (ICH Q3A/3),
* Elemental impurities (ICH Q3D),
* Technical and regulatory considerations for pharmaceutical product lifecycle management (ICH Q12),
* Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk (ICH M7),
* Guideline in development on Biopharmaceutics Classification System (BCS)-based biowaivers (ICH M9),
* How food-based regulations can impact on pharmaceutical development,
* The effect of MAPPS (medicines adaptive pathways to patients) and stability for lifecycle management
This is an excellent opportunity to learn from expert speakers who have been actively involved in the development of the guidances on these key topics.
Dr James Butler - GlaxoSmithKline
Julia Claus - Pfizer
Dr Graham Cook - Pfizer
Dr James Harvey - GlaxoSmithKline
Kevin Hughes - Colorcon
Dr Frank Montgomery - AstraZeneca
Dr Matt Popkin - GlaxoSmithKline
Dr Helmut Rockstroh - Roche
Dr Andrew Teasdale - AstraZeneca
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Delegates at a symposium held at the Royal Pharmaceutical Society