MEETINGS Thursday 7th May 2020ICH Q3E (Extractables and Leachables): setting the sceneRoyal Society of Chemistry, LondonDOWNLOAD BROCHUREWANT TO PRESENT A POSTER?
Extractables and Leachables (E&Ls) have for a long time being an important consideration for devices and container closures for liquid or semi-solid products. However, it has been evident that for decades the guidance for E&Ls wasn't aligned with the safety based impurity guidance on other specific impurities, e.g. ICH Q3C (residual solvents), ICH Q3D (residual metals) and ICH M7 (mutagenic impurities).
This meeting will seek to provide an overview of the ICH process, the current situation for ICH Q3E and opportunities to influence the desired outcomes. Regulators and Industry will then describe the current situation and highlight areas where they would like to see change.
The disconnects between E&L guidance and ICH Q3D (residual metals) and ICH M7 (mutagenic impurities).will be described and those areas needing clarification and harmonisation will be highlighted. An overview of the current analytical and toxicological requirements for E&L will be provided before finishing with an update from the ELSIE (Extractables & Leachables Safety Information Exchange) consortium, which seeks to apply PDEs to common E&Ls.DOWNLOAD BROCHURE
There will be an opportunity to present posters on the broad subject area of the symposium, subject to acceptance of a submitted abstract. Click here
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Delegate fees include registration, documentation, lunch and refreshments.DELEGATE RATES:
Concession : £ 45.00
Exhibitor GOLD : £ 1200.00
Exhibitor LEAFLET for authorised exhibitor : £ 300.00
Exhibitor SILVER : £ 850.00
Exhibitor-BRONZE : £ 700.00
Member : £ 195.00
Non-Member : £ 295.00
Student : £ 45.00
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JPAG / RSC Toxicology Group Symposium: ICH Q3E (Extractables and Leachables): setting the scene / Thursday 7th May 2020 / Royal Society of Chemistry, LondonTITLE OF EVENT:
ICH Q3E (Extractables and Leachables): setting the sceneDATE OF EVENT:
Thursday 7th May 2020EVENT LINK:
Royal Society of Chemistry, London
Burlington House, Piccadilly, London W1J 0BAVENUE LINK:
Joint Pharmaceutical Analysis GroupWEB LINK:
Royal Pharmaceutical Society and Royal Society of ChemistryCONTACT:
Hon Events Secretary JPAG, email@example.comSPEAKERS:
Dr David Elder - JPAG/Consultant
Dr Andrew Teasdale - AstraZeneca
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