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Thursday 10th October 2013
ICH Q3D (Metals Guidelines): Opportunities and challenges
Royal Society of Chemistry, London
What do you know about ICH Q3D, and how will it affect your practice? Are you concerned about your lack of awareness of ICH Q3D? Are you confused as to how the USP will implementing new general chapters on metals (<232> and <233>) and how this will align with Q3D? What do the other pharmacopoeias plan to do?
What are the regulators views? What are industry views? Is the implementation of ICP (inductively coupled plasma) methodology for API, excipients or drug products “do-able”? Why are we looking for 27 metals? What are the historical experiences of metal concentrations in API, excipients or drug products? What are the safety perspectives? What are the technical challenges? That’s a lot to take in!
Well help is at hand! Experts and thought leaders from across the pharmaceutical and excipient industries, the pharmacopoeias and European regulators will reveal their understandings of the key challenges and opportunities posed by the emerging guidance.
They will share experiences on the toxicological challenges posed by this guidance, the types of risk assessment that are being proposed, and the types of testing required. Are these tests pragmatic? Are they achievable? Indeed, are they necessary?
You will have the opportunity to network with experts and fellow workers trying to assess the complexity and resource burden that this guidance may bring.
Butterworth Laboratories will be exhibiting at the event.
ICH Q3D (Metals Guidelines): Opportunities and challenges
Royal Society of Chemistry, London
What do you know about ICH Q3D, and how will it affect your practice? Are you concerned about your lack of awareness of ICH Q3D? Are you confused as to how the USP will implementing new general chapters on metals (<232> and <233>) and how this will align with Q3D? What do the other pharmacopoeias plan to do?
What are the regulators views? What are industry views? Is the implementation of ICP (inductively coupled plasma) methodology for API, excipients or drug products “do-able”? Why are we looking for 27 metals? What are the historical experiences of metal concentrations in API, excipients or drug products? What are the safety perspectives? What are the technical challenges? That’s a lot to take in!
Well help is at hand! Experts and thought leaders from across the pharmaceutical and excipient industries, the pharmacopoeias and European regulators will reveal their understandings of the key challenges and opportunities posed by the emerging guidance.
They will share experiences on the toxicological challenges posed by this guidance, the types of risk assessment that are being proposed, and the types of testing required. Are these tests pragmatic? Are they achievable? Indeed, are they necessary?
You will have the opportunity to network with experts and fellow workers trying to assess the complexity and resource burden that this guidance may bring.
Butterworth Laboratories will be exhibiting at the event.
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PAST MEETINGS
Symposium - October 2011
Delegates at a symposium held at the Royal Pharmaceutical Society
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