|ICH Q3D Metal Impurities Workshop
REGISTER NOW or on site! April 4-5, 2012
Marriott Bethesda North Hotel
5701 Marinelli Road
Bethesda, Maryland 20852
IPEC-Americas, SOCMA (Society of Chemical Manufacturers and Affiliates, Inc.) and CHPA (Consumer Healthcare Products Association) are partnering together to offer a workshop that will discuss the ICH Q3D Metal Impurities Guideline. New limits for element impurities in drug products are being recommended that could have a DIRECT IMPACT on your business.
This workshop will offer an opportunity to confidentially share data and then have it taken back to ICH for consideration. This is not just an excipient manufacturer's issue - users will also be impacted!
Here are some of the questions - and reasons why you should be involved in this workshop:
- How will the new ICH Q3D Metal Impurity limits impact your drug product? What actual levels REALLY exist in excipients? How do these levels vary?
- HAVE A VOICE in determining the outcome for how these new requirements will ultimately be implemented!!!
- The workshop offers a confidential method to PROVIDE & DISCUSS DATA on actual levels of Metal Impurities that exist in commonly used excipients and what levels this may create in various dosage forms. Data from excursions that may occur due to natural variation in excipients will be included.
- The workshop will be a FORUM FOR DISCUSSION of how these typical levels will impact the implementation of the Q3D guideline and the associated compendial chapters.
- The discussions and data covered in the workshop will be COMPILED INTO A REPORT that will be presented to the ICH Q3D Expert Working Group (EWG) for their consideration during the upcoming June meetings where Q3D will probably move onto the next stage.