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FILE NAME Talc TALC DATE 2011 Apr 18 DOC TALC207 DOCUMENT DESCRIPTION Email from and to CPCUS Members From To CC Sent Subject Nettesheim Susan CPCUS Lemmo John CPCUS Serbiak Paul J. CPCUS Mathew Noble CONGB Jiwrajka Santosh CPCUS McCarthy Timothy CPCUS Swei Homer CPCUS Hicks Don CPCUS Karaisz Kenneth CPCUS 4/18/2011 8:31:05 PM RE URGENT Talc Monograph Modernization I talk to the PCPC to see if they can reach out to the USP team and endorse Drew's nomination Susan 908 874-1665 874-1665 From Lemmo John CPCUS Sent Monday April 18 2011 4:16 PM To Nettesheim Susan CPCUS Serbiak Paul J. CPCUS Mathew Noble CONGB Jiwrajka Santosh CPCUS Cc McCarthy Timothy CPCUS Swei Homer CPCUS Hicks Don CPCUS Karaisz Kenneth CPCUS Subject RE URGENT Talc Monograph Modernization In my opinion we JNJ Consumer are best served on this committee by having a knowledgeable talc expert from RJ Lee Group - specifically Drew Van Orden Drew is the person we sent to China recently to directly interact with the SFDA on our behalf thru Jane Cai as interpreter RJ Lee Group are the experts we turn to for analysis of talc from our finished powder products as well as evaluation of potential new mine sources around the world As experts in the field they are knowledgeable about talc for consumer use as well as also other industrial grades No single & employee is as well versed in the subject matter I just spoke with Drew on this matter not yet heard back from USP he has submitted an application to be part of the USP talc Expert Panel He has From Nettesheim Susan CPCUS Sent Monday April 18 2011 3:41 PM To Serbiak Paul J. CPCUS Mathew Noble CONGB Jiwrajka Santosh CPCUS Cc McCarthy Timothy CPCUS Swei Homer CPCUS Hicks Don CPCUS Karaisz Kenneth CPCUS Lemmo John CPCUS Subject URGENT Talc Monograph Modernization The USP is updating the Talc monograph Key at this point is USP has approved the formation of an Expert Panel to review evaluate and generate proposals procedures and data for the test for Absence of Asbestos in the Talc monograph in support of USP's monograph modernization initiative The Expert Panel will make recommendations to and work at the direction of the Monographs EXC Expert Committee The deadline for nominations is Friday I called the PCPC They were unaware of this as were Tim and I. Were any of you aware of this I would have thought that our suppliers would have let us know about this earlier QUESTIONS Do we want to recommend someone for this expert panel I'm not sure we need a & person ? but I would think we certainly would want someone from RJ Lee Agree Any other experts we'd want to reach out to Do you want me to lead this or should it be someone in one of team Also here is what I got from the website Posted April 1 2011 Call for Candidates USP invites qualified candidates to apply to serve as scientific experts on the Talc Expert Panel The purpose of this Expert Panel is to review evaluate and generate proposals procedures and data for the test for Absence of Asbestos in the Talc Protected Document to Protective Order JNJNL61_000099255 monograph in support of USP's monograph modernization initiative The Expert Panel will make recommendations to and work at the direction of the Monographs EXC Expert Committee Candidates interested in sharing their time and expertise should have depth knowledge of Asbestos testing Procedure development and validation Compendial procedures USP anticipates establishing the Expert Panel by May 1 2011. Most of the work of the Expert Panel will be conducted via teleconference at a frequency to be determined It is likely that there will be at least one face meeting at USP during the lifetime of the Expert Panel Apply for this Expert Panel by following the link here The deadline for applications is April 22 2011. For more information about the role of USP Expert Panels in the standards setting process click here Susan 908 874-1665 874-1665 From McCarthy Timothy CPCUS Sent Monday April 2011 1:30 PM To Mathew Noble CONGB Hicks Don CPCUS Karaisz Kenneth CPCUS Lemmo John CPCUS Subject FW Talc Monograph Modernization Importance High FYI I do not think am the right person for this from & Should Ken Karaisz or John Lemmo from Analytical be involved --Original --Original Message From Sharma Shripal RTM Shripal.Sharma@riotinto.com Shripal.Sharma@riotinto.com Sent Monday April 2011 1:11 PM To McCarthy Timothy CPCUS Subject FW Talc Monograph Modernization Importance High Hello Tim am not sure if you are aware of the latest developments with USP re talc They are planning to modernize the talc monograph and are inviting experts Are you interested to be part of the panel Have you considered RJ Lee to be part of the panel The deadline for an application is April 20th Julie Pier from RTM plans to apply Please let me know your thoughts on this am available fora phone discussion today Best regards Shripal Shripal Sharma Global Director Product Stewardship Rio Tinto Minerals - Denver +1 303-713-5227 0 +1 303-882-4638 M From Kevin Moore ktm@usp.org Sent Thursday April 07 2011 11:22 AM To Sharma Shripal RTM Subject RE Talc Monograph Modernization Dear Shripal Protected Document to Protective Order JNJNL61_000099256 I just wanted to follow up with you on some progress with regards to the Monograph modernization initiative USP has approved the formation of an Expert Panel to review evaluate and generate proposals procedures and data for the test for Absence of Asbestos in the Talc monograph in support of USP's monograph modernization initiative The Expert Panel will make recommendations to and work at the direction of the Monographs EXC Expert Committee Based on our previous conversations I would like to extend an invitation to you to apply for participation in the Expert Panel which can be found at the following link Please feel free to share this link with some of your colleagues who may also be interested in participating in this panel Feel free to contact me if you have any questions http://www.usp.org/hottopics/monographs.hht p:/ w t.usp.org/homt opics/monlgraphs.html Kind Regards Kevin Kevin T. Moore Ph.D. Senior Scientist United States Pharmacopeia Department of Standards Development 12601 Twinbrook Parkway Rockville Maryland 20852 301-816-8369 Office 301-816-8373 Fax http://www.usp.org/goto/workshops ) Protected Document to Protective Order JNJNL61_000099257