Document B5enGw33RmaNVOq0YvyOgMbOE

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, [CPCUS] McCarthy, Timothy [CPCUS]; Swei, Homer [CPCUS]; Hicks, [CPCUS] 4/18/2011 8:31:05 PM RE: URGENT: Talc Monograph Modernization Noble [CONGB]; Jiwrajka, Santosh Don [CPCUS]; Karaisz, Kenneth I will talk to the PCPC to see If they can reach out to the USP team and endorse Drew's nomination. Susan (908) 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 pharma/consumer ussoeuracsewseallroausnadlsthoeowthoerlrdi.ndAussterixapl egrrtasdeinst.heNfoiesldintghleeyJ&arJe knowledgeable employee is as about talc for well versed in the subject matter. I just spoke with Drew on this matter; he has submitted an application to be part of the USP talc Expert Panel. He has not yet heard back from USP. 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 forthe 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--Excipients (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? Iwould have thought that oursuppliers would have let us know about this earlier.... QUESTIONS: Do we wantto recommend someone forthis expert panel? I'm not sure we need a J8J person (?), but Iwould think we certainly would want someone from RJ Lee? Agree? Any other "experts" we'd wantto reach out to? Do you want me to lead this, orshould it be someone in one of yourteam? 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 fo r t h e test for Absence of A sb estos in the Talc Protected Document-Subject to Protective Order JNJNL61_000099255 monograph in support of USP's monograph modernization in itiative . The Expert Panel will make recommendations to and work at the direction of the Monographs-- Excipients (EXC) Expert Com mittee. Candidates interested in sharing their time and expertise should have in -depth know ledge of: Asbestos testing Procedure development and validation Compendial procedures US P a n t ic ip a t e s e s t a b lis h in g th e Expert Panel by May 1, 2011. M ost o f th e w o rk of th e Expert Panel will be co nd u cted via te le c o n fe re n ce at a frequency to be determined. It is likely that there will be at least one face-to-face meeting at USP during the lifetime of the Expert Panel. A p p ly f o r th is Expert Panel by follo w in g th e li n k h e re . T h e deadline fo r applications is April 22, 2011. For more in form a tio n a b ou t the role of USP Expert Panels in the standards setting process, click here. Susan (908) 874-1665 ..... Original Message...... From: McCarthy, Timothy [CPCUS] Sent: Monday, April 18, 20111:30 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 I am the right person for this from J&J. Should Ken Karaisz or John Lemmo from Analytical be involved? ..... Original Message...... From: Sharma, Shripal (RTM) imailto:ShripaI.Sharma(a)riotinto.com] Sent: Monday, April 18, 20111:11 PM To: McCarthy, Timothy [CPCUS] Subject: FW: Talc Monograph Modernization Importance: High Hello Tim, I 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 yourthoughts on this. I am available fora phone discussion today. Best regards, Shripal Shripal Sharma Global Director, Product Stewardship Rio Tinto Minerals - Denver +1303-713-5227(0) +1303-882-4638 (M) ..... Original Message...... From: Kevin Moore rmailto:ktm(a)usp.org1 Sent: Thursday, April 07, 201111:22 AM To: Sharma, Shripal (RTM) Subject: RE: Talc Monograph Modernization DearShripal, Protected Document-Subject to Protective Order JNJNL61 000099256 Ijust 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 forthe 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--Excipients (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.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-Subject to Protective Order