Return-Path: Received: from vps.transocean.com by vps.transocean.com with LMTP id CGvHLmMT1lpYagAAInt2oQ ; Tue, 17 Apr 2018 08:31:47 -0700 Return-path: Envelope-to: sandyn@transocean.com Delivery-date: Tue, 17 Apr 2018 08:31:47 -0700 Received: from omp.seminar.globalcompliancepanel.com ([129.145.68.201]:53637) by vps.transocean.com with esmtps (TLSv1.2:ECDHE-RSA-AES256-GCM-SHA384:256) (Exim 4.89_1) (envelope-from ) id 1f8SZu-0007Eo-Ph for sandyn@transocean.com; Tue, 17 Apr 2018 08:31:47 -0700 DKIM-Signature: v=1; a=rsa-sha256; c=relaxed/relaxed; s=globalcompliancepanel; d=seminar.globalcompliancepanel.com; h=MIME-Version:Content-Type:Content-Transfer-Encoding:Date:To:From:Reply-To: Subject:List-Unsubscribe:Message-ID; i=info@seminar.globalcompliancepanel.com; bh=llytj0SKB+4NgnTL4HT2IpYEz+KiILbBPveLZd9s0Vs=; b=fO9ybB0FDhaUivxMfSM/6a+yFwV7ipYQqMSH6wWr2kxMdE0dqASj9sN9Ne5EPdWwpZxpjdkhRTfl dsp8M2YIrwdcuckFeO5/XRF481YSjUXkIRUEUcvl/ipaNUE9eEhsc88MNB85FPR9aBMN45TODRq6 KFVTL+sLLtcL06b4TsU= Received: by omp.seminar.globalcompliancepanel.com id hqo9l62b6107 for ; Tue, 17 Apr 2018 08:30:38 -0700 (envelope-from ) X-CSA-Complaints: whitelist-complaints@eco.de MIME-Version: 1.0 Content-Type: text/html; charset="ISO-8859-1" Content-Transfer-Encoding: quoted-printable Date: Tue, 17 Apr 2018 08:30:38 -0700 To: sandyn@transocean.com From: =?ISO-8859-1?B?UGhhc2UgSSBEcnVncyBHTVAgSU5EIFJlcXVpcmVtZW50cw==?= Reply-To: =?ISO-8859-1?B?UGhhc2UgSSBEcnVncyBHTVAgSU5EIFJlcXVpcmVtZW50cw==?= Subject: Different requirements for Phase I Investigational Drug Products: which GMPs apply since most Phase I drugs are exempt from full GMP requirements and what IND data requirements are necessary as a result? Feedback-ID: 10655:115342:oraclersys List-Unsubscribe: , X-sgxh1: kHgKPgxljHgkhJLHgQJhu X-rext: 5.interact2.EoZcdoE9-1D66Li2oSWEN8v6H07sjmcFAouwIOqsJNmPP4j1zcHPTmyifVQ X-cid: netzealou.33842 Message-ID: <0.1.407.FAF.1D3D66109DFD782.0@omp.seminar.globalcompliancepanel.com> X-Spam-Status: No, score=2.4 X-Spam-Score: 24 X-Spam-Bar: ++ X-Ham-Report: Spam detection software, running on the system "vps.transocean.com", has NOT identified this incoming email as spam. The original message has been attached to this so you can view it or label similar future email. If you have any questions, see root\@localhost for details. Content preview: Different requirements for Phase I Investigational Drug Products: which GMPs apply since most Phase I drugs are exempt from full GMP requirements and what IND data requirements are necessary as a result? [...] Content analysis details: (2.4 points, 3.0 required) pts rule name description ---- ---------------------- -------------------------------------------------- 0.0 URIBL_BLOCKED ADMINISTRATOR NOTICE: The query to URIBL was blocked. See http://wiki.apache.org/spamassassin/DnsBlocklists#dnsbl-block for more information. [URIs: globalcompliancepanel.com] -0.0 SPF_PASS SPF: sender matches SPF record 0.7 MIME_HTML_ONLY BODY: Message only has text/html MIME parts 0.8 BAYES_50 BODY: Bayes spam probability is 40 to 60% [score: 0.5000] 0.0 HTML_MESSAGE BODY: HTML included in message 0.1 DKIM_SIGNED Message has a DKIM or DK signature, not necessarily valid -0.1 DKIM_VALID Message has at least one valid DKIM or DK signature -0.1 DKIM_VALID_AU Message has a valid DKIM or DK signature from author's domain 1.0 FROM_EXCESS_BASE64 From: base64 encoded unnecessarily X-Spam-Flag: NO <=21DOCTYPE html PUBLIC =22-//W3C//DTD XHTML 1=2E0 Transitional//EN=22 =22h= ttp://www=2Ew3=2Eorg/TR/xhtml1/DTD/xhtml1-transitional=2Edtd=22> Different requirements for Phase I Investigational Drug Products:= which GMPs apply since most Phase I drugs are exempt from full GMP require= ments and what IND data requirements are necessary as a result? <=21-- START OF PRE-HEADER A= REA BLOCK-->
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Your Gateway to Regulatory Compliance View Online
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About Us= Webinars(= =2410) Seminars
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2-day In-person Seminar
Different requirements for Phase I Investigationa= l Drug Products: which GMPs apply since most Phase I drugs are exempt from = full GMP requirements and what IND data requirements are necessary as a res= ult?
Click Here for Mo= re Details=21
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Overview: In January 2006, FDA i= ssued a final rule which specified that most pharmaceutical products (inclu= ding biologics) produced for use in Phase I clinical trial studies were exe= mpted from complying with GMP requirements, as defined in 21 CFR Part 211 u= nder 21 CFR 210=2E2(c)=2E Section 501(a)(2)(B) of the FD&C Act requires dru= gs, including IND products, to comply with cGMPs or if they are not manufac= tured in compliance with cGMPs, they are deemed adulterated=2E Based on thi= s statutory requirement for manufacturers to follow GMPs, FDA issued cGMP r= egulations for drug and biological products in the Code of Federal Regulati= ons (in 21 CFR parts 210 and 211)=2E Read more=2E=2E=2E
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= Date & Time
Date: May 10th & 11th, 2018
Time: 9:00 AM= to 6:00 PM
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= Venue
Salt Lake City, UT <= /span>
Hilton Garden Inn Salt Lake Ci= ty Airport
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= Stephanie Cooke
President/CEO, Cooke Consulting Inc=2E
Stephanie Co= oke, is the President/CEO of Cooke Consulting, Inc=2E Stephanie us= es her roughly 20 years of experience to provide global consulting services= in various areas of Regulatory Affairs, Quality Assurance and validation f= or pharmaceutical, biological/biotech products, medical device, combination= drug/device and nutraceutical firms=2E
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