Return-Path: Delivered-To: louk@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id iHPvFFbN0FqseQAAInt2oQ for ; Fri, 13 Apr 2018 08:31:34 -0700 Return-path: Envelope-to: louk@transocean.com Delivery-date: Fri, 13 Apr 2018 08:31:34 -0700 Received: from omp.news.grceducators.com ([129.145.68.217]:45920 helo=om-axonstech.rsys2.com) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1f70fd-00086W-Cm for louk@transocean.com; Fri, 13 Apr 2018 08:31:34 -0700 DKIM-Signature: v=1; a=rsa-sha256; c=relaxed/relaxed; s=grceducators; d=news.grceducators.com; h=MIME-Version:Content-Type:Content-Transfer-Encoding:Date:To:From:Reply-To: Subject:List-Unsubscribe:Message-ID; i=grceducators@news.grceducators.com; bh=onSHOC+30ogKi0YsdZw+BLrlnRhYfPzGVDUpj4z2K0A=; b=Ia4MedevC5dnY+m+4IgtwSLzw1Wl0ii41R3P6PX7/70NLtBqyCNH+EOvxGiNCuZz1UCrYLvTnvDC 0jUennsmla2/gXRRH4v2ditdedP7s+t3k1KcrZUEMMnsCpnx/6ZvEnPERafcLyZCZ9dT2+qULzMG 5UrMSKm3tGArktnY4QVw0eq6o7ykawtPeloVeiKS4XOo8LxMNTIym62m6maERbKZwofRB0pbg3nM B/Q+JUXe0RWfZIBo73l3kFhcnvDJXWQOS0XVtkIn1vYdNLjBsZSOcFnndt7OXH4ElzUzTetND7MP QmR4glcXe3ks/CG6iiF1I61RtEVjlCUKk1F7Vg== Received: by om-axonstech.rsys2.com id hq36kq2b610e for ; Fri, 13 Apr 2018 08:30:45 -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: Fri, 13 Apr 2018 08:30:45 -0700 To: louk@transocean.com From: =?ISO-8859-1?B?V2ViaW5hciB1cGRhdGVz?= Reply-To: =?ISO-8859-1?B?V2ViaW5hciB1cGRhdGVz?= Subject: New And Expected Guidance on Data Standards and Electronic Submission Feedback-ID: 10775:169482:oraclersys List-Unsubscribe: , X-sgxh1: thmsxljHgkhJLHgQJhu X-rext: 5.interact2.EkkvPRjh8ZTSBdxrBHwIjhYXMJoeoLjP_pxfeBSZmN3bgtY X-cid: axonstech.162482 Message-ID: <0.1.89.DF6.1D3D33C63DF3E8A.0@om-axonstech.rsys2.com> X-Spam-Status: No, score=1.6 X-Spam-Score: 16 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: New and Expected Guidance on Data Standards and Electronic Submission 740-870-0321 New and Expected Guidances on Data Standards and Electronic Submissions for Drug and Medical Products [...] Content analysis details: (1.6 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: mailinblue.com] -0.0 SPF_PASS SPF: sender matches SPF record 0.0 HTML_FONT_LOW_CONTRAST BODY: HTML font color similar or identical to background 0.0 HTML_MESSAGE BODY: HTML included in message 0.7 MIME_HTML_ONLY BODY: Message only has text/html MIME parts -0.0 BAYES_40 BODY: Bayes spam probability is 20 to 40% [score: 0.2880] 0.0 AC_DIV_BONANZA RAW: Too many divs in a row... spammy template -0.1 DKIM_VALID_AU Message has a valid DKIM or DK signature from author's domain 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 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> New and Expected Guidance on Data Standards and Electronic Submis= sion <=21--=5Bif gte mso 11=5D><=21=5Bendif= =5D--><=21--=5Bif =21mso=5D><=21--> <=21--<=21=5Bendif=5D--><=21--=5Bif gte mso 15=5D>96<=21=5Bendif=5D--><=21--=5Bif gte mso 9=5D>96<=21=5Bendif=5D-->
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740-870-0321
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New and Expected Guidances on Dat= a Standards and Electronic Submissions for Drug and Medical Products
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THURSDAY MAY 3 2018 =7C 01:00 PM EST =7C 90 MINUTE= S
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This webinar will provide the new and expected guidan= ces on data standards and electronic submissions for drugs and medical prod= ucts=2E We will explain what the policies and the requirements for submissi= ons and standards for drugs in US are and globally and how it affects healt= hcare/drug industry to adopt them=2E

All functional groups and professionals who have responsibil= ity in the submissions and approval process for medical products and need t= o have an overview of the field should attend=2E

Each FDA center has different guidelines and processes to fo= llow in order to have a successful submission for the regulatory review of = the medical product=2E The submission process for drugs, biologics and medi= cal devices is rigorous and has specific timelines and standards to follow= =2E

The agencies (FDA, EMEA) encourage electronic submissions an= d they have developed data standards and other guidelines=2E The Common Tec= hnical Document (CTD) describes the modules, sections and documents to be u= sed by an Applicant for a Marketing Authorization for a medical product for= human use ( EU, Japan and US)=2E Different Standard Development Organizati= ons (HL7, ISO, CDISC, ICH) work to produce and harmonize standards national= ly and worldwide to improve regulatory submissions

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REGISTER NOW
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Event Marketing =7C GRC Educators =7C 740-870-0321 =7C support=40grcedu= cators=2Ecom =7C www=2Egrceducators=2Ecom =7C 806 Clark Street, P=2EO Box 1= 71, Philo, OH-43771 USA
 
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© 2018 GRC Educators
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