Return-Path: Delivered-To: louk@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id QBdOD7a0r1r3agAAInt2oQ for ; Mon, 19 Mar 2018 06:01:42 -0700 Return-path: Envelope-to: louk@transocean.com Delivery-date: Mon, 19 Mar 2018 06:01:42 -0700 Received: from omp.news.grceducators.com ([129.145.68.217]:47704 helo=om-axonstech.rsys2.com) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1exuPt-00079P-VO for louk@transocean.com; Mon, 19 Mar 2018 06:01:42 -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=qtyKVStVJCr6KMw1mERJEPnxwCjVyEgJYZ5KMfn98Ms=; b=Um0dGAz2mgPsiS3SWfNeInGlWsuD+9Ii9x46QLOFyHsUJZxVTAay9ePlaDsHco5rBrCrFO/aRW/S zaGbiPbh5/8AqIH1w6ZPyWzjXwCrnMjec1l/7QJJYDHxWDhLiaOhq5EUMOIqn+llfT11Jw90LG4g ulW626riQrHJXX6HRiLrNKyuPvwWigUYhD7zmgnKifSLo7ijTOQu7oxbAxXQPB/1+oLl0d2Rt5Y8 DSYXRLuX73B8bAXNBXl79yXDDnjySEBXd8l0wMe04898SanxQEyOUDZBvSrbFHrVKpPEK1jcJm4E 1cHucyjoJ4+dcnuJgu0lcCNWYJGDeq+dQhEwNw== Received: by om-axonstech.rsys2.com id hluqas2b610o for ; Mon, 19 Mar 2018 06:00:54 -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: Mon, 19 Mar 2018 06:00:54 -0700 To: louk@transocean.com From: =?ISO-8859-1?B?V2ViaW5hciB1cGRhdGVz?= Reply-To: =?ISO-8859-1?B?V2ViaW5hciB1cGRhdGVz?= Subject: FDA Meeting Requests,Preparation and Conduct Feedback-ID: 10775:126122:oraclersys List-Unsubscribe: , X-sgxh1: thmsxljHgkhJLHgQJhu X-rext: 5.interact2.EgxRDb4mTBojWY20tvyV0WTfWCX4w4sKp9ot9zaEtzKWstw X-cid: axonstech.125462 Message-ID: <0.1.12F.524.1D3BF825096535E.0@om-axonstech.rsys2.com> X-Spam-Status: No, score=1.1 X-Spam-Score: 11 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: FDA Meeting Request, Preparation and Conduct 740-870-0321 FDA Meeting Requests,Preparation and Conduct [...] Content analysis details: (1.1 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: grceducators.com] -0.0 SPF_PASS SPF: sender matches SPF record -0.0 T_RP_MATCHES_RCVD Envelope sender domain matches handover relay domain 0.7 MIME_HTML_ONLY BODY: Message only has text/html MIME parts 0.0 HTML_FONT_LOW_CONTRAST BODY: HTML font color similar or identical to background -0.5 BAYES_05 BODY: Bayes spam probability is 1 to 5% [score: 0.0376] 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> FDA Meeting Request, Preparation and Conduct <=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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FDA Meeting Requests,Preparation = and Conduct
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WEDNESDAY APRIL 18 2018 =7C 11:00 AM EST =7C 90 MI= NUTES
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The FDA has published guidance regarding the types of= meetings that will generally be granted, and the information needed to con= duct the meeting=2E However, the guidance tends to be general and interpret= ed in multiple ways=2E This topic will provide practical examples and sugge= stions for standard meetings as well as requesting and conducting non-typic= al meetings (such as during fast track, clinical hold, or for breakthrough = therapy topics)=2E

Learning Objectives:
  • Standard FDA meeting types and timing
  • General qualifying requirements
  • Preparing the meeting request
  • Preparing the briefing document
  • Rehearsing for the meeting
  • Conduct of the meeting
  • Post-meeting follows up
  • Non-typical FDA meetings
  • Preparation for non-typical meetings
  • Documenting informal meetings and correspondence
  • Reference to meetings during future submissions
 
Rehearsal, post-meeting follow-up, and documenting no= n-formal FDA interactions will also be discussed in detail=2E
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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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