Return-Path: Received: from vps.transocean.com by vps.transocean.com with LMTP id wPXwNdWtXFp3eAAAInt2oQ ; Mon, 15 Jan 2018 05:34:13 -0800 Return-path: Envelope-to: JOHN@TRANSOCEAN.COM Delivery-date: Mon, 15 Jan 2018 05:34:13 -0800 Received: from mx.newscpt18.de ([185.11.253.152]:59946) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1eb4tj-00082W-Qn for JOHN@TRANSOCEAN.COM; Mon, 15 Jan 2018 05:34:13 -0800 Content-Type: multipart/mixed; boundary="===============5753405681994996237==" DKIM-Signature: v=1; a=rsa-sha256; c=relaxed/relaxed; d=newscpt18.de; s=default; t=1516023189; bh=SdgPjACGgKkwKPz/eCXJQBQaKSzlI3H7mlwuFI7gwuM=; h=X-CSA-Complaints:Reply-To:Subject:From:To:List-Id: List-Unsubscribe:Date:Reply-To:From:Subject:Date:To: List-Unsubscribe:List-Id:X-CSA-Complaints; b=A3qvKVrc2ECy9JQKXBlEcoQv5AlNFm80MwzJXFwL08ukCJFgCt69IYNOhMAlljmA7 2stXQrosB+VA66IEC1sr/Z4qDeEnAtHpLnm70Yu6kmP18/4CnD7rygX81ZdceamyE3 JFrgIRPJyhGo1HZebyjZUmo4QImpsDiWPud+Bkkc= MIME-Version: 1.0 X-CSA-Complaints: Reply-To: Personal Care Products Safety Act Subject: Regulatory Updates for Implementing a Serious Adverse Event Program From: Personal Care Products Safety Act To: BOUNCED_id_tdat_newsletter: 3488315 List-Id: <475626380> BOUNCED_id_tdat_nl_subscriber: 475626380 bounced_nl: true BOUNCED_tdat_nl_subscriber_pw: a2fbbf1269b6e082d34a526d26fed577 List-Unsubscribe: hermes_uid: b141496c2650f74d7e061cb800df1a53 Date: Mon, 15 Jan 2018 13:33:08 -0000 Message-Id: <20180115133309.2A3C41C422D@mx.newscpt18.de> 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: Sie können diesen HTML Newsletter nicht sehen? Dann verpassen Sie wirklich etwas. Rufen Sie folgende URL auf, um den Newsletter anzuzeigen: http://ea.newscpt18.de/_ns/e641f10c73c50adc3f81aa09f8c54014.html [...] 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: hcaudioconf.com] 0.2 HEADER_FROM_DIFFERENT_DOMAINS From and EnvelopeFrom 2nd level mail domains are different -0.0 T_RP_MATCHES_RCVD Envelope sender domain matches handover relay domain -0.0 SPF_PASS SPF: sender matches SPF record 0.0 HTML_MESSAGE BODY: HTML included in message 0.8 BAYES_50 BODY: Bayes spam probability is 40 to 60% [score: 0.4999] 0.0 HTML_FONT_LOW_CONTRAST BODY: HTML font color similar or identical to background 0.6 KAM_ADVERT2 RAW: This is probably an unwanted commercial email... 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 0.0 T_HTML_TAG_BALANCE_CENTER Malformatted HTML X-Spam-Flag: NO --===============5753405681994996237== Content-Type: multipart/alternative; boundary="===============4588848282680746393==" MIME-Version: 1.0 --===============4588848282680746393== MIME-Version: 1.0 Content-Transfer-Encoding: 8bit Content-Type: text/plain; charset="utf-8" Sie können diesen HTML Newsletter nicht sehen? Dann verpassen Sie wirklich etwas. Rufen Sie folgende URL auf, um den Newsletter anzuzeigen: http://ea.newscpt18.de/_ns/e641f10c73c50adc3f81aa09f8c54014.html Um sich von diesem Newsletter abzumelden, rufen Sie folgende URL auf: http://ea.newscpt18.de/_u/e641f10c73c50adc3f81aa09f8c54014.html /// Can't see this html newsletter? You're really missing out. Visit this URL to view the newsletter: http://ea.newscpt18.de/_ns/e641f10c73c50adc3f81aa09f8c54014.html To instantly unsubscribe from our newsletter, visit this URL: http://ea.newscpt18.de/_u/e641f10c73c50adc3f81aa09f8c54014.html --===============4588848282680746393== MIME-Version: 1.0 Content-Transfer-Encoding: 8bit Content-Type: text/html; charset="utf-8" Care Coordination: Strategy for Managing Cost & Length of Stay
Adverse Event Reporting for Cosmetics, OTC Drugs and Dietary Supplements
Presented By: Norma Skolnik
Live Webinar
Date: Tuesday, January 30, 2018 | Length: 60 minutes
Time: 1 pm ET | 12 pm CT | 11 am MT | 10 am PT
REGISTER NOW
Get Regulatory Insights and Tips for Implementing a Successful SAE Program
In this session, expert speaker Norma Skolnik will cover everything you need to know about how to define a serious adverse event (SAE) and serious adverse event reporting requirements for OTC drugs, cosmetics and dietary supplements. Norma will also cover what to expect regarding reporting changes for cosmetics when the Personal Care Products Safety Act is passed.

You will get references to all relevant FDA regulations, guidance documents, and FDA websites for adverse event reporting, along with regulatory insights and FDA contacts. Read more
Session Highlights
This session will cover:
  • Background to FDA serious adverse event reporting regulations
  • How to define a serious adverse event
  • What products are covered and what changes are coming
  • Specific SAE reporting and recordkeeping requirements and information
  • Changes that are coming for cosmetics with the Personal Care Products Safety Act
  • And more
Apply "PM20" at check-out to get $20 off on registration
  CLICK HERE TO REGISTER  
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About Our Speaker
Norma Skolnik Norma Skolnik has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as Director of Regulatory Affairs for the Americas for Cadbury Adams. Read more
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