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    Archived pages: 171 . Archive date: 2014-10.

  • Title: International Pharmaceutical Quality (IPQ)
    Descriptive info: .. Log in.. |.. Lost Password.. Home.. Newsroom.. The News in Depth.. Updates in Brief.. RSS Feed.. Subscription / License.. Archives.. Customer Service.. Frequently Asked Questions.. Privacy Policy.. Tell a Colleague.. Advertise.. About Us.. Staff.. Welcome to International Pharmaceutical Quality (IPQ).. From breaking news to in-depth analysis,.. International Pharmaceutical Quality.. places its readers ".. Inside the Global Regulatory Dialogue.. " where the initiatives that will reshape the landscape are being defined.. IPQ's incisive, cutting-edge analysis allows its readers to understand the forces that are driving the industry/regulator dialogue and the emerging solutions that are being proposed.. IPQ provides the context and insight needed to respond to and impact these pivotal quality regulatory trends and developments and make informed decisions.. Learn More.. Subscribe Now.. New CMC Submission Approach Needed to Foster Transparency and Continuous Improvement, PhRMA Team Says; Embedding Control Strategy as Regulatory Commitment in QOS Proposed.. A working group of prominent CMC experts across the member companies of the Pharmaceutical Research and Manufacturers of America (PhRMA) has formulated a proposal for a more performance and risk-based regulatory approach to CMC submissions that would better accommodate post-approval manufacturing and control improvements.. October 3 2014 /.. Read More.. Amgen “Analytics of the Future” Initiative Develops MS-based “Multi-Attribute Methodology” to Streamline Biotech Development and QC Testing.. Amgen is among the major biotech companies working hard on empowering, while at the same time streamlining, their analytical toolbox at the development and quality control testing levels as the next frontier of quality by design.. September 13 2014 /.. Transparent Discussions, Long-term Relationships and Global Event Monitoring Mark Amgen’s Supply Oversight Program.. Detailed, transparent technical discussions with  ...   Click to Enlarge.. Click here.. for the July Monthly Update.. IPQ s Mission:.. IPQ is dedicated to helping advance the dialogue on evolving and harmonizing the regulation of pharmaceutical and biologic quality and manufacturing.. IPQ takes its readers from:.. ● the headlines to the forces driving them.. ● regulations and policies to their underlying intent.. ● the pieces of the puzzle to their interconnection.. ● requirements to implementation pathways.. ● random data to critical trends.. ● the sidelines to helping shape the outcome.. ● compliance problems to proactive quality tools.. ● information to intelligence.. and get 24/7 access to the IPQ family of publications:.. “.. In the News.. ”.. — breaking stories on our website;.. Weekly News Alert.. — sent via email;.. Monthly Update.. — the key CMC and GMP developments in the US, Europe and internationally;.. Special Reports.. — in-depth analysis of specific, emerging issues of regulator/industry concern; and.. — live links to all the documents referenced in our stories and full access to IPQ s valuable archive library.. SIGN UP for your FREE Weekly "IPQ Alerts" email.. Get the latest news on pharmaceutical and biopharmaceutical quality regulation and manufacturing.. Bill Paulson:.. IPQ Editor-in-Chief.. Before launching IPQ, Bill served for over two decades as the primary author of “The Gold Sheet.. ” During his career tracking the drug and biotech quality regulatory process, Bill's identification of key issues and problem areas and emerging solutions has been influential in the targeting of resources by industry and FDA and has impacted the dialogue on the shaping of new CMC and GMP policies.. More about About Bill Paulson.. IPQ Sponsor Links.. 2014 IPQ Publications..

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  • Title: Subscriptions and Licenses | IPQ Newsletter
    Descriptive info: Subscriptions and Licenses.. Annual on-line access to IPQ can be purchased as a single person subscription or as a company-wide access license.. ORDER INFORMATION.. Type of order.. individual subscription.. company license.. individual story.. Order Amount.. Name.. Title.. Company.. Email.. Phone.. Address.. Street Address.. Address Line 2.. City.. State / Province / Region.. Zip / Postal Code.. Afghanistan.. Albania.. Algeria.. American Samoa.. Andorra.. Angola.. Antigua and Barbuda.. Argentina.. Armenia.. Australia.. Austria.. Azerbaijan.. Bahamas.. Bahrain.. Bangladesh.. Barbados.. Belarus.. Belgium.. Belize.. Benin.. Bermuda.. Bhutan.. Bolivia.. Bosnia and Herzegovina.. Botswana.. Brazil.. Brunei.. Bulgaria.. Burkina Faso.. Burundi.. Cambodia.. Cameroon.. Canada.. Cape Verde.. Central African Republic.. Chad.. Chile.. China.. Colombia.. Comoros.. Congo.. Costa Rica.. Côte d'Ivoire.. Croatia.. Cuba.. Cyprus.. Czech Republic.. Denmark.. Djibouti.. Dominica.. Dominican Republic.. East Timor.. Ecuador.. Egypt.. El Salvador.. Equatorial Guinea.. Eritrea.. Estonia.. Ethiopia.. Fiji.. Finland.. France.. Gabon.. Gambia.. Georgia.. Germany.. Ghana.. Greece.. Greenland.. Grenada.. Guam.. Guatemala.. Guinea.. Guinea-Bissau.. Guyana.. Haiti.. Honduras.. Hong Kong.. Hungary.. Iceland.. India.. Indonesia.. Iran.. Iraq.. Ireland.. Israel.. Italy.. Jamaica.. Japan.. Jordan.. Kazakhstan.. Kenya.. Kiribati.. North Korea.. South Korea.. Kuwait.. Kyrgyzstan.. Laos.. Latvia.. Lebanon.. Lesotho.. Liberia.. Libya.. Liechtenstein.. Lithuania.. Luxembourg.. Macedonia.. Madagascar.. Malawi.. Malaysia.. Maldives.. Mali.. Malta.. Marshall Islands.. Mauritania.. Mauritius.. Mexico.. Micronesia.. Moldova.. Monaco.. Mongolia.. Montenegro.. Morocco.. Mozambique.. Myanmar.. Namibia.. Nauru.. Nepal.. Netherlands.. New Zealand.. Nicaragua.. Niger.. Nigeria.. Norway.. Northern Mariana Islands.. Oman.. Pakistan.. Palau.. Palestine.. Panama.. Papua New Guinea.. Paraguay.. Peru.. Philippines.. Poland.. Portugal.. Puerto  ...   MD 20814).. Electronic transfer.. (IPQ will email you the information needed).. Credit Card.. (To pay by credit card please contact Wayne Rhodes by phone (202-841-9470) or email (wrhodes@ipqpubs.. com)).. Questions: Call Wayne Rhodes 202-841-9470 – FAX 301-913-0119.. INDIVIDUAL SUBSCRIPTIONS:.. Single Person Annual Subscriptions:.. $3000/year, or $5,000 for two years, with additional individual subscriptions purchased together $1000 each.. *.. [NOTE: IPQ information cannot be shared.. by individual subscribers.. within a company or externally without permission.. IPQ information may be freely shared within the company covered by a license.. ].. COMPANY ACCESS LICENSES:.. IPQ encourages taking advantage of the added value and cost-effectiveness of a company access license.. License pricing is based on the total number of employees at the company rather than on the number of users.. Pricing.. :.. No.. of employees cost.. in the company.. Up to 100.. $5,000.. 100-500.. $6,000.. 500-1,000.. $7,000.. 1,000-2,000 $8,000.. 2,000-5,000 $10,000.. 5,000-10,000.. $15,000.. 10,000-20,000 $20,000.. Above 20,000 add $1,000 per 5,000 employees.. Special license pricing is available for suppliers to the pharmaceutical industry and companies that have significant non-pharma-oriented components.. Contact Wayne Rhodes (.. wrhodes@ipqpubs.. com.. ) for information.. UNIVERSITY OR GOVERNMENTAL AGENCY ACCESS LICENSES:.. A one year access license for a university or governmental agency is $3000.. Special pricing may be available.. To purchase a license or for more information, please contact IPQ s Sales/Marketing Coordinator Wayne Rhodes:.. ,.. (202) 841-9470..

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  • Title: IPQ Newsletter › Log In
    Descriptive info: IPQ Newsletter.. Username.. Password.. Remember Me.. Lost your password?.. Back to IPQ Newsletter..

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  • Title: IPQ Newsletter › Lost Password
    Descriptive info: Please enter your username or email address.. You will receive a link to create a new password via email.. Username or E-mail:..

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  • Title: The News In Depth | IPQ Newsletter
    Descriptive info: October 3, 2014 | Posted in.. CMC Review Policy.. Post-approval Changes.. Region/International.. US/Canada.. Read More.. September 13, 2014 | Posted in.. Biotech Therapeutics.. CMC Standards.. GMP Policy.. Laboratory.. Specific Product Type.. August 23, 2014 | Posted in.. Component Supply.. General.. International.. Supply Chain/GDPs.. IPQ Monthly Update, July 2014.. IPQ’s coverage during July focused heavily on the efforts worldwide to address the threats that loom along the global supply chain to the quality of the products that patients receive.. Included in the July Monthly Update are stories addressing: ● APEC’s broad-based, multi-faceted initiatives ● pharmacopeial modernization and harmonization efforts, and ● FDA’s track and trace implementation.. Also in this issue are valuable insights from FDA’s microbiology review staff on: ● top micro deficiencies in applications, and ● upgrading micro methods and processes.. August 17, 2014 | Posted in.. Europe.. Generic.. Generic/Biosimilar.. International Harmonization.. Marketing Application/General.. Pharmacopeias.. Track and Trace.. Guides on FDA’s Generic Drug Review Process Continue Apace in July; EU Pilot Pursues Generic Drug Review Streamlining Internationally.. The efforts by the Office of Generic Drugs (OGD) to clarify and streamline the Abbreviated New Drug Application (ANDA) process and facilitate the implementation of the Generic Drug User Fee Act (GDUFA) continued apace in mid-July with the release of draft guidances on post-approval supplements and easily correctable deficiencies.. Comments on the drafts are due by mid-September.. August 16, 2014 | Posted in.. Inspections/Info  ...   interoperable product transaction requirements for manufacturers, distributors, and repackagers kicking in on January 1, 2015.. July 30, 2014 | Posted in.. GDP/Supply Chain.. APEC’s Assessment of Gaps in Supply Chain Regulation Reveals Surprising Differences in Country Approaches.. The assessment by the Asia Pacific Economic Cooperation (APEC) organization of the gaps in the ability of regulatory agencies to address the problems of an international supply chain has revealed some surprising differences in their practices.. July 27, 2014 | Posted in.. Asia.. Diversion.. GMP Enforcement Activity.. Latin/South America.. Other Organizations.. Shipping Storage.. WHO.. FDA Will Support Efforts to Upgrade Micro Methods and Processes, CDER Reviewer Affirms.. FDA Center for Drug Evaluation and Research (CDER) microbiology reviewers are assuring companies that they will be supportive of efforts to upgrade lab methods and manufacturing processes to take advantage of post-approval scientific advancements.. July 22, 2014 | Posted in.. Top Deficiencies Found in CDER’s Micro Review of Regulatory Submissions Include Incomplete Information on Validation of Aseptic and Terminal Processes.. Incomplete media fill information for aseptic processes and an inadequate comparison between production and validation conditions for terminal sterilization are among the microbiology concerns in regulatory submissions that most frequently generate information requests and deficiency letters from FDA’s Center for Drug Evaluation and Research (CDER).. July 21, 2014 | Posted in.. General/Quality.. Pages:.. 1.. 2.. 3.. 4.. 5.. 6.. 7.. 8.. 9.. 10.. 40.. 41.. 42.. Next..

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  • Title: RSS Feed | IPQ Newsletter
    Descriptive info: Click to view the IPQ RSS Feed.. RSS How to Subscribe:.. Subscribe to.. IPQ s.. RSS (Really Simple Syndication) feed to get news delivered directly to your desktop.. Copy the URL/shortcut.. Paste the URL into your RSS reader.. Help with adding an RSS Feed:.. RSS is an internet format that gives you a new way to quickly and easily access web-based headlines, blurbs, and article links from a wide variety of sources.. It s most often used for showing the latest headlines from online newspapers, magazines, web blogs, and vendor and technology information sites.. Using Automatic Discovery.. To access an RSS feed you need a software program known as a news aggregator or RSS reader.. If you already have a news aggregator and it supports auto-discovery, you can usually add an RSS link for a given site by using your aggregator to surf the home page of that web site.. Adding an RSS Link Manually.. Here s a short list of RSS readers you might like to try:.. Microsoft Office Outlook.. Internet Explorer.. Firefox.. Apple Safari.. What is RSS?.. Most sources define RSS as an acronym standing for Really Simple Syndication; other sources say the acronym derives from Rich Site Summary or RDF Site Summary.. In fact, all may be correct.. Whatever the letters stand for, RSS is a light-weight XML format for distributing headlines, links, and brief descriptions of web-based content.. Web content providers develop and serve RSS feeds, or streams of headline content designed to be accessed by news aggregator or RSS reader client software.. An RSS reader lets you peruse headlines, read summaries, and  ...   advertising associated with or targeted toward the RSS Content, are strictly prohibited.. You must use the RSS feeds as provided by.. , and you may not edit or modify the text, content or links supplied by.. Link to Content Pages:.. The RSS service may be used only with those platforms from which a functional link is made available that, when accessed, takes the viewer directly to the display of the full article on.. You may not display the RSS Content in a manner that does not permit successful linking to, redirection to or delivery of the applicable.. web page.. You may not insert any intermediate page, splash page or other content between the RSS link and the applicable.. Ownership.. retains all ownership and other rights to the RSS Content, and any and all IPQPubs.. com logos and trademarks used in connection with the RSS Service.. You must provide attribution to the appropriate IPQPubs.. com web site in connection with your use of RSS feeds.. If you provide this attribution using a graphic, you must use the appropriate IPQPubs.. com web site s logo incorporated into the RSS feed.. Right to Discontinue Feeds.. reserves the right to discontinue providing any or all of the RSS feeds at any time and to require you to cease displaying, distributing or otherwise using any or all of the RSS feeds for any reason including, without limitation, your violation of any provision of these.. assumes no liability for any of your activities in connection with the RSS feeds or for your use of the RSS feeds in connection with your web site..

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  • Title: Issue Archive | IPQ Newsletter
    Descriptive info: Your Search Results.. IPQ Monthly Update July, 2014.. The Monthly Update for July 2014 is now available.. August 18, 2014 | Posted in.. Current Issue.. Issue Archive.. IPQ Monthly Update June 2014.. IPQ's Monthly Update for June 2014 is now available.. July 17, 2014 | Posted in.. IPQ Monthly Update May 2014.. The Monthly Update for May is now available.. June 19, 2014 | Posted in.. Uncategorized.. IPQ Monthly Update March/April.. The Monthly Update for March/April is now available.. May 16, 2014 | Posted in.. IPQ Monthly Update February 2014.. The Monthly Update for February is now available.. March 10, 2014 | Posted  ...   s Most Read Stories of 2013.. As a retrospective on the past year, IPQ is providing a compilation of the four stories that generated the largest readership.. [Available in full to non-subscribers as well as subscribers.. ].. January 25, 2014 | Posted in.. Special Report.. IPQ Monthly Update November/December 2013.. The IPQ November/December Monthly Update is now available.. January 7, 2014 | Posted in.. 欧州FMD実施、優れたAPI調達知識と省庁間通信推進.. CASSS CMC Strategy Forum Japan の参加者の皆様方に IPQ のレポートの価値をさらにご理解 いただくために、 最近の月例アップデートの中から1つ記事を抜粋し、日本語に翻訳して紹介させていただきます。また、どのような 範囲の話題を月例アップデートに取り上げているのかをご理解いただけるように、日本語に翻訳した第1面の目次 も一緒に送信しました。この記事の日本語PDF版については次のウェブサイトをご覧ください:.. December 3, 2013 | Posted in.. IPQ October Monthly Update October 2013.. The Monthly Update for October is now available.. November 7, 2013 | Posted in..

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  • Title: Customer Service | IPQ Newsletter
    Descriptive info: Send Customer Service a note:.. Your Name (required).. Your Email (required).. Subject.. Your Message..

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  • Title: International Pharmaceutical Quality Frequently Asked Questions | IPQ Newsletter
    Descriptive info: What is International Pharmaceutical Quality (IPQ)?.. What does IPQ cover?.. Who benefits from reading IPQ?.. How is IPQ delivered?.. How do I get a subscription?.. How do I get a site license?.. What benefits do I receive as a subscriber?.. Who writes IPQ?.. Why should I subscribe to IPQ?.. The IPQ family of publications includes breaking stories “In the News” on our web site, “Weekly News Alerts” sent via e-mail, and the “Monthly Update.. ” These accompany our uniquely valuable in-depth “Special Reports” on emerging areas of concern drawing particular attention from industry and regulators.. IPQ’s offerings support our mission of helping readers understand, engage in and respond to the dialogue and developments around evolving and harmonizing the regulation of pharmaceutical and biologic quality and manufacturing.. Subscribers and license holders to IPQ have access to all of these sources of cutting-edge news and in-depth analysis as well as to the full IPQ archives.. IPQ covers the initiatives and developments around drug and biologic quality regulation and standard-setting and their discussion at key conferences and forums around the world.. Its purview stretches from marketing application review to GMP inspections, from drug development to post-market manufacturing, from product to process analytics, from the ingredient supply chain through product distribution, and from the three ICH regions to regulators worldwide.. Those involved in and  ...   and regulators.. Non-subscribers have access only to the In the News summaries and greatly-abbreviated sample versions of the Monthly summaries and Special Reports.. IPQ’s senior editorial staff has been engaged in tracking the drug and biotech regulatory process for the past three decades, accumulating the depth and breadth of experience needed to understand the underlying forces and trends shaping the regulatory landscape.. To find out about our senior editorial staff,.. The regulatory paradigm for pharmaceutical quality is undergoing a major transformation.. Keeping up with this transformation is critical to your job and the success of your organization.. places its readers.. “Inside the Global Regulatory Dialogue”.. ™ where the initiatives that will reshape the landscape are being defined.. IPQ helps its readers understand:.. ●.. The critical quality regulatory trends impacting the pharmaceutical industry.. What key regulators are thinking and saying about their top concerns.. What reviewers are looking for in CMC applications and in interacting with applicants.. How to plan for, manage, and respond to regulatory agency inspections.. Current investigator focal points and enforcement action triggers.. How to design compliant processes and keep them that way.. The knowledge needed to make informed decisions and develop effective in-house policies.. How to influence the rule-making process and assure that standards are viable.. The meaning and purpose behind complex regulations and how to implement them..

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  • Title: Privacy Policy | IPQ Newsletter
    Descriptive info: Reasons.. Our principles.. What information do we collect?.. Optional Services.. What does IPQ Publications do with the information it gathers and tracks?.. With whom does IPQ Publications share the information it gathers and tracks?.. Blogs and RSS feeds.. Children s Guidelines.. Opting-Out, Corrections and Cancellations.. Additional Information Or to Report a Problem.. Reasons:.. At.. IPQ Publications.. we collect different types of information about our users for two main reasons:.. To help us improve the services we offer.. To provide personalized services unique to individual users.. Top of Page.. Our principles:.. We are absolutely committed to protecting your privacy.. Our policy can be summarized in one sentence: We will not share your information with others without your prior consent.. To uphold these principles,.. has established the following four principles:.. We will continue to invest in high-quality security and do our utmost to protect user privacy through the appropriate use of the latest security technology.. We will respect your email privacy.. You will not receive unsolicited mail from.. and/or from third parties screened by.. unless you have agreed to this.. We will, however, email you occasionally information about your registration and/or your subscription account.. We will not pass on any individual user details (including your eMail address) unless we have your prior consent.. Otherwise, we will only share anonymous aggregate statistics about our users, sales, and traffic patterns with our advertisers.. Should we elect to change our privacy policy we will post the changes here.. Where the changes are significant, we may also choose to eMail all our registered users with new details.. IPQ Publications.. has adopted a set of information management guidelines that serve as the basis for our customer and advertiser relationships.. These guidelines have been developed with the recognition that internet technologies are rapidly evolving and that underlying business models are still not established.. Accordingly, guidelines are subject to change.. Any such changes will be posted on this page.. is not responsible for the content or the privacy policies of web sites to which it might link.. Optional Services:.. For certain optional services,.. requires that you supply a unique subscriber ID, email address, and  ...   our.. eMail management page.. ).. Data Security:.. To prevent unauthorized access, maintain data accuracy, and ensure the appropriate use of information,.. has put in place appropriate physical, electronic, and managerial procedures to protect the information it collects online.. These security measures are reviewed and updated as necessary to provide a secure data environment.. With whom does.. share the information it gathers and tracks?.. uses the information it gathers to promote special offers.. The information gathered may also be shared with advertisers and other partners.. will provide registered users with all personal information collected at the time of registration upon request.. This information will be sent only to the eMail address on file for the unique subscriber ID associated with it.. During the registration process, new users may select to register for various eMail publications.. If you select this option,.. mayuse the information collected on the registration form to send targeted eMails to you on behalf of advertisers.. subscribers may opt-out of this service at any time.. Blogs and RSS feeds:.. offers optional resources for communications.. Any information you disclose when posting a message in these tools becomes public.. Moreover, subscribers who post a message in our communications make their eMail address available to others through a feature of our communications software, which could result in unsolicited eMail from other subscribers or parties.. Children s Guidelines:.. No section of.. is directed at children 12 and under.. We collect no personally identifiable information from visitors known to be children.. Opting-Out, Corrections, and Cancellations:.. Upon request, IPQ Publications will a) Remove you and your personal information from our database, thereby canceling your registration; b) Correct personal information that you state is erroneous; or c) Permit you to opt out of further eMail contact (excepting notification of major changes to the service) while still allowing access to the site.. To request a correction or cancellation, contact.. To manage your IPQ Publications eMail profile, please go to our.. Additional Information Or to Report a Problem:.. Please eMail.. Bill Paulson.. , or call directly at.. 1-800-394-0115 ext 111.. Address:.. Attention: Bill Paulson.. 7920 Norfolk Ave.. , Suite 900.. Bethesda, MD 20814..

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  • Title: Tell a Colleague » E-Mail | IPQ Newsletter
    Descriptive info: Warning.. : Illegal string offset 'id' in.. /home/ipqpubs/public_html/wp-content/plugins/wp-email/wp-email.. php.. on line.. 1134.. : Illegal string offset 'yourname' in.. 1144.. : Illegal string offset 'youremail' in.. 1150.. : Illegal string offset 'yourremarks' in.. 1156.. : Illegal string offset 'friendname' in.. 1162.. : Illegal string offset 'friendemail' in..  ...   Just enter the information requested below and click send.. Your message will be sent immediately.. * Required Field.. Your Name: *.. Your E-Mail: *.. Your Remark:.. Friend's Name: *.. Separate multiple entries with a comma.. Maximum 5 entries.. Friend's E-Mail: *.. Image Verification: *.. Loading.. Subscription Benefits..

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    Archived pages: 171