Calendar - The Elm

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/* If the end date is the same as the start date, hide the end date */ if ($('.start_date').text() == $('.end_date').text()) { $('.end_date').hide(); $('.date_dash').hide(); } /* If the start time is 12:00 am and the end time is 11:59 pm, display "all day"*/ if (($('.start_time').text() == '12:00 AM') && ($('.end_time').text() == '11:59 PM')) { $('.end_time').hide(); $('.time_dash').hide(); $('.start_time').text('All day') } /* If the end time is the same as the start time, hide the end time */ if ($('.start_time').text() == $('.end_time').text()) { $('.end_time').hide(); $('.time_dash').hide(); } /*If the recurrence is 'never' or 'Ad-Hoc', hide recurrence information*/ if (($('.recurrence').text() == 'Never') || ($('.recurrence').text() == 'Ad-Hoc')) { $('.recur_info').hide(); } /*If the recurrence is not 'Ad-Hoc', hide the ad-hoc dates*/ if ($('.recurrence').text() != 'Ad-Hoc') { $('.ad-hoc_dates').hide(); } }); </script> <p class="category_header">School of Pharmacy</p> <h3 class="event-title">CRCG and FDA Public Workshop</h3>  <div class="eventdatetimeplace fulltext"> <p><span class="start_date">Wednesday, November 06, 2024</span><span class="date_dash"> - </span><span class="end_date">Thursday, November 07, 2024</span>  <a class="ical-download-link" href="https://calendar.umaryland.edu/ics-share/event-617215.ics">Add to my calendar</a> <span class="ad-hoc_dates"> </span> <span class="recur_info"><br />Recurs every <span class="recurrence" style="text-transform:lowercase;">Never</span> until </span> <br /><span class="start_time">8:30 AM</span><span class="time_dash"> - </span><span class="end_time">4:30 PM</span> <br />Hybrid </p> </div> <span class="full_desc"><span class="event_image"><img src="https://calendar.umaryland.edu/events/sop/marketing/CRCG---Updates-400x200.jpg" width="400" height="200" alt="Graphic promoting the Updates: Acceptable Intakes of NDSRIs & BE Assessment for Reformulated Drugs workshop on Nov. 6-7, 2024." /></span><h3>FDA and the Center for Research on Complex Generics (CRCG) will host a public training on Nov. 6-7, 2024: Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products</h3> <p>This interactive two-day workshop will discuss the regulatory recommendations on confirmatory testing methods for the formation of Nitrosamine Drug Substance Related Impurities (NDSRIs), safety testing methods for NDSRIs, and recommended acceptable intake limits for NDSRIs.</p> <p>The workshop will share the latest research and recommendations for detecting NDSRI formation as well as strategies to mitigate risks of their formation and ensure compliance with evolving regulatory requirements. Get up-to-date information on the latest guidance and recommendations on formulation stability and bioequivalence approaches, and hear firsthand from experts on regulatory approaches for pre- and post- approval changes in ANDA/NDA submissions and supplements.</p> <p>This workshop is your opportunity to stay ahead of the curve, network with peers, and take away practical solutions to enhance your drug development and manufacturing processes.</p> <p><strong>Virtual Attendees<span> </span></strong>will enjoy free access to all workshop presentations and panel discussions. Virtual attendees will be able to:</p> <ul> <li>Attend all presentations and panel discussions</li> <li>Participate in all Q&A panel discussions by submitting questions online in real time to the speakers and panelists</li> <li>Enjoy free access to workshop recordings of presentations and panel discussions</li> </ul> <p><strong>In-Person Attendees<span> </span></strong>will enjoy all of the benefits of virtual attendees and will have networking opportunities with the speakers and panelists while engaging in active dialogue with the panelists.  In-person attendees will be able to:</p> <ul> <li>Collaborate in person with FDA, industry, and academic experts throughout the workshop</li> <li>Enjoy priority over virtual attendees to ask questions to the panelist</li> <li>Engage in dialogue with attendees and faculty about the strategies to mitigate risks and ensure compliance with evolving regulatory requirements</li> <li>Converse with panelists during discussion panel Q&As</li> <li>Network with colleagues during breaks</li> </ul> <p><strong><a href="https://www.complexgenerics.org/education-training/updates-on-approaches-to-acceptable-intakes-of-nitrosamine-drug-substance-related-impurities-ndsris-and-bioequivalence-assessment-for-reformulated-drug-products/">Register here.</a></strong> </p></span> <p class="umb_light">Organized by <a href="mailto:info@complexgenerics.org">Center for Research on Complex Generics</a></p> <div class="calendar_clearfix"></div></div><div id="calendar_column"><div class="calendar_box"><table summary="Calendar of Events"><thead><tr role="presentation"><th role="presentation"><a href="https://calendar.umaryland.edu/?month=10&day=1&year=2024&view=month&id=d.en.617215&timestamp=1730899800&"><</a></th><th colspan="5" role="presentation"><a href="https://calendar.umaryland.edu/?month=11&day=06&year=2024&view=month&id=d.en.617215&timestamp=1730899800&" >November 2024</a></th><th role="presentation"><a href="https://calendar.umaryland.edu/?month=12&day=1&year=2024&view=month&id=d.en.617215&timestamp=1730899800&">></a></th></tr><tr><th scope="col">M </th><th scope="col">T </th><th scope="col">W </th><th scope="col">T </th><th scope="col">F </th><th scope="col">S </th><th scope="col">S </th></tr></thead><tr><td class="fillday hasevent"><a href="https://calendar.umaryland.edu/?month=10&day=28&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="October 28, 2024" >28</a></td><td class="fillday hasevent"><a href="https://calendar.umaryland.edu/?month=10&day=29&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="October 29, 2024" >29</a></td><td class="fillday hasevent"><a href="https://calendar.umaryland.edu/?month=10&day=30&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="October 30, 2024" >30</a></td><td class="fillday hasevent"><a href="https://calendar.umaryland.edu/?month=10&day=31&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="October 31, 2024" >31</a></td><td class="thismonth hasevent"><a href="https://calendar.umaryland.edu/?month=11&day=01&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="November 1, 2024" >01</a></td><td class="thismonth hasevent"><a href="https://calendar.umaryland.edu/?month=11&day=02&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="November 2, 2024" >02</a></td><td class="thismonth">03</td></tr><tr><td class="thismonth hasevent"><a href="https://calendar.umaryland.edu/?month=11&day=04&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="November 4, 2024" >04</a></td><td class="thismonth hasevent"><a href="https://calendar.umaryland.edu/?month=11&day=05&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="November 5, 2024" >05</a></td><td class="thismonth viewrange hasevent"><a href="https://calendar.umaryland.edu/?month=11&day=06&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="November 6, 2024" >06</a></td><td class="thismonth hasevent"><a href="https://calendar.umaryland.edu/?month=11&day=07&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="November 7, 2024" >07</a></td><td class="thismonth hasevent"><a href="https://calendar.umaryland.edu/?month=11&day=08&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="November 8, 2024" >08</a></td><td class="thismonth hasevent"><a href="https://calendar.umaryland.edu/?month=11&day=09&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="November 9, 2024" >09</a></td><td class="thismonth">10</td></tr><tr><td class="thismonth hasevent"><a href="https://calendar.umaryland.edu/?month=11&day=11&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="November 11, 2024" >11</a></td><td class="thismonth hasevent"><a href="https://calendar.umaryland.edu/?month=11&day=12&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="November 12, 2024" >12</a></td><td class="thismonth hasevent"><a href="https://calendar.umaryland.edu/?month=11&day=13&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="November 13, 2024" >13</a></td><td class="thismonth hasevent"><a href="https://calendar.umaryland.edu/?month=11&day=14&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="November 14, 2024" >14</a></td><td class="thismonth hasevent"><a href="https://calendar.umaryland.edu/?month=11&day=15&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="November 15, 2024" >15</a></td><td class="thismonth">16</td><td class="thismonth">17</td></tr><tr><td class="thismonth hasevent"><a href="https://calendar.umaryland.edu/?month=11&day=18&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="November 18, 2024" >18</a></td><td class="thismonth hasevent"><a href="https://calendar.umaryland.edu/?month=11&day=19&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="November 19, 2024" >19</a></td><td class="thismonth hasevent"><a href="https://calendar.umaryland.edu/?month=11&day=20&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="November 20, 2024" >20</a></td><td class="thismonth hasevent"><a href="https://calendar.umaryland.edu/?month=11&day=21&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="November 21, 2024" >21</a></td><td class="thismonth hasevent"><a href="https://calendar.umaryland.edu/?month=11&day=22&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="November 22, 2024" >22</a></td><td class="thismonth today">23</td><td class="thismonth">24</td></tr><tr><td class="thismonth hasevent"><a href="https://calendar.umaryland.edu/?month=11&day=25&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="November 25, 2024" >25</a></td><td class="thismonth hasevent"><a href="https://calendar.umaryland.edu/?month=11&day=26&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="November 26, 2024" >26</a></td><td class="thismonth hasevent"><a href="https://calendar.umaryland.edu/?month=11&day=27&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="November 27, 2024" >27</a></td><td class="thismonth hasevent"><a href="https://calendar.umaryland.edu/?month=11&day=28&year=2024&view=day&id=d.en.617215&timestamp=1730899800&" aria-label="November 28, 2024" >28</a></td><td class="thismonth">29</td><td class="thismonth">30</td><td class="fillday">01</td></tr></table></div><div id = "view_switchers"><a href="https://calendar.umaryland.edu/?month=11&day=06&year=2024&view=day&id=d.en.617215&timestamp=1730899800&">Day</a> | <a href="https://calendar.umaryland.edu/?month=11&day=06&year=2024&view=week&id=d.en.617215&timestamp=1730899800&">Week</a> | <a 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