qepler.com
Open in
urlscan Pro
2a02:4a8:ac24:110::10:119
Public Scan
Submitted URL: https://qepler.com/events/gti23.html
Effective URL: https://qepler.com/events/3rd-genotoxic-impurities-in-pharmaceuticals-summit-2023.html
Submission: On November 21 via api from US — Scanned from DE
Effective URL: https://qepler.com/events/3rd-genotoxic-impurities-in-pharmaceuticals-summit-2023.html
Submission: On November 21 via api from US — Scanned from DE
Form analysis 11 forms found in the DOM
POST https://qepler.com/virtual-registration-form.html
<form class="form-inline justify-content-center" method="post" action="https://qepler.com/virtual-registration-form.html">
<input type="hidden" name="eventID" value="969">
<input type="hidden" name="package" value="Online ticket">
<input type="hidden" name="packageID" value="GP2">
<input type="hidden" name="price" value="345">
<input type="hidden" name="priceEB" value="245">
<input type="hidden" name="discount" value="100">
<input type="hidden" name="eventURL" value="https://qepler.com/events/3rd-genotoxic-impurities-in-pharmaceuticals-summit-2023.html">
<input type="hidden" name="workemail" value="">
<select name="delegatesCount" class="form-control form-control-sm product-quantity">
<option value="1">1</option>
</select>
<button type="submit" name="VGO" class="btn btn-primary btn-sm">SELECT</button>
</form>POST https://qepler.com/virtual-registration-form.html
<form class="form-inline justify-content-center" method="post" action="https://qepler.com/virtual-registration-form.html">
<input type="hidden" name="eventID" value="969">
<input type="hidden" name="package" value="Online GROUP 2-3">
<input type="hidden" name="packageID" value="GP4">
<input type="hidden" name="price" value="295">
<input type="hidden" name="priceEB" value="195">
<input type="hidden" name="discount" value="100">
<input type="hidden" name="eventURL" value="https://qepler.com/events/3rd-genotoxic-impurities-in-pharmaceuticals-summit-2023.html">
<input type="hidden" name="workemail" value="">
<select name="delegatesCount" class="form-control form-control-sm product-quantity">
<option value="2">2</option>
<option value="3">3</option>
</select>
<button type="submit" name="VGO" class="btn btn-primary btn-sm">SELECT</button>
</form>POST https://qepler.com/virtual-registration-form.html
<form class="form-inline justify-content-center" method="post" action="https://qepler.com/virtual-registration-form.html">
<input type="hidden" name="eventID" value="969">
<input type="hidden" name="package" value="Online GROUP 4+">
<input type="hidden" name="packageID" value="GP4">
<input type="hidden" name="price" value="255">
<input type="hidden" name="priceEB" value="155">
<input type="hidden" name="discount" value="100">
<input type="hidden" name="eventURL" value="https://qepler.com/events/3rd-genotoxic-impurities-in-pharmaceuticals-summit-2023.html">
<input type="hidden" name="workemail" value="">
<select name="delegatesCount" class="form-control form-control-sm product-quantity">
<option value="4">4</option>
<option value="5">5</option>
<option value="6">6</option>
<option value="7">7</option>
<option value="8">8</option>
<option value="9">9</option>
<option value="10">10</option>
</select>
<button type="submit" name="VGO" class="btn btn-primary btn-sm">SELECT</button>
</form>POST https://qepler.com/virtual-registration-form.html
<form class="form-inline justify-content-center" method="post" action="https://qepler.com/virtual-registration-form.html">
<input type="hidden" name="eventID" value="969">
<input type="hidden" name="package" value="Online - NPO/Academic">
<input type="hidden" name="packageID" value="DP1D">
<input type="hidden" name="price" value="195">
<input type="hidden" name="priceEB" value="95">
<input type="hidden" name="discount" value="100">
<input type="hidden" name="eventURL" value="https://qepler.com/events/3rd-genotoxic-impurities-in-pharmaceuticals-summit-2023.html">
<input type="hidden" name="workemail" value="">
<select name="delegatesCount" class="form-control form-control-sm product-quantity">
<option value="1">1</option>
<option value="2">2</option>
<option value="3">3</option>
<option value="4">4</option>
<option value="5">5</option>
<option value="6">6</option>
<option value="7">7</option>
<option value="8">8</option>
<option value="9">9</option>
<option value="10">10</option>
</select>
<button type="submit" name="VGO" class="btn btn-primary btn-sm">SELECT</button>
</form>POST https://qepler.com/virtual-registration-form.html
<form class="form-inline justify-content-center" method="post" action="https://qepler.com/virtual-registration-form.html">
<input type="hidden" name="eventID" value="969">
<input type="hidden" name="package" value="Past Attendees">
<input type="hidden" name="packageID" value="DPPA">
<input type="hidden" name="price" value="195">
<input type="hidden" name="priceEB" value="95">
<input type="hidden" name="discount" value="100">
<input type="hidden" name="eventURL" value="https://qepler.com/events/3rd-genotoxic-impurities-in-pharmaceuticals-summit-2023.html">
<input type="hidden" name="workemail" value="">
<select name="delegatesCount" class="form-control form-control-sm product-quantity">
<option value="1">1</option>
<option value="2">2</option>
<option value="3">3</option>
<option value="4">4</option>
<option value="5">5</option>
<option value="6">6</option>
<option value="7">7</option>
<option value="8">8</option>
<option value="9">9</option>
<option value="10">10</option>
</select>
<button type="submit" name="VGO" class="btn btn-primary btn-sm">SELECT</button>
</form>POST https://qepler.com/sponsorship-registration-form.html
<form class="form-inline justify-content-center" method="post" action="https://qepler.com/sponsorship-registration-form.html">
<input type="hidden" name="eventID" value="969">
<input type="hidden" name="package" value="ONLINE Promo Sponsorship">
<input type="hidden" name="packageID" value="DP2D">
<input type="hidden" name="additionalprice" value="245">
<input type="hidden" name="includedparticipants" value="1">
<input type="hidden" name="price" value="895">
<input type="hidden" name="packageCount" value="1">
<input type="hidden" name="includedparticipantsprice" value="0">
<input type="hidden" name="priceEB" value="">
<input type="hidden" name="discount" value="">
<input type="hidden" name="eventURL" value="https://qepler.com/events/3rd-genotoxic-impurities-in-pharmaceuticals-summit-2023.html">
<input type="hidden" name="workemail" value="">
<select name="delegatesCount" class="form-control form-control-sm product-quantity">
<option value="1">1</option>
<option value="2">2</option>
<option value="3">3</option>
<option value="4">4</option>
<option value="5">5</option>
</select>
<button type="submit" name="SGO" class="btn btn-primary btn-sm">SELECT</button>
</form>POST https://qepler.com/sponsorship-registration-form.html
<form class="form-inline justify-content-center" method="post" action="https://qepler.com/sponsorship-registration-form.html">
<input type="hidden" name="eventID" value="969">
<input type="hidden" name="package" value="ONLINE - Presenter Sponsorship">
<input type="hidden" name="packageID" value="GP2">
<input type="hidden" name="price" value="1,595">
<input type="hidden" name="additionalprice" value="195">
<input type="hidden" name="includedparticipants" value="2">
<input type="hidden" name="packageCount" value="1">
<input type="hidden" name="includedparticipantsprice" value="0">
<input type="hidden" name="priceEB" value="">
<input type="hidden" name="discount" value="">
<input type="hidden" name="eventURL" value="https://qepler.com/events/3rd-genotoxic-impurities-in-pharmaceuticals-summit-2023.html">
<input type="hidden" name="workemail" value="">
<select name="delegatesCount" class="form-control form-control-sm product-quantity">
<option value="2">2</option>
<option value="3">3</option>
<option value="4">4</option>
<option value="5">5</option>
</select>
<button type="submit" name="SGO" class="btn btn-primary btn-sm">SELECT</button>
</form>POST https://qepler.com/sponsorship-registration-form.html
<form class="form-inline justify-content-center" method="post" action="https://qepler.com/sponsorship-registration-form.html">
<input type="hidden" name="eventID" value="969">
<input type="hidden" name="package" value="ONLINE - Partner Sponsorship">
<input type="hidden" name="packageID" value="GP4">
<input type="hidden" name="price" value="2,595">
<input type="hidden" name="additionalprice" value="145">
<input type="hidden" name="includedparticipants" value="3">
<input type="hidden" name="packageCount" value="1">
<input type="hidden" name="includedparticipantsprice" value="0">
<input type="hidden" name="priceEB" value="">
<input type="hidden" name="discount" value="">
<input type="hidden" name="eventURL" value="https://qepler.com/events/3rd-genotoxic-impurities-in-pharmaceuticals-summit-2023.html">
<input type="hidden" name="workemail" value="">
<select name="delegatesCount" class="form-control form-control-sm product-quantity">
<option value="3">3</option>
<option value="4">4</option>
<option value="5">5</option>
</select>
<button type="submit" name="SGO" class="btn btn-primary btn-sm">SELECT</button>
</form>POST
<form class="ajax_form" method="post">
<div class="row label">
<div class="form-group">
<input type="hidden" name="ip" value="2a01:4a0:1338:92::6">
<input type="hidden" name="eventName" value="3rd Annual Genotoxic Impurities in Pharmaceuticals Virtual Summit">
<input type="hidden" name="link" value="https://qepler.com/events/3rd-genotoxic-impurities-in-pharmaceuticals-summit-2023.html">
<input type="hidden" name="formDate" value="21.11.2022 - 20:25">
<input type="hidden" name="workemail" value="">
</div>
<div class="col-lg-12">
<div class="form-group">
<label>Title: </label>
<br>
<label class="custom-control custom-radio">
<input type="radio" class="custom-control-input" name="title[]" required="" value="Mr.">
<span class="custom-control-indicator"></span>
<span class="custom-control-description">Mr.</span>
</label>
<label class="custom-control custom-radio">
<input type="radio" class="custom-control-input" name="title[]" required="" value="Ms.">
<span class="custom-control-indicator"></span>
<span class="custom-control-description">Ms.</span>
</label>
<label class="custom-control custom-radio">
<input type="radio" class="custom-control-input" name="title[]" required="" value="Mrs.">
<span class="custom-control-indicator"></span>
<span class="custom-control-description">Mrs.</span>
</label>
<label class="custom-control custom-radio">
<input type="radio" class="custom-control-input" name="title[]" required="" value="Dr.">
<span class="custom-control-indicator"></span>
<span class="custom-control-description">Dr.</span>
</label>
</div>
</div>
<div class="col-lg-4">
<div class="form-group">
<label for="firstName">First Name:</label>
<input id="firstName" type="text" class="form-control" placeholder="First Name*" value="" required="" name="firstName">
</div>
</div>
<div class="col-lg-4">
<div class="form-group">
<label for="lastName">Last Name:</label>
<input id="lastName" type="text" class="form-control" placeholder="Last Name*" value="" required="" name="lastName">
</div>
</div>
<div class="col-lg-4">
<div class="form-group">
<label for="jobTitle">Job Title:</label>
<input id="jobTitle" type="text" class="form-control" placeholder="Job Title*" value="" required="" name="jobTitle">
</div>
</div>
<div class="col-lg-7">
<div class="form-group">
<label for="companyName">Company Name:</label>
<input id="companyName" type="text" class="form-control" placeholder="Company Name*" value="" required="" name="companyName">
</div>
</div>
<div class="col-lg-5">
<div class="form-group">
<label for="contactEmail">Email:</label>
<input id="contactEmail" type="text" class="form-control" placeholder="Corporate Email*" value="" required="" name="contactEmail">
</div>
</div>
<div class="col-lg-12">
<div class="form-group">
<label for="hearFrom">Where did you hear about us?</label>
<select class="form-control" required="" id="hearFrom" value="" name="hearFrom">
<option value="" disabled="" selected="" hidden="">Please Choose*</option>
<option value="Email">Email</option>
<option value="Colleague's">Colleague's recommendation</option>
<option value="Google">Google</option>
<option value="LinkedIn">LinkedIn</option>
<option value="Other">Other method</option>
</select>
</div>
</div>
<div class="col-lg-12">
<div class="form-group">
<label for="commentMessage">Comment Message</label>
<textarea id="commentMessage" class="form-control" rows="6" value="" name="commentMessage"></textarea>
</div>
<div class="form-group">
<label class="custom-control custom-checkbox">
<input id="agree" type="checkbox" class="custom-control-input" value="" required="" name="agree">
<span class="custom-control-indicator"></span>
<span class="custom-control-description">Click here to indicate that you have read and agree to the terms presented in the <a href="terms-and-conditions.html" target="_blank">Terms and Conditions</a> agreement.</span>
</label>
<label class="custom-control custom-checkbox">
<input id="agree" type="checkbox" class="custom-control-input" value="" required="" name="gdpr">
<span class="custom-control-indicator"></span>
<span class="custom-control-description">Click here to indicate that you have read and agree to the privacy policy in the <a href="privacy-policy.html" target="_blank">Privacy Policy</a> agreement.</span>
</label>
</div>
<button type="submit" class="btn btn-primary center-block">Send Query</button>
</div>
</div>
<input type="hidden" name="af_action" value="f46231b81d67a752156b4677047a4dd1">
</form>POST
<form class="ajax_form" method="post">
<div class="row label">
<div class="form-group">
<input type="hidden" name="ip" value="2a01:4a0:1338:92::6">
<input type="hidden" name="eventName" value="3rd Annual Genotoxic Impurities in Pharmaceuticals Virtual Summit">
<input type="hidden" name="link" value="https://qepler.com/events/3rd-genotoxic-impurities-in-pharmaceuticals-summit-2023.html">
<input type="hidden" name="formDate" value="21.11.2022 - 20:25">
<input type="hidden" name="workemail" value="">
</div>
<div class="col-lg-12">
<div class="form-group">
<label>Title: </label>
<br>
<label class="custom-control custom-radio">
<input type="radio" class="custom-control-input" name="title[]" required="" value="Mr.">
<span class="custom-control-indicator"></span>
<span class="custom-control-description">Mr.</span>
</label>
<label class="custom-control custom-radio">
<input type="radio" class="custom-control-input" name="title[]" required="" value="Ms.">
<span class="custom-control-indicator"></span>
<span class="custom-control-description">Ms.</span>
</label>
<label class="custom-control custom-radio">
<input type="radio" class="custom-control-input" name="title[]" required="" value="Mrs.">
<span class="custom-control-indicator"></span>
<span class="custom-control-description">Mrs.</span>
</label>
<label class="custom-control custom-radio">
<input type="radio" class="custom-control-input" name="title[]" required="" value="Dr.">
<span class="custom-control-indicator"></span>
<span class="custom-control-description">Dr.</span>
</label>
</div>
</div>
<div class="col-lg-4">
<div class="form-group">
<label for="firstName">First Name:</label>
<input id="firstName" type="text" class="form-control" placeholder="First Name*" value="" required="" name="firstName">
</div>
</div>
<div class="col-lg-4">
<div class="form-group">
<label for="lastName">Last Name:</label>
<input id="lastName" type="text" class="form-control" placeholder="Last Name*" value="" required="" name="lastName">
</div>
</div>
<div class="col-lg-4">
<div class="form-group">
<label for="jobTitle">Job Title:</label>
<input id="jobTitle" type="text" class="form-control" placeholder="Job Title*" value="" required="" name="jobTitle">
</div>
</div>
<div class="col-lg-4">
<div class="form-group">
<label for="companyName">Company Name:</label>
<input id="companyName" type="text" class="form-control" placeholder="Company Name*" value="" required="" name="companyName">
</div>
</div>
<div class="col-lg-5">
<div class="form-group">
<label for="contactEmail">Email:</label>
<input id="contactEmail" type="text" class="form-control" placeholder="Corporate Email*" value="" required="" name="contactEmail">
</div>
</div>
<div class="col-lg-3">
<div class="form-group">
<label for="contactPhone">Phone Number:</label>
<input id="contactPhone" type="text" class="form-control" placeholder="+420 000 000 000" value="" required="" name="contactPhone">
</div>
</div>
<div class="col-lg-12">
<div class="form-group">
<label for="contactAddress">Address:</label>
<input id="contactAddress" type="text" class="form-control" placeholder="* 123, Main Street" value="" required="" name="contactAddress">
</div>
</div>
<div class="col-lg-4">
<div class="form-group">
<label for="contactCountry">Country:</label>
<input id="contactCountry" type="text" class="form-control" placeholder="Country*" value="" required="" name="contactCountry">
</div>
</div>
<div class="col-lg-3">
<div class="form-group">
<label for="contactCity">City:</label>
<input id="contactCity" type="text" class="form-control" placeholder="City*" value="" required="" name="contactCity">
</div>
</div>
<div class="col-lg-2">
<div class="form-group">
<label for="contactPost">Postal Code:</label>
<input id="contactPost" type="text" class="form-control" placeholder="100 00" value="" required="" name="contactPost">
</div>
</div>
<div class="col-lg-3">
<div class="form-group">
<label for="euVat">EU VAT #</label>
<input id="euVat" type="text" class="form-control" placeholder="CZ 00000000" value="" name="euVat">
</div>
</div>
<div class="col-lg-6">
<div class="form-group">
<label for="paymentMethod">Payment Method:</label>
<select class="form-control" name="paymentMethod" required="" id="paymentMethod" value="">
<option value="" disabled="" selected="" hidden="">Select the payment method*</option>
<option value="Bank Transfer">Bank Transfer</option>
<option value="Credit Card">Credit Card</option>
<option value="PayPal">PayPal</option>
</select>
</div>
</div>
<div class="col-lg-6">
<div class="form-group">
<label for="hearFrom">Where did you hear about us?</label>
<select class="form-control" required="" id="hearFrom" value="" name="hearFrom">
<option value="" disabled="" selected="" hidden="">Please Choose*</option>
<option value="Email">Email</option>
<option value="Colleague's">Colleague's recommendation</option>
<option value="Google">Google</option>
<option value="LinkedIn">LinkedIn</option>
<option value="Other">Other method</option>
</select>
</div>
</div>
<div class="col-lg-12">
<div class="form-group">
<label for="commentMessage">Comment Message</label>
<textarea id="commentMessage" class="form-control" rows="6" value="" name="commentMessage"></textarea>
</div>
<div class="form-group">
<span class="custom-control-description label">* Presentation content and contact details are subjects to approval for distribution.</span>
</div>
<div class="form-group">
<label class="custom-control custom-checkbox">
<input id="agree" type="checkbox" class="custom-control-input" value="" required="" name="agree">
<span class="custom-control-indicator"></span>
<span class="custom-control-description">Click here to indicate that you have read and agree to the terms presented in the <a href="terms-and-conditions.html" target="_blank">Terms and Conditions</a> agreement.</span>
</label>
<label class="custom-control custom-checkbox">
<input id="agree" type="checkbox" class="custom-control-input" value="" required="" name="gdpr">
<span class="custom-control-indicator"></span>
<span class="custom-control-description">Click here to indicate that you have read and agree to the privacy policy in the <a href="privacy-policy.html" target="_blank">Privacy Policy</a> agreement.</span>
</label>
</div>
<button type="submit" class="btn btn-primary center-block">Send Query</button>
</div>
</div>
<input type="hidden" name="af_action" value="46edf245c7dc69789485490183174a95">
</form>POST
<form class="ajax_form" method="post">
<div class="row">
<div class="col-lg-12">
<h5 class="heading">Your <span class="text-primary">Details:</span></h5>
</div>
<div class="row">
<div class="form-group">
<input type="hidden" name="ip" value="2a01:4a0:1338:92::6">
<input type="hidden" name="eventName" value="3rd Annual Genotoxic Impurities in Pharmaceuticals Virtual Summit">
<input type="hidden" name="link" value="https://qepler.com/events/3rd-genotoxic-impurities-in-pharmaceuticals-summit-2023.html">
<input type="hidden" name="formDate" value="21.11.2022 - 20:25">
<input type="hidden" name="workemail" value="">
</div>
</div>
<div class="col-lg-4">
<img id="blah" src="images/avatar.png" class="img-fluid" style="max-height: 240px; max-width: 240px;" alt="">
<br><br>
</div>
<div class="col-lg-8">
<div class="row">
<div class="col-lg-12">
<div class="form-group">
<label>Title: </label>
<br>
<label class="custom-control custom-radio">
<input type="radio" class="custom-control-input" name="title[]" required="" value="Mr.">
<span class="custom-control-indicator"></span>
<span class="custom-control-description">Mr.</span>
</label>
<label class="custom-control custom-radio">
<input type="radio" class="custom-control-input" name="title[]" required="" value="Ms.">
<span class="custom-control-indicator"></span>
<span class="custom-control-description">Ms.</span>
</label>
<label class="custom-control custom-radio">
<input type="radio" class="custom-control-input" name="title[]" required="" value="Mrs.">
<span class="custom-control-indicator"></span>
<span class="custom-control-description">Mrs.</span>
</label>
<label class="custom-control custom-radio">
<input type="radio" class="custom-control-input" name="title[]" required="" value="Dr.">
<span class="custom-control-indicator"></span>
<span class="custom-control-description">Dr.</span>
</label>
</div>
</div>
<div class="col-lg-6">
<div class="form-group">
<label for="firstName">First Name:</label>
<input id="firstName" type="text" class="form-control" placeholder="First Name*" value="" required="" name="firstName">
</div>
</div>
<div class="col-lg-6">
<div class="form-group">
<label for="lastName">Last Name:</label>
<input id="lastName" type="text" class="form-control" placeholder="Last Name*" value="" required="" name="lastName">
</div>
</div>
<div class="col-lg-6">
<div class="form-group">
<label for="jobTitle">Job Title:</label>
<input id="jobTitle" type="text" class="form-control" placeholder="Job Title*" value="" required="" name="jobTitle">
</div>
</div>
<div class="col-lg-6">
<div class="form-group">
<label for="companyName">Company Name:</label>
<input id="companyName" type="text" class="form-control" placeholder="Company Name*" value="" required="" name="companyName">
</div>
</div>
<div class="col-lg-6">
<div class="form-group">
<label for="contactEmail">Email:</label>
<input id="contactEmail" type="email" pattern="[a-z0-9._%+-']+@[a-z0-9._%+-]+\.[a-z]{2,3}$" class="form-control" placeholder="Corporate Email*" value="" required="" name="contactEmail">
</div>
</div>
<div class="col-lg-6">
<div class="form-group">
<label for="contactPhone">Phone Number:</label>
<input id="contactPhone" type="tel" class="form-control" placeholder="+420 000 000 000" value="" required="" name="contactPhone">
</div>
</div>
</div>
</div>
</div>
<div class="row">
<div class="col-lg-6">
<div class="form-group">
<label for="contactCountry">Country:</label>
<input id="contactCountry" type="text" class="form-control" placeholder="Country*" value="" required="" name="contactCountry">
</div>
</div>
<div class="col-lg-6">
<div class="form-group">
<label for="contactCity">City:</label>
<input id="contactCity" type="text" class="form-control" placeholder="City*" value="" required="" name="contactCity">
</div>
</div>
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By continuing to use qepler.com you will be agreeing to the website Terms and Conditions and the Use of Cookies while using the website and our services. Please also read our Cookies Policy under which, to the extent stated, you consent to the processing of your personal data. Cookies Policy Accept * Home * Events * Past Events * Our Speakers * About Us * Contact Us 3RD ANNUAL GENOTOXIC IMPURITIES IN PHARMACEUTICALS VIRTUAL SUMMIT 2023 * Qepler.com * Upcoming Events * 3rd Annual Genotoxic Impurities in Pharmaceuticals Virtual Summit * * * * Event Location: Online Conference Platform: HOPIN Date: 09 - 10 March 2023 Language: English REGISTER NOW * Brief of Event * You Will Meet * Agenda * Participate * Sponsorship * Become a Speaker * Newsletter Form CONTACT PERSON: EVGENIA MAKAR * * * CONTACT PERSON: DENIS POLIKARPOV * * * CONFERENCE OVERVIEW For the transformation of starting material into the product is needed API synthesis, which involves multiple reaction steps, including reagents, intermediates, catalysts, solvents and others. As a result, low levels of by-products may appear in API as impurities. This impurity may have toxicity, incl. carcinogenicity and genotoxicity, what may cause mutations, potentially leading to cancer. Due to this fact and focusing on ensuring safety of public health is critical to identify, monitor, analyse and control genotoxic impurities and strive to their minimum level. This has led to the crucial need in the development and improvement of analytical methods. The Genotoxic Impurities in Pharmaceuticals Summit 2023 is focusing on overcoming challenges and barriers, sharing knowledge, strategies, best techniques and new methodologies in GTI predictions, analysis and control during the drug development process, overview and practical implementation of GTI guidelines and regulations (ICH M7 and ICH Q3D), risk assessment, exposure limits calculation and predictions' empowerment through in silico. THE FEATURED TALKS ON: * Exploring the scale of potential nitrosamine risk associated with existing approved APIs * Development of a drug product workflow for nitrosamine risk assessments? * Quantitative analysis of in vivo mutagenicity dose-response data for risk assessment and regulatory decision-making: a case study of alkylnitrosamines. * Setting Limits for Complex Nitrosamines (NDSRIs) * Incorporating Nitrosamine Risk Mitigation Activities Across a Diverse Development Portfolio * Analytical testing and control approaches for GTIs in drug substance * Case Studies of Nitrosamines in Pharmaceuticals * How Sanofi scientists streamlined their in silico hazard assessment of potential genotoxic impurities by collaborating with Discngine * Development of in silico systems for expert review under ICH M7 guideline: increasing efficiency through automated arguments. * Review of in silico predictions * Analytical Strategies for Enhancing Selectivity and Sensitivity of Genotoxic Impurities * Applications of computational methods in the assessment of extractables and leachables Back to navigation WHO YOU WILL MEET BY SENIORITY LEVEL * C-Level, Presidents, Chairs, Members of the Board & VPs * Directors, & Heads * Leaders & Managers * Fellows, Principals & Scientists * Toxicologists & Chemists * Advisors, Coordinators, Auditors & Consultants * Other Professionals, Experts & Specialists BY DIVISION * ADME * Analytical Chemistry * Analytical Development * Analytical R&D * Analytical Science * Analytical Science & Technology * Analytical Sciences * API * Biocompatibility * Chemical Toxicology * CMC * Compound Safety * Computational Toxicology * Data Sciences & Artificial Intelligence * Drug Development * Drug Safety * Drug Safety Research & Evaluation * Genetic Toxicology * Genetics & Mutagenesis * Genotoxicity * GMP * GTIs * Impurities * In Silico Toxicology * Metabolism * Mutagenicity * Pharmaceutical Sciences * Pharmacokinetics * Pharmacology * Pharmacovigilance * Process Chemistry * Process Development * QbD * Quality Assurance & Operations * Quality Control * Regulatory Affairs & Compliance * Research & Development * Risks Assessment * Small Molecules * Toxicology * Toxicology Discovery * Validation BY COMPANY TYPE * Pharmaceuticals * Biotechnology * CRO * CMO * Technologies & software providers * Equipment providers * Regulatory agencies * NOP * Other BY REGION * Central and Eastern Europe * North America * Middle East and Africa * Asia-Pacific * Other Back to navigation CONFERENCE PROGRAMME Download in PDF Format DAY ONE - THURSDAY 09, MARCH 2023 TENTATIVE SCHEDULE: CENTRAL EUROPEAN TIME (CET, PRAGUE, UTC/GMT +1 HOUR) 10:00 Registration 11:20 Opening Address 11:30 To Be Announced Dr. Andrew Teasdale, Senior Principal Scientist / Head of Impurity Management & CMC Strategy, AstraZeneca, UK 12:10 To Be Announced Dr. Tino Otte, Senior Scientific Consultant, Intertek (Schweiz) AG, Basel-Landschaft, Switzerland 12:50 Exploring the scale of potential nitrosamine risk associated with existing approved APIs Dr. Michael Burns, Principal Research Scientist, Lhasa Limited, United Kingdom 13:30 Coffee break 13:50 Development of a Drug Product workflow for Nitrosamine Risk Assessments Mike Urquhart, Scientific Director, GlaxoSmithKline, Stevenage, United Kingdom 14:30 Quantitative analysis of in vivo mutagenicity dose-response data for risk assessment and regulatory decision-making: a case study of alkylnitrosamines * Nitrosamine impurities are detectable in some pharmaceutical products. * Risk assessment of nitrosamine impurities can be carried out using genetic toxicology data. * Benchmark dose metrics can be calculated from in vivo gene mutation data which are used to calculate permitted daily exposures (PDE). * A threshold mechanism’ must be defined before the PDE can be used. * Adjustment/uncertainty factors used in the PDE may differ when using genetic toxicity data compared to when using cancer bioassay data. Dr. George Johnson, Associate Professor in the Institute of Life Science, Swansea University, United Kingdom 15:10 To Be Announced Mark Harrison, Principal Analyst, AstraZeneca, Sheffield, United Kingdom 15:50 Coffee break 16:10 Setting Limits for Complex Nitrosamines (NDSRIs) * Differences between ICH M7 and nitrosamine guidances * Setting AIs for NDSRIs using SAR/read-across * Case studies - De-risking of NDSRIs of drug classes (Ca channel blockers, β-blockers, ACE inhibitors) Raphael Nudelman, Ph.D., ERT, Senior Director Impurity Expert, Teva Pharmaceutical Industries Ltd., Israel 16:50 Incorporating Nitrosamine Risk Mitigation Activities Across a Diverse Development Portfolio Jared Fennell, Senior Scientist, Eli Lilly and Company, Indiana, United States 17:30 Panel Discussion: Olivier Dirat, Senior Director, Pfizer, UK Lance Smallshaw, Regulatory Intelligence and External Advocacy (Quality Analytical and Pharmacopoeia), UCB Biopharma sprl., BE Dr. Alexander Amberg, Head of In Silico Toxicology, Sanofi Aventis Deutschland GmbH, DE Dr. M. Vijay Reddy, Senior Principal Scientist in the department of Genetic Toxicology, Merck & Co., Inc., USA 18:10 Closing remarks and end of day one DAY TWO - FRIDAY 10, MARCH 2023 TENTATIVE SCHEDULE: CENTRAL EUROPEAN TIME (CET, PRAGUE, UTC/GMT +1 HOUR) 10:00 Opening Address 10:10 Analytical testing and control approaches for GTIs in drug substance Tom van Wijk, Principal Scientist, Analytical Science and Technology Team lead Pharmaceutical analysis, Abbott Healthcare Products B.V., Weesp, The Netherlands 10:50 To Be Announced Dr. Stephanie Simon, PhD, Head, Genetic Toxicology, Merck Healthcare KGaA, DE 11:30 To Be Announced Jason Creasey, Managing Director, Maven E&L Ltd, Stevenage, United Kingdom 12:10 Case Studies of Nitrosamines in Pharmaceuticals * NDMA in Metformin DP * Analytical challenges * Some NDSRI(s) Dr. Joerg Schlingemann, Director, Principal Expert Quality Control Systems, Merck Healthcare KGaA, DE 12:50 Nitrocellulose blister material as a source of N-nitrosamine contamination of pharmaceutical drug products Rok Grahek, Head of Department, Sandoz, Slovenia 13:30 Coffee break 13:50 Partnership Presentation AVAILABLE 14:30 How Sanofi scientists streamlined their in silico hazard assessment of potential genotoxic impurities by collaborating with Discngine Sébastien Conilleau, PhD, Customer Success and Delivery Manager, Discngine, FR 15:10 Development of in silico systems for expert review under ICH M7 guideline: increasing efficiency through automated arguments Robert Foster, Senior Scientist, Lhasa Limited, United Kingdom 15:50 Coffee break 16:10 Review of in silico predictions Alyssa Musso, Senior Scientist, Drug Safety Research and Development, Global Risk Assessment Services Toxicologist, Pfizer, USA 16:50 Analytical Strategies for Enhancing Selectivity and Sensitivity of Genotoxic Impurities C. J. Venkatramani, Senior Principle Scientist, Genentech, USA 17:30 To Be Announced Leon F. Stankowski, Senior Scientific Director, Genetic and In Vitro Toxicology, Charles River Laboratories, Chicago, USA 18:10 Applications of computational methods in the assessment of extractables and leachables * Use of in silico approaches supporting the assessment of Extractables and Leachables (E&L) * Prevalence of predicted mutagens and potent sensitizers in large representative databases of E&L * Use of in silico models to assess leachable reactivity with biomolecules * Biomolecule reactivity in silico workflow Dr. Candice Johnson, Senior Research Scientist, Instem, Ohio, United States 18:50 Closing remarks and end of summit Download in PDF Format Back to navigation REGISTRATION FORM Download FORM in PDF Format To register to the summit as a Delegate, please provide the details below. Once the form is submitted, we will send you the official confirmation and the invoice for payment. In case of doubt, contact us at info@qepler.com. *Please note, all participation packages, contains complete conference materials distribution after the event (Slides, list of participants, stream and video recording). You don't need to order an additional "Documentation Packages". ONLINE PARTICIPATION: Early bird discount until 01 January 2023 ONLINE TICKET *PER PERSON - SAVE € 100 €245/ €345 1 SELECT 2-Days Summit Early bird discount until 01 January 2023 ONLINE GROUP 2-3 *PER PERSON - SAVE € 100 €195/ €295 2 3 SELECT 2-Days Summit Early bird discount until 01 January 2023 ONLINE GROUP 4+ *PER PERSON - SAVE € 100 €155/ €255 4 5 6 7 8 9 10 SELECT 2-Days Summit Early bird discount until 01 January 2023 NPO / ACADEMIC *PER PERSON - SAVE € 100 €95/ €195 1 2 3 4 5 6 7 8 9 10 SELECT 2-Days Summit Early bird discount until 01 January 2023 PAST ATTENDEES *PER PERSON - SAVE € 100 €95/ €195 1 2 3 4 5 6 7 8 9 10 SELECT 2-Days Summit Download FORM in PDF Format Back to navigation REGISTRATION FORM Download FORM in PDF Format To register to the summit as a Delegate, Exhibitor or Sponsor, please provide the details below. Once the form is submitted, we will send you the official confirmation and the invoice for payment. In case of doubt, contact us at info@qepler.com. *Please note, all participation packages, contains complete conference materials distribution after the event (Slides, list of participants, stream and video recording). You don't need to order an additional "Documentation Packages". ONLINE SPONSORSHIP: Available until 09 March 2023 PROMO SPONSORSHIP PACKAGE €895 * 1 PASS INCLUDED * ADDITIONAL PASS: €245 * COLOR ADVERT IN AGENDA: 1/4 PAGE * LOGO AND URL PLACEMENT * LINK TO LANDING PAGE * SOCIAL MEDIA RECOGNITION * PROMO MATERIALS DISTRIBUTION 1 2 3 4 5 SELECT 2-Days Summit Available until 09 March 2023 PRESENTER SPONSORSHIP PACKAGE €1,595 * 2 PASSES INCLUDED * ADDITIONAL PASS: €195 * SESSION: 30 MINUTES * COLOR ADVERT IN AGENDA: 1/2 PAGE * LOGO AND URL PLACEMENT * LINK TO LANDING PAGE * SOCIAL MEDIA RECOGNITION * PROMO MATERIALS DISTRIBUTION 2 3 4 5 SELECT 2-Days Summit Available until 09 March 2023 PARTNER SPONSORSHIP PACKAGE €2,595 * 3 PASSES INCLUDED * ADDITIONAL PASS: €145 * KEYNOTE PRESENTATION: 20 MINUTES * SESSION: 40 MINUTES * OR WORKSHOP: 60 MINUTES * CHAIRING OF DAY 1 OR 2 * COLOR ADVERT IN AGENDA: 1 PAGE * LOGO AND URL PLACEMENT * LINK TO LANDING PAGE * LINK TO VIRTUAL EXHIBITION * SOCIAL MEDIA RECOGNITION * PROMO MATERIALS DISTRIBUTION 3 4 5 SELECT 2-Days Summit Download FORM in PDF Format Back to navigation NEWSLETTER FORM Please fill in the details below to get the latest news, discounts, early-bird rates, and upcoming annual details. 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Click here to indicate that you have read and agree to the terms presented in the Terms and Conditions agreement. Click here to indicate that you have read and agree to the privacy policy in the Privacy Policy agreement. Send Query Back to navigation SPEAKER FORM Please fill in all the details carefully and submit your application. Should you face any problems with filling the form, please contact us at info@qepler.com YOUR DETAILS: Title: Mr. Ms. Mrs. Dr. First Name: Last Name: Job Title: Company Name: Email: Phone Number: Country: City: Twitter link: LinkedIn link: Biography: SESSION INFORMATION: Session Title: Session Overview: Learning outcomes: Tags (comma-separated): Target audience: Format: Presentation format* 30 min - interview 40 min - case study 1 hour - workshop 2 hours - workshop Your role: What is your role? Speaker Moderator Chairman Click here to indicate that you have read and agree to the terms presented in the Terms and Conditions agreement. Click here to indicate that you have read and agree to the privacy policy in the Privacy Policy agreement. Send Query Back to navigation DOWNLOAD BROCHURE Please use the button below to get the latest summit brochure in PDF format. Download in PDF Format MEET OUR SPEAKERS View Profile DR. GEORGE JOHNSON Associate Professor in the Institute of Life Science Swansea University View Profile DR. TINO OTTE Senior Scientific Consultant Intertek (Schweiz) AG View Profile DR. ALEXANDER AMBERG Head of In Silico Toxicology Sanofi Aventis Deutschland GmbH View Profile ROK GRAHEK Head of Department Sandoz View Profile DR. STEPHANIE SIMON Head, Genetic Toxicology Merck Healthcare KGaA View Profile DR. MICHAEL BURNS Principal Research Scientist Lhasa Limited View Profile ALYSSA MUSSO Senior Scientist, Drug Safety Research and Development, Global Risk Assessment Services Toxicologist Pfizer View Profile SÉBASTIEN CONILLEAU Customer Success and Delivery Manager Discngine View Profile VIJAY REDDY Senior Principal Scientist in the department of Genetic Toxicology Merck & Co., Inc. View Profile DR. CANDICE JOHNSON Senior Research Scientist Instem View Profile TOM VAN WIJK Principal Scientist, Analytical Science and Technology Team lead Pharmaceutical analysis Abbott Healthcare Products B.V. View Profile RAPHAEL NUDELMAN Senior Director Impurity Expert Teva Pharmaceutical Industries Ltd. View Profile JARED FENNELL Senior Scientist Eli Lilly and Company View Profile LEON F. STANKOWSKI Senior Scientific Director, Genetic and In Vitro Toxicology Charles River Laboratories View Profile DR. ANDREW TEASDALE Senior Principal Scientist / Head of Impurity Management & CMC Strategy AstraZeneca View Profile C. J. VENKATRAMANI Senior Principle Scientist Genentech View Profile OLIVIER DIRAT Senior Director Pfizer View Profile LANCE SMALLSHAW Regulatory Intelligence and External Advocacy (Quality Analytical and Pharmacopoeia) UCB Biopharma sprl. View Profile MIKE URQUHART Scientific Director GlaxoSmithKline View Profile DR. JOERG SCHLINGEMANN Director, Principal Expert Quality Control Systems Merck Healthcare KGaA View Profile ROBERT FOSTER Senior Scientist Lhasa Limited View Profile JASON CREASEY Managing Director Maven E&L Ltd View Profile MARK HARRISON Principal Analyst AstraZeneca View Profile DR. GEORGE JOHNSON Associate Professor in the Institute of Life Science Swansea University View Profile DR. TINO OTTE Senior Scientific Consultant Intertek (Schweiz) AG View Profile DR. ALEXANDER AMBERG Head of In Silico Toxicology Sanofi Aventis Deutschland GmbH View Profile ROK GRAHEK Head of Department Sandoz View Profile DR. STEPHANIE SIMON Head, Genetic Toxicology Merck Healthcare KGaA View Profile DR. MICHAEL BURNS Principal Research Scientist Lhasa Limited View Profile ALYSSA MUSSO Senior Scientist, Drug Safety Research and Development, Global Risk Assessment Services Toxicologist Pfizer View Profile SÉBASTIEN CONILLEAU Customer Success and Delivery Manager Discngine View Profile VIJAY REDDY Senior Principal Scientist in the department of Genetic Toxicology Merck & Co., Inc. View Profile DR. CANDICE JOHNSON Senior Research Scientist Instem View Profile TOM VAN WIJK Principal Scientist, Analytical Science and Technology Team lead Pharmaceutical analysis Abbott Healthcare Products B.V. View Profile RAPHAEL NUDELMAN Senior Director Impurity Expert Teva Pharmaceutical Industries Ltd. View Profile JARED FENNELL Senior Scientist Eli Lilly and Company View Profile LEON F. STANKOWSKI Senior Scientific Director, Genetic and In Vitro Toxicology Charles River Laboratories View Profile DR. ANDREW TEASDALE Senior Principal Scientist / Head of Impurity Management & CMC Strategy AstraZeneca View Profile C. J. VENKATRAMANI Senior Principle Scientist Genentech View Profile OLIVIER DIRAT Senior Director Pfizer View Profile LANCE SMALLSHAW Regulatory Intelligence and External Advocacy (Quality Analytical and Pharmacopoeia) UCB Biopharma sprl. View Profile MIKE URQUHART Scientific Director GlaxoSmithKline View Profile DR. JOERG SCHLINGEMANN Director, Principal Expert Quality Control Systems Merck Healthcare KGaA View Profile ROBERT FOSTER Senior Scientist Lhasa Limited View Profile JASON CREASEY Managing Director Maven E&L Ltd View Profile MARK HARRISON Principal Analyst AstraZeneca prev next OUR SPONSORS INTERTEK PREVIOUS EVENT SNAPSHOT OF ATTENDEES Abbott Healthcare Products B.V. - Alkaloid AD - Angelini - Astellas Pharma Europe BV - AstraZeneca - Bayer AG - Bristol-Myers Squibb - Charles River Laboratories - Cipla Limited - Elanco Animal Health - Elpen Pharmaceutical Co.Inc. - Eurofarma labs - F. Hoffmann-La Roche Ltd - Fresenius Kabi Deutschland GmbH - GlaxoSmithKline - Intertek (Schweiz) AG - Lhasa Limited - Merck & Co., Inc. - Nelson Labs Europe - S-IN Soluzioni Informatiche Srl - SCIEX - Smithers Rapra Ltd. - Teva - Teva Pharmaceutical Industries Ltd. - ToxMinds BVBA - UCB Biopharma sprl. - Others Presentatons GENOTOXIC IMPURITIES IN PHARMACEUTICALS SUMMIT 2019 BERLIN, GERMANY GTI strategies & new methodologies: analysis, in silico & regulations. Challenges & opportunities. 11-12 APRIL 2019 RIU PLAZA BERLIN 2 DAYS 18 TOPICS LIVE DISCUSSIONS PRACTICAL CASE STUDIES 50 + PARTICIPANTS Case Studies Networking ANDREW FEILDEN SMITHERS RAPRA LTD. chaired a panel discussion, with speakers from Nelson Labs Europe, Angelini, Astellas, UCB Biopharma, Roche, AstraZeneca, Fresenius Kabi, Bristol-Myers Squibb and Teva. Read More About This Conference REGISTER NOW QUICK LINKS * Home * Upcoming Events * Past Events * Our Speakers * About Qepler * Contact Us OUR POLICIES * Terms & Conditions * Privacy Policy * Cookies Policy CONTACT US Qepler s.r.o. Vršovická 733/83, 100 00 Praha 10-Vršovice, Prague, Czech Republic IČO: 06582893 / DIČ: CZ06582893 +420 770 699 211 +420 223 558 277 info@qepler.com © All rights reserved Qepler s.r.o. 2019 * * * * * This website stores cookies on your computer. These cookies are used to collect information about how you interact with our website and allow us to remember you. We use this information in order to improve and customize your browsing experience and for analytics and metrics about our visitors both on this website and other media. To find out more about the cookies we use, see our Cookies Policy.