qepler.com
Open in
urlscan Pro
2a02:4a8:ac24:110::10:119
Public Scan
Submitted URL: https://qepler.com/events/hpapi23.html
Effective URL: https://qepler.com/events/3rd-annual-highly-potent-apis-summit-2023.html
Submission: On November 21 via api from US — Scanned from DE
Effective URL: https://qepler.com/events/3rd-annual-highly-potent-apis-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="968">
<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-annual-highly-potent-apis-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="968">
<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-annual-highly-potent-apis-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="968">
<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-annual-highly-potent-apis-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="968">
<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-annual-highly-potent-apis-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="968">
<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-annual-highly-potent-apis-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="968">
<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-annual-highly-potent-apis-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="968">
<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-annual-highly-potent-apis-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="968">
<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-annual-highly-potent-apis-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="2001:1b60:2:240:3247::10">
<input type="hidden" name="eventName" value="3rd Annual Highly Potent APIs Summit">
<input type="hidden" name="link" value="https://qepler.com/events/3rd-annual-highly-potent-apis-summit-2023.html">
<input type="hidden" name="formDate" value="21.11.2022 - 20:38">
<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="d6e29cb3baae621be8bab5a9e1f6a06b">
</form>POST
<form class="ajax_form" method="post">
<div class="row label">
<div class="form-group">
<input type="hidden" name="ip" value="2001:1b60:2:240:3247::10">
<input type="hidden" name="eventName" value="3rd Annual Highly Potent APIs Summit">
<input type="hidden" name="link" value="https://qepler.com/events/3rd-annual-highly-potent-apis-summit-2023.html">
<input type="hidden" name="formDate" value="21.11.2022 - 20:38">
<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="005de577dbf3247b7da1a4eca688c00f">
</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="2001:1b60:2:240:3247::10">
<input type="hidden" name="eventName" value="3rd Annual Highly Potent APIs Summit">
<input type="hidden" name="link" value="https://qepler.com/events/3rd-annual-highly-potent-apis-summit-2023.html">
<input type="hidden" name="formDate" value="21.11.2022 - 20:38">
<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>
<div class="col-lg-6">
<div class="form-group">
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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 HIGHLY POTENT APIS SUMMIT 2023 * Qepler.com * Upcoming Events * 3rd Annual Highly Potent APIs Summit * * * * Event Location: Online Conference Platform: HOPIN Date: 22 February 2023 - 24 February 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 The increasing incidence of cancer and the ever-rising demand for anticancer drugs results in significant growth for the highly potent active pharmaceutical ingredients (HPAPIs) market. The highly toxic properties of HPAPIs, however, present manufacturing and handling challenges. Our meeting facilitates hands-on experience sharing with focus on early process development and scale up, occupational health regulations and safety standards, cross-contamination risk assessment and control, aseptic facilities and equipment maintenance and cleaning, outsourcing and technology transfer strategies. THE FEATURED TALKS ON: * HPAPI Process Design and Project Implementation * How to handle HPAPIs within Chemical Development * Garment selection criteria for the safe handling of HPAPI * HPAPI manufacturing in early Chemical Development * Manufacturing of Oncological Products by a CDMO * How to develop a high potent Antibody Drug Conjugate ADC production suite * Ultra-Potent Pharmaceuticals: Verifying Containment * Looking Beyond Pharma 4.0: Future Initiatives and Advanced Manufacturing Approaches * Sources of cross-contamination risk in solid dosage form manufacturing * Cleaning validation – Enhanced approach required for Highly Potent APIs? * EHS Integration in Capital Projects and Tech Transfer * Integrating EHS into the RFP Process for HPAPIs * Quantitative Measurement of Risk in Cleaning using ASTM Standards * Occupational Hygiene Programs and Practice Standards of Care * The Ongoing Significant Toxicological Challenges in Developing Efficacious Antibody Drug Conjugates (ADCs) * Digital SHE: promotion of safety culture throughout the organisation * Exposure Assessment Challenges for New Modality Potent Compounds in R&D * Flexible Isolator- Occupational Hygiene Experience * Occupational Exposure Bands * Health-based exposure limits (HBELs) for biotechnological products – when needed and how are they set? * How to derive health-based exposure limits (HBEL) for ADCs * HBEL - containment and occupational hygiene monitoring * Antibody-Drug Conjugates – antibodies meeting HPAPIs for specific and efficient biopharmaceutical drugs * Ensuring product & worker safety in multi-product GMP facilities * Continuous Processing as a Tool for HPAPI Development and Manufacturing Back to navigation WHO YOU WILL MEET BY SENIORITY LEVEL * C-Level, Presidents, Chairs & Members of the Board & VPs * CEOs, CMOs, CTOs, CQOs, CDOs, & CROs * Directors, & Heads * Leaders & Managers * Toxicologists, Chemists, Hygienists Physicians, & Engineers * Coaches, Consultants, Supervisors, & Advisers * Qualified Persons * Other Professionals & Specialists BY DEPARTMENT * API, HPAPI & Impurities * Environmental, Health & Safety * Industrial Hygiene * Occupational Toxicology * Risk Assessment, Evaluation & Mitigation * Hazard Assessments * ADE, PDE, OELs, OEBs * Quality Control & Assurance * Aseptic Processing * ADC & New Molecules * CMC * Chemical Manufacturing, Processes & Synthesis * Compounds Manufacturing * Contamination * Containment * Drug Process Development * Extraction * Isolation * Formulation Development * Laboratory Services * Manufacturing * Materials Management * New Technologies * Plant & Site Management * Facility Design & Equipment Selection * Cleanrooms * Process Chemistry * Process Development & Engineering * Raw Materials * Regulatory * Research & Development * Toxicology * Validation * Corporate & Business Development * External Supply * Marketing * Outsourcing * Partnerships & Alliances * Sales Development * Strategic Development BY COMPANY ACTIVITY * Pharmaceutical * Biotechnology * Chemical * CDMOs * CMOs * CROs * API & HPAPI manufacturers & suppliers * Bioprocessing services and equipment * EHS consultancies * Engineering contractors * Equipment suppliers * Exposure and containment solution providers * Finance and investment institutions * Handling and containment services * Occupational and industrial health & safety advisors * PPE manufacturers * Raw materials suppliers * Safety services * Training providers 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 - WEDNESDAY 22, FEBRUARY 2023 TENTATIVE SCHEDULE: CENTRAL EUROPEAN TIME (CET, PRAGUE, UTC/GMT +1 HOUR) 10:00 Registration 11:20 Opening Address 11:30 HPAPI Process Design and Project Implementation * Potent drug safety in R&D and Scale-Up environments * Exposure risk in the Laboratory Setting * HPAPI Process Design (influencing potent drug safety early in the project timeline) * HPAPI Process Transfer and Scale-up Jeremy Justin Mason-Home, BSc (Hons), FRSC, Director, HPAPI Project Services Limited, Hoylake, United Kingdom 12:10 How to handle HPAPIs within Chemical Development * GMP-Compliance and Regulatory Environment * Prevention of Cross-Contamination in HPAIs Shared Facilities * Cleaning of Equipment in the Manufacturing of HPAIs Dr. Thomas Adam, Head of GQA Chemical APIs, Bayer AG, Wuppertal, Germany 12:50 Garment selection criteria for the safe handling of HPAPI Based on the manufacturing environment and the workplace risk assessments, it is important to select the right protective garments to protect the workers from getting contaminated with HPAPI without risking to contaminate the HPAPI that are handled or produced. This presentation will highlight the most important aspects to be taken into consideration when selecting the appropriate protective garments in grade A-D pharmaceutical cleanrooms. * The role of PPE in the containment strategy * Risk assessment * Understanding permeation & penetration * Which garments to use in grade A-D pharmaceutical cleanrooms? Steve Marnach, EMEA Training Specialist & Pharma Specialist, DuPont Personal Protection, LU 13:30 Coffee break 13:50 HPAPI manufacturing in early Chemical Development * Case study on small scale production * Feasibility study of new lab facility Dr. Jürgen Schnaubelt, Director Early Drug Substance Development, Boehringer Ingelheim, DE 14:30 Manufacturing of Oncological Products by a CDMO * New Product Introduction: Change Control - Risk Assessment * Case Study: ADC Manufacturing * Waste & Wastewater treatment Fabio Zenobi, EHS Director, BSP Pharmaceuticals S.p.A., IT 15:10 Partnership Presentation AVAILABLE 15:50 Coffee break 16:10 How to develop a high potent Antibody Drug Conjugate ADC production suite. * How to design the Containment from inside to the outside * Design criteria for high potent Aseptic Manufacturing * Cleaning requirements to prevent Contamination and Cross Contamination Richard Denk, Head of Sales Containment, Skan AG, Munich, Germany 16:50 Ultra-Potent Pharmaceuticals: Verifying Containment The pharmaceutical sector uniquely carries out extensive testing of their products on human subjects. This testing provides data that allows toxicologists to develop safe limits for occupational exposure. However, ultra-high potent pharmaceuticals, with exposure limits below 10 ng/m3 provide challenges by pushing the containment technology and the verification of this technology to the limits of what is achievable. Martin William Axon, CFFOH, CMIOSH, Senior Scientific Advisor, SafeBridge Europe, Ltd., Stevenage, United Kingdom 17:30 PANEL DISCUSSION: Looking Beyond Pharma 4.0: Future Initiatives and Advanced Manufacturing Approaches Douglas E. Kiehl, Senior Director Spectroscopy, Elemental Impurities, Extractables & Leachables, Eli Lilly & Company, Indiana, United States 18:30 Closing remarks and end of day one DAY TWO - THURSDAY 23, FEBRUARY 2023 TENTATIVE SCHEDULE: CENTRAL EUROPEAN TIME (CET, PRAGUE, UTC/GMT +1 HOUR) 11:40 Opening Address 11:50 Sources of cross-contamination risk in solid dosage form manufacturing * Guidelines regarding cross contamination and toxicological approach * Complexity in risk analysis of cross contamination * Case study - a tabletting plant Dr. Ildiko Ziegler, Quality Assurance Manager, Vanessa Research, Hungary 12:30 Cleaning validation – Enhanced approach required for Highly Potent APIs? * Health Authority Requirements * Case Studies * Cleaning Process Design Phase Andreas Schreiner, Director of Validation, Manufacturing Science and Technology, Novartis, Basel, Switzerland 13:10 Coffee break 13:30 EHS Integration in Capital Projects and Tech Transfer * Risk Reduction and EHS Management Elements * Proactive approach for EHS review and input during TT and Capital planning process * How to Address EHS issues early during the design phase. * EHS deliverables during the planning, design and installation of processes, equipment and facilities to support TT * Verification: FAT/SAT/PSSR Dr. Ing. Olindo Lazzaro, PE, MSc, CSP, EMBA, Head, Global EHS by Design, CSL Behring, Switzerland 14:10 Integrating EHS into the RFP Process for HPAPIs * Integrate EHS as early in the process as possible * Having the right team F2F with customers/clients * Information needs to ensure a smooth scoping process * Resolving OEB and/or OEL disagreements with customers/clients quickly * Determine who pays for containment, risk assessments, and waste costs Jay L. Brown, Associate Director of EHS, Piramal Pharma Solutions, USA 14:50 Quantitative Measurement of Risk in Cleaning using ASTM Standards * Why do we Need to Measure Risk in Cleaning? * What are the ASTM Cleaning Standards? * What are the Components of Risk in Cleaning? * What are the Toxicity, Process Capability and Detectability Scales? * What is the Shirokizawa Matrix? Andrew Walsh, President, Center for Pharmaceutical Cleaning Innovation (CPCI™), USA 15:50 Coffee break 16:10 Occupational Hygiene Programs and Practice Standards of Care * The Future Benchmark for Occupational/Industrial Hygiene Programs * What Might a Pharma Mercedes Benz Look Like? * Free OH Program Development & Management Tools * Who Are Your Critical Team Players? Nancy M. McClellan, M.P.H., CIH, CHMM, Principal Industrial Hygiene Expert & CEO, Occupational Health Management, PLLC, USA 16:50 The Ongoing Significant Toxicological Challenges in Developing Efficacious Antibody Drug Conjugates (ADCs) * History of ADCs * Monoclonal Antibody (or Antibodies Selection) * Linker Technology * Payload/Warhead/Small Molecule Selection * Approved/Marketed ADCs and Efficacy * Containment Requirements Dr. Greg Erexson, PhD, DABT, FATS, FRSB, ERT AbbVie Retiree, Greg Erexson Toxicology Consulting, LLC, USA 17:30 Digital SHE: promotion of safety culture throughout the organisation Rodrigo Tenuta, Adoption Lead Non-Mfg Sites NAM/ LATAM - Digital SHE Stream, Roche, AR 18:10 Exposure Assessment Challenges for New Modality Potent Compounds in R&D As the shift in the pharmaceutical R&D environment goes from small molecule, solid, powder handling transitions to large molecule, liquid handling, how does Industrial Hygiene and the greater EHS team adapt to new methods of risk assessment and control? This presentations addresses: * The partnership of Industrial Hygiene and Biosafety practices to mitigate employee exposure to pharmaceutical ingredients that have both biological and chemical components or require additional employee protection. * Understanding that traditional Industrial Hygiene risk assessments can be difficult when there is limited knowledge or data on the API being handed. How do we make our best educated recommendation on controls that’s not overly conservative? * Designing spaces for adaptability and flexibility. * Case studies highlighting the challenges of controlling for new modality potent compounds in an R&D setting. Andrea Guytingco, MPH, CIH, Sr. EHS Business Partner, Takeda Pharmaceutical Company Limited, USA 18:50 Closing remarks and end of day two DAY THREE - FRIDAY 24, FEBRUARY 2023 TENTATIVE SCHEDULE: CENTRAL EUROPEAN TIME (CET, PRAGUE, UTC/GMT +1 HOUR) 11:20 Opening Address 11:30 Workshop: Flexible Isolator - Occupational Hygiene Experience. * technical details and design of a flexible isolator by lugaja * results of exposure monitoring at the flexible isolator * Results of exposure monitoring of the operator * scope and challenges between monitoring of operator exposure according to EN689 and monitoring of containment performance according to SMEPAC * practical part for the audience in teams (About 6 persons per team ) to define own monitoring strategy for predefined equippment (e.g. Glovebox or bag transfer system) * presentation and discussion oft he results by the audience Silke Buechl, Deputy Managing Director, Occupational hygienist, Praevena AG, Basel, Switzerland Thomas Weingartner, Managing Director, Lugaia Deutschland GmbH, Germany 12:30 Occupational Exposure Bands Dr. Martin Kohan PhD, ERT, DABT, Managing Toxicologist, SafeBridge Europe, Ltd., United Kingdom 13:10 Health-based exposure limits (HBELs) for biotechnological products – when needed and how are they set? Dr. Claudia Sehner, Senior Toxicologist, Boehringer Ingelheim, Germany 13:50 Coffee break 14:10 How to derive health-based exposure limits (HBEL) for ADCs * History of drug conjugates * What are HBEL (OEL, PDE)? * How are HBEL derived for ADC? * Default vs calculation approaches Lisa Wiesner, Occupational Toxicologist, Lonza, Basel, Switzerland 14:50 HBEL - containment and occupational hygiene monitoring Dr. Friederike Hermann, Head of Occupational Hygiene, Lonza, CH 15:30 Antibody-Drug Conjugates – antibodies meeting HPAPIs for specific and efficient biopharmaceutical drugs * The development and manufacture of ADCs - challenges and solutions * The make-or-buy question – what to outsource and what to do in-house? * Bayer’s ADC production concept * Best practices for CDMO selection and outsourcing * Understanding the success factors, risks and mitigations Dr. Ulrich Rümenapp, Head of Launch Preparation and Coordination, Bayer AG, Berlin, Germany 16:10 Coffee break 16:30 Ensuring product & worker safety in multi-product GMP facilities * Identifying the ‘must haves’ vs the ‘nice to haves’ * Ensuring safety and acceptable risk without ‘over-engineering’ * Leveraging HBELs to achieve the required standard * Choosing between flexible/disposable and rigid containment solutions Richard Arnett, Manager, Industrial Hygiene & Toxicology, Pharmascience Inc., CA 17:10 Continuous Processing as a Tool for HPAPI Development and Manufacturing Christopher Lippelt, Manager, Pharmaceutical Project Management, Eli Lilly & Company, Indiana, United States 17:50 To Be Announced Sean Keenan, Pilot Plant Manager, CONTINUUS Pharmaceuticals, Inc., Massachusetts, United States 18:30 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. 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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 SILKE BUECHL Deputy Managing Director, Occupational hygienist Praevena AG View Profile THOMAS WEINGARTNER Managing Director Lugaia Deutschland GmbH View Profile DR. GREG EREXSON AbbVie Retiree Greg Erexson Toxicology Consulting, LLC View Profile DR. ULRICH RÜMENAPP Head of Launch Preparation and Coordination Bayer AG View Profile DR. ILDIKO ZIEGLER Quality Assurance Manager Vanessa Research View Profile FABIO ZENOBI EHS Director BSP Pharmaceuticals S.p.A. View Profile RODRIGO TENUTA Adoption Lead Non-Mfg Sites NAM/ LATAM - Digital SHE Stream Roche View Profile STEVE MARNACH EMEA Training Specialist & Pharma Specialist DuPont Personal Protection View Profile DR. FRIEDERIKE HERMANN Head of Occupational Hygiene Lonza View Profile DR. JÜRGEN SCHNAUBELT Director Early Drug Substance Development Boehringer Ingelheim View Profile RICHARD DENK Head of Sales Containment Skan AG View Profile RICHARD ARNETT Manager, Industrial Hygiene & Toxicology Pharmascience Inc. View Profile ANDREW WALSH President Center for Pharmaceutical Cleaning Innovation (CPCI™) View Profile DR. MARTIN KOHAN Managing Toxicologist SafeBridge Europe, Ltd. View Profile CHRISTOPHER LIPPELT Manager, Pharmaceutical Project Management Eli Lilly & Company View Profile SEAN KEENAN Pilot Plant Manager CONTINUUS Pharmaceuticals, Inc. View Profile JEREMY JUSTIN MASON-HOME Director HPAPI Project Services Limited View Profile MARTIN WILLIAM AXON Senior Scientific Advisor SafeBridge Europe, Ltd. View Profile DR. CLAUDIA SEHNER Senior Toxicologist Boehringer Ingelheim View Profile DOUGLAS KIEHL Senior Director Spectroscopy, Elemental Impurities, Extractables & Leachables Eli Lilly & Company View Profile DR. THOMAS ADAM Head of GQA Chemical APIs Bayer AG View Profile JAY L. BROWN Associate Director of EHS Piramal Pharma Solutions View Profile DR. OLINDO LAZZARO Head, Global EHS by Design CSL Behring View Profile ANDREAS SCHREINER Director of Validation, Manufacturing Science and Technology Novartis View Profile ANDREA GUYTINGCO Sr. EHS Business Partner Takeda Pharmaceutical Company Limited View Profile ANGELA M. WAGNER, PH.D. Director, Sterile & Specialty Products Merck & Co., Inc. View Profile NANCY M. MCCLELLAN Principal Industrial Hygiene Expert & CEO Occupational Health Management, PLLC View Profile LISA WIESNER Occupational Toxicologist Lonza View Profile SILKE BUECHL Deputy Managing Director, Occupational hygienist Praevena AG View Profile THOMAS WEINGARTNER Managing Director Lugaia Deutschland GmbH View Profile DR. GREG EREXSON AbbVie Retiree Greg Erexson Toxicology Consulting, LLC View Profile DR. ULRICH RÜMENAPP Head of Launch Preparation and Coordination Bayer AG View Profile DR. ILDIKO ZIEGLER Quality Assurance Manager Vanessa Research View Profile FABIO ZENOBI EHS Director BSP Pharmaceuticals S.p.A. View Profile RODRIGO TENUTA Adoption Lead Non-Mfg Sites NAM/ LATAM - Digital SHE Stream Roche View Profile STEVE MARNACH EMEA Training Specialist & Pharma Specialist DuPont Personal Protection View Profile DR. FRIEDERIKE HERMANN Head of Occupational Hygiene Lonza View Profile DR. JÜRGEN SCHNAUBELT Director Early Drug Substance Development Boehringer Ingelheim View Profile RICHARD DENK Head of Sales Containment Skan AG View Profile RICHARD ARNETT Manager, Industrial Hygiene & Toxicology Pharmascience Inc. View Profile ANDREW WALSH President Center for Pharmaceutical Cleaning Innovation (CPCI™) View Profile DR. MARTIN KOHAN Managing Toxicologist SafeBridge Europe, Ltd. View Profile CHRISTOPHER LIPPELT Manager, Pharmaceutical Project Management Eli Lilly & Company View Profile SEAN KEENAN Pilot Plant Manager CONTINUUS Pharmaceuticals, Inc. View Profile JEREMY JUSTIN MASON-HOME Director HPAPI Project Services Limited View Profile MARTIN WILLIAM AXON Senior Scientific Advisor SafeBridge Europe, Ltd. View Profile DR. CLAUDIA SEHNER Senior Toxicologist Boehringer Ingelheim View Profile DOUGLAS KIEHL Senior Director Spectroscopy, Elemental Impurities, Extractables & Leachables Eli Lilly & Company View Profile DR. THOMAS ADAM Head of GQA Chemical APIs Bayer AG View Profile JAY L. BROWN Associate Director of EHS Piramal Pharma Solutions View Profile DR. OLINDO LAZZARO Head, Global EHS by Design CSL Behring View Profile ANDREAS SCHREINER Director of Validation, Manufacturing Science and Technology Novartis View Profile ANDREA GUYTINGCO Sr. EHS Business Partner Takeda Pharmaceutical Company Limited View Profile ANGELA M. WAGNER, PH.D. Director, Sterile & Specialty Products Merck & Co., Inc. View Profile NANCY M. MCCLELLAN Principal Industrial Hygiene Expert & CEO Occupational Health Management, PLLC View Profile LISA WIESNER Occupational Toxicologist Lonza View Profile SILKE BUECHL Deputy Managing Director, Occupational hygienist Praevena AG View Profile THOMAS WEINGARTNER Managing Director Lugaia Deutschland GmbH View Profile DR. GREG EREXSON AbbVie Retiree Greg Erexson Toxicology Consulting, LLC View Profile DR. ULRICH RÜMENAPP Head of Launch Preparation and Coordination Bayer AG prev next PREVIOUS EVENT SNAPSHOT OF ATTENDEES 2020 AbbVie - Acino Pharma AG - Affygility Solutions, LLC - Allergan plc - AMRI ITALY SRL - Andreas Flueckiger Consulting - Angelini Pharma S.p.A. - Bayer AG - Boehringer Ingelheim Pharma GmbH & Co. KG - F. Hoffmann-La Roche AG - Ferring International Center SA - Ferring Pharmaceuticals - Fresenius Kabi Austria GmbH - FUJIFILM Diosynth - GEA Process Engineering nv - Gedeon Richter Plc. - Hebeler Process Solutions LLC - Heraeus Deutschland GmbH & Co. KG - HPAPI Project Services Limited - ILC Dover - Lonza Pharma & Biotech - Merck & Cie - Merck Group - Merck Healthcare KGaA - Merck Performance Materials KGaA - Minakem High Potent - oncomed manufacturing a.s. - Pfizer CentreOne - Pharmacare Premium - Praevena AG - Quinta-Analytica - Raybow Pharmaceutical - SafeBridge Europe, Ltd. - Seqens R&D SERVICES - Servier - Synthon - Takeda - University of Oxford - Vanessa Research Magyarország Kft. - Vetter Pharma-Fertigung GmbH & Co. KG - Zentiva k.s. - Zhejiang Juli Electric Tools Co., Ltd and others. Presentatons 2ND ANNUAL HIGHLY POTENT APIS SUMMIT 2020 PRAGUE, CZECH REPUBLIC Our meeting facilitates hands-on experience sharing with focus on early process development and scale up, occupational health regulations and safety standards and many others... 19-21 FEBRUARY 2020 NOVOTEL PRAHA WENCESLAS SQUARE HOTEL * 3 DAYS * 15 TOPICS | 3 WORKSHOPS * LIVE DISCUSSIONS * PRACTICAL CASE STUDIES * 70+ PARTICIPANTS Networking Workshops WORKSHOPS: * How to make a Valid/Convincing Business Case to justify Containment and other Process Investments * Skills of an occupational hygienist * A Hard Business-Focussed Approach to HPAPI Projects Read More About Previous 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. 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