www.biospectrumindia.com Open in urlscan Pro
202.38.172.94  Public Scan

Form analysis
1 forms found in the DOM

Name: paperForm — POST /webinar-thermofisher_biologics_regulatory_CMC

<form class="form-horizontal" action="/webinar-thermofisher_biologics_regulatory_CMC" name="paperForm" method="post">
  <div class="form-group">
    <div class="col-md-12">
      <input class="form-control" id="fname" placeholder="First Name *" name="paperForm[fname]" required="" type="text">
    </div>
  </div>
  <div class="form-group">
    <div class="col-md-12">
      <input class="form-control" id="lname" placeholder="Last Name *" name="paperForm[lname]" required="" type="text">
    </div>
  </div>
  <div class="form-group">
    <div class="col-md-12">
      <input class="form-control" id="jtitle" placeholder="Job Title *" name="paperForm[jtitle]" required="" type="text">
    </div>
  </div>
  <div class="form-group">
    <div class="col-md-12">
      <input class="form-control" id="cname" placeholder="Company Name *" name="paperForm[cname]" required="" type="text">
    </div>
  </div>
  <div class="form-group">
    <div class="col-md-12">
      <input class="form-control" id="cname" placeholder="Department" name="paperForm[department]" type="text">
    </div>
  </div>
  <div class="form-group">
    <div class="col-md-12">
      <input type="email" class="form-control" placeholder="E-mail *" name="paperForm[email]" required="">
    </div>
  </div>
  <div class="form-group">
    <div class="col-md-12">
      <select name="paperForm[country]" required="" class="form-control">
        <option value="" disabled="" selected="">Select Country*</option>
        <option value="Afghanistan">Afghanistan</option>
        <option value="Albania">Albania</option>
        <option value="Algeria">Algeria</option>
        <option value="AmericanSamoa">AmericanSamoa</option>
        <option value="Andorra">Andorra</option>
        <option value="Angola">Angola</option>
        <option value="Anguilla">Anguilla</option>
        <option value="Antarctica">Antarctica</option>
        <option value="Argentina">Argentina</option>
        <option value="Armenia">Armenia</option>
        <option value="Aruba">Aruba</option>
        <option value="Australia">Australia</option>
        <option value="Austria">Austria</option>
        <option value="Azerbaijan">Azerbaijan</option>
        <option value="Bahamas">Bahamas</option>
        <option value="Bahrain">Bahrain</option>
        <option value="Bangladesh">Bangladesh</option>
        <option value="Barbados">Barbados</option>
        <option value="Belarus">Belarus</option>
        <option value="Belgium">Belgium</option>
        <option value="Belize">Belize</option>
        <option value="Benin">Benin</option>
        <option value="Bermuda">Bermuda</option>
        <option value="Bhutan">Bhutan</option>
        <option value="Bolivia">Bolivia</option>
        <option value="BosniaandHerzegowina">BosniaandHerzegowina</option>
        <option value="Botswana">Botswana</option>
        <option value="BouvetIsland">BouvetIsland</option>
        <option value="Brazil">Brazil</option>
        <option value="BritishIndianOceanTerritory">BritishIndianOceanTerritory</option>
        <option value="BruneiDarussalam">BruneiDarussalam</option>
        <option value="Bulgaria">Bulgaria</option>
        <option value="BurkinaFaso">BurkinaFaso</option>
        <option value="Burundi">Burundi</option>
        <option value="Cambodia">Cambodia</option>
        <option value="Cameroon">Cameroon</option>
        <option value="Canada">Canada</option>
        <option value="CapeVerde">CapeVerde</option>
        <option value="CaymanIslands">CaymanIslands</option>
        <option value="CentralAfricanRepublic">CentralAfricanRepublic</option>
        <option value="Chad">Chad</option>
        <option value="Chile">Chile</option>
        <option value="China">China</option>
        <option value="ChristmasIsland">ChristmasIsland</option>
        <option value="Cocos(Keeling)Islands">Cocos(Keeling)Islands</option>
        <option value="Colombia">Colombia</option>
        <option value="Comoros">Comoros</option>
        <option value="Congo">Congo</option>
        <option value="Congo,theDemocraticRepublicofthe">Congo,theDemocraticRepublicofthe</option>
        <option value="CookIslands">CookIslands</option>
        <option value="CostaRica">CostaRica</option>
        <option value="Coted'Ivoire">Coted'Ivoire</option>
        <option value="Croatia(Hrvatska)">Croatia(Hrvatska)</option>
        <option value="Cuba">Cuba</option>
        <option value="Cyprus">Cyprus</option>
        <option value="CzechRepublic">CzechRepublic</option>
        <option value="Denmark">Denmark</option>
        <option value="Djibouti">Djibouti</option>
        <option value="Dominica">Dominica</option>
        <option value="DominicanRepublic">DominicanRepublic</option>
        <option value="Ecuador">Ecuador</option>
        <option value="Egypt">Egypt</option>
        <option value="ElSalvador">ElSalvador</option>
        <option value="EquatorialGuinea">EquatorialGuinea</option>
        <option value="Eritrea">Eritrea</option>
        <option value="Estonia">Estonia</option>
        <option value="Ethiopia">Ethiopia</option>
        <option value="FalklandIslands(Malvinas)">FalklandIslands(Malvinas)</option>
        <option value="FaroeIslands">FaroeIslands</option>
        <option value="Fiji">Fiji</option>
        <option value="Finland">Finland</option>
        <option value="France">France</option>
        <option value="FrenchGuiana">FrenchGuiana</option>
        <option value="FrenchPolynesia">FrenchPolynesia</option>
        <option value="FrenchSouthernTerritories">FrenchSouthernTerritories</option>
        <option value="Gabon">Gabon</option>
        <option value="Gambia">Gambia</option>
        <option value="Georgia">Georgia</option>
        <option value="Germany">Germany</option>
        <option value="Ghana">Ghana</option>
        <option value="Gibraltar">Gibraltar</option>
        <option value="Greece">Greece</option>
        <option value="Greenland">Greenland</option>
        <option value="Grenada">Grenada</option>
        <option value="Guadeloupe">Guadeloupe</option>
        <option value="Guam">Guam</option>
        <option value="Guatemala">Guatemala</option>
        <option value="Guinea">Guinea</option>
        <option value="Guinea-Bissau">Guinea-Bissau</option>
        <option value="Guyana">Guyana</option>
        <option value="Haiti">Haiti</option>
        <option value="HeardandMcDonaldIslands">HeardandMcDonaldIslands</option>
        <option value="HolySee(VaticanCityState)">HolySee(VaticanCityState)</option>
        <option value="Honduras">Honduras</option>
        <option value="HongKong">HongKong</option>
        <option value="Hungary">Hungary</option>
        <option value="Iceland">Iceland</option>
        <option value="India">India</option>
        <option value="Indonesia">Indonesia</option>
        <option value="Iran(IslamicRepublicof)">Iran(IslamicRepublicof)</option>
        <option value="Iraq">Iraq</option>
        <option value="Ireland">Ireland</option>
        <option value="Israel">Israel</option>
        <option value="Italy">Italy</option>
        <option value="Jamaica">Jamaica</option>
        <option value="Japan">Japan</option>
        <option value="Jordan">Jordan</option>
        <option value="Kazakhstan">Kazakhstan</option>
        <option value="Kenya">Kenya</option>
        <option value="Kiribati">Kiribati</option>
        <option value="Korea,DemocraticPeople'sRepublicof">Korea,DemocraticPeople'sRepublicof</option>
        <option value="Korea,Republicof">Korea,Republicof</option>
        <option value="Kuwait">Kuwait</option>
        <option value="Kyrgyzstan">Kyrgyzstan</option>
        <option value="LaoPeople'sDemocraticRepublic">LaoPeople'sDemocraticRepublic</option>
        <option value="Latvia">Latvia</option>
        <option value="Lebanon">Lebanon</option>
        <option value="Lesotho">Lesotho</option>
        <option value="Liberia">Liberia</option>
        <option value="LibyanArabJamahiriya">LibyanArabJamahiriya</option>
        <option value="Liechtenstein">Liechtenstein</option>
        <option value="Lithuania">Lithuania</option>
        <option value="Luxembourg">Luxembourg</option>
        <option value="Macau">Macau</option>
        <option value="Macedonia,TheFormerYugoslavRepublicof">Macedonia,TheFormerYugoslavRepublicof</option>
        <option value="Madagascar">Madagascar</option>
        <option value="Malawi">Malawi</option>
        <option value="Malaysia">Malaysia</option>
        <option value="Maldives">Maldives</option>
        <option value="Mali">Mali</option>
        <option value="Malta">Malta</option>
        <option value="MarshallIslands">MarshallIslands</option>
        <option value="Martinique">Martinique</option>
        <option value="Mauritania">Mauritania</option>
        <option value="Mauritius">Mauritius</option>
        <option value="Mayotte">Mayotte</option>
        <option value="Mexico">Mexico</option>
        <option value="Micronesia,FederatedStatesof">Micronesia,FederatedStatesof</option>
        <option value="Moldova,Republicof">Moldova,Republicof</option>
        <option value="Monaco">Monaco</option>
        <option value="Mongolia">Mongolia</option>
        <option value="Montserrat">Montserrat</option>
        <option value="Morocco">Morocco</option>
        <option value="Mozambique">Mozambique</option>
        <option value="Myanmar">Myanmar</option>
        <option value="Namibia">Namibia</option>
        <option value="Nauru">Nauru</option>
        <option value="Nepal">Nepal</option>
        <option value="Netherlands">Netherlands</option>
        <option value="NetherlandsAntilles">NetherlandsAntilles</option>
        <option value="NewCaledonia">NewCaledonia</option>
        <option value="NewZealand">NewZealand</option>
        <option value="Nicaragua">Nicaragua</option>
        <option value="Niger">Niger</option>
        <option value="Nigeria">Nigeria</option>
        <option value="Niue">Niue</option>
        <option value="NorfolkIsland">NorfolkIsland</option>
        <option value="NorthernMarianaIslands">NorthernMarianaIslands</option>
        <option value="Norway">Norway</option>
        <option value="Oman">Oman</option>
        <option value="Pakistan">Pakistan</option>
        <option value="Palau">Palau</option>
        <option value="Panama">Panama</option>
        <option value="PapuaNewGuinea">PapuaNewGuinea</option>
        <option value="Paraguay">Paraguay</option>
        <option value="Peru">Peru</option>
        <option value="Philippines">Philippines</option>
        <option value="Pitcairn">Pitcairn</option>
        <option value="Poland">Poland</option>
        <option value="Portugal">Portugal</option>
        <option value="PuertoRico">PuertoRico</option>
        <option value="Qatar">Qatar</option>
        <option value="Reunion">Reunion</option>
        <option value="Romania">Romania</option>
        <option value="RussianFederation">RussianFederation</option>
        <option value="Rwanda">Rwanda</option>
        <option value="SaintKittsandNevis">SaintKittsandNevis</option>
        <option value="SaintLUCIA">SaintLUCIA</option>
        <option value="SaintVincentandtheGrenadines">SaintVincentandtheGrenadines</option>
        <option value="Samoa">Samoa</option>
        <option value="SanMarino">SanMarino</option>
        <option value="SaoTomeandPrincipe">SaoTomeandPrincipe</option>
        <option value="SaudiArabia">SaudiArabia</option>
        <option value="Senegal">Senegal</option>
        <option value="Seychelles">Seychelles</option>
        <option value="SierraLeone">SierraLeone</option>
        <option value="Singapore">Singapore</option>
        <option value="Slovakia(SlovakRepublic)">Slovakia(SlovakRepublic)</option>
        <option value="Slovenia">Slovenia</option>
        <option value="SolomonIslands">SolomonIslands</option>
        <option value="Somalia">Somalia</option>
        <option value="SouthAfrica">SouthAfrica</option>
        <option value="SouthGeorgiaandtheSouthSandwichIslands">SouthGeorgiaandtheSouthSandwichIslands</option>
        <option value="Spain">Spain</option>
        <option value="SriLanka">SriLanka</option>
        <option value="St.Helena">St.Helena</option>
        <option value="St.PierreandMiquelon">St.PierreandMiquelon</option>
        <option value="Sudan">Sudan</option>
        <option value="Suriname">Suriname</option>
        <option value="SvalbardandJanMayenIslands">SvalbardandJanMayenIslands</option>
        <option value="Swaziland">Swaziland</option>
        <option value="Sweden">Sweden</option>
        <option value="Switzerland">Switzerland</option>
        <option value="SyrianArabRepublic">SyrianArabRepublic</option>
        <option value="Taiwan,ProvinceofChina">Taiwan,ProvinceofChina</option>
        <option value="Tajikistan">Tajikistan</option>
        <option value="Tanzania,UnitedRepublicof">Tanzania,UnitedRepublicof</option>
        <option value="Thailand">Thailand</option>
        <option value="Togo">Togo</option>
        <option value="Tokelau">Tokelau</option>
        <option value="Tonga">Tonga</option>
        <option value="TrinidadandTobago">TrinidadandTobago</option>
        <option value="Tunisia">Tunisia</option>
        <option value="Turkey">Turkey</option>
        <option value="Turkmenistan">Turkmenistan</option>
        <option value="TurksandCaicosIslands">TurksandCaicosIslands</option>
        <option value="Tuvalu">Tuvalu</option>
        <option value="Uganda">Uganda</option>
        <option value="Ukraine">Ukraine</option>
        <option value="UnitedArabEmirates">UnitedArabEmirates</option>
        <option value="UnitedKingdom">UnitedKingdom</option>
        <option value="UnitedStates">UnitedStates</option>
        <option value="UnitedStatesMinorOutlyingIslands">UnitedStatesMinorOutlyingIslands</option>
        <option value="Uruguay">Uruguay</option>
        <option value="Uzbekistan">Uzbekistan</option>
        <option value="Vanuatu">Vanuatu</option>
        <option value="Venezuela">Venezuela</option>
        <option value="VietNam">VietNam</option>
        <option value="VirginIslands(British)">VirginIslands(British)</option>
        <option value="VirginIslands(U.S.)">VirginIslands(U.S.)</option>
        <option value="WallisandFutunaIslands">WallisandFutunaIslands</option>
        <option value="WesternSahara">WesternSahara</option>
        <option value="Yemen">Yemen</option>
        <option value="Zambia">Zambia</option>
        <option value="Zimbabwe">Zimbabwe</option>
      </select>
    </div>
  </div>
  <div class="form-group">
    <div class="col-md-12">
      <input type="text" class="form-control" name="paperForm[state]" placeholder="State">
    </div>
  </div>
  <div class="form-group">
    <div class="col-md-12">
      <input type="number" class="form-control" name="paperForm[phone]" required="" placeholder="Phone No. *">
    </div>
  </div>
  <div class="form-group">
    <div class="col-md-12">
      <div><input type="checkbox" name="paperForm[other4]" value="Checked" class="other3-chk" required=""> By submitting this form, you agree with our
        <a href="https://www.thermofisher.com/in/en/home/global/terms-and-conditions.html" target="_blank">Terms and Conditions.</a> We will process your details in accordance with our
        <a href="https://www.thermofisher.com/in/en/home/global/privacy-policy.html" target="_blank">Privacy Policy.</a></div>
    </div>
  </div>
  <div class="form-group">
    <div class="col-md-12">
      <div>
        <div><input type="checkbox" name="paperForm[other5]" value="Checked" class="other3-chk"> I would like to be contacted by a Sales representative.</div>
      </div>
    </div>
  </div>
  <div class="form-group">
    <div class="col-md-12">
      <div>
        <div><input type="checkbox" name="paperForm[other6]" value="Checked" class="other3-chk"> I want to receive marketing newsletter, updates, and other information from Thermo Fisher Scientific, Pharma Services.</div>
      </div>
    </div>
  </div>
  <div class="form-group">
    <div class="col-md-12 text-center">
      <button type="submit" class="btn-n btn btn-md">Submit</button>
    </div>
  </div>
  <div class="form-group">
    <div class="col-md-12">
      <div class="lable_a">**Under no circumstances we will share or sell your email and contact information with any govt or private entity.</div>
    </div>
  </div>
</form>

Text Content

WATCH ON DEMAND. AVAILABLE NOW!


TITLE

Building a robust FIH biologics regulatory CMC package


SYNOPSIS

When you enter the clinical trial stage of your molecule’s development, you must
prepare a dossier to support conducting the clinical research. A critical
component of this dossier is the package of documentation that supports the
chemistry, manufacturing, and controls (CMC) of your molecule. A robust CMC
package provides health authorities with the information to assess the quality
of material entering clinical trials. Inadequate CMC supportive evidence or
insufficient detail can delay the go-ahead to enter the clinic. At the same
time, unnecessary granularity can impact the lifecycle management of the
dossier.

Watch this on-demand webinar to learn how to develop a robust first-in-human
(FIH) regulatory CMC package for recombinant biological molecules by integrating
the following activities into your project plan.

The webinar will start after the introduction of Patheon pharma services’
integrated CDMO services offerings.


LEARNING POINTS

 * Progressively developing knowledge of the molecule’s critical quality
   attributes to justify the manufacturing and control strategy
 * Planning for continuing development
 * Identifying opportunities to enhance with scientific advice

WATCH NOW

Select Country* Afghanistan Albania Algeria AmericanSamoa Andorra Angola
Anguilla Antarctica Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas
Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia
BosniaandHerzegowina Botswana BouvetIsland Brazil BritishIndianOceanTerritory
BruneiDarussalam Bulgaria BurkinaFaso Burundi Cambodia Cameroon Canada CapeVerde
CaymanIslands CentralAfricanRepublic Chad Chile China ChristmasIsland
Cocos(Keeling)Islands Colombia Comoros Congo Congo,theDemocraticRepublicofthe
CookIslands CostaRica Coted'Ivoire Croatia(Hrvatska) Cuba Cyprus CzechRepublic
Denmark Djibouti Dominica DominicanRepublic Ecuador Egypt ElSalvador
EquatorialGuinea Eritrea Estonia Ethiopia FalklandIslands(Malvinas) FaroeIslands
Fiji Finland France FrenchGuiana FrenchPolynesia FrenchSouthernTerritories Gabon
Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam
Guatemala Guinea Guinea-Bissau Guyana Haiti HeardandMcDonaldIslands
HolySee(VaticanCityState) Honduras HongKong Hungary Iceland India Indonesia
Iran(IslamicRepublicof) Iraq Ireland Israel Italy Jamaica Japan Jordan
Kazakhstan Kenya Kiribati Korea,DemocraticPeople'sRepublicof Korea,Republicof
Kuwait Kyrgyzstan LaoPeople'sDemocraticRepublic Latvia Lebanon Lesotho Liberia
LibyanArabJamahiriya Liechtenstein Lithuania Luxembourg Macau
Macedonia,TheFormerYugoslavRepublicof Madagascar Malawi Malaysia Maldives Mali
Malta MarshallIslands Martinique Mauritania Mauritius Mayotte Mexico
Micronesia,FederatedStatesof Moldova,Republicof Monaco Mongolia Montserrat
Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands NetherlandsAntilles
NewCaledonia NewZealand Nicaragua Niger Nigeria Niue NorfolkIsland
NorthernMarianaIslands Norway Oman Pakistan Palau Panama PapuaNewGuinea Paraguay
Peru Philippines Pitcairn Poland Portugal PuertoRico Qatar Reunion Romania
RussianFederation Rwanda SaintKittsandNevis SaintLUCIA
SaintVincentandtheGrenadines Samoa SanMarino SaoTomeandPrincipe SaudiArabia
Senegal Seychelles SierraLeone Singapore Slovakia(SlovakRepublic) Slovenia
SolomonIslands Somalia SouthAfrica SouthGeorgiaandtheSouthSandwichIslands Spain
SriLanka St.Helena St.PierreandMiquelon Sudan Suriname
SvalbardandJanMayenIslands Swaziland Sweden Switzerland SyrianArabRepublic
Taiwan,ProvinceofChina Tajikistan Tanzania,UnitedRepublicof Thailand Togo
Tokelau Tonga TrinidadandTobago Tunisia Turkey Turkmenistan
TurksandCaicosIslands Tuvalu Uganda Ukraine UnitedArabEmirates UnitedKingdom
UnitedStates UnitedStatesMinorOutlyingIslands Uruguay Uzbekistan Vanuatu
Venezuela VietNam VirginIslands(British) VirginIslands(U.S.)
WallisandFutunaIslands WesternSahara Yemen Zambia Zimbabwe


By submitting this form, you agree with our Terms and Conditions. We will
process your details in accordance with our Privacy Policy.
I would like to be contacted by a Sales representative.
I want to receive marketing newsletter, updates, and other information from
Thermo Fisher Scientific, Pharma Services.
Submit
**Under no circumstances we will share or sell your email and contact
information with any govt or private entity.


-- SPEAKERS --






DANIELA DECINA

SENIOR DIRECTOR, NA REGULATORY AFFAIRS,
THERMO FISHER SCIENTIFIC






MICHELE DUGGAN

SENIOR MANAGER, REGULATORY AFFAIRS,
THERMO FISHER SCIENTIFIC

© 2022 MM Activ Sci-Tech Communications. All rights reserved | Disclaimer

Web Interface Conceived and Powered By : SCI Knowledge Interlinks