www.onlinecomplianceexperts.com Open in urlscan Pro
199.119.121.22  Public Scan

Form analysis
4 forms found in the DOM

Name: addform — GET https://www.onlinecomplianceexperts.com/control/addWebItems;jsessionid=FE3C278717AB4C081FCACCEAAA8EA318.jvm1

<form name="addform" action="https://www.onlinecomplianceexperts.com/control/addWebItems;jsessionid=FE3C278717AB4C081FCACCEAAA8EA318.jvm1" onsubmit="return addItems(this)" method="get">
  <div class="Price-Details-inner">
    <div class="Price-Details-hedding">Price Details</div>
    <!-- ========= Live Webinar ================== -->
    <div class="Price-Panel-inner-div">
      <div class="webinar-type-title">Live Webinar</div>
      <input class="inp-cbx" type="checkbox" id="live_ID" name="add_product_id" value="502227LIVE" onchange="doalert(this)" onclick="updateProductLive(this.value)" checked="" style="display: none;">
      <label class="cbx" for="live_ID"><span><svg width="12px" height="10px" viewBox="0 0 12 10">
            <polyline points="1.5 6 4.5 9 10.5 1"></polyline>
          </svg></span><span></span></label>
      <div class="price">
        <strong style="color:#ff0000">$<span id="livePrice">149</span> </strong>
        <span id="attendee">One Attendee</span>
      </div>
    </div>
    <!-- ========= Multi Live Webinar ================== -->
    <div class="Price-Panel-inner-div">
      <input class="inp-cbx" onclick="updateProductLive(this.value)" type="checkbox" id="multi_Live" name="add_product_id" value="502227MULT_LIVE" style="display: none;">
      <label class="cbx" for="multi_Live"><span><svg width="12px" height="10px" viewBox="0 0 12 10">
            <polyline points="1.5 6 4.5 9 10.5 1"></polyline>
          </svg></span><span></span></label>
      <div class="price">
        <strong style="color:#ff0000">$299 </strong> Corporate Live
      </div>
    </div>
    <script>
      $(function() {
        $('.tooltip-show').tooltip('hide');
      });
      $(function() {
        $('.tooltip-show').on('show.bs.tooltip', function() {})
      });
    </script>
    <style>
      .Duration-none {
        display: none;
      }
    </style>
    <!-- ========= Recorded Webinar ================== -->
    <div class="Price-Panel-inner-div">
      <div class="webinar-type-title">Recorded Webinar</div>
      <input class="inp-cbx" onclick="updateProductLive(this.value)" id="REC_1" type="checkbox" name="add_product_id" value="502227REC" onchange="doalert3(this)" style="display: none;">
      <label class="cbx" for="REC_1"><span><svg width="12px" height="10px" viewBox="0 0 12 10">
            <polyline points="1.5 6 4.5 9 10.5 1"></polyline>
          </svg></span><span></span></label>
      <div class="price">
        <strong style="color:#ff0000">$199</strong> One Attendee
      </div>
    </div>
    <!-- ========= Recorded Webinar 2 ================== -->
    <div class="Price-Panel-inner-div">
      <input class="inp-cbx" onclick="updateProductLive(this.value)" id="REC_2" type="checkbox" name="add_product_id" value="502227REC_2" style="display: none;">
      <label class="cbx" for="REC_2"><span><svg width="12px" height="10px" viewBox="0 0 12 10">
            <polyline points="1.5 6 4.5 9 10.5 1"></polyline>
          </svg></span><span></span></label>
      <div class="price">
        <strong style="color:#ff0000">$399</strong> Corporate Recorded
      </div>
    </div>
  </div>
  <!-- ========= Combo Live Recorded ================== -->
  <div class="Combo-Offers-min">
    <div class="Combo-Offers">Combo Offers</div>
    <span class="combo-price-text1">Live + Recorded</span>
    <input class="inp-cbx" onclick="updateProductLive(this.value)" type="checkbox" id="COMBO_1" name="add_product_id" value="502227COMBO_1" onchange="doalert2(this)" style="display: none;">
    <label class="cbx" for="COMBO_1"><span><svg width="12px" height="10px" viewBox="0 0 12 10">
          <polyline points="1.5 6 4.5 9 10.5 1"></polyline>
        </svg></span><span></span></label>
    <div class="Combo-inner Combo-inner2">
      <strong style="color: #ff0000">$299 </strong>
      <strike>$348</strike>
      <span class="combo-price-text">Live + Recorded</span>
    </div>
    <!-- ========= Combo Corp Live Recorded ================== -->
    <span class="combo-price-text1">Corporate (Live + Recorded)</span>
    <input class="inp-cbx" onclick="updateProductLive(this.value)" type="checkbox" id="COMBO_2" name="add_product_id" value="502227COMBO_2" style="display: none;">
    <label class="cbx" for="COMBO_2"><span><svg width="12px" height="10px" viewBox="0 0 12 10">
          <polyline points="1.5 6 4.5 9 10.5 1"></polyline>
        </svg></span><span></span></label>
    <div class="Combo-inner Combo-inner2">
      <strong style="color:#ff0000">$599</strong>
      <strike>$698</strike>
      <span class="combo-price-text">Corporate <br>(Live + Recorded)</span>
    </div>
  </div>
  <div class="btn-submit-div">
    <input type="submit" class="btn-submit" value="Buy Now">
  </div>
  <div class="refundpolicy">
    <a href="/control/w_refundpolicy" target="_blank"> <img src="/images/refundpolicy_icon.jpg" border="0"><b>Refund Policy</b></a>
  </div>
</form>

<form><input type="hidden" id="titleName123" name="titleName123" value="titleName123"></form>

<form>
  <input type="hidden" name="add_product_id" id="add_product_id" value="502227LIVE">
  <input type="hidden" name="add_product_desc" id="add_product_desc" value="Japan - Regulatory Filing Requirements and Compliance Processes for L ...">
  <input type="hidden" name="add_product_instructor" id="add_product_instructor" value="Robert J. Russell&nbsp;">
  <input type="hidden" name="add_product_date" id="add_product_date" value="Wednesday, September 4, 2024 10:00 AM PDT | 01:00 PM EDT">
  <input type="hidden" name="add_product_duration" id="add_product_duration" value="90 Minutes">
  <input type="hidden" name="add_product_amount" id="add_product_amount" value="$149.00">
</form>

Name: searchfooter — /subscribeForm

<form name="searchfooter" action="/subscribeForm">
  <input type="text" placeholder="Email Address" name="email">
  <button>Subscribe</button>
</form>

Text Content

 * Live Webinars
 * Rec Webinars

OnlineComplianceExperts
Knowledge. Creativity. Performance

Cart 0 Sign In Sign Up


JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE PROCESSES FOR LIFE
SCIENCES

Instructor:
Robert J. Russell 
Wednesday, September 4, 2024
10:00 AM PDT | 01:00 PM EDT
90 Minutes
Webinar ID: 502227

More Trainings by this Expert

Price Details
Live Webinar
$149 One Attendee
$299 Corporate Live
Recorded Webinar
$199 One Attendee
$399 Corporate Recorded
Combo Offers
Live + Recorded
$299 $348 Live + Recorded
Corporate (Live + Recorded)
$599 $698 Corporate
(Live + Recorded)

Refund Policy


Live: One Dial-in One Attendee

Corporate Live: Any number of participants

Recorded: Access recorded version, only for one participant unlimited viewing
for 6 months ( Access information will be emailed 24 hours after the completion
of live webinar)

Corporate Recorded: Access recorded version, Any number of participants
unlimited viewing for 6 months ( Access information will be emailed 24 hours
after the completion of live webinar)


Overview:


This course specifically focuses on the overall regulatory compliance
requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and
Combination Products in Japan.

The course will cover topics relating to pre-clinical and clinical requirements,
as well as, addressing the structure of the regulatory agencies in Japan.
Content will also include descriptions of the methods by which regulators in the
corresponding agencies process filings and registrations and what is expected in
the authorization and dossier maintenance of licensed products.

The current regulatory climate will be discussed in depth and several examples
will be provided to illustrate effective compliance procedures and techniques.
Common issues which have caused difficulties for Life Sciences firms will also
be discussed. Course content will also explain how Japan interacts with and
utilizes ICH standards and how they relate with other national regulatory
agencies. The course will also discuss how personnel can best address the
conflicts that sometimes arise and the approach that can best be taken for
resolution.

This course will also be useful for sales or general management personnel who
need an overview of the Regulatory Compliance requirements within Japan and how
best to consider the country into one's Business Strategy.

Learning Objectives: This course is designed to provide an overview of the
regulatory environment in Japan and will provide training in:

 * What is the Regulatory Structure in Japan
 * Understanding the specific procedures for Pharmaceuticals, Medical Devices,
   Biologics and Combination Products
 * How to begin your company involvement in Japan
 * How current regulations effect product development strategies
 * Pricing issues
 * Understanding the concerns/issues of Japanese Regulatory Personnel
 * Understanding the Local Culture: How to negotiate with the regulators
 * Information necessary for effective submissions
 * Maintenance of Authorized Products


Areas Covered in the Session:
 * Japan's Regulatory Structure for the Life Science Product Industries
   * Demographic
   * Regulatory Framework: Key Agencies Involved / Reporting Structure
   * MHLW (Ministry of Health, Labour and Welfare)
   * PMDA (Pharmaceutical and Medical Device Agency)
   * PAFSC (Pharmaceutical Affairs and Food Sanitation Council)
 * Beginning Your Company Involvement in Japan
   * Local Office and Personnel Requirements
   * License Types
   * Overseas Manufacturers
 * Life Science Regulations and the Regulatory Processes in Japan
   * Pre-Clinical
   * Conducting Clinical Trials
   * New Product Registrations & Filings
   * Adverse Drug Reactions
   * Post-Marketing Requirements
   * Maintenance of Licensed Products
   * Reimbursement, Audits
   * Risk Management
 * Japan's Use of ICH Standards/Principles
 * Marketing Authorization Processes - Filings & Registrations
   * Drugs, Medical Devices, Biologics
   * Similar Products & Devices
   * Labelling Requirements
   * PIL
 * Variations: Changes to Marketed Products
 * Renewals
   * Cultural Issues
   * How and When to Influence the Regulatory Process
 * The Do's and Don'ts of Regulatory Involvement


Who Will Benefit:
 * Regulatory Personnel whose responsibilities require knowledge of Japan's
   regulatory environment
 * Administrative staff responsible for ensuring compliance with regulatory
   filings and overall regulatory compliance requirements will also find this
   training highly relevant
 * Any sales or general management employee requiring an understanding of how
   regulations and compliance issues impact the organization will also benefit




Speaker Profile

Robert J. Russell is a Global Regulatory and CMC expert with 28 years of prior
industry experience in international regulatory management and compliance,
global business development and global supply chain management. Mr. Russell
formerly held senior leadership positions, in these functional areas, at Dow
Pharmaceuticals and Cordis-Dow Medical Devices.

His experience and knowledge span Healthcare Authority's requirements and
regulatory processes across Life Science products. For the past 18 years, Bob
has been President & CEO of RJR Consulting, Inc. The company assists the
pharmaceutical, medical device and biotech industries in understanding
Regulations affecting compliance and in conducting product registrations with
their clients in more than 95 countries. He holds a BS / MS in Chemistry."

View More Trainings by this Speaker





YOU RECENTLY VIEWED

Japan - Regulatory Filing Requirements and Compliance Processes for L ...

by : Robert J. Russell 

Date : Wednesday, September 4, 2024 10:00 AM PDT | 01:00 PM EDT

Duration : 90 Minutes

Price : $149.00

View Details






SUBSCRIBE TO OUR NEWSLETTER

Subscribe for Compliance Alerts Research Reports Absolutely Free

Subscribe
OnlineComplianceExperts

39658 Mission Boulevard, Fremont, CA 94539, USA. +1-800-447-9407
Fax: 302 288 6884
support@onlinecomplianceexperts.com


LINKS

About Us Contact Us Privacy Policy Refund Policy Terms & Conditions FAQ Support
Featured Speakers Speaker Opportunity Suggest a Topic Unsubscribe


SAFE & SECURE






Copyright © 2024 onlinecomplianceexperts. All rights reserved.