[Openflow-dev] Drug Registration Requirements for Pharmaceuticals in Brazil

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<td style="PADDING-BOTTOM: 10px; LINE-HEIGHT: 20px; PADDING-LEFT: 10px; PADDING-RIGHT: 0px; FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #333333; FONT-SIZE: 11px; FONT-WEIGHT: bold; TEXT-DECORATION: none; PADDING-TOP: 0px" class="time" height="auto" valign="top" width="460"><span>Instructor: <a class="sub_head3" style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMm~wpXDv8S~xb~Gv8_~yLKSTsqsWf7QDEN_T7~Pv~E&amp;2=39035">Roberta Rodrigues</a></span><br />
<span>Date: Thursday, October 30, 2014</span><br />
<span>Time: 11:30 AM PDT | 02:30 PM EDT</span><br />
<span>Duration: 90 Minutes</span><br />
<span>Price: $243.00 Live Session for one participant</span><br />
<span style="LINE-HEIGHT: 30px; COLOR: #cd0e20">Super combo offer Live + Training CD at $549.00</span></td>
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<td style="PADDING-BOTTOM: 0px; PADDING-LEFT: 10px; PADDING-RIGHT: 10px; PADDING-TOP: 10px" class="content" height="auto" valign="top" width="460"><span><strong>Webinar Description:</strong></span><br />
There are a lot of requirements involved in the registration of pharmaceutical products in Brazil and even though they have been developed based on international requirements as FDA, EMA and others they are very specific.<br />
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The course will focus on the regulation involved in the development of the application of pharmaceutical products classified as generic, similar (Brand name) and new. The purpose of the course is to give you the knowledge to prepare a Brazilian dossier and understand the critical documents evaluated by Anvisa, which are the main motivations of registration queries and rejection. The webinar gives a complete overview of the regulation involved in the registration of pharmaceutical products, and how to give you the knowledge to develop a quality dossier in accordance with the Brazilian regulation. Let us understand better Brazilian scenario to be able to place pharmaceutical products in compliance with market Brazilian requirements.<br />
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<span><strong>Why Should you Attend:</strong></span><br />
Brazil is considered as one of the major and best markets in pharmaceutical products. As a country intends to license products already registered by other health authority, there is a need to understand Brazilian requirements in order to give a great support to the companies interested on the registration or on the transfer of a new technology/product already well consolidated in other countries. As Brazil has specific requirements to the products to be placed on the market, if you have knowledge about them you can win time to assure your product is in compliance with Brazilian requirements.<br />
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<span><strong>Objectives of the Presentation:</strong></span><br />
This webinar will cover the following areas:
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<li>Anvisa´s structure and responsibilities</li>
<li>General information about products under health surveillance</li>
<li>Registration of new pharmaceutical products</li>
<li>Registration of generic and similar products</li>
<li>Simplified registration (clone products)</li>
<li>Stability studies for Brazilian products</li>
<li>Labeling for pharmaceutical products (generic, similar, new)</li>
<li>Pharmaceutical equivalence and bioequivalence tests</li>
<li>Variations to be submitted at Anvisa and annual reports</li>
<li>API: DMF, registration, quality control, validation and stability studies</li>
<li>Deficient Letters</li>
<li>Anvisa´s Trends.</li>
</ul>
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<td height="35" valign="center" width="218" align="center"><a class="reg1" style="FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #ffffff; FONT-SIZE: 17px; CURSOR: pointer; FONT-WEIGHT: bold; TEXT-DECORATION: none" href="http://holkoi.custhelp.com/rd?1=AvMm~wpXDv8S~xb~Gv8_~yLKSTsqsWf7QDEN_T7~Pv~E&amp;2=39036">Register Now</a></td>
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<td style="PADDING-LEFT: 10px" class="content" height="auto" valign="top" width="242"><span><strong>Who can Benefit:</strong></span>
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<li>Professional working in regulatory affairs area or intends to be part of this area</li>
<li>Professionals involved or intends to be involved with Brazilian market of pharmaceutical products</li>
<li>Professionals involved in Regulatory affairs, quality assurance, development of new business, technical Service (compliance officer), quality control, package development, research &amp; development and other areas with high interface with regulatory affairs area and Brazilian regulation.</li>
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<td style="PADDING-LEFT: 10px" class="content" height="35" valign="center" colspan="2" align="left"><strong>Instructor Profile:</strong></td>
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<td style="PADDING-LEFT: 10px" class="content" height="auto" valign="top" width="197"><strong>Roberta Rodrigues</strong><br />
Regulatory Affairs at Sandoz (Novartis Group),</td>
<td valign="top" width="45" align="left"><a style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMm~wpXDv8S~xb~Gv8_~yLKSTsqsWf7QDEN_T7~Pv~E&amp;2=39037"><img alt="Image" border="0" height="40" src="http://www.onlinecompliancepanel.com/images/speakers/24234/rodrigues_32_40.jpg" width="32" /></a></td>
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<td style="PADDING-BOTTOM: 10px; PADDING-LEFT: 10px; PADDING-RIGHT: 10px; PADDING-TOP: 0px" class="content" height="auto" valign="top" width="242">Regulatory affairs expert with over 10 (ten) years of professional experience in Regulatory Affairs Area, being responsible for regulatory affairs training, auditing, regulatory strategy and negotiation, regulatory support to project teams and areas of the company, project leader, external relationship, team coordination and qualified person, development, review and approval of applications to be submitted to the HA in order to have granted the registration, variations and renewal of the products under Health Authority Surveillance. Responsible for assurance regulatory compliance. <a style="CURSOR: pointer; TEXT-DECORATION: underline"
href="http://holkoi.custhelp.com/rd?1=AvMm~wpXDv8S~xb~Gv8_~yLKSTsqsWf7QDEN_T7~Pv~E&amp;2=39038">More...</a></td>
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