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2024药品出海新兴市场注册策略(巴基斯坦、俄罗斯、哈萨克斯坦及巴西)全流程指导专题培训班 <span style="float: right">更新时间:2024-11-14T10:44:04</span> </p> </div> <!--detail message--> <div class="container"> <div class="detail_message container"> <div class="left"> <table class="event_infomation"> <tr> <td style="width: 308px"> <a> <img width="288" height="180" class="media-object" src="https://pic.huodongjia.com/guest/2024-11-14/1731552243.398951!hdj123" alt="2024药品出海新兴市场注册策略(巴基斯坦、俄罗斯、哈萨克斯坦及巴西)全流程指导专题培训班"> </a> <div class="wl" > <span class="collect" ><img src="https://pic.huodongjia.com/static/images/images/hdj/icon_collection_normal.png" width="24" height="24">收藏人</span> <div class="bdsharebuttonbox"> <span style="color: #999;font-size: 12px">分享到</span> <a class="bds_weixin n_wx" data-cmd="" title="分享到微信"></a> <a href="#" class="bds_sqq" data-cmd="sqq" title="分享到QQ好友"></a> <a href="#" class="bds_tsina" data-cmd="tsina" title="分享到新浪微博"></a> <a href="#" class="bds_douban" data-cmd="douban" title="分享到豆瓣网"></a> <!--<a href="#" class="bds_tieba" data-cmd="tieba" title="分享到百度贴吧"></a>--> </div> </div> </td> <td > <h1 class="event_name"> <a href="https://www.huodongjia.com/event-405311515.html">2024药品出海新兴市场注册策略(巴基斯坦、俄罗斯、哈萨克斯坦及巴西)全流程指导专题培训班 </a> <div style="width:100%;font-weight: 500;position: relative;top: 8px;"> </div> </h1> <p>会议时间:2024-12-21 09:00至 2024-12-22 18:00结束</p> <p>会议地点: <span> <a style="color: #535A6D;" href="/Online/">线上活动</a> 详细地址会前通知 </span> </p> <p>会议规模:暂无</p> <p>主办单位:<span> <a href="/sponsor-077068085048078122073051.html" target="_blank">药成材信息技术(北京)有限公司</a> </span></p> <table class="invoice"> <tr> <td style="padding-top: 10px"> 发票类型:增值税普通发票 增值税专用发票 </td> </tr> <!-- <tr> --> <!--<td style="color: #666;width: 60px;">退款说明:</td>--> <!-- <td>退款说明: --> <!-- 不支持退款 (由于本活动各项资源需提前采购,一经售出不接受退款,谢谢支持。) --> <!-- 支持退款 退款时将收取票价的10%作为手续费。 --> <!-- </td> --> <!-- </tr> --> </table> </td> </tr> </table> <!--<h3 id="meeting_0" class="event_part" style="font-size: 20px;font-weight: 600;color: #555;">会议报名</h3>--> 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17:00</td> <td class="change" > <span class="sub"></span> <!--<img class="sub" src="https://pic.huodongjia.com/static/images/sub.png" width="20" height="20">--> <span class="count"><input disabled class="number" type="text" value="1"></span> <!--<img class="add" src="https://pic.huodongjia.com/static/images/add.png" width="20" height="20" >--> <span class="add "></span> </td> <td style="position: relative;"><img class="choose_price" src="https://pic.huodongjia.com/static/images/images/hdj/icon_selected.png"></td> </tr> </tbody> <tfoot> <tr class="t_footer" > <!--标准--> <td colspan="5" style="padding: 20px 0;"> <div style="float: left;color: #FF3377;margin-top: 8px;text-align:left;"> <span class="hj"> 合计: </span><span id="all" style="font-size: 20px;position: relative;top: 2px;"></span><span class="preferential" style="font-size: 14px"></span> <br> </div> <form class="new_free_form" action="/free_signup_page/" method="post" target="_blank"> <input type="hidden" name="event_id" value="405311515"> <input type="hidden" name="event_name" value="2024药品出海新兴市场注册策略(巴基斯坦、俄罗斯、哈萨克斯坦及巴西)全流程指导专题培训班"> <input type="hidden" name="vipfree" id="vipfree"> <input type="hidden" name="price_id"> <input type="hidden" name="price_name"> </form> <button style="display: none;margin: 0" id="apply" class="apply">免费报名</button> <button style="margin-right: 0" id="bz_apply" class="apply">我要报名</button> <div class="zm"> </div> </td> </tr> </tfoot> </table> <form action="/signup/405311515/" method="post" name="signup_form"> <input type='hidden' name='csrfmiddlewaretoken' value='3FjKvgzLwjKr5Z2kbiBKHiDvp4lIOgdV' /> <input type="hidden" name="event_name" value="2024药品出海新兴市场注册策略(巴基斯坦、俄罗斯、哈萨克斯坦及巴西)全流程指导专题培训班"> <input type="hidden" name="event_id" value="405311515"> <input type="hidden" id="price" value="4000.0" name="price" /> <input type="hidden" id="property" value="会务费" name="property" /> <input type="hidden" id="Currency__sign" value="¥" name="Currency__sign" /> <input type="hidden" id="amount" value="0" name="amount" /> <input type="hidden" id="price_id" value="" name="price_id" /> <input type="hidden" id="total_fee" value="" name="total_fee" /> <input type="hidden" id="coupon" name="coupon"> <input type="hidden" name="invoice_type_cn_name" value="0,1"> </form> </div> <!--标准--> <!--免费--> <!--免费--> <!--待定--> <!--待定--> <!-- <img class="adv_img" style="display:block;margin-top:15px;" width="100%" src="" alt=""> --> <div class="event_content"> <div class="meetingBgs event_part" id="meeting_1"> <h3 class="first_title"> <img src="https://pic.huodongjia.com/static/images/icon_xiangqing.png" alt=""> 会议介绍 <p class="second_titles" style="display:inline"> <span class="second_title act_s ">会议内容</span> <span class="second_title">主办方介绍</span> </p> </h3> <hr> <div class="meeting_content"> <div class="s_tag act "> <img src="https://pic.huodongjia.com/guest/2024-11-14/1731552243.398951!hdj123" alt="2024药品出海新兴市场注册策略(巴基斯坦、俄罗斯、哈萨克斯坦及巴西)全流程指导专题培训班"> <p style="text-align: center;font-size: 12px;">2024药品出海新兴市场注册策略(巴基斯坦、俄罗斯、哈萨克斯坦及巴西)全流程指导专题培训班宣传图</p> <div class="new_content"> <div class="con_box"> <p><strong>主办单位</strong></p> <p>中国化工企业管理协会医药化工委员会</p> <p>药成材培训在线直播平台</p> <p>各有关单位:</p> <p>随着全球医药市场的持续繁荣与不断进化,<a href="/tag/36979/">药品出海</a>已成为众多制药企业竞相探索的战略高地。巴基斯坦、俄罗斯、哈萨克斯坦及巴西等地区,凭借其巨大的市场潜力与日益增长的健康需求,正吸引着全球制药企业的广泛关注与深入布局。这些地区不仅为医药产业提供了广阔的发展空间,也对药品的质量、安全性和有效性提出了更为严格且全面的要求。</p> <p>在此背景下,新兴国家及国际组织的监管框架,如某些国家的类似TGA(以澳大利亚的治疗商品管理局为例)的监管机构,以及世界卫生组织(WHO)所制定的相关法规与标准,为全球药品出口设立了更为严苛且细致的基准。这些标准不仅涵盖了药品的研发、生产、质量控制、临床试验及上市后的监测等全生命周期,还强调了药品的合规性、可追溯性及患者安全性,从而确保了全球患者能够享受到高质量、安全可靠的医药产品。</p> <p>对于致力于药品出海战略的制药企业而言,深入理解并严格遵循这些国际标准与法规,不仅是获取目标市场准入资格的必要条件,更是提升企业品牌形象、增强国际竞争力的重要基石。因此,制药企业在推进药品出海的过程中,需不断加强与国际监管机构的沟通与合作,提升自身的研发创新能力与质量管理水平,以更加优质的产品和服务,满足全球患者的多元化健康需求,共同推动全球医药产业的健康、可持续发展。</p> <p>鉴于此,我单位将于<strong>2024年<strong>12月21日-22日</strong>线上直播举办 “2024药品出海新兴市场注册策略(巴基斯坦、俄罗斯、哈萨克斯坦及巴西)全流程指导专题培训班”,</strong>以协助业内公司对相关出海政策法规进行系统性解读,快速捋清监管要求,为产品制定清晰的出海计划,并在注册申报过程中做出正确的决定。</p> <p> </p> <p><strong>会议安排</strong></p> <p>会议地点:线上直播</p> <p>会议时间:2024年12月21日- 22 日</p> <h3> </h3> <p> </p> </div> <p class="get_more">查看更多</p> </div> </div> <!--主办方介绍--> <div class="s_tag"> <span><a href="https://www.huodongjia.com/sponsor-077068085048078122073051.html" target="_blank">药成材信息技术(北京)有限公司</a></span> <p></p> </div> <!--主办方介绍--> </div> </div> <div class="meetingBgs event_part" id="meeting_2"> <h3 class="first_title"> <img src="https://pic.huodongjia.com/static/images/icon_richeng.png" alt=""> 会议日程 </p> <font>(最终日程以会议现场为准)</font> </h3> <hr> <div class="meeting_content"> <div class="new_content"> <div class="con_box"> <strong></strong><p><br/></p><p><strong><strong>会议主要交流内容</strong></strong></p><p><br/></p><p><br/><strong>课程大纲</strong></p><p>第一天<strong>09:00-12:00</strong><strong>:</strong><strong>13:30-16:30</strong></p><p><strong>T</strong><strong>opic </strong><strong>1</strong><strong> </strong><strong>俄罗斯</strong><strong>药品注册的监管要求</strong></p><p>è<strong>俄罗斯医药市场</strong><strong>:</strong></p><p>ü欧亚经济联盟</p><p>ü俄罗斯医药市场情况</p><p>è<strong>俄罗斯</strong><strong>药</strong><strong>品</strong><strong>法规</strong><strong>及注册</strong></p><p>ü俄罗斯的药品监管部门</p><p>ü主要药品注册法规</p><p>ü药品注册流程(各阶段时间,费用,互认程序,等)</p><p>ü关于注册代理</p><p>ü注册申报资料的要求(制剂,原料药)</p><p>üGMP核查要求</p><p>ü特殊审评途径</p><p>è<strong>案例分析</strong>(产品进入路径选择和申报注册的关键影响因素分析及解决的方式)</p><p><strong>T</strong><strong>opic </strong><strong>2</strong><strong> </strong><strong>巴基斯坦药品</strong><strong>注册的监管要求</strong></p><p>è<strong>巴基斯坦医药市场</strong><strong>:</strong></p><p>ü巴基斯坦人口、经济与宗教</p><p>ü主要疾病谱</p><p>ü当地医药市场发展</p><p>è<strong>巴基斯坦</strong><strong>注册</strong><strong>法规解读</strong><strong>:</strong></p><p>ü监管机构</p><p>ü药品注册法令</p><p>ü药品注册分类</p><p>ü注册资料准备要点(质量,非临床,临床及GMP认证等)</p><p>ü医药注册流程(时间,费用等)</p><p>ü医药进入巴基斯坦市场的路径</p><p>ü申报注册的关键因素分析</p><p>è<strong>案例分析</strong>(产品进入路径选择和申报注册的关键影响因素分析及解决的方式)</p><p>答疑、互动</p><p>第二天<strong>09:00-12:00</strong><strong>:</strong><strong>13:30-16:30</strong></p><p><strong>T</strong><strong>opic </strong><strong>3</strong><strong> </strong><strong>哈萨克斯坦药品的法规解读</strong></p><p>è<strong>哈萨克斯坦</strong><strong>药法规框架</strong></p><p>ü哈萨克斯坦医药市场情况</p><p>ü哈萨克斯坦的药品法规(互认程序,与国内法规的对比等)</p><p>ü哈萨克斯坦的药品注册(注册分类,注册资料,注册程序与国内对比)</p><p>ü注册检验</p><p>ü应对哈萨克斯坦GMP评估该如何准备</p><p>è<strong>案例分析</strong>(产品进入路径选择和申报注册的关键影响因素分析及解决的方式)</p><p><strong>T</strong><strong>opic 4 </strong><strong>巴西药品的法规解读</strong></p><p>è<strong>巴西</strong><strong>药</strong><strong>品</strong><strong>法规框架</strong></p><p>ü巴西医药市场情况</p><p>ü巴西医药市场情况</p><p>ü巴西的药品法规特点(与国内法规的对比等)</p><p>ü巴西药品注册</p><p>üü注册分类(路径的选择要点),</p><p>üü注册资料准备要点(与国内对比)</p><p>üü注册审评程序</p><p>üüGMP检查</p><p>üü注册的关键影响因素总结</p><p>üè案例分析(产品进入路径选择和申报注册的关键影响因素分析及解决的方式) 的药品法规特点(与国内法规的对比等)</p><p>答疑、互动</p> </div> <p class="get_more">查看更多</p> <!--主办方介绍--> <!--主办方介绍--> <!--场馆介绍--> <!--场馆介绍--> </div> </div> </div> <div class="meetingBgs event_part" id="meeting_3"> <h3 class="first_title"> <img src="https://pic.huodongjia.com/static/images/icon_jiabin.png" alt=""> 会议嘉宾 </p> <font>(最终出席嘉宾以会议现场为准)</font> </h3> <hr> <div class="meeting_content"><div class="guest_content"> <div class="con_box"> <p>✦ <strong>主讲老师介绍</strong><strong> </strong>✦</p> <p> </p> <p><strong>王老师 :二十年国内外法规注册工作经验,曾任职于国家知名跨国药企负责中国以及欧美法规注册事务,</strong>在法规注册方面,带领亚太以及中国市场法规注团队,集中于新产品全球同步开发和注册上市策略,以及中国市场已上市产品的法规注册维护工作。同时还参与并且制定亚太区各个国家和地区市场的法规注册工作,涉及地区及国家包括中国香港,中国台湾,澳大利亚,泰国,菲律宾、越南、俄罗斯等。</p> <p><strong>康老师:北京凯瑞科德药物技术有限公司 高级注册咨询经理</strong></p> <p>十余年分析及海内外注册咨询服务经历,经验涉及国内注册(原辅包、OTC、滴眼液、注射剂)、欧美注册(OTC、生物制品)以及药品进口注册;,一带一路国家注册申报(南非、坦桑尼亚、巴基斯坦、乌兹别克斯坦、土库曼斯坦、巴西等)。</p> <p>作为药品注册和药品合规跨部门小组的负责人,曾参加了美国FDA的药品关联审评和批准前检查的工作,并参加过药品全生命周期的注册和风险管理工作(包括WHO PQ项目,TGA项目),可搭建不同大洲之间的药品注册桥梁。</p> <p><strong>裴</strong><strong>老师</strong><strong>:曾就职于大型国有企业无菌制剂生产车间,具备药品生产和质量管理经验,</strong>当前任药品国际注册认证总监,曾带领团队参与和完成了东南亚(如印尼、菲律宾、泰国、马来西亚、越南等)、中亚和西亚(如约旦、哈萨克斯坦等中亚五国)、非洲(如坦桑尼亚、尼日利亚、苏丹、也门、刚果、肯尼亚、乌干达、埃塞俄比亚等)、东欧(如摩尔多瓦、乌克兰、俄罗斯)、拉美(如巴西、哥伦比亚、秘鲁、哥斯达黎加等)、国际组织(如WHO、UNICEF、IDA)等多个制剂产品的国际注册和认证工作,以及欧盟、日本、美国、韩国等多个原料产品的注册申报工作。</p> <p><strong>康老师:北京凯瑞科德药物技术有限公司 高级注册咨询经理</strong></p> <p>十余年分析及海内外注册咨询服务经历,经验涉及国内注册(原辅包、OTC、滴眼液、注射剂)、欧美注册(OTC、生物制品)以及药品进口注册;,一带一路国家注册申报(南非、坦桑尼亚、巴基斯坦、乌兹别克斯坦、土库曼斯坦、巴西等)。</p> <p>作为药品注册和药品合规跨部门小组的负责人,曾参加了美国FDA的药品关联审评和批准前检查的工作,并参加过药品全生命周期的注册和风险管理工作(包括WHO PQ项目,TGA项目),可搭建不同大洲之间的药品注册桥梁。</p> <p> </p> </div> <p class="get_more">查看更多</p> </div></div> </div> <div class="meetingBgs event_part" id="meeting_4"> <h3 class="first_title"> <img src="https://pic.huodongjia.com/static/images/icon_zhinan.png" alt=""> 参会指南 <p class="second_titles" style="display:inline"> <span class="second_title act_s ">会议门票</span> </p> </h3> <hr> <div class="meeting_content"> <div class="s_tag act "> <div class="new_content"> <div class="con_box"> <p><strong>会议费用</strong></p><p> </p><p>会务费:4000元/单位(会务费包括:培训、研讨、 电子版资料、电子版培训证书、一年视频回放等);(为了给企业节约学习成本及方便工作安排可以投屏全员观看+视频回看一年)</p> </div> <p class="get_more">查看更多</p> </div> </div> <!--主办方介绍--> <!--主办方介绍--> </div> </div> <div style="padding:0 15px 20px;background:#fff;"> <p class="m_tips"> <span style="font-size:16px;color:#FF5500;">温馨提示</span><br> <b>酒店与住宿:</b> 为防止极端情况下活动延期或取消,建议“异地客户”与活动家客服确认参会信息后,再安排出行与住宿。<br> <b>退款规则:</b> 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