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Event Details

【Am Cham China Offer Special Price for Group Ticket & Bundle Ticket.】

Please note that this training series will be conducted in Chinese.


Why shall we develop this training series ?

This series of training sessions are tailored-made by Beijing DHH Law Firm, a leading Asian law firm dedicated to serving foreign-invested enterprises and listed companies, for AmCham China members. Eight senior lawyers specializing in international trade, intellectual property rights, corporate compliance etc., in the pharmaceutical and medical device industries will deliver lectures to share practical experiences and real cases for members.



Teaching Method & Who should attend ?

All 8 professional lawyers were invited to teach this training series #1~#5 based on real cases. Both case analysis and policy analysis will be demonstrated, including Q&A, so it contains a series of very practical training sessions, specially designed for junior managers, senior managers, R&D departments, IPR, etc who is working in the field of medicine and medical devices industry, to facilitate long-term development.



Session #2 IP Protection and Management of Drugs (Generic Drugs) & Medical Device in China


April 15 | 2:00pm-4:00pm


Please click "Agenda" below to read the course outline in details.



Part 1 IP Protection and Management of Drugs (Generic Drugs) in China (Mr. Li Guocong)

Drug R&D is characterized by high cost, great difficulty, time-consuming, and high risk. However, it obvious generate great returns once the drug has been launched successfully. It is crucial that drug R&D is protected by related patent policies to obtain the market monopoly in a certain period. Otherwise, generic drugs will emerge into the market and participate in the competition. Therefore, for survival and development, pharmaceutical enterprises have always been challenging by how to protect the intellectual property right of drugs (generic drugs) in all aspects.


The trainer (lawyer) will share his practical experiences and lead the audience to go through real cases on how to protect the intellectual property right of drugs (generic drugs) in China and manage relevant critical problems. It will provide pharmaceutical enterprises with ideas for achieving all-round protection on the intellectual property right of drugs (generic drugs).


Part 2 IP Protection and Management of Medical Device in China (Ms Li Ying)

With the recent COVID-19 crisis, public health systems in different countries have been brought to the forefront. Although medical devices have their high market value and can bring huge economic benefits to enterprises, they also have relatively high costs on R&D and regulatory approval.


Through discussion on patent protection strategies and case analysis on patent infringement disputes, this training will enable the medical device enterprises to obtain comprehensive system management of intellectual property rights in terms of patent layout and internal management.


Microsoft Teams (web or app) is required to access this webinar. Registration is required and a weblink / URL will be provided for successful registrants to access the webinar through Microsoft Teams on Tuesday/April 14 afternoon. The registration will be close on Wednesday/April 15 at 11:00am.




【未来三讲 课程介绍/时间/律师 】



  • 第三讲 医药企业进出口实务及海关风险防范
  • 时间:4月22日 2:00pm-4:00pm

Part 1关于走私医疗设备、医疗产品和药品犯罪的有关问题 (叶茂标律师)

国内疫情接近尾声,企业与政府部门各项工作逐渐步入常轨。口岸监管部门也从重心快速验放疫情物资,转向服务与监管并重的新局面。跨境交易医疗器械和药品的监管与征税是管理部门重点关注对象。海关税则号列是税率及监管政策适用的基础所在,是跨境交易合规风险的重心。德和衡海关及贸易团队将结合工作经验,与大家就海关税则号列的实务及部分当前的关注点进行分享。


Part 2 医疗器械及医药类商品进出口税号实务及风险分享 (彭勇律师)

在世界范围内医疗资源是稀缺资源,对于医疗设备、医疗器械以及药品的流动是从研发、生产地区向需求区和需求人群扩散的。大型的医疗设备、医疗器械和药品的研发生产企业需要明确对出口国家和地区的法律规范,在确保合法、合规地出口产品的同时,对自己的品牌、专利技术、以及区域销售权益等进行有效保护。走私犯罪是中国进出口领域严重的经济犯罪,对出口企业、进口企业均产生巨大的负面影响,本次培训专门为中美商会医疗产品行业单位设置,培训与交流内容包括中国近年来医疗产品走私犯罪现状、医疗企业的走私犯罪表现与预防、海关归类与医疗产品(叶茂标律师)等,境外医疗企业如何合法维护中国区域销售权益等,旨在明确医疗产品的进口风险与防范,明确企业海关知识产权与区域销售权益维护。


  • 第四讲 药品、医疗器械广告发布法律风险
  • 时间:4月29日 2:00pm-4:00pm

Part 1 药品、医疗器械广告发布法律风险 (戎燕茹律师)

2019年12月,国家市场监督管理总局发布的《药品、医疗器械、保健食品、特殊医学用途配方食品广告审查管理暂行办法》,已于2020年3月1日起施行。《中华人民共和国药品管理法》第二次修正案也已于2019年12月1日起施行。还有国家药品总局发布有关药品质量等琳琅满目行业政策文件,这些您都了解了吗?近两年内,国内因未经审查、虚假广告、混淆广告用语等受到行政处罚,以及发生不正当竞争、侵害商标权案例,您了解过吗?此次系列培训会以案例拆解为主,条例解析为辅的形式,并包含问答环节,以行业广告为视角,展示药品、医疗器械行业最新合规经营要求和司法裁判方向,致力于为参与者提升应对市场法律风险能力,立足企业规范经营提供帮助。


Part 2 药品、医疗器械注册临床试验中致受试者人身损坏的法律风险(李子潇律师)

几乎所有的药品和尖端医疗器械在上市注册过程中都必须经过临床试验,临床实验中可能面临受试者产生不良反应乃至人身损坏,因此基于临床试验的特殊性,各国在受试者保护方面均进行了严格的规定。中国在受试者保护层面立法相对不够完善,很多规则是在司法过程中形成的,主要体现在临床试验中产生相关纠纷归责原则采取了推定过错原则,所以申办人和试验机构需要承受很高的举证责任风险。本次课程将会阐述中国对受试者损害的司法倾向,在受试者损害法律归责标准,举证责任承担等诸多方面给出经验性建议,助力药品及医械企业在临床试验中对受试者损害合规管理法律风险。


  • 第五讲 医疗机构合规与法律风险管理 (李子潇律师)
  • 时间:5月6日 2:00pm-4:00pm

近年来,中国始终推行"健康中国战略", 国家大力鼓励和引导社会资本发展医疗卫生事业,促进社会办医给医疗行业添加新鲜血液,对于医疗机构目前是非常好的发展时期。但是,中国对医疗机构和医疗责任的规则和国外有很大不同。在实际行政执法或司法裁判过程中,都体现了非常强烈的患者保护倾向,对医疗机构违规行为的处罚相对严格。同时医疗机构因形式上未合规所引起的行政处罚,极易成为司法裁判中医疗机构承担责任的原因。本次课程将对医疗机构从商业运营到医疗行为多方面全周期的法律风险结合律师实战经验进行分析,促进医疗机构管理层明确合规方向,准确风险管理。


Apr 15, 2020

2 PM - 4 PM (GMT+8)

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Online Training 在线培训
Microsoft Teams (web or app) is required to access this training. Registration is required and a weblink / URL will be provided for successful registrants to access the webinar through Microsoft Teams on Tuesday/April 14 afternoon.
China

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Agenda

  • Day 1 (April 15, 2020)
    2 PM - 2:50 PMIP Protection and Management of Drugs (Generic Drugs) in China
    Outline:

    Starting with the new use patent of Radixivir filed by Wuhan Virus Institute as an entry point, the IP protection and management of drugs (generic drugs) in China will be explained in the following aspects:

    I. In view of the characteristics of drug research and development itself, drug innovation needs more patent protection.


    II. How do drugs (generic drugs) achieve comprehensive IP protection in China.

    李国聪 先生

    律师 at 北京德和衡律师事务所 Beijing DHH Law Firm

    2:50 PM - 3:45 PMIntellectual Property Management and Protection Strategies of Medical Device Enterprises in China
    1.Overview and Trends on Intellectual Property Protection of Medical Device of Foreign Enterprises in China

    1. Overview of Intellectual Property Protection of Foreign Medical Device Enterprises in China

    2. Trends of Intellectual Property Protection of Foreign Medical Device Enterprises in China

    II. Intellectual Property Protection Strategy of the Field of Medical Device in China

    1.Types of patent protection in the field of medical device in China

    2. Regulations and Provisions of the Patent Law on drafting in the field of medical device in China

    3. Factors to be considered in the layout of Chinese patents in the field of medical device

    4. Case Studies: 4 cases

    III、Intellectual Property Management Strategies for Enterprises of Medical Device in China

    1. Establishment of Intellectual Property Management System

    1) Set up an independent intellectual property department in the organizational structure

    2) Establishments of sub-sectors for New employees, marketing personnel, internal designers, internal R& D personnel, and full-time intellectual property management personnel.

    2.Establishment of Risk Control System for Intellectual Property

    李颖 女士

    律师,专利代理人 & 联席合伙人 at 北京德和衡律师事务所 Beijing DHH Law Firm

    3:45 PM - 4 PMQ&A
    7 Days after the event (April 22, 2020)
    2 PM - 2:50 PMPractices and Risk Sharing of Import and Export HS Codes for Medical Devices and Pharmaceutical Products
    Outline:

    I. Market-based Procurement Excludes Special Tariffs on the United States

    II. Chinese Government's Tariff Coding Management Mechanism from a Global Perspective

    III. Taxation, Regulation, and Derivation Risks Carried in Tariff Lines

    IV. Some Rules for the Determination of HS Numbers of Medical Devices and Pharmaceutical Products

    V. Discussion on Tax Numbers of Some Current Popular Commodities

    VI. Professional Written Statements Help get Customs Approval

    彭勇 先生

    律师 & 高级合伙人 at 北京德和衡律师事务所 Beijing DHH Law Firm

    2:50 PM - 3:45 PMIssues concerning the Crime of Smuggling Medical Equipment, Medical Products and Drugs
    Outline:

    I. What is the Smuggling Crimes

    II. Prevention of Smuggling Crims in Medical Product Manufacturing Enterprises

    1. The Devastating Effects of Smuggling Crimes on Enterprises
    2. Crimes related to smuggling of Medical Equipments, Products and Drugs
    3. Multiple Incidents of Smuggling Medical Equipments, Products and Drugs

    III. Rights and Interests of Overseas Medical Equipments and Products

    叶茂标 先生

    律师 & 合伙人 at 北京德和衡律师事务所 Beijing DHH Law Firm

    3:45 PM - 4 PMQ&A
    14 Days after the event (April 29, 2020)
    2 PM - 2:50 PMAdvertising Compliance for Drugs and Medical Devices
    Outline:

    I. Market Access and Post-marketing Supervision of the Drug and Medical Device Industries

    II. Advertising Review and Compliance for the pharmaceutical and medical device industries

    III Implications for compliance operations

    戎燕茹 女士

    律师 & 联席合伙人 at 北京德和衡律师事务所 Beijing DHH Law Firm

    2:50 PM - 3:45 PMLegal Risks of Personal Injury to Subjects in Clinical Trials of Drug and Medical Device Registration
    Outline:

    I. Overview of Clinical Trials of Drugs and Medical Devices

    II、 Overview of Subject Damage of Clinical Trials

    III、 Liability for Damage to Clinical Subjects

    IV、 Legal Risk Management for Subject Damage in Clinical Trials

    李子潇 先生

    律师 at 北京德和衡律师事务所 Beijing DHH Law Firm

    3:45 PM - 4 PMQ & A
    21 Days after the event (May 6, 2020)
    2 PM - 3:45 PMMedical Institution Compliance and Legal Risk Management
    Outline:

    I. The Importance of Medical Institution Compliance and Possible Legal Consequences

    II.Compliance and Legal Risks of Commercial Operations of Medical Institutions
    2.1. Compliance and Legal Risk of Medical Advertisement
    2.2. Price Compliance and Legal Risks Relating to Medical Services
    2.3. Compliance and Legal Risks of Medical Service Marketing

    III. Medical Behavioral Compliance and Legal Risks of Medical Institutions
    3.1. Compliance and Legal Risks of Diagnosis and Treatment Scopes of Medical Institutions
    3.2. Compliance and Legal Risks of Medical Personnel in Practice
    3.3. Compliance and Legal Risks of Drugs and Medical Devices

    李子潇 先生

    律师 at 北京德和衡律师事务所 Beijing DHH Law Firm

    3:45 PM - 4 PMQ & A

Speakers

  • 李国聪 先生 (律师 at 北京德和衡律师事务所 Beijing DHH Law Firm)

    李国聪 先生

    律师 at 北京德和衡律师事务所 Beijing DHH Law Firm

    Read Bio
  • 叶茂标 先生 (律师 & 合伙人 at 北京德和衡律师事务所 Beijing DHH Law Firm)

    叶茂标 先生

    律师 & 合伙人 at 北京德和衡律师事务所 Beijing DHH Law Firm

    Read Bio
  • 彭勇 先生 (律师 & 高级合伙人 at 北京德和衡律师事务所 Beijing DHH Law Firm)

    彭勇 先生

    律师 & 高级合伙人 at 北京德和衡律师事务所 Beijing DHH Law Firm

    Read Bio
  • 李颖 女士 (律师,专利代理人 & 联席合伙人 at 北京德和衡律师事务所 Beijing DHH Law Firm)

    李颖 女士

    律师,专利代理人 & 联席合伙人 at 北京德和衡律师事务所 Beijing DHH Law Firm

    Read Bio
  • 戎燕茹 女士 (律师 & 联席合伙人 at 北京德和衡律师事务所 Beijing DHH Law Firm)

    戎燕茹 女士

    律师 & 联席合伙人 at 北京德和衡律师事务所 Beijing DHH Law Firm

    Read Bio
  • 李子潇 先生 (律师 at 北京德和衡律师事务所 Beijing DHH Law Firm)

    李子潇 先生

    律师 at 北京德和衡律师事务所 Beijing DHH Law Firm

    Read Bio
  • 李子潇 先生 (律师 & 高级合伙人 at 北京德和衡律师事务所 Beijing DHH Law Firm)

    李子潇 先生

    律师 & 高级合伙人 at 北京德和衡律师事务所 Beijing DHH Law Firm

    Read Bio

Cancellation Policy

If you cannot attend a training for which you have registered, please cancel your registration no later than two business days prior to the training. If you fail to notify AmCham China of your cancellation in a timely fashion, you will be charged for training costs. To cancel you can: 1) email training@amchamchina.org, or 2) cancel online if you registered for the training through the website. Your cooperation in this matter supports AmCham China in maintaining the quality of its trainings and is appreciated by your fellow members and the organization.

Tickets

Cardholders Ticket: Series #2 on April 15

This ticket is ONLY for attending training session #2 on April 15. Please register and pay before April 13.

Member Price RMB 300
Employee of Member Company ticket: Series #2 on April 15

This ticket is ONLY for attending training session #2 on April 15. Please register and pay before April 13.

RMB 350
Non-Member ticket: Series #2 on April 15

This ticket is ONLY for attending training session #2 on April 15. Please register and pay before April 13.

RMB 500
Bundle ticket for Cardholders (attend 3 out of 4)

Choose 3 Training sessions to attend and get your exclusive discount.
Please inform AmCham China staff your choices when filling out your registration form. *Please be noted that you must register and complete the payment by at least 5 days before your first training starts.

Member Price RMB 750
Bundle ticket for employee of member company (attend 3 out of 4)

Choose 3 Training sessions to attend and get your exclusive discount.
Please inform AmCham China staff your choices when filling out your registration form. *Please be noted that you must register and complete the payment by at least 5 days before your first training starts.

RMB 900
Bundle ticket for Non-member (attend 3 out of 4)

Choose 3 Training sessions to attend and get your exclusive discount.
Please inform AmCham China staff your choices when filling out your registration form. *Please be noted that you must register and complete the payment by at least 5 days before your first training starts.

RMB 1,300
Cardholders Ticket: Series #3 on April 22

This ticket is ONLY for attending training session #3 on April 22. Please register and pay before April 20.

Member Price RMB 300
Employee of Member Company ticket: Series #3 on April 22

This ticket is ONLY for attending training session #3 on April 22. Please register and pay before April 20.

RMB 350
Non-Member ticket: Series #3 on April 22

This ticket is ONLY for attending training session #3 on April 22. Please register and pay before April 20.

RMB 500
Bundle ticket for Cardholders (Attend ALL FOUR training sessions)

Get your exclusive discount and attend all training sessions on April 15, April 22, April 29, and May 6. Please be noted that you must register and complete the payment before April 13, to gain this special discounted price.

Member Price RMB 900
Bundle ticket for Employee of Member Company (Attend ALL FOUR training sessions)

Get your exclusive discount and attend all training sessions on April 15, April 22, April 29, and May 6. Please be noted that you must register and complete the payment before April 13 to gain this special discounted price.

RMB 1,050
Bundle ticket for Non-member (Attend ALL FOUR training sessions)

Get your exclusive discount and attend all training sessions on April 15, April 22, April 29, and May 6. Please be noted that you must register and complete the payment before April 13, to gain this special discounted price.

RMB 1,500
Cardholders Ticket: Series #4 on April 29

This ticket is ONLY for attending training session #4 on April 29. Please register and pay before April 27.

Member Price RMB 300
Non-Member ticket: Series #4 on April 29

This ticket is ONLY for attending training session #4 on April 29. Please register and pay before April 27.

RMB 500
Employee of Member Company ticket: Series #4 on April 29

This ticket is ONLY for attending training session #4 on April 29. Please register and pay before April 27.

RMB 350
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