醫藥品法規變革-從法規及法律面的見解及分享

• 活動名稱：

  醫藥品法規變革-從法規及法律面的見解及分享

• 日　　期：

  2022/2/16 (三) 15:00~16:30

• 會議地點：

  Webinar

• 主辦單位：

  ERM、理律法律事務所

• 聯 絡 人：

  Clare Chang - clare.chang@erm.com
  Michelle Lee – michelle.lee@erm.com

• 報名網站：

  https://erm.zoom.us/webinar/register/9516430951701/WN_1iA0I2EnQuq50S4PiWxB4g

As the regulations for pharmaceutical product update frequently, the actual practice of regulatory activities in the industry requires strong adaptability and flexibility in order to meet business objectives and government requirements. How can we see a regulatory revolution from a different perspective? 由於台灣醫藥產品法規更新頻繁，業者在實際執行上應於法規遵循及商業需求之間取得平衡。為此，在 2 月 16 日下午3時至4時30分，我們舉辦了一場線上研討會，邀請您來一起探討我們應如何從不同的角度看待台灣醫藥產品法規變化的影響。   Join us for a webinar on 16 February as we unfold he implications of regulatory changes in Taiwan.   請點擊以下連結報名: The presentation will be given by Katherine Juang, an associate partner from Lee and Li, Attorneys-at-Law and Clare Chang, a senior consultant from ERM. Both speakers are experts in the medical regulatory sector and have firsthand experience in handling related cases. 研討會將由理律法律事務所的初級合夥人莊郁沁律師和永灃環境管理顧問股份有限公司的資深經理張人尹小姐演講。兩位主講人為醫療法規領域的專家，都具有處理相關案件的第一手經驗。   Topics covered in the webinar: 研討會主題： Time Agenda 3:00pm - 3:10pm Opening: Company introduction by ERM and Lee & Li 公司介紹 3:10pm - 3:40pm Topic 1: The Legal and Regulatory Framework for the Protection of Medicinal Products 醫藥產品的法規保護機制 3:40pm - 4:10pm Topic 2: The Concepts of Pharmaceutical Regulations and Case Studies 台灣醫藥產品法規實務 4:10pm - 4:30pm Panel Discussion and Q&A 問題與討論   Take Charge of your pharmaceutical regulatory journey. Are you ready to shift or risk being shifted out?    Reserve your virtual seat now!   Know your speakers
			When   Wednesday, 16 February 2022   3:00 PM- 4:30 PM Taiwan Time 8:00 AM- 9:30 AM Central European Time (CET)   All timings mentioned above are based on their respective time zones. Where Taiwan | Zoom   Format: 01:10 minutes: Opening & Presentation 00:20 minutes: Q&A followed by Wrap-up   RSVP By: Tuesday, 15 February 2022   For any queries, please contact: Clare Chang - clare.chang@erm.com Michelle Lee – michelle.lee@erm.com
	呂文賢 博士  Dr. James Leu   永灃環境管理顧問股份有限公司ERM 資深合夥人 Senior Partner   呂文賢博士為ERM資深合夥人及中東亞產品監管負責人，擁有超過25年的環境安全衛生諮詢經驗，呂博士學歷為英國里茲大學環境工程碩士與英國倫敦大學國王學院環境科學博士。呂文賢博士指導和管理了許多次第一和第二階段環境現場評估、環境健康和安全(EHS)、管理體系和企業審計計劃、EHS盡職調查、環境和社會盡職調查、產品監管和化學品註冊、現場調查和整治、廢物管理、環境許可、EHS監測和當地和跨國公司的法規遵從性評估。呂文賢博士的客戶包括Ørsted、Northland Power、CIP、Macquarie Capital、WPD、Vena Energy、Formosa Solar、巴斯夫、塞拉尼斯、蘋果、谷歌、美光、台積電、友達、帝斯曼、贏創、強生、戴爾、通用電氣、Capmark、Vishay 、福特汽車、殼牌、BP、美林、德意志銀行、新生銀行、台塑集團、康寧、中國石油公司、台灣環保署、輝瑞、台灣新幹線軌道合資公司和三菱重工。此外,呂文賢博士在台灣、中國、泰國、越南和菲律賓指導、管理和實施了1,000多件EHS和產品監管相關的諮詢計畫項目。     Dr. James Leu is a Senior Partner of ERM Taiwan and regional Leader for Central East Asia Product Stewardship with more than 25 years of EHS consulting experience. Dr. Leu has directed and managed numerous Phase I and II environmental site assessment, environmental health and safety (EHS) management system and corporate audit programs, EHS due diligence, environmental & social due diligence, product stewardship & chemical registration, site investigation and remediation, waste management, environmental permitting, EHS monitoring and regulatory compliance assessments for both local and multi-national corporations. His clients include Ørsted, Northland Power, CIP, Macquarie Capital, WPD, Vena Energy, Formosa Solar, BASF, Celanese, Apple, Google, Micron, TSMC, AUO, DSM, Evonik, Johnson & Johnson, Dell, GE, Capmark, Vishay, Ford Motors, Shell, BP, Merrill Lynch, Deutsche Bank, Shinsei Bank, Formosa Plastics Group, Corning, China Petroleum Company, Taiwan EPA, Pfizer, Taiwan Shinkansen Trackwork JV, and Mitsubishi Heavy Industries. He has directed, managed and conducted over 1,000 EHS and product stewardship related consulting projects in Taiwan, China, Thailand, Vietnam and the Philippines.
	牛豫燕 律師Jill Niu    理律法律事務所 Lee and Li, Attorneys-at-Law 合夥人 Partner   牛豫燕律師長期協助國內外藥廠及醫院客戶處理與醫療及藥品等領域之相關問題，包括藥品採購、藥價調查、臨床試驗、藥品行銷推廣及經銷、藥品查驗登記，並協助本地製藥協會處理藥品行銷規範之制訂、執行與相關爭議之調查與處理，亦處理藥害救濟以及醫療糾紛等。代表國際性原廠藥藥廠處理專利侵權以及違反公平交易法等案件。亦協助國際性藥廠客戶處理因資產收購及分割之員工移轉相關事宜，及處理勞資爭議相關事件。   Jill is one of the partners heading Lee & Li's Healthcare and Life Science Practice Group. She has been an attorney in Taiwan for more than 20 years and she has been working at Lee & Li for more than 15 years. Since she joined Lee & Li in 2001, she has been advising for many of the firm's healthcare/life science industry clients on various types of matters including product registration and regulatory compliance, clinical trials, activities of sales, marketing and promotion of healthcare products, interactions with HCPs/patient groups and privacy/data protection issues. Jill also has extensive experience in assisting local chain medical centers in establishing SOPs for risk management and in negotiations and mediations on malpractice claims and other claims in connection with medical services and counselling local association with respect to the code of marketing practices and the procedure of mediation on disputes over the compliance thereof.
	莊郁沁 律師 Katherine Juang    理律法律事務所 Lee and Li, Attorneys-at-Law 初級合夥人 Associate Partner   莊郁沁律師係任職於理律法律事務所投資部之初級合夥人，並為公司醫療藥事分工小組之核心成員。針對提供醫藥產業全面法律服務，莊郁沁律師具有豐富之經驗。她經常就藥廠與醫療專業人員之互動、個人資料保護、行銷活動及一般行銷規範提供風險控管及法規遵循等法律諮詢服務，及針對健保藥價協商及爭議提供法律策略並進行爭訟。此外，其曾代理許多國際性藥廠處理專利訴訟、不正競爭、智慧財產共同開發及授權之協商、專利期間延長等事。此外，莊郁沁律師亦長期耕耘產品責任業務，包括於產品生命週期中會涉及之上市前法規遵循評估、上市後合規追蹤、產品回收及消費者爭議等，均長期向大型國際性廠商及事務所提供法律諮詢服務。   Katherine is an associate partner at Lee & Li's Corporate and Investment Department and is a core member of the Healthcare & Life Sciences practice group. Katherine has substantial experience in providing comprehensive legal services to clients from the health and life science sector. She has been providing legal consultation on risk management and compliance regarding transactions and interaction with health care providers, regulatory matters, data protection, promotional activities, general code of conduct, and has assisted clients in negotiation and remedy in reimbursement price disputes. She has also represented many multinational pharmaceutical companies in patent litigation, unfair competition claims, IP collaboration and licensing negotiations, and patent term extension disputes. In addition, Katherine also advises on product liability issues, including the pre-marketing and post-marketing legal compliance, product recalls and other product regulatory issues in Taiwan.
	張人尹 經理Clare Chang 永灃環境管理顧問股份有限公司ERM 資深經理 Senior Consultant   張人尹小姐擁有超過11年醫藥品法規經驗, 主要專長為藥品法規, 包括新藥(NDA)/學名藥(ANDA)˴ 工廠登記(PMF)書面審查/ 實地查廠˴ 各種法規相關變更與許可證展延案˳ 對於醫療器材˴食品˴化妝品產品也曾經手過產品登記並且熟悉法規, 對於電器商品法規也曾成功主導過法規專案的執行˳她曾經也任職衛福部食品藥物管理署(TFDA)˴ 代理商˴ 快速消費品外商˴ 及醫藥品外商, 並在TFDA時曾經為指示藥品法規制定小組一員˳於醫藥品外商的經驗中, 她成功登記公司第一個生物相似性藥品˳ 對於處理過的藥品查驗登記案件經驗, 她曾經經手審核上千個產品, 原料藥GMP˴ 藥品許可證及原料藥核備函的維持約有同時處理上百件的經驗˳   Clare is a Senior consultant based in ERM Taiwan with over 11 years in medical products regulation experience prior to join ERM. Major in pharmaceutical regulation including NDA/ANDA registration, PMF registration/ site audit, any kind of variation, and license maintenance. Also familiar with medical device, food, cosmetic, and electronic product regulations. She has successfully handled regulatory cross-function project and registered many medical products. Clare is a strong support and a solution maker for business department or clients to solve business/ supply/ import/ hospital listing/ regulation problems. For the reviewing and licenses handling experience, she has reviewed over thousands of whole technical dossiers for pharmaceutical products. Furthermore, she has successfully handled and maintained hundreds API GMP certificates, product licenses, and Drug master files (DMFs).
About ERM At ERM, sustainability is our business. As the largest global pure play sustainability consultancy, we partner with the world’s leading organizations, creating innovative solutions to sustainability challenges and unlocking commercial opportunities that meet the needs of today while preserving opportunity for future generations. Our diverse team of world-class experts supports clients across the breadth of their organizations to operationalize sustainability, underpinned by our deep technical expertise in addressing their environmental, health, safety, risk and social issues. We call this capability our “boots to boardroom” approach for its comprehensive service model that allows ERM to develop strategic and technical solutions that advance objectives on the ground or at the executive level.   有關ERM   永灃環境管理顧問股份有限公司為Environmental Resources Management（ERM）Group之台灣分支機構，ERM係一個全球性的環境工程顧問公司，在全球有超過5,500名的專業人員，分佈在美洲、歐洲、亞太地區等40餘國160多個分支機構。ERM集團的基本信念在提供全球各地的客戶卓越的專業技術、可信賴的諮詢服務以及高水準的工作品質。ERM在亞洲地區已有三十餘年的歷史，為亞洲地區最著名的環境工程顧問公司之一，目前在亞太地區的12個國家設有23個分公司，超過900餘名專業人員分佈在台灣、香港、中國大陸的北京、上海、馬來西亞、泰國、印度以及澳洲的雪梨、布里斯本等重要國家及都市，各分支機構間合作密切，資源流通順暢，不論在專業經驗與人力資源方面，皆形成陣容堅強的專業支援網路。ERM台灣分公司於1999年成立，在台灣地區我們執行完成了許多項各種專業設計、規劃及評估，我們的客戶層涵蓋國內外政府單位、外商公司以及台灣本地企業。   主要服務:   l   大型資本專案計畫管理 l   環安衛管理與法令遵循 l   企業營運管理優化 l   企業永續經營及氣候變遷策略諮詢 l   資產組合管理及整治(包含土壤 / 地下水整治政策、措施、指導方針規劃) l   產品監管(包含許可證之申請與相關技術性工作) l   數位化服務 l   企業合併收購諮詢管理 l   安全管理服務     About Lee and Li Our professionalism and achievements have long been recognized and relied on by our clients in Taiwan and abroad, many of whom have been with us for decades. The bond between our clients and us can be mostly ascribed to our strong work ethic and an abiding sense of responsibility. Because of our seamless teamwork, functional specialization and  various quality-control mechanisms (for example, the legal opinion review mechanism), we are highly sought after by clients and consistently recognized as the preeminent law firm in Taiwan. Recognition has come from abroad as well. We are often named as one of the best law firms in evaluations of international law firms/intellectual property right firms. For instance, we were selected as the best pro bono law firm in Asia and the best law firm in Taiwan many years consecutively by the International Financial Law Review (the IFLR); we were also named the National Deal Firm of the Year for Taiwan and awarded the Super Deal of the Year by Asian Legal Business. For many years, the renowned Global Competition Review has included Lee and Li on its list of the top 100 competition law firms in the world; we have the distinction of being the only law firm in Taiwan on this list. Meanwhile, our intellectual property right practice has been chosen by Managing Intellectual Property and Asia Law & Practice as the best intellectual property right law firm in Taiwan. Our performance is not only recognized by our clients but also by international professional institutes. 長期以來，理律的專業資源及優異表現受到國內外客戶信賴與肯認，有不少客戶與理律建立數十年之合作情誼。 理律與客戶間之所以能夠建立及維持長期良好合作關係，除了客戶肯定理律的經營理念外，理律同仁所提供服務品質及效益，亦是重要原因。為了維持服務品質的領先地位，理律充分落實專業分工以及團隊合作之特點，並建立品質管控機制（例如: 法律意見審查機制）。 理律專業服務品質受到國內外客戶高度肯定，在國際優良法律/智慧財產權事務所甄選活動中，經常獲選為最佳法律服務機構。例如：獲國際財經法律雜誌（International Financial Law Review，IFLR）選為亞洲最佳公益事務所（The Best Pro Bono Law Firm in Asia）及連續多年選為台灣最佳法律事務所（The Best Law Firm in Taiwan）、獲Asian Legal Business選為台灣最佳法律事務所（National Deal Firm of the Year for Taiwan）及年度傑出商業交易獎（Super Deal of the Year）。國際知名之競爭法刊物Global Competition Review亦連續多年將理律列入全球競爭法領域之前一百大事務所，理律為台灣唯一上榜之事務所。在智慧財產權業務方面，理律亦連續多年獲Managing Intellectual Property、Asia Law & Practice等選為台灣最佳智慧財產權業務事務所。上開殊榮突顯理律在法律專業領域之優異品質及領先地位，除了廣獲國內外客戶肯認外，更獲得國際專業機構推崇與推薦。

• 會議議程：

  • 時間

  • 講題

    與會人員

    備註

  • 15:00-15:10

  • Opening: Company introduction by ERM and Lee & Li 公司介紹

  • 15:10-15:40

  • Topic 1: The Legal and Regulatory Framework for the Protection of Medicinal Products
    醫藥產品的法規保護機制

  • 15:40-16:10

  • Topic 2: The Concepts of Pharmaceutical Regulations and Case Studies
    台灣醫藥產品法規實務

  • 16:10-16:30

  • Panel Discussion and Q&A 問題與討論