【你没生出来的孩子，也有佛性】
Your Unborn Child Has Buddha Nature Too

幾天前上的影片尾端裡，略略提到為水子靈超度的重要性。有觀眾留言，想要瞭解更多超度的詳情。

無論是流產還是墮胎的水子靈，父母應該：
一、安水子靈牌位
（給孩子地方住聽法學佛）
二、每個月供養孩子
（送吃的用的）
三、每個月報名超度
（為孩子消業增福，加速往生淨土/投胎更好家庭的機會）
四、懺悔己過
（孩子最需要的是父母的悔過）

很多家庭的問題都是這些孩子在搞的「鬼」。

如果你是水子靈的兄弟姐妹，或有血緣關係的親屬，也可以為水子靈報名。畢竟是一家人，沒理由不伸出援手。

今天再分享之前的影片，大家可以去了解如何化解與水子靈的恩怨，報名法會/安水子靈的詳情在以下貼文中。

願 世間的怨氣都能逐漸化解，人心能夠向善 🙏

———————————————

I uploaded a video few days ago and at the end of the video, I briefly spoke about the importance of bardo deliverance for fetal spirits.

Some viewers left comments inquiring about that. Thus I am sharing a video I made on this topic some time ago.

Whether the baby was lost through a miscarriage or an abortion, parents should:
1) register for a tablet at a temple
- gives the fetal spirit a home to stay, hear the Dharma and practice Buddhism

2) make monthly offerings to the fetal spirit
- i.e. buy things for the child to use and eat

3) register for monthly bardo deliverance
- helps the fetal spirit to increase his/her good fortune and eradicate the negative karma, while also expediting the chance of being reborn in the Pureland/ a better family.

4) repent for your misdeed
- children wish most to see that the parents do regret their mistakes

These little ghosts are the cause of many family problems.

If you are the sibling or blood-related relative of the fetal spirit, you can also help the child in the above. You are family after all. There is no reason not to lend a helping hand.

You can learn more on how to resolve the debt of enmity with the fetal spirits in this video below. Registration details are in the caption.

May such grievances be resolved amicably.

May kindness be abound in human hearts.

An Indonesian migrant worker who received a stem cell transplant in Taiwan in June thanked the nation on Thursday for expediting her treatment by lifting travel restrictions for her family amid COVID-19 thereby facilitating the operation that saved her life.

<已截止> 2020/8/13 (Thu.)
Regulatory Affairs: Introduction of FDA organization, FDA meetings and eCTD as well as Expedited Drug Approval Process

**此次課程報名已截止,也請勿再填寫表單及匯款！謝謝！*****
如欲參加下次課程，可先至預約報名系統登記：
http://www.biotech-edu.com/custom_cg9078.html
後續如有開課，將會優先通知報名，謝謝！

「醫療迫切需求新藥加速上市、FDA有效溝通及SPA臨床試驗計畫評估指引」

為滿足現階段醫療需求，FDA近年來積極促進治療嚴重或危及生命情況的藥物開發，同時也加快對藥物的審查。近三年來，新藥核准持續創下新高，這些新藥(novel drugs)往往是解決未滿足醫療需求或能顯著推進患者治療的創新產品。

根據美國FDA發布的2019新藥年度報告中，FDA使用了多種監管通道加強新藥開發和核准的速度。在2019年獲准的新藥當中， 60%的新藥至少獲得了FDA加速核准資格、突破性療法認定、快速通道資格、優先審查資格等四大資格認定中的一種。

此次光鹽生技學苑特別邀請到擁有二十餘年國際藥物開發實務經驗的龔曉嘉博士為我們剖析， 此課程分為兩個部分第一部分FDA組織、eCTD及如何與FDA開會及溝通。第二個部分針對FDA所公佈特別試驗計畫審查 (SPA)指引，SPA主要是藥廠向FDA諮商特定臨床試驗規模和設計，以決定是否足以支持藥證申請。

主辦單位：台灣光鹽生物科技學苑
課程地點：光鹽會議中心 (台北市復興北路369號7樓 -保富通商大樓)
課程日期：109年8月13日 (四) 14:00至17:00 (13:30開始報到)
授課師資：
龔曉嘉 博士 / 翼答生技顧問有限公司 董事長

【授課大綱】
The course will consist of two separate sessions. The first part of the course will cover the FDA organization and various of FDA meetings and eCTD format. The second part of the course will introduce the expedited drug approval process as well as SPA (Special Protocol Assessment)

Part Ⅰ:
1. FDA organization:
CEDR: Center for Drug Evaluation & Research
CEBR: Center for Biologics Evaluation & Research
Office of New Drugs
2. FDA Meetings
Pre-IND, End of Phase 1 (EOP1); End of Phase 2 (EOP2); Pre-NDA/pre-BLA
3. How do you request a meeting? And how to prepare the submission package ahead of the meetings
4. Meeting granted-What to expect afterwards
5. Modular Structure of Common Technical Document (eCTD)

Part Ⅱ:
• Methods for Expediting Innovative Novel Drugs to Market

FDA issued a Guidance for expedited programs for serious condition in 2014. There are 4 expedited programs: Fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation. In this course, each of these 4 designations will be described and data needed to be qualified for these designations will be discussed.

In addition to the preclinical and clinical requirement, the manufacturing and product quality consideration will be discussed to complement the preclinical and clinical development.

In addition, the approval of the new drugs in 2019 and early 2020 will be presented and the specific designations will be explained

• SPA: Special Protocol Assessment Guidance for industry

SPA is a process in which sponsors may request to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal trials to determine if they adequately address scientific and regulatory requirements.

Sponsors submit specific questions in protocol design, scientific and regulatory requirements to submit to FDA for review. FDA issues a SPA letter consisting of assessment of the protocol agreement or non-agreement with the proposed protocol, answers of the sponsor’s relevant questions.

學員對象：
(1)任職於大學學術單位、研究機構、新藥公司/藥廠，有藥物開發相關經驗者。
(2)曾從事藥物開發或臨床試驗工作者

報名方式：<報名已截止>

課程費用：每人2,200元 團體報名:2人(含)以上每人 2000元

*上課達滿時數三小時，將核發本課程結業證書

【師資介紹】

龔曉嘉 博士

現職：
翼答生技顧問有限公司董事長

經歷：
翼陞生物科技股份有限公司 執行長
宣捷細胞生物製藥股份有限公司 執行長
太景生物科技股份有限公司 資深副總經理
康龍化成（北京）新藥技術股份有限公司 共同創辦人
SRI International 總監
Gryphon Therapeutics 副總
美國毒理學會認證毒理學家

學歷：
俄亥俄州立大學毒物學、生理學與營養學博士學位

【溫馨提醒】

本學苑採用線上繳費系統，請注意下列重要事項：

1.請學員報名務必先填寫Google報名表單後，再進入線上繳費系統(繳費資訊/連結提供於表單提交後跳出的文字敘述中)。
2.本線上系統有下列兩種繳費方式
(1)信用卡繳費-需輸入卡號、有效月/年、卡片背面末三碼、手機驗證
(2)ATM櫃員機-產生虛擬帳號，由ATM轉帳
3.如您需報帳，可直接於線上繳費系統中輸入公司正確統編，或您可來信學苑告知。
(凡發票打抬頭統編者，視為單位/公司付費派訓，結訓證書將署名「xxx單位/公司(統編公司)及學員姓名」，敬請學員自行評估，務必確認，謝謝。)
4.因繳費系統產生之帳單三日後即失效，敬請特別留意，如有任何問題，請來信或來電與學苑聯絡。
5.公司報名作業，如無法於本繳費系統作業者，再來信或來電本學苑洽詢。

*因應疫情變化，為維護上課學員之健康，實施下列安心防疫培訓政策：
1.自本學苑公告日起(2020/3/11)至開課日(2020/8/13)，全面限制自境外返台者(不分國家)參加本學苑課程。
2.自課程公告日起(2020/7/14)至開課日(2020/8/13)凡有收到居家隔離、居家檢疫、自主健康管理者，均不得參加本學苑課程。

學苑信箱：bioschool@biotech-edu.com 學苑電話：02-2545-9721

同學期待的政治英文影片第一集總算出爐了! 在此先聲明，我跟Howard老師純粹是分析英文，兩位總統都是神人級的第二語言使用者! 此影片的目的不在於比較兩者的英文能力，而是提供學習者英文口語的實際操作和可以注意的小細節。 以下是影片中提到的一些資訊，請看完再發表評論:

馬英九（1950年7月13日－），中華民國政治人物，曾任中華民國第12、13任總統、國民黨主席等職。畢業於國立台灣大學法律學系，其後前往美國深造，獲紐約大學法學碩士學位，哈佛大學司法學博士學位。曾經擔任蔣經國總統的英文翻譯。

影片: https://youtu.be/lRACKQkgFqc?t=32
Former President of Taiwan Ma Ying-jeou, in conversation with Jerome A. Cohen, discusses student exchanges between Germany and France.

●沒有看稿子
●非常有經驗的講者
●發音大致上標準 (Prussia 普魯士, herald, tribune, presidency)
●good use of stress (enhancements)
●流暢度有練過特別停頓來思考
●提連貫性跟內容組織的部分
●會以故事的方式去切入重點

用的評分系統: https://www.ielts.org/-/media/pdfs/sp...

●wide range and skillful use of vocabulary: are aware of, feel uneasy, visionary leaders, engage in a massive student exchange, worked miracles, became cornerstones
●mistakes: skip school, quit school, tense--become cornerstone
●short, concise sentences suited for clear public speaking
●lexically dense sentences

★★★★★★★★★★★★

蔡英文（1956年8月31日－）是中華民國（臺灣）的政治人物、法律學者、律師，為現任中華民國總統，原擔任民主進步黨主席。她先後獲得國立臺灣大學法律學系法學士、康奈爾法學院法學碩士、及倫敦政治經濟學院法學博士，曾任教於國立政治大學法學院和東吳大學法學院。

影片: https://youtu.be/5ygpAnK02uk?t=55
President Tsai Ing-wen in Harvard giving advice to students on policy challenges, choices, and leadership in the next decade

●沒有看稿子
●英式發音* (taught, good), 非常清楚
*其實很多英國人不喜歡英式口音這個標籤，英國人覺得他們自己講的才是真正標準的英文，是美國人才有口音

而且現在的英國(聯合王國)也是四個國家組成的，每個區域的發音都有一些區別。

用的評分系統: https://www.ielts.org/-/media/pdfs/sp...

●用詞豐富: rebellious, challenge your teachers and contemporaries, make yourself suited for changes, sharing values, expediting
●流暢度, 有些停頓, 但是思考內容的停頓絕對是自然的!
●文法沒有任何的錯誤 (a rebellious one, meaning...分詞構句, everything that is taught 形容詞子句, what is true today...名詞子句)

★★★★★★★★★★★★

對我而言，英文是一種工具，不覺得每一個政治人物都需要英文，有專業和可靠的翻譯輔助，就足夠了。

媒體報導: https://wp.me/p44l9b-1G4

在此提供我的「心智圖詞彙攻略」課程: https://bit.ly/2teELDq

也獻上Howard老師會走路的翻譯機，《會走路的翻譯機，神級英文學習攻略本》 http://bit.ly/2DfGrhH

最後要感謝炙瞳夢 RED FILM幾位大導演的友情協助，幫我們拍出一級棒的影片!

★★★★★★★★★★★★

NOTE: Thank you for the comments, everyone, both the positive and negative ones. We'll continue to do our best to produce entertaining yet educational videos.

There is a lot of information that we could not fit in a 10 min video, and some parts could be more clearly presented. For example, pauses are entirely natural when one searches for content. This point was stated in the video but went unnoticed by many commenters. Some have also expressed concerns about the clips selected. We selected them based on the following criteria: be related to education, have "spontaneous" interaction, and be in the public domain. Not many clips on the net meet these criteria, and the two above were the only ones we had access to. Last, some comments (from both sides) have accused us of bias. We tried to be as impartial as possible, and if you require more information on our thoughts, please refer to our notes in the video description. As previously stated, both candidates are advanced second language users, and it is not our aim to compare or criticize them. Again, thank you all for your feedback. We will strive to do better in the future.