5월14일 표현(수업설명 포함) 올립니다

[조원미]

DF

<병렬표현정리>

1. (a) beacon of hope : 희망의 신호 등불

2. an existing ____stockpile_______ of the medication : 기존 의약품 비축량 (단수)

3. glossed over : 얼버무리다  (To cover up a mistake or a crime)

6. a vocal ___advocate=an enthusiastic supporter_________ for : 개혁의 목소리를 대변하는 사람

10. new or re-emergent strains of influenza : 신종, 혹은 변종한 (a variant/a mutant)재발 인플루엔자

1. be on to (something)~ :~(대단한 것) 발견해[이뤄] 낼 가능성이 있다.  

2. be ___underway/undergoing______ with: ~와 함께 진행 중이다.

7. be _____aimed/targeted/directed________ towards~ : ~을 겨냥한 것이다.

8 ______sequence _____ RNA : RNA를 순서대로 배열하다.

9. _____block______ viral entry : 바이러스 유입을 차단하다.

10. be ___geared_________ towards : ~에 맞춰지다, ~에 맞게 준비/구성되다 =favor

12. end up being ______sidelines_____: 결국 빛을 보지 못하다.

Ex) To get water tested by mail for lead content, contact any of the following___ ___ ___ ____________:

식수에 있는 납 함량을 우편으로 검사받고자 하는 분들은 다음으로 연락하십시오. 

 (규칙, 법률 같은)~에 의하여, ~에 따라(=in accordance with) /pertaining to

Ex) ※ Classification of quasi-drugs into three groups _____pursuant to ______ the ‘Designation of the Scope of Quasi-Drugs (Notice of Ministry of Food and Drug Safety)

3. For ____external______ use only: 외용으로만 사용, 외용 전용

7. Have a transition time of~: ~동안의 전이 spread  시간, 기간을 갖다  /적용 기간

Ex) Manufacturers of currently approved medical devices will have a transition time of three years until May 26th 2020 to meet the requirements of the regulation.

8. Corrigenda(corrigendum의 복수형태) for~: ~의 정오표, 정정해야 할 잘못

Ex) The corrigenda for the MDR and IVDR have also been made public in this official journal.

10.  vt.~을 지시, 명령하다 

Ex) The MDR ___mandate_____ the use of unique device identification (UDI) mechanisms.

6. is the first case __granted approval____ __________ by the ministry: 승인 (허가)를 받은 첫번째 케이스

7. since regulations on respiratory products were tightened/strengthened/toughened,->loosen/ease/relax in 2017. A에 관한 규정이 엄격/강화 해 진 이후로..

1. EFFECTIVE DATE- (약정,계약,보험기간의) 발효일,유효일, 시작시기

THE REVIEW WILL INCLUDE REGULAR ASSESSMENT BASED ON ADDITIONAL INFORMATION PROVIDED BY THE SPONSOR OF THE PROGRESS MADE WITH RESPECT TO THE APPROVAL, LICENSURE, OR CLEARANCE OF THE UNAPPROVED PRODUCT, OR OF THE UNAPPROVED USE OF AN APPROVED PRODUCT, FOR WHICH AN EUA WAS ISSUED. 

  정책실행 행사는 진행: events will be in placeà will be hosted

THE EMERGENCY AUTHORITIES IN SECTION 564A APPLY ONLY TO THOSE MEDICAL PRODUCTS THAT ARE “ELIGIBLE” (AS DEFINED IN SECTION 564A(A))

4. AS DEFINED IN SECTION (규정)- ~~ 정의된 규정에 따라

FDA-APPROVED MCM STOCKPILED FOR USE IN A CBRN EMERGENCY IF THE EXTENSION IS SUPPORTED BY AN APPROPRIATE SCIENTIFIC EVAL‎UATION THAT IS CONDUCTED OR ACCEPTED BY FDA. 

5. STOCKPILE- (많은) 비축량

- (대량으로) 비축하다

FDA may consider extending that the expiration date and imposing conditions in connection with an EUA request as discussed in section III.D.2.a of this guidance.

6. in connection with- ~와 관련되어

Investigations into 사후/inspection of 사전

Be responsible for 사전/사후//  hold 사람 accountable  사후

e.g., when an inspection of the manufacturing site and processes has raised significant questions regarding the purity, potency, or safety of the EUA product that materially affect the risk/benefit assessment upon which the EUA was based);

9. raise a question- 문제점을 제기하다, 의문을 제기하다

1. A cosmetic product must be ___labled____according to cosmetic labeling regulations.

분류하다  classify  fall into

2,3. In contrast, the law requires strict adherence to GMP requirements for drugs, and there are regulations  명시한specifying minimum current GMP requirements for drugs.

 Adhere to 동사

GMP: Good Manufacturing Practice (우수 의약품 제조 및 품질관리 기준)

4. It is intended only to ___alert__you to some important differences between the laws and regulations for cosmetics and drugs in the areas of approval, good manufacturing practice, registration, and labeling.

일깨워주기 위한…

5. Among the many nonprescription drug categories covered by OTC monographs are:

nonprescription drug: 비처방 약 /OTC drugs 일반의약품

10. …, without adhering to requirements for drugs.

5. re-eval‎uate(정성평가) current classification: 현재 분류체계를 재평가하다/assess?  데이터 (정량평가)

6. the drugs are generally recognized as safe and effective, and not _misbranded_________: 의약품이 안전하고, 효과적이며 부정표시 (不正標示)되지 않았다고 인식된다.

7. on a ____class-by-class_____basis: 품목별 분류방식에 따라

9. be introduced into ___commerce_______: 시판되다

10. are ____marketed_____ side by side with cosmetics: 화장품과 같이 판매되다

1. ~(법률을) 위반하다, 어기다

medical devices that are medicines may _breach_____the Medicines Act 1981.

2. 올바르게 시판된

to ensure their products are correctly marketed and regulated.

3. 명시적/암시적

Note that a therapeutic purpose, either ____claimed___or implied__________

5. 보여주기 위한 목적

The following examples are provided for ___illustrative_______-- purposes only.

6. ~을 다양하게 수반하다  entail=require

This _____encompasses_______ a wide range of diagnostic medical devices

7. 고지할 의무가 있다

same medical device each importer is required to __notify_________

8. ~에 편승하다

one sponsor to "piggy-back" on another sponsor's notifications.

 Cf)piggyback promotion 묻어가는 홍보전략

9. 개선조치

in the event of a recall or ____corrective______ action  cf) collective action집단소송/ make collective or concerted efforts 전세계의 노력

10. 적용가능한 법률

It is the supplier's responsibility to ensure that their products comply with all applicable legislation. (UC)

 1) ___hailed as__ __ "highly significant" “매우 중요” 한 것으로 환영을 받다

6) is it worth ____pinning_____our hopes on? 우리의 희망을 걸 가치가 있는가?

7) __broad-spectrum___________ antiviral drugs 광범위한 항바이러스제

8) Remdesivir is given _____intravenously______ to people in hospital. 

렘데시비르는 환자들에게 정맥 주사로 투약한다. 

9) compassionate 온정적인 /인정상use studies (허가전) 임상시험 clinical trials (허가후)

Compassionate drug use (or sometimes just compassionate use) is the use of a new, unapproved drug to treat a seriously ill patient when no other treatments are available.

10) someone on the ____verge_ of dying 죽음이 임박한 사람들