Glossary entry (derived from question below)
Japanese term or phrase:
準備面談（医薬品医療機器総合機構）
English translation:
pre-consultation meeting
Added to glossary by
cinefil
Sep 1, 2016 09:57
7 yrs ago
5 viewers *
Japanese term
Martinique
Specializing in medical translation
Native in: English
Works in: Japanese to English, French to English
相談区分：医療機器プロトコル相談 治験（準備面談済）
Japanese to English
Medical
Medical (general)
I was hoping that someone could shed some light on the phrase above and confirm whether or not I am right in thinking the term in parentheses above means 'preliminary interview completed'. In my research I end up on the PMDA website but I haven't had any luck finding any reference to the above phrase in English. Thank you in advance for your help.
Proposed translations
(English)
| 3 +1 | pre-consultation meeting |
cinefil
|
| 3 +1 | post-screening |
David Gibney
|
| 4 | 準備面談 |
sarahunting
|
| 2 | preparation interview |
Erzsébet Czopyk
|
Change log
Sep 2, 2016 17:40: cinefil Created KOG entry
Proposed translations
+1
2 hrs
Japanese term (edited):
準備面談
Selected
pre-consultation meeting
4 KudoZ points awarded for this answer.
Comment: "Thank you very much for your help"
1 hr
Erzsébet Czopyk
Hungary
Hungary
Specializes in field
Hungary
sworn translator, linguist, DPO
Native in: Hungarian (Variant: Hungary) 
Works in: Russian to Hungarian, Hungarian to Russian, Latvian to Russian, and 10 more.
preparation interview
対面助言のうち対面助言準備面談 | 独立行政法人 医薬品医療機器総合機構
https://www.pmda.go.jp/review-services/f2f-pre/.../0011.html
対面助言のうち対面助言準備面談. ◇医療機器・体外診断用医薬品対面助言準備面談の受付及び実施日程について 日程は下記の通りになります。
https://www.pmda.go.jp/review-services/f2f-pre/.../0011.html
対面助言のうち対面助言準備面談. ◇医療機器・体外診断用医薬品対面助言準備面談の受付及び実施日程について 日程は下記の通りになります。
+1
11 hrs
David Gibney
Ireland
Ireland
Native in English
Specializes in field
Ireland
Professional, punctual translations
Native in: English
Works in: Japanese to English, English to Japanese
Related KudoZ points
:
183
Japanese term (edited):
準備面談済
post-screening
I think it's just being used here to indicate the interview is after the initial screening interview. I would go with "post-screening" for brevity and to avoid confusion with any other post-screening interviews.
21 hrs
準備面談
I think it refers to a meeting held prior to the consultation with PMDA as part of the consultation system for clinical study protocols to improve and reinforce the quality of clinical studies, as mentioned in the site below.
Reference comments
1 hr
Reference:
FYI
https://www.pmda.go.jp/english/review-services/consultations...
[PDF] Overview of Consultation System in Japan
https://www.pmda.go.jp/files/000157641.pdf
22 Mar 2012 ... ☆OPSR (KIKO). ○Equivalence review for generic drugs. ○Clinical Trial Consultation. PMDA. Establishment of. PMDA. 2001 ... Expansion of the consultation category. ①Consultation before IND. ②Consultation after completion of phase II study for drug ... Pre-PI. Pre-Application. Pre-PII. End-of-PII . Safety. Quality. Additional. Additional. （Consultation only for Toxicity and Pharmacology）.
[PDF] Pre-consultation system at the authority for clinical trials and NDA in ...
https://www.pmda.go.jp/files/000163784.pdf
PMDA. 2001. ○ Grant approval. ○ Approval review. ○ Clinical trial notifications. ○ Pharmaceutical consultations ... Pre-PI. Pre-Application. Pre-PII. End-of-PII. Safety. Quality. Additional. Additional. （Consultation only for Toxicity and Pharmacology） ... Consultation Pre-early phase II study for drugs .... (Numbers of category).
Consultations | Pharmaceuticals and Medical Devices Agency
https://www.pmda.go.jp/english/review.../consultations/0002....
PMDA offers consultations to give guidance and advice on clinical trials of drugs, medical devices, and cellular and tissue-based products ... in which its reviewers evaluate data on the quality, efficacy, and safety of a product in the pre- submission stage and ... for advice on product development and regulatory submission, in such categories as new medical devices and cellular and tissue- based products
Expanded PMDA pre-consultation program now available for ...
www.emergogroup.com/.../japans-pmda-now-offers-pre-consulta... medical-device-registrants
17 Dec 2014 ... The Pharmaceutical and Medical Devices Agency (PMDA) now offers multiple pre-consultation options for registrants before they begin their market authorization applications. Learn more about Japan's medical deivice ...
[PDF] Japan: Key considerations for successful PMDA consultation meetings
https://embed.topra.org/.../15-3_regulatory-rapporteur-pmda-...
review; Consultation; Pre-meeting; Briefing document; Clinical study design; Priority-track. Abstract ... Applicants looking to take advantage of a PMDA consultation are required to submit an ... Consultation category. Consultation contents.
[PDF] The clinical trial consultation system - TOPRA
https://embed.topra.org/sites/default/files/.../1/.../intfoc...
The PMDA prepares the consultation minutes after the face-to-face meeting with the ... 2 Pre-Early Phase II consultation. Suggestions and advice are ... under this category, even if the early Phase II trial has not yet started. 4 End-of-Phase II ...
https://www.pmda.go.jp/files/000163784.pdf
[PDF] Overview of Consultation System in Japan
https://www.pmda.go.jp/files/000157641.pdf
22 Mar 2012 ... ☆OPSR (KIKO). ○Equivalence review for generic drugs. ○Clinical Trial Consultation. PMDA. Establishment of. PMDA. 2001 ... Expansion of the consultation category. ①Consultation before IND. ②Consultation after completion of phase II study for drug ... Pre-PI. Pre-Application. Pre-PII. End-of-PII . Safety. Quality. Additional. Additional. （Consultation only for Toxicity and Pharmacology）.
[PDF] Pre-consultation system at the authority for clinical trials and NDA in ...
https://www.pmda.go.jp/files/000163784.pdf
PMDA. 2001. ○ Grant approval. ○ Approval review. ○ Clinical trial notifications. ○ Pharmaceutical consultations ... Pre-PI. Pre-Application. Pre-PII. End-of-PII. Safety. Quality. Additional. Additional. （Consultation only for Toxicity and Pharmacology） ... Consultation Pre-early phase II study for drugs .... (Numbers of category).
Consultations | Pharmaceuticals and Medical Devices Agency
https://www.pmda.go.jp/english/review.../consultations/0002....
PMDA offers consultations to give guidance and advice on clinical trials of drugs, medical devices, and cellular and tissue-based products ... in which its reviewers evaluate data on the quality, efficacy, and safety of a product in the pre- submission stage and ... for advice on product development and regulatory submission, in such categories as new medical devices and cellular and tissue- based products
Expanded PMDA pre-consultation program now available for ...
www.emergogroup.com/.../japans-pmda-now-offers-pre-consulta... medical-device-registrants
17 Dec 2014 ... The Pharmaceutical and Medical Devices Agency (PMDA) now offers multiple pre-consultation options for registrants before they begin their market authorization applications. Learn more about Japan's medical deivice ...
[PDF] Japan: Key considerations for successful PMDA consultation meetings
https://embed.topra.org/.../15-3_regulatory-rapporteur-pmda-...
review; Consultation; Pre-meeting; Briefing document; Clinical study design; Priority-track. Abstract ... Applicants looking to take advantage of a PMDA consultation are required to submit an ... Consultation category. Consultation contents.
[PDF] The clinical trial consultation system - TOPRA
https://embed.topra.org/sites/default/files/.../1/.../intfoc...
The PMDA prepares the consultation minutes after the face-to-face meeting with the ... 2 Pre-Early Phase II consultation. Suggestions and advice are ... under this category, even if the early Phase II trial has not yet started. 4 End-of-Phase II ...
https://www.pmda.go.jp/files/000163784.pdf
Discussion
If there's an additional explanation after the screening interview and informed consent interview I would use post consent. The protocol has to be explained before consent can be given.