게시판-관련소식
뉴스레터 2023년 11월호
2023-11-30 by ISPE Korea
MFDS 소식
2023년 의약품 신속심사보고서 발간 알림
2023년 11월 1일에 개최된 "2023년도 GMP 정책설명회 및 QbD 워크숍"의 발표자료를 붙임과 같이 게시합니다.
GMP 가이드라인
[FDA] Submitting Patient-Reported Outcome Data in Cancer Clinical Trials
This document provides technical specifications for submitting patient-reported outcome (PRO) data collected in cancer clinical trials to support a marketing application for a medical product in oncology, where a PRO is a type of clinical outcome assessment (COA) used to collect patient experience data. The FDA Patient-Focused Drug Development (PFDD) Glossary defines a PRO as a measurement based on a report that comes directly from the patient (i.e., study subject) about the status of a patient's health condition without interpretation of the patient's response by a clinician or anyone else, where a PRO can be measured by self-report or by interview, provided that the interviewer records only the patient's response. ~
[PIC/S] Concept Paper on the revision of Annex 11 of the guideline on Good Manufacturing Practice for medicinal products-Computerised Systems
This concept paper addresses the need to update Annex 11, Computerised Systems, of the Good Manufacturing Practice (GMP) guide. Annex 11 is common to the member states of the European Union (EU)/European Economic Area (EEA) as well as to the participating authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The current version was issued in 2011 and does not give sufficient guidance within a number of areas. Since then, there has been extensive progress in the use of new technologies. ~
ISPE 국내외 소식
[한글판] PHARMACEUTICAL ENGINEERING
November-December 2023 / Volume 43, Number 6
- OPTIMIZING COST OF GOODS for Cell Therapy Manufacturing
- COMPARABILITY CONSIDERATIONS for Cellular and Therapy Procucts
- LIVE BIOTHERAPEUTIC PRODUCTS: Moving the Microbiome to the Patient
- BENEFITS AND CHALLENGES of Process Capability Metrics
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ISPE KOREA 교육회원 모집
* 가입대상: 제약 및 Biopharma 관련업계 종사하는 모든 분
* 회원혜택
- 한글판 Pharmaceutical Engineering 열람 및 다운로드
- 온라인 & 오프라인 교육비 40% 할인
- 동영상 교육자료 무료시청
* 가입방법: 홈페이지(www.ispe.or.kr) - 회원가입 - 교육회원 - 신청서 작성 - 회원가입비 납부
* 회원가입비: 연 25만원
Upcoming Conferences
2023 ISPE Pharma 4.0 & Annex 1 Conference
11-12 December 2023
Barcelona, Spain and Virtual
2024 ISPE Facilities of the Future Conference
29-30 January 2024
San Francisco, CA USA and Virtual
Guidance Documents
Good Practice Guide: Process Gases 2nd Edition
Published: October 2023
Pages: 152
Member Price: $295.00
Non-Member Price: $595.00
Guide: 503B Compounding
Published: August 2023
Page: 122
Member Price: $295.00
Non-Member Price: $595.00
Good Practice Guide: Containment for Potent Compounds
Published: December 2022
Pages: 258
Member Price: $295.00
Non-Member price: $595.00
광고문의 TEL. 043-213-0442 E-MAIL. ispe@hanmail.net
ISPE Korea Affiliate | Office : 충북 청주시 흥덕구 직지대로 530, 702호 (송정동, 청주테크노S타워)