EMAからの最新Guideline/FDA・EMA・PIC/S/Welcome to ISPE JAPAN ISPE日本本部
Comparison of regulatory pathways for the approval of advanced therapies in the European Union and the United States - Cytotherapy
PDF) A New Drug Approval Process in Europe: A Review
Change management for the EudraVigilance system | European Medicines Agency
Transparency and the European Medicines Agency — Sharing of Clinical Trial Data | NEJM
30_11_21_CTIS Sponsor Handbook 2021
The arrival of biosimilar monoclonal antibodies in oncology: clinical studies for trastuzumab biosimilars | British Journal of Cancer
Clinical Trials Regulation
Commentary on the EMA Guideline on strategies to identify and mitigate risks for first‐in‐human and early clinical trials with investigational medicinal products - Gerven - 2018 - British Journal of Clinical Pharmacology -
Tag | CRO, Clinical, TMF, eTMF, trial master file, inspection, audit, audit ready, inspection ready, Clinical Research Organisation, regulation, EU, EMA, MHRA, Andy FIsher | Pharma IQ
Overview of comments - Requirements to the chemical and pharmaceutical quality documentation concerning investigational medicina
Draft guideline on computerised systems and electronic data in clinical trials
Frontiers | Transitioning From Preclinical Evidence to Advanced Therapy Medicinal Product: A Spanish Experience
Introduction to the Clinical Trials Regulation (EU) No 536/2014 CTIS Training Programme – Module 01
Frontiers | Advanced Therapy Medicinal Products' Translation in Europe: A Developers' Perspective
Reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples
Clinical Trial Regulation 536/2014 - Ema.europa.eu PDF documents
EU Clinical Trials Regulation: The Application Process | Pharmaceutical Engineering
Frontiers | Entering First-in-Human Clinical Study With a Single-Strain Live Biotherapeutic Product: Input and Feedback Gained From the EMA and the FDA
Current landscape of clinical development and approval of advanced therapies: Molecular Therapy - Methods & Clinical Development
EudraVigilance system overview | European Medicines Agency
Draft guideline on computerised systems and electronic data in clinical trials
EMA Guidelines for Clinical Trial Management - Pepgra Healthcare by PepGra CRO - Issuu
Accelerating Clinical Trials in the EU (ACT EU)
