30_11_21_CTIS Sponsor Handbook 2021
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 -
PDF) Adaptive clinical trial designs for European marketing authorization: A survey of scientific advice letters from the European Medicines Agency
Clinical Trial Regulation
Frontiers | Advanced Therapy Medicinal Products' Translation in Europe: A Developers' Perspective
Introduction to the Clinical Trials Regulation (EU) No 536/2014 CTIS Training Programme – Module 01
EudraVigilance system overview | European Medicines Agency
clinicaltrialsregulation - Twitter Search / Twitter
Overview of comments - Requirements to the chemical and pharmaceutical quality documentation concerning investigational medicina
The arrival of biosimilar monoclonal antibodies in oncology: clinical studies for trastuzumab biosimilars | British Journal of Cancer
PDF) A New Drug Approval Process in Europe: A Review
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
CT authorisation in the EU: present and future
When innovation outpaces regulations: The legal challenges for direct‐to‐patient supply of investigational medicinal products - Malone - 2022 - British Journal of Clinical Pharmacology - Wiley Online Library
The European Medicines Agency Clinical Data Website Enables Insights I | OAJCT
Drugs and Devices: Comparison of European and U.S. Approval Processes - ScienceDirect
Reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples
Change management for the EudraVigilance system | European Medicines Agency
Current landscape of clinical development and approval of advanced therapies: Molecular Therapy - Methods & Clinical Development
Frontiers | Transitioning From Preclinical Evidence to Advanced Therapy Medicinal Product: A Spanish Experience
Transparency and the European Medicines Agency — Sharing of Clinical Trial Data | NEJM
EMAからの最新Guideline/FDA・EMA・PIC/S/Welcome to ISPE JAPAN ISPE日本本部
PDF) Drug approval process in US, Europe and India and its regulatory requirements: A Review
Frontiers | Entering First-in-Human Clinical Study With a Single-Strain Live Biotherapeutic Product: Input and Feedback Gained From the EMA and the FDA
Draft guideline on computerised systems and electronic data in clinical trials
