EMA & FDA Approvals and Recommendations in 2020 for Oncology Drugs and Diagnostics/Devices | CATO SMS
Clinical Trial Regulation
The European Medicines Agency and the Regulation of Medicines in the European Union - ScienceDirect
Regulatory Affairs 101: Introduction to Investigational New Drug Applications and Clinical Trial Applications
Transparency and the European Medicines Agency — Sharing of Clinical Trial Data | NEJM
The arrival of biosimilar monoclonal antibodies in oncology: clinical studies for trastuzumab biosimilars | British Journal of Cancer
Clinical Trial Regulation
CT authorisation in the EU: present and future
Complex clinical trials – Questions and answers
PDF) A New Drug Approval Process in Europe: A Review
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
Patients and consumers | European Medicines Agency
Current landscape of clinical development and approval of advanced therapies: Molecular Therapy - Methods & Clinical Development
EU Clinical Trials Regulation: The Application Process | Pharmaceutical Engineering
EMA Guidelines for Clinical Trial Management - Pepgra Healthcare by PepGra CRO - Issuu
Frontiers | Transitioning From Preclinical Evidence to Advanced Therapy Medicinal Product: A Spanish Experience
PDF) Comparison of the EMA and FDA Guidelines on Ulcerative Colitis Drug Development
Frontiers | Entering First-in-Human Clinical Study With a Single-Strain Live Biotherapeutic Product: Input and Feedback Gained From the EMA and the FDA
Clinical Trials Regulation
Drugs and Devices: Comparison of European and U.S. Approval Processes - ScienceDirect
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
Draft guideline on computerised systems and electronic data in clinical trials
The European Medicines Agency Clinical Data Website Enables Insights I | OAJCT
Comparison of regulatory pathways for the approval of advanced therapies in the European Union and the United States - Cytotherapy
Accelerating Clinical Trials in the EU (ACT EU)
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 -
30_11_21_CTIS Sponsor Handbook 2021
