Towards a better use of scientific advice for developers of advanced therapies-Reference-Cited by-同舟云学术

Towards a better use of scientific advice for developers of advanced therapies

Published:2020-12-11 Issue:6 Volume:87 Page:2459-2464
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Br J Clin Pharmacol

Author:

Tavridou Anna¹^ORCID,Rogers Dolca²,Bonelli Milton¹,Schiel Anja³⁴,Hidalgo‐Simon Ana⁵

Affiliation:

1. Scientific Advice Office, Human Medicines Division European Medicines Agency Amsterdam The Netherlands

2. Pharmaceutical Quality Office, Human Medicines Division European Medicines Agency Amsterdam The Netherlands

3. Regulatory and Pharmacoeconomic Statistics Norwegian Medicines Agency (NoMA) Norway

4. Chair of Scientific Advice Working Party (SAWP) European Medicines Agency Amsterdam The Netherlands

5. Head of Advanced Therapies, Human Medicines Division European Medicines Agency Amsterdam The Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.14672

Reference17 articles.

1. Where do new medicines originate from in the EU?

2. Clinical Development of Advanced Therapy Medicinal Products in Europe: Evidence That Regulators Must Be Proactive

3. Challenges in Advanced Therapy Medicinal Product Development: A Survey among Companies in Europe

4. Marketing authorisation applications submitted to the European Medicines Agency by small and medium-sized enterprises: an analysis of major objections and their impact on outcomes

5. European Medicines Agency. Scientific advice and protocol assistance. Published September 17 2018. Accessed July 10 2020.https://www.ema.europa.eu/en/human‐regulatory/research‐development/scientific‐advice‐protocol‐assistance

Cited by 6 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. How to balance valuable innovation with affordable access to medicines in Belgium?;Frontiers in Pharmacology;2022-09-16

2. Compliance in Non-Clinical Development of Cell-, Gene-, and Tissue-Based Medicines: Good Practice for Better Therapies;Stem Cells Translational Medicine;2022-07-13

3. The value of patient-reported outcomes in early-phase clinical trials;Nature Medicine;2022-01

4. Current landscape of clinical development and approval of advanced therapies;Molecular Therapy - Methods & Clinical Development;2021-12

5. Comparability: what we can learn from the review of advanced therapy medicinal products;Regenerative Medicine;2021-07