Research ethics committees and post-approval activities: a qualitative study on the perspectives of European research ethics committee representatives
Sign Up to like & getrecommendations! Published in 2022 at "Current Medical Research and Opinion"
DOI: 10.1080/03007995.2022.2115773
Abstract: Abstract Objective To explore the views of Research Ethics Committee (REC) representatives in the European Union (EU) on what the status quo is in terms of RECs’ activities after the approval of trial protocols for… read more here.
Keywords: ethics committee; approval; research ethics; research ... See more keywords
Acute and midterm outcomes of the post-approval MELODY Registry: a multicentre registry of transcatheter pulmonary valve implantation.
Sign Up to like & getrecommendations! Published in 2019 at "European heart journal"
DOI: 10.1093/eurheartj/ehz201
Abstract: AIMS The post-approval MELODY Registry aimed to obtain multicentre registry data after transcatheter pulmonary valve implantation (TPVI) with the Melody™ valve (Medtronic plc.) in a large-scale cohort of patients with congenital heart disease (CHD). METHODS… read more here.
Keywords: approval melody; melody; valve; tpvi ... See more keywords
Real-world clinical outcomes with a next-generation left atrial appendage closure device: the FLXibility Post-Approval Study
Sign Up to like & getrecommendations! Published in 2023 at "Europace"
DOI: 10.1093/europace/euac270
Abstract: Abstract Aims The FLXibility Post-Approval Study collected data on unselected patients implanted with a WATCHMAN FLX in a commercial clinical setting. Methods and results Patients were implanted with a WATCHMAN FLX per local standard of… read more here.
Keywords: approval study; flxibility post; device; post ... See more keywords
Improved performance and safety from Argus II retinal prosthesis post‐approval study in France
Sign Up to like & getrecommendations! Published in 2020 at "Acta Ophthalmologica"
DOI: 10.1111/aos.14728
Abstract: To evaluate the post‐approval long‐term outcomes of the Argus II Retinal Prosthesis, with a specific focus on its functional visual benefit in patients’ daily activities. read more here.
Keywords: retinal prosthesis; argus retinal; post approval;
Quality evaluation of investigator‐initiated trials using post‐approval cancer drugs in Japan
Sign Up to like & getrecommendations! Published in 2017 at "Cancer Science"
DOI: 10.1111/cas.13223
Abstract: Investigator‐initiated trials (IIT) are important aspects of medical research and have contributed substantially to modern oncology. IIT using post‐approval drugs have been conducted by domestic institutions in Japan. Data from the present study were obtained… read more here.
Keywords: phase; initiated trials; using post; investigator initiated ... See more keywords
Abstract CT211: EF-19 - A post-approval registry study of TTFields for the treatment of recurrent glioblastoma (GBM)
Sign Up to like & getrecommendations! Published in 2020 at "Cancer Research"
DOI: 10.1158/1538-7445.am2020-ct211
Abstract: Background: Tumor Treating Fields (TTFields) are an anti-mitotic, regional treatment modality, utilizing low intensity alternating electric fields delivered non-invasively to the tumor using a portable medical device. In phase 3 studies leading to FDA approvals,… read more here.
Keywords: gbm; treatment; recurrent; post approval ... See more keywords
Benefit, burden, and impact for a cohort of post-approval cancer combination trials
Sign Up to like & getrecommendations! Published in 2019 at "Clinical Trials"
DOI: 10.1177/1740774519873883
Abstract: Background: After approval, drug developers often pursue trials aimed at extending the uses of a new drug by combining it with other drugs. Little is known about the risk and benefits associated with such research.… read more here.
Keywords: combination; approval; drug; cancer ... See more keywords
Diminishing clinical impact for post-approval cancer clinical trials: A retrospective cohort study
Sign Up to like & getrecommendations! Published in 2022 at "PLoS ONE"
DOI: 10.1371/journal.pone.0274115
Abstract: Background Once a drug gets FDA approved, researchers often attempt to discover new applications in different indications. The clinical impact of such post-approval activities is uncertain. We aimed to compare the clinical impact of research… read more here.
Keywords: approval trajectories; clinical impact; post approval; approval ... See more keywords
Post-approval Change Submission: ICH Q12 Impact Analysis on India and Japan
Sign Up to like & getrecommendations! Published in 2020 at "Indian Journal of Pharmaceutical Sciences"
DOI: 10.36468/pharmaceutical-sciences.617
Abstract: The present research provides a discussion on post approval change management of pharmaceuticals, biologics and drug device combinations, which is an important part of life cycle management. The present study focuses on understanding the existing… read more here.
Keywords: india japan; post approval; approval change; ich q12 ... See more keywords
Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS) - Through Enhanced Science and Risk-Based Approaches Industry One-Voice-of-Quality (1VQ) Solutions.
Sign Up to like & getrecommendations! Published in 2020 at "PDA journal of pharmaceutical science and technology"
DOI: 10.5731/pdajpst.2020.011734
Abstract: Post-approval changes are inevitable and necessary throughout the life of a drug product-to implement new knowledge, maintain a state of control, and drive continual improvement. Many post-approval changes require regulatory agency approval by individual countries… read more here.
Keywords: quality; approval; quality system; post approval ... See more keywords
Industry One-Voice-of-Quality Solutions Management Review of Post-Approval Changes Guide
Sign Up to like & getrecommendations! Published in 2021 at "PDA Journal of Pharmaceutical Science and Technology"
DOI: 10.5731/pdajpst.2021.012627
Abstract: Post-approval changes (PACs) are inevitable and necessary throughout the life of a drug product. Because many PACs require prior approval by individual regulatory agencies each having their own reporting requirements and approval timelines, this results… read more here.
Keywords: quality; approval; one voice; voice quality ... See more keywords