Valerie Mulholland On Improving Rbdm Effectiveness,
2023
GMP Training & Pharmaceutical Regulatory Science Team (PRST), TU Dublin, Ireland
Valerie Mulholland On Improving Rbdm Effectiveness, Valerie Mulholland
Level 3
No abstract provided.
Agenda From June 1st Conference,
2023
Technological University Dublin
Speaker Bios,
2023
Technological University Dublin
Ipq Descriptor,
2023
Technological University Dublin
Hpra’S Kevin O’Donnell On The Ich Q9 Revision And Considerations For Its Implementation,
2023
Health Product Regulatory Authority, Ireland
Hpra’S Kevin O’Donnell On The Ich Q9 Revision And Considerations For Its Implementation, Kevin O'Donnell
Level 3
At the June 2023 PRST meeting on the ICH Q9 revision, HPRA Market Compliance Manager and Senior GMP Inspector Kevin O’Donnell, who has been serving as rapporteur for ICH Q9 (R1), addressed the changes introduced in the revision, the practicalities of implementation, and his “personal thoughts” on the implementation process. Click here for ICH Q9(R1) with the changes highlighted by O’Donnell, and here for the slides accompanying O’Donnell’s remarks. Formatting
changes and other minor edits have been made for clarity by IPQ. Expressions of thanks to the meeting organizers/attendees and disclaimers that the presentation represents the speaker’s views and not …
Balancing Quality Assurance & Innovation In Pharma,
2023
Pharmaceutical Regulatory Science Team (PRST)
Balancing Quality Assurance & Innovation In Pharma, Emma Ramnarine
Level 3
At the Pharmaceutical Regulatory Science Team (PRST) workshop on ICH Q9(R1), held at the Technological University Dublin in early June 2023, Boehringer Ingelheim US Biopharma Operations Product Management & Development Operations Head Emma Ramnarine shared her insights on balancing quality assurance and innovation in pharmaceutical manufacturing. She addressed: ● patient-centered transformation ● a watershed moment in her career ● understanding the drug shortage problem ● disruptive collaboration, and ● systems thinking
approaches. Click here for the slides accompanying Ramnarine’s remarks. She connected some of her remarks for the pharmaceutical industry to those made in the previous talk by Ed Hoffman, …
Quality Reborn,
2023
Quality Business Administration
Quality Reborn, Anders Vinther
Level 3
It is time for Quality leaders to not only fulfill the traditional role of ensuring cGMP compliance within the company but also take the Quality profession to the level of business leadership like Deming did in Japan after World War II. FDA has recently stated that they have low confidence in quality management maturity of the pharmaceutical industry.
For quality leaders to also become good business leaders we must educate them in ways that are different from what we currently do. The education should be in the 6 areas
- Visibly Demonstrating Responsibility of Quality
- Risk-Informed Decision Making and Communication
- Engaging …
Preface,
2023
Technological University Dublin
Risk-Based Decision-Making – Using Knowledge Of Risk Throughout The Lifecycle,
2023
Novo Nordisk A/S
Risk-Based Decision-Making – Using Knowledge Of Risk Throughout The Lifecycle, Michael Schousboe
Level 3
This article is based on a presentation given at the event ICH Q9(R1): The Next Frontier hosted by TU Dublin, Grangegorman 01-June-2023
An audience with international thought leaders exploring how the effective use of knowledge can enhance QRM outcomes to benefit the patient
Introducing Research Collaboration And Gmp Human Resource Development At Three Universities With Gmp Laboratories In Japan,
2023
TOKYO University of Science (TUS)
Introducing Research Collaboration And Gmp Human Resource Development At Three Universities With Gmp Laboratories In Japan, Shingou Sakurai, Osamu Hiruta, Ryoko Naruse
Level 3
This paper summarises initiatives presented on June 1st 2023 at a seminar during a visit to Technological University Dublin. The authors travelled from 3 universities in Japan to share some of the collaborative research, education and training initiatives developed by them,
In their presentation the authors gave an overview of the current situation of Knowledge Management and Quality Culture in Japan, highlighting some recent issues and challenges, and presented some initiatives under development to specifically address these challenges.
Leveraging Advanced Analytics In The Pharmaceutical Industry,
2023
PRST & EY
Leveraging Advanced Analytics In The Pharmaceutical Industry, Patrick O'Sullivan
Level 3
This article is a transcribed and lightly edited version of Patrick O’Sullivan’s oral presentation to a seminar hosted on 1 June 2023 by the Pharmaceutical Regulatory Science Team (PRST), TU Dublin, titled ICH Q9(R1): The Next Frontier – An audience with international thought leaders exploring how the effective use of knowledge can enhance QRM outcomes to benefit the patient. Patrick presented an overview of how one could leverage advanced analytics in the pharmaceutical Industry.
Regulators Are Exploring With Industry How To Strengthen Quality Risk Management Practices, With Revision Of Ich Q9 A Key Focal Point, ( Ipq )
Level 3
No abstract provided.
Industry/Regulator Dialogue On Knowledge Management Is Intensifying In Wake Of Ich’S Q12 Initiative,
2023
IPQ
Industry/Regulator Dialogue On Knowledge Management Is Intensifying In Wake Of Ich’S Q12 Initiative, ( Ipq )
Level 3
No abstract provided.
Exploring The Role Of Knowledge In The Pharma Workplace Of The Future: An Interactive Workshop Exploring Culture, Km And Opex,
2023
PRST & Eli Lilly
Exploring The Role Of Knowledge In The Pharma Workplace Of The Future: An Interactive Workshop Exploring Culture, Km And Opex, Stephanie Friedrichsen, Nuala Calnan (Editor), Martin J. Lipa
Level 3
This article presents a summary of an interactive workshop facilitated by Nuala Calnan and Stephanie Friedrichsen during the conference: ‘ICH Q9(R1): The Next Frontier’ held in Technological University Dublin, Ireland, on 1 June 2023. The summary was prepared by the workshop facilitators in conjunction with Martin Lipa who was a participant at the workshop. The article is written to give a high-level overview of the discussions which took place during the workshop and is not intended to be a complete representation of all the activities, insights and findings.
Links To Prst Past Monographs And Level 3 Special Editions,
2023
Technological University Dublin
Links To Prst Past Monographs And Level 3 Special Editions
Level 3
No abstract provided.
Ipq Bibliography Pac Km Qrm 2010 - 2023,
2023
Technological University Dublin
Conversion Of Cellulose To 5-Hydroxymethylfurfural As Sustainable Energy: A Bibliometric Analysis By Vosviewer,
2023
Institut Teknologi Sepuluh Nopember
Conversion Of Cellulose To 5-Hydroxymethylfurfural As Sustainable Energy: A Bibliometric Analysis By Vosviewer, Royyan Faradis, Ardiansyah Bagus Suryanto, Irmina Kris Murwani
Journal of Environmental Science and Sustainable Development
The developments of the global economy and society impact resources and the environment. This condition requires an alternative to find new, safe, and sustainable energy types. The conversion of cellulose to 5-hydroxymethylfurfural (5-HMF) has become a significant area of research interest. It has triggered the development of research directions related to biomass and energy because it can be an intermediary source for making polymers, solvents, pharmaceuticals, and biofuels. The primary objective of this study is to give a bibliometric analysis of 1753 reports on the development of research on cellulose conversion to 5-HMF from 1965 to 2021. The data were …
Assessing The Performance Of Newly Developed Silica Nanoparticles Against Lead And Phosphate Ion Removal From Contaminated Solutions Using Adsorption Isotherm,
2023
Faculty of Science, Beirut Arab University, Debbieh, Lebanon
Assessing The Performance Of Newly Developed Silica Nanoparticles Against Lead And Phosphate Ion Removal From Contaminated Solutions Using Adsorption Isotherm, Hasan Shamseddine, Nour Abi Aad, Rami Oweini, Ghassan Younes
BAU Journal - Science and Technology
This study investigates the removal of Lead and Phosphate ion from aqueous solution using new silica nanoparticles doped with europium (H1) which was characterized using Scanning Electron Microscopy (SEM), Dynamic Light Scattering (DLS), Fourier-transform Infrared Spectroscopy (FTIR). The aim of this research is to develop a novel adsorbent material that can efficiently remove contaminated ions from wastewater or aqueous solutions. The adsorption of lead and phosphate ion onto the silica nanoparticles is investigated, and the efficiency of this removal is evaluated. Equilibrium data analysis reveals linear fitting with Langmuir isotherm with 24.76 mg/g Lead ion uptake, while for phosphate the …
Accelerated Iron Valence Cycling In Fenton System Using Activated Hydrogen Enhanced By Mil-100(Fe) Modified By Nano-Pd0 Particle, Yun-Dong Wang, Yi-Jun Chen, Mei-Na Cheng, Xin Liu
Turkish Journal of Chemistry
In this paper, a novel Fenton reaction system which was called MHACF-MIL-100(Fe) was constructed. In this system, based on active hydrogen-accelerated FeIII reduction, the hydroxyl radical was continuously produced with a trace amount of total iron. The MIL-100(Fe) modified with the nano-Pd0 particle could be used to activate the H2. Under normal temperature and pressure, the target organic pollutants, such as sulfamethazine and 4-chloro phenol, could be degraded fast. In the condition of initial aqueous solution pH 3, 2 g L–1 dosage of MIL-100(Fe) catalyst loaded with nano-Pd0, Pd/MIL-100(Fe), 20 mM 30 wt% hydrogen peroxide, 25 μM ferrous chloride and …
Phytochemical Investigation On The Aerial Parts Of Veratrum Versicolor F. Viride Nakai And Their Biological Activities,
2023
TÜBİTAK
Phytochemical Investigation On The Aerial Parts Of Veratrum Versicolor F. Viride Nakai And Their Biological Activities, Seong Su Hong, Jae Yeon Lee, Yeon Woo Jeong, Ji Eun Lee, Yun-Hyeok Choi, Wonsik Jeong, Eun-Kyung Ahn, Chun Whan Choi, Il Ho Ahn, Joa Sub Oh
Turkish Journal of Chemistry
Veratrum spp. have traditionally been used in folk medicine to treat various pathologies. In this study, nine compounds, comprising one simple phenolic compound (1), three stilbenoids (2–4), and five flavonoids (5–9), were isolated from the aerial parts of Veratrum versicolor f. viride Nakai. The structures of these compounds were elucidated by spectroscopic analyses and comparison with reported data. Together, all reported compounds were isolated from V. versicolor f. viride for the first time in the study. Among them, two flavone aglycone tricetins (7 and 9) have never been isolated from the genus Veratrum or the family Melanthiaceae. The ethanol extract …
