Physical Sciences and Mathematics Commons^™

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

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, …

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.

Ipq Descriptor

Level 3

No abstract provided.

Ipq Bibliography Pac Km Qrm 2010 - 2023

Level 3

No abstract provided.

Preface, Anne Greene, Martin Lipa, Bill Paulson

Level 3

No abstract provided.

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.

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 …

Links To Prst Past Monographs And Level 3 Special Editions

Level 3

No abstract provided.

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 …

Agenda From June 1st Conference

Level 3

No abstract provided.

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 1^st 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.

Achieving Warranted Acceptance Of Biotechnologies, Emily Grayek, Baruch Fischhoff

Level 3

The U.S. has faced long-standing shortages of generic drugs, causing negative health effects and spikes in drug costs. To address these shortages, investments in critical technologies and policies to support their adoption will be needed. The success of these technologies and policies depends on public acceptance. We studied public acceptance using the mental model approach, which identifies gaps in understanding that can be addressed with communications. We began with semi-structured interviews with experts in pharmaceutical manufacturing. Based on these interviews, we developed and conducted surveys of the general public, physicians, and pharmacists. Similar strategies could be applied to improve communications …

Industry/Regulator Dialogue On Knowledge Management Is Intensifying In Wake Of Ich’S Q12 Initiative, ( Ipq )

Level 3

No abstract provided.

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.

Speaker Bios

Level 3

No abstract provided.

Valerie Mulholland On Improving Rbdm Effectiveness, Valerie Mulholland

Level 3

No abstract provided.

Emerging Technologies: Empowering People To Capture, Share And Transfer Tacit Knowledge, Donncadh J. Nagle, Melanie J. Adams

Level 3

ICH Q10 was published in 2008, and presented a model for an effective Pharmaceutical Quality System (PQS). However, the industry still has some way to go in embracing and implementing its principles in order to achieve greater product realisation, to establish and maintain a state of control, and to facilitate continual improvement.

ICH Q10 introduced us to two key enablers: Knowledge Management (KM) and Quality Risk Management (QRM).^[1] While the pharmaceutical industry has made progress in implementing the principles of QRM since 2008, there has been significantly slower progress in implementing knowledge management practices. However, there may be solutions …

Managing Risk And Knowledge: Frameworks To Guide Knowledge-Enabled Technology Transfer, Martin Lipa Dr, Anne Greene

Level 3

Technology transfer is not only about the transfer of technology, but also about the transfer of knowledge, as evidenced by definitions of KM within the biopharma industry and beyond. However, knowledge transfer is often not well structured and its effectiveness – in particular for tacit knowledge (i.e., know how) – is an opportunity for improvement which can lead to many benefits. This article profiles recent research into the topic of improving knowledge transfer during technology transfer and presents several recently developed frameworks for improving such. The article furthermore explains how the frameworks can be co-deployed in support of robust knowledge …

Exploring Pathways From Data To Knowledge To Insights In The Pharmaceutical Industry: ‘Introducing The Pharmaceutical Knowledge Ecosystem’, Melanie J. Adams, Paige E. Kane, Anne Greene (Editor), Martin Lipa

Level 3

The ecosystem of how the pharmaceutical industry acquires data, transforms these data into tangible knowledge, and derives valuable insights throughout the process, is highly complex. Data, information, knowledge, and the resulting insights, are necessary to support decision- making, manage risk, problem solve, ensure product realisation, enable continual improvement, and enhance operational effectiveness. Building on the fundamental concepts established in the well-known Data Information Knowledge Wisdom (DIKW) hierarchy, this paper reviews the basic concepts involved in the DIKW pathway and begins to relate these concepts to both established capabilities (e.g., PAT), existing requirements (e.g., data integrity), and emerging trends in the …

Improving Risk-Based Decision Making (Rbdm) Effectiveness Through A Framework Which Integrates Knowledge And Risk, Martin Lipa, Valerie Mulholland, Anne Greene (Editor)

Level 3

This paper explores the emergence of the importance of knowledge in Risk-Based Decision Making (RBDM) and Quality Risk Management (QRM) through a detailed review of ICH Q9(R1) (Step 2) and presents a framework(the RKI cycle) to integrate knowledge and risk and associated six principles to operationalise it.

“Transitioning Organisations From A Data Quagmire To Knowledge Nirvana Through The Digital Thread”, David Twohig, Barry Heavey

Level 3

Historically, organisations have managed product data in a combination of Microsoft Office, Sharepoint and Document Management Systems. In this paper, we explore how different technologies can be leveraged to create digital product profiles, and in doing so structure data to enable effective knowledge management.