International QA Virtual Conference Programme 2023

INTERNATIONAL QA VIRTUAL CONFERENCE 2023 23RD - 24TH MAY 2023 FULL PROGRAMME

INTERNATIONAL QA VIRTUAL CONFERENCE 2023 23RD - 24TH MAY 2023 *Please note programme is subject to change, view the RQA website for the most up to date times* TUESDAY 23RD MAY 2023 PLENARY SESSION 09.00 Conference Opening, Tim Stiles, RQA Chair 09.10 Sponsor welcome - Fabrizio Maniglio, Sparta Systems, a Honeywell Company 09.20 Keynote - Survival of the Fittest - A Darwinistic Take on the Evolution of Quality - Fabrizio Maniglio In this session, Fabrizio Maniglio will discuss how the life science industry is rapidly evolving and the importance of continually evolving the way we think about quality in order to ensure resilience and survival for a life science business in this climate.

GOOD CLINICAL PRACTICE: 11.00 Clinical Quality Management System (CQMS) for Operational Excellence & Compliance with GCP Amer Alghabban While ICH has provided a guidance on a QMS for pharmaceutical manufacturing (ICH Q10), no such ICH or regulatory guidance exists for CQMS. So far, this journey has mostly achieved Clinical Quality Systems (CQS) but not a CQMS. A proposal for a CQMS with defined principles and elements.

11.30 Death by CAPA - Oleg Shevaldishev Is a CAPA needed for all non-compliances / non-conformances / issues / audit findings in GCP area?

The easy answer is "no" - but what are the pros and cons for having too many (or too few) CAPAs? (A CRO perspective) 12.00 Modernisation of Clinical Vendor Oversight Through Effective Risk Management Tools – Natalia Buchneva Over the last 10 years, designs of clinical trials and methods of data collection became more sophisticated and it called for effective risk management and data surveillance tools to ensure adequate sponsor oversight. The use of various service providers which collect and process the primary endpoint data has significantly increased and there were new technological companies coming into the market without proper understanding of the ICH E6 R2 “Good Clinical Practice”. Traditionally, the sponsors are focusing on the amount of studies the vendor involved in to define the operational oversight. However, this approach does not support the recommendations of ICH E8 R1 for critical to quality factors which should focus stakeholders on risk-proportionate operational oversight and prospective identification of what matters for patient safety, feasible conduct of the study and data quality. Management of the multistakeholder activities are barely possible without central monitoring of 2 data, risk management system which will track risks, mitigations and issues relevant to vendors used in clinical trials.

In this presentation, the subjects matter experts will review scenarios for how to strengthen the clinical vendor oversight using Risk Management system and tools at the stage of vendor selection, risk assessment, defining the tailored oversight model and using the dashboards which can help monitor the performance of the vendors in clinical trial.

12.30 Lunch

14.00 GCP QA Clinic - GCP Committee Bring your GCP related questions and discuss them with the RQA GCP Committee.

15.30 Break 16.00 The Italian Non-Profit Phase 1 Clinical Trial Units: Present Challenges and Future Opportunities Davide Di Tonno Italian phase 1 units that want to conduct non-profit phase 1 clinical trials must be compliant with the international clinical trial-related guidelines and the Italian reference legislation, which requires specific quality standards and hospital organisation. In fact, the above-mentioned units must possess a Clinical Trial Quality Team that manages all aspects of a non-profit phase 1 clinical trial, from the regulatory submission process to study closure.

16.30 Update on the Regulatory Landscape of Decentralised Trials - Fatemeh Jami To provide an update on the regulations governing non-traditional trials and how we should be prepared to audit such studies.

17.00 Privacy and e/Consent - Profiles - Ivan Tosco e/consent is a way to replace paper-supported consent collection/documentation and offers opportunities to effectively enable transnational compliance in clinical trials; this may be achieved through the use of electronic signatures; this latter, however, is a tool not entirely harmonised between European Countries. The presentation introduces to a an Italian approach to achieving an effective harmonisation.

IT: 11.00 How to Leverage Supplier Input in CSA, New Insights from GAMP 5 2nd Edition and Updated ISO 27001 - Hans de Raad 2022 was a good year for updates on guidances and regulations in the IT/cyber domain, especially the focus on supplier involvement in CSA/CSV is of great benefit for organisations in the GxP domain.

11.30 Where ICHQ9 (R1) and GAMP5 2e Meet: Applying risk-based Principles to Maximise Efficiency in CSV - John Cheshire This presentation will explore the relationship between ICH Q9(R1) and GAMP 5 2e to establish where risk based principles and critical thinking can be applied. By focusing on effective quality risk management and defining a commensurate approach, CSV can become an efficient process which leaves burdensome blockers and barriers at the door!

12.00 Computerised System UAT: Faster and Easier - Anna Petrovskaya I'm going to share some ideas how to make PQ stage easier and faster. This is in line with the promoted risk based approach to computerised systems validation.

12.30 Lunch 14.00 IT QA Clinic Use of test tools in CSV - how does this impact the regulatory expectations for documented evidence Hans de Raad, Nina Häuselmann and Keith Thornley 15.30 Break

16.00 RQA IT Committee - Long-term perspective on digital transformation: Managing risks of digital obsolescence. What are current computing practices and a framework for long-term software care?

– Presentations and Expert Roundtable discussion - Nina Häuselmann, Hugh O’Neill, Natasa MilicFrayling, Richie Siconolfi, Hans de Raad.

16.00 Introduction - Nina Hauselmann 16.10hrs Current Computing Practices - Hugh O’Neill 16.30 A Framework for Long-term Software Care - Natasa Milic-Frayling 16.50 Break 17.00 Expert Roundtable on the management of digital obsolescence.

Discussion of digital transformation planning practices and management of software lifecycle. Reflection on the existing and new processes for managing legacy software. Considering ways to remove obstacles for achieving longevity of data and reliable validation of research and studies – Hugh O’Neill, Richie Siconolfi, Hans De Raad, Natasa Milic-Frayling.

YOUR HEALTH: 11.00 Beating Stress at Work, Helen Moon As part of our Your Health, with RQA schedule, join Helen to learn some tips and tricks in putting yourself first and dealing with the stresses of working life.

12.30 Lunch FUTURE OF QUALITY: 14.00 A Comparison of Criteria used to Define Real World Non-Interventional Studies - Jeffrey Kirsch When laying the foundations for assessing the quality of Real-World Non-Interventional Studies (RWNIS) it is important to know how these studies are defined. This presentation provides an overview of the different approaches and criteria applied by different agencies and organisations when defining RWNIS and how this may be influenced by their respective perspectives.

14.30 SmartConnected Devices - The Future of MedTech - Prem Iyangar The Internet of Medical Things (IoMT) is disrupting the medical device industry. The regulatory landscape in MedTech is also changing rapidly. This presentation talks about how IoMT is disrupting the MedTech industry and how can we ensure staying compliant with the regulations while constantly innovating and providing better patient outcomes.

15.00 Cultivating a Culture of Quality: Transforming your Organisation for the Better - Zillery Fortner 15.30 Break 18.00 Future of Quality Panel Session- Zillery Fortner and others ANIMAL AND VETERINARY PRODUCTS: 16.00 The Three Pillars - Quality, Safety & Welfare - Maryna Cronje 16.30 Fit for farm? Does livestock technology fit within a GCPv setting? - Lindsay Heasman 17.00 General Veterinary Q&A - Marci Murphy Bring your Veterinary products related questions and discuss them with the RQA Animal and Veterinary Products Committee.

WEDNESDAY 24TH MAY 2023 GOOD LABORATORY PRACTICE: 09.00 Roles and Responsibilities of GLP QA: OECD Advisory Document No.23 Perspective - Anand Pandya The presentation will discuss on the involvement by QAU in various activities at the test facility. By using a risk based approach is a recommended method to perform daily activities and evaluate the effectiveness of the audits performed at the test facility.

09.30 Risk-Based Assessment is a Novel QA Auditing Strategy - Hemangini Patel A risk-based strategy improves the quality of QAP and facility operations by detecting the risk at an early stage and focusing resources in a more proactive and effective manner.

10.00 Challenges to QA in the Era of Electronic Data - Smit Patel This presentation will discuss critical aspects of electronic data and challenges for QA auditor while conducting audit these data to ensure the GLP compliance 10.30 Break 11.00 GLP QA Clinic - Cate Ovington, Jane Elliston, Fiona Wilder, Sven Buckingham, Vicky Massie Bring your GLP related questions and discuss them with the RQA GLP Committee.

12.30 Lunch 13.30 The Key to Compliance? - Lisa Heely The "Key to Compliance?" will be a joint presentation by a Study Director and member of the Quality Assurance team. The presentation will explore how Study Directors and QA personnel can work together effectively and efficiently to ensure that studies meet the requirements of GLP and that GLP compliance within the facility is maintained.

14.00 Inspection Hot Topics - Emma Whale, MHRA Join Emma Whale from the MHRA to discuss currently GLP inspection hot topics.

15.00 Break 15.30 OECD 23 Changes and How QA can Address These – Sven Buckingham and Lisa Heeley The OECD guidance #4 on the role of Quality Assurance was significantly revised and replaced by OECD guidance #23, issued in 2022. This presentation will highlight the key changes made and then discuss what impact these may have on a QA programme and how changing requirements could be implemented.

PHARMACOVIGILANCE: 09.00 How will ICH E-19 Affect PV Practice, Especially in Japan - Teiki Iwaoka ICH E19 which challenged to "Selective Safety Data Collection", reached to Step 4. What will be the influence to PV practice then? Analysis will be given focusing generally and also to Japanese pharma industries.

09.30 Assessment of IT Systems For Drug Safety - Shikha Jain The life sciences industry is still a long way from achieving 100% compliance (if it is even possible), especially considering that several important terms and derogations still need to be clarified in Member States' guidelines. But over the past six months, there has been a significant shift toward a positive attitude and readiness to comply with the GDPR standards, reinforced by greater governance, which is giving firms a solid internal structure to promote compliance.

10.00 To Identify Risk Factors Associated with Cybersecurity, Threats for Medical Device Functionality -Shikha Jain To reduce Cyber security threat companies need to implement procedures for restricted access, get rid of unwanted hardware, ensure signed software policies, encrypting sensitive information, conducting regular cybersecurity training for staff and for users will also need to continuously monitor network traffic along with incident response plan and trend analysis from previous identified issues.

10.30 Break 11.00 Auditing Automated and Manual Safety Case Processing Systems - Checks and Balances Graeme Ladds Safety case processing numbers continue to rise year on year with increasing demands for accuracy and completeness in order to determine safety signals as early as possible.

11.30 Ensuring Compliance Through the Establishment and Functioning of the QPPV Office - Gaurav Shah A QPPV is responsible for the establishing and maintenance of the pharmacovigilance system and does not necessarily have the bandwidth or expertise to perform all the activities by itself. Hence a QPPV needs to have access to experts’ resources in relevant areas. We aim to demonstrate how QPPV office can be setup to guarantee total control over the pharmacovigilance system.

12.00 Description of Pharmacovigilance System - Jana Hyankova 12.30 Lunch GOOD CLINICAL PRACTICE: 13.30 Inspection Findings - What can we Learn From Them - How to Analyse the Data to get the Most out of it - Loveleen Kukreja and Milind Nadgouda The Good Clinical Practice (GCP) inspection findings provide an opportunity for clinical trial organisations to gain valuable insights into their operations, identify areas for improvement and take targeted actions to address any issues. This PowerPoint presentation will focus on what can be learned from GCP inspection findings and how to analyse the data to get the most out of it.

15.00 Break 15.30 Training Compliance and the Emperor's New Clothes - Iain Searle This session will explore the topic of training compliance, take a ‘behind the scenes’ look at training records, and look at different ways organisations ensure people are competent and qualified.

16.00 Using Politeness Theory to Improve Outcomes in Audits and Inspections - Denise Lacey Have you ever been on either side of a contentious audit? In this session we'll adapt tools from "politeness theory" to avoid conflicts and help audits run more effectively for both auditors and auditees.

FUTURE OF QUALITY: 09.00 Answer the Two Most Often and not Expected to be Answered Questions: How to Measure the Quality here and I am Stuck, Not Sure Where to go, What to do - Willi Ramseier What is quality and how to measure it? Who is Boss – QA or resource management or business Process? Trust, why is it most important and how do I get it? How much can I as QA interfere?

09.30 Technology and Empowering your Company - Carmen Au The future of Quality is not only about control points and checking off boxes. It also means finding theright systems and leveraging its functionality to deliver high level of quality greater and foster organisational learning. This presentation will include two examples of tools we use to improve quality and communication: - Implementation of MS teams - Using project management application 10.00 Smart Quality: The New Paradigm - Filip Heitbrink Quality is seen as a necessary evil; a cost-heavy burden of doing business. The traditional mindset is focuses predominantly on compliance rather than on really knowing the root causes and effects of quality nonconformities. Smart Quality is a new methodology that empowers everyone in an organization to take ownership of quality, engage employees, and reduce compliance risk. In essence, it transforms Quality into a competitive advantage.

10.30 Break 11.00 Reflections on a New RQA SIG - Quality Practices for Real World Non-Interventional Studies -Jeffrey Kirsch An overview of the RQA RW-NIS SIG, it’s development over the past 24 months as well as highlights from SIG meetings will be presented. Future plans and outputs will be summarised as well as the results of a recent SIG membership survey. This will be of interest to all quality professionals working on RW-NIS who would like to know more about the RW-NIS SIG and what it has to offer.

11.30 How much do we know about Digital Healthcare? - Josipa Ljubicic QA in e-services is extremely important since QMSs are moving from paper to electronic. Companies are often faced with issues because systems are not prepared/validated, developers do not understand QA needs, Operational colleagues are not IT skilled, the migration process can be painful, etc.. This is the future of each corporation and how to set up the system in an e-environment should become more userfriendly. This presentation will explain how.

12.00 Quality in Dialogue with Quantification - Suzanne Studinger About the sense and nonsense of software supported and software-controlled processes, exemplified on the topics of requirements analysis, risk management, and testing. Ending with an excursion and questions about some “what if’s“ on QA within traditional as well as digital naive companies.

12.30 Lunch FUTURE OF QUALITY: 13.30 3 Steps to Compete in Digital Quality - Kevin Ballard Exclusive research from MasterControl reveals the current state of digitization in life sciences, the drivers and blockers for increasing maturity, and most importantly, how companies can gain a competitive advantage by digitizing their quality processes. We found that the most common reason for digitizing was to achieve a competitive advantage. However, to know whether you’re progressing, you need to have some way of determining where you are and measuring that progress. Enter the quality

management maturity model. In this presentation, you’ll learn the details of that model and where your peers in the life sciences rank on the digital maturity spectrum. We’ll discuss why becoming more digitally mature is so important to outpacing your competitors and what tools are available to help you do that. You’ll see how our original research can guide you through determining where you are and what your next steps should be.

REGULATORY: 14.00 IVD, CDx, LDT (IH-IVD): Challenges of the Current Regulatory Landscape - Alessandra Grande The IVDR is having a tremendous impact on all the involved stakeholders: devices manufacturer, compound Sponsors (for the precision medicine area), Notified Body. We would like to propose not only an update of the regulatory framework but also analyse what the regulation itself is implying for a special kind of IVD: the LDT (in house IVD).

14.30 Challenges in Chemistry Manufacturing and Controls (CMC) for Innovative Therapies - Rachel Harte This session will look at the various regulatory challenges associated with the Chemistry Manufacturing and Controls sections for innovative therapies. Development of innovative therapies and Advanced therapy medicinal products is complex and time consuming, timelines are often dictated by clinical outcomes and sometimes CMC development can struggle to keep up. We will review specific quality considerations for ATMPs and identify some of the CMC challenges frequently encountered. We will consider key strategies for developing robust CMC sections and outlines potential routes to avoid common deficiencies that can lead to a longer regulatory review cycle. The session will also provide some insights into global divergence in CMC requirements.

15.00 Break FUTURE OF QUALITY: 15.30hrs Healthcare Digitalisation – Maria Veleva The aim of the module is to provide some background information, real life examples of the practical implementation of digitalisation in HealthCare as well as bring light to some of the Key Benefits, Key Challenges and Key Trends of the Digital HealthCare of the future.

17.00 Close of Conference - Tim Stiles, RQA Chair

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