Praxis Australia Ltd | Non-profit organisation

Praxis Australia Ltd

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25.01.2022 Develop Excellence in Research Design and Practice... PRAXIS Australia's Research Essentials is a world class, competency based clinical trials and research training program composed of over 65 distinct online modules and electives. Learn more here: https://praxisaustralia.com.au/services/research-essentials/... Enrol now: https://praxisaustralia.com.au/enrol-now/

24.01.2022 Isnt this a glorious example of #respect for #research participants? Rather than the usual you are invited to participate in a research study opening on a #PICF, lets show empathy. Thanks @UKRIO and David Carpenter. #RECs #HRECs #IRB #consent #virtueethics

24.01.2022 Whats the best way to allocate scarce resources to growing populations in a pandemic? A lottery! Its the closest method to an #RCT, that supports equity of access. The use of #Remdisivir to treat #Covid19 is not without its challenges. Only limited amounts are currently available and allocation methods at the point of delivery largely dont factor equity. Nor do they support ongoing data collection about use and efficacy- information still critical for a drug whose use is b...ased on limited #clinicaltrial evidence. Lets hope countries given access to #Remdisivir use this opportunity to gather the data that is so necessary to fill the gaps in our knowledge about the disease. Link to JAMA discussion piece: https://lnkd.in/gZiwjZs #clinicaltrials #specialaccess #efficacy #safety #equity #randomisation

24.01.2022 PRAXIS Webinar Series: NEW RELEASE WEBINARS! Join PRAXIS and sector leaders as we address and discuss the following topics: The Changing Face of Consent to Research: Dynamic, Virtual and E-Consent ... Registration Link: https://us02web.zoom.us//register/WN_TdLv5-_2SE2z3TDLu4mirA Date: 24th August Session Time: 11-12:30pm AEST Disruption, Adaptation and Adoption: What does the new face of clinical trials look like? Registration Link: https://us02web.zoom.us//register/WN_jZqxC7cGRsekkG1c6kE7SA Date: 20th August Session Time: 11-12:30pm AEST PRAXIS' Free Webinar Series is generously supported by SMGCP, MTPConnect, the NSW Health Office for Health and Medical Research, SA Health Medical Education and Training Unit and our newest sponsor, Health Translation SA. PRAXIS would like to express our most sincere thanks to these sponsors for their generous support. Keep up to date with PRAXIS' latest offerings by subscribing to our mailing list here: https://praxisaustralia.com.au/contact/

23.01.2022 50 Words In Australian Indigenous Languages A new online resource- the 50 Words Project makes words from local Indigenous languages available for every Australian to hear and learn. Hear the words in local language via Sound Cloud. A constantly evolving repository. Celebrating and protecting Indigenous language and culture. ... Creators: Allyra Murray, Associate Professor Nick Thieberger, Dr Jill Vaughan, Kobe Atkinson and Professor Rachel Nordlinger #NAIDOC2020 #AlwaysWasAlwaysWillBe http://www.powertopersuade.org.au//50-words-in-a/9/11/2020

23.01.2022 Why RCTs (randomised clinical trials) are the safest, ethical way to find the best vaccine candidates compared to designs such as observational studies. Time is critical-yes. But there are trade offs for being fast in this race. #covid19research #clinicaltrials #trialdesign #researchethics #vaccines #drugdevelopment... https://www.sciencedirect.com//artic/pii/S0264410X20310483

22.01.2022 Our latest PRAXIS Australia Ltd FREE webinar is now open for enrolment! GCP for Medical Devices The third update to ISO 14155:2020 (Clinical Investigation of Medical Devices for Human Subjects Good Clinical Practice) was released in June and describes how to implement Good Clinical Practice (GCP) for medical device clinical studies involving humans. This version introduces changes that facilitate compliance to other international standards, such as #ICHGCP. But what are th...e key differences and what do you need to know? Join our guest facilitators, Tanya Symons (T Symons Associates) and Paul Christensen (Senior Clinical Program Manager at Medtronic), for this rapid update session, as we walk you through the standard and explore how it differs from ICH-GCP. Well outline the key changes incorporated in this revision and how these changes impact those working in clinical trials that involve the use of devices. Enrolment link is here: https://lnkd.in/g98mQ94 This series is generously sponsored by MTPConnect, NSW Health, Health Translation SA, Sophie Mepham GCP (SMGCP) and SA Health. #medicaldevices #GCP #clinicaltrials #regulatoryaffairs #regulatoryrequirements #medtech #praxisaus #fromcompliancetoexcellence

22.01.2022 Journal of Bioethical Inquiry: Covid19 Bioethics Symposium Following an extraordinary response from authors from across the globe, the Journal of Bioethical Inquiry is pleased to share the first set of remarkable articles from its symposium on social and ethical implications of the COVID-19 pandemic. Led by PRAXIS Australia Ltd Directors Ian Kerridge and Paul Komesaroff, and featuring many of our colleagues and contributors, the collection brings together global leaders i...n bioethics, who share their perspectives across 7 themes. I was thrilled to be invited to co-author a paper in this collection too; Science at Warp Speed- Medical Research, Publication, and Translation During the COVID-19 Pandemic. Link to collection here: https://lnkd.in/eUA_Zgg #covid19 #bioethics #symposium #openaccess #researchethics

21.01.2022 PRAXIS Australia | Virtual Workshop Series Browse all upcoming sessions in our series! 29th September: Animal Research Ethics ... *Limited spaces Enrol: https://praxisaustralia.com.au//animal-research-ethics-es/ 7th October: Productivity and Time Management Enrol: https://praxisaustralia.com.au//productivity-and-time-man/ 14th October: Quality Management Systems Enrol: https://praxisaustralia.com.au//quality-management-system/ 15th October, 3rd December: Privacy In Research Enrol: https://praxisaustralia.com.au//privacy-in-research-virtu/ 22nd October: Monitoring Approved Research Enrol: https://praxisaustralia.com.au//monitoring-approved-resea/ Tues, 10th November: Leadership and Management Enrol: https://praxisaustralia.com.au//leadership-and-management/ 18th November: Project Management Fundamentals *Limited spaces Enrol: https://praxisaustralia.com.au//project-management-fundam/ Spaces are filling quickly - claim yours now.

21.01.2022 Learn with PRAXIS Online! PRAXIS AUSTRALIA | New Release Virtual Workshop Series: 9th September $150pp... Virtual Project Management 29th September $150pp Virtual Animal Ethics 7th October $150pp Virtual Productivity and Time Management 14th October $150pp Virtual Quality Management 10th November $150pp Virtual Leadership and Management Further Information: https://praxisaustralia.com.au/services/virtual-workshops/ * Listed costs not inclusive of GST.

19.01.2022 Privacy In Research | Virtual Workshop | PRAXIS Australia Essential knowledge for Researchers, Research Managers and Coordinators, HRECs and Research Governance staff. Facilitated by Andrea Calleia, Salinger Privacy.... Background Ethical research requires consideration of privacy and confidentiality in research design and conduct. Federal, State and Territory privacy law delegates some important decision-making about when the use and disclosure of personal information will be legally allowed. What do these phrases mean? Where does consent fit in? When can privacy considerations be overridden? This 2-hour virtual workshop is specially designed to explore Federal privacy law, and its application to research. This virtual workshop is applicable to anyone involved in research design, conduct, ethical review and governance. Enrol Now: https://praxisaustralia.com.au/enrol-now/

19.01.2022 Updated Therapeutic Goods Administration Clinical Trial Notification (#CTN)User Guide V1.2, 21 August 2020 Changes: minor enhancements to items such auto-population of contact details, and updated submission process. Link to guide: https://lnkd.in/gGX4qQp... #clinicaltrials #CTN #drugdevelopment #deviceregulation #regulatoryaffairs

18.01.2022 Global Science v Global Equity: the challenges of testing #Covid19 vaccines. To rapidly and effectively test vaccines, they must be tested in regions where viral spread and case numbers are high. With Covid19, high incidence has been in groups or countries already marginalised or economically disadvantaged. If testing in these regions is necessary, then it is critical that protections for the vulnerable are robust and that post approval access to treatments, normally most ac...cessible to those who can pay, are also guaranteed. This article also highlights the benefits of countries having dedicated and sophisticated clinical trials facilities that are highly skilled in large phase 3 vaccine studies. Certainly missing in our Australian landscape and a real opportunity. Article: https://lnkd.in/gQesfWk #clinicaltrials #vaccines #bioethics #equity #vulnerability #respect #justice #beneficence

17.01.2022 Journal of Bioethical Inquiry-#covid19 Symposium Lead Essay: Inside the pandemic. Authors: Paul Komesaroff Michael Chapman Ian Kerridge Ross Upshur In the midst of an emergency we grapple as well as we can with the problems that present themselves. We formulate the issues to be decided on the basis of the extant knowledge and evidence, which are shaped by the theoretical and cultural frameworks within which they arise. We draw on the available resources, which are themse...lves marked by culture, politics, belief systems, and other factors. Our answers are partial and inchoate and often prove inadequate as the problems deepen and spread. But we keep trying, spurred on by our commitment to our history and traditions, our shifting value frameworks, and to each other. #bioethics #covid19research #research #researchethics

17.01.2022 International Journal of Bioethical Inquiry COVID-19 Special SymposiumPart 1 Co-edited by PRAXIS Australia Ltd Directors Ian Kerridge and Paul Komesaroff, and featuring many of our colleagues and contributors, the collection brings together global leaders in bioethics, who share their perspectives across 7 themes: overviews and provocations; society and the lifeworld; global perspectives; voices from different places; bioethical debates; clinical implications; and surveillan...ce and the panopticon. Read the lead essay and other symposium articles on the bioethical inquiry website: https://bioethicalinquiry.com/symposium-social-and-ethical/ #covid19 #bioethics #symposium #openaccess #researchethics

16.01.2022 The uncertainties continue! Recent Cochrane UK review reveals we are no closer to understanding a defined set of symptoms for the diagnosis of #covid19 . Read the report summary here: https://lnkd.in/gV-XXjx

16.01.2022 PRAXIS Australia | Virtual Workshop Series | New Session! 1st October | 10:00 - 12:00 midday AEST | $150pp 25th November | 10:00 - 12:00 midday AEST | $150pp ... Marketing and Communications: Building Your Research or Clinical Trial Brand This Virtual Workshop is designed to equip you with the practical skills and tools to feel confident communicating and marketing your clinical trial organisation. Presented by Luke Mead, Founder, IPM Media IPM Media Enrol Now: https://praxisaustralia.com.au/enrol-now/

15.01.2022 Monitoring Approved Research | Virtual Workshop | PRAXIS Australia This virtual workshop will consider local regulatory requirements and guidance related to monitoring of ethically approved research and clinical trials. It will allow students to better understand the role, purpose and function of monitoring in clinical research, and the role and responsibility of the institution and HREC and other key stakeholders including researchers and research support staff.... Through group discussion and case scenarios, we will explore expectations and requirements so that all students have a clearer sense of the role of monitoring as a critical aspect of clinical research practice. These sessions are applicable to : HREC Executive Officers Research Administrators Researchers Research Governance and Integrity Officers Research Managers/coordinators 22nd October | 10:00am - 12midday | $150pp plus GST Enrol Now: https://praxisaustralia.com.au/enrol-now/

15.01.2022 PRAXIS Australia | Research News Archives The latest scientific advances, updates and issues from the research ethics, clinical research and clinical trials sectors brought to you by PRAXIS Australia. Explore the PRAXIS News Archives: https://praxisaustralia.com.au/category/news/

15.01.2022 25th November: Marketing and Communications Virtual Workshop: Building Your Research or Clinical Trials Brand This Virtual Workshop is designed to equip you with the practical skills and tools to feel confident communicating and marketing your clinical trial organisation. 10:00 am - 12:00 midday, AEDST ... Facilitated by Luke Mead, IPM Media Session Outline 1. What is marketing and communications and why is it critical to your research? 2. Actionable marketing and communications strategies for research and clinical trials brands. 3. Building a successful marketing and communications team. 4. Measuring success with analytics. What previous students are saying about the session: "I really appreciate you sharing your knowledge in this area. I’ve always had some ideas on how to improve our engagement etc. on social media and via email but you’ve given me some tools and direction to be able to make this happen" "Thanks, an excellent presentation,informative and engaging presenters" "Another excellent module with fully engaged presenters with expert experience and knowledge sharing talents" "I thought the session was great! It was great to see what we are already doing as a business and what we need to do - action list is underway!" Learn More: t.ly/gm21 Enrol: t.ly/VVC8

14.01.2022 Brush-up on your understanding of Australia's animal ethics system... PRAXIS Australia | Virtual Workshop Series | Animal Research Ethics: Essential Knowledge Join us in an interactive virtual workshop that explores the ethics of animal research. The workshop is targeted towards research managers and ethics advisors and is also relevant to Animal Ethics Committee members.... Presented by Dr Tim Dyke, Chair, La Trobe University and Walter and Eliza Hall Institute Ethics Committees. 29th September, 2020 10:00AM - 12:00PM AEST $150PP (plus GST) View this offering on the PRAXIS website: https://praxisaustralia.com.au//animal-research-ethics-es/

14.01.2022 Manage your trials and research with greater confidence... PRAXIS Australia | Virtual Workshop Series | Project Management Fundamentals for Research and Clinical Trials This virtual workshop will introduce key elements of what it takes to manage projects successfully and methodically in a research or clinical trials setting. ... Facilitated by Dr Tim Tyke, Leading Well and Melanie Gentgall, CEO PRAXIS Australia. 9th September, 2020 10:00AM - 12:00PM AEST $150pp (plus GST) View offering on the PRAXIS website: https://praxisaustralia.com.au//project-management-fundam/

11.01.2022 Virtual Workshop | Animal Research Ethics Join PRAXIS in an interactive virtual workshop that explores the ethics of animal research. The workshop is targeted towards research managers and ethics advisors and is also relevant to Animal Ethics Committee members. 29th September | 10:00 - 12:00 midday | $150pp ... Session facilitated by Dr Timothy Dyke, Chair, La Trobe University and Walter and Eliza Hall Institute Ethics Committees. Learn More on Our Website: https://praxisaustralia.com.au//animal-research-ethics-es/ Enrol Now: https://praxisaustralia.com.au/enrol-now/ *Limited spaces remaining!

11.01.2022 PRAXIS now has a YouTube channel! We've received so many requests for links to our webinar recordings recently that we decided to create a dedicated channel to house them all. These recordings are publicly accessible, so no access passwords necessary. ... Enjoy the content, and please let us know if you have benefitted from these resources. PRAXIS YouTube: t.ly/Ahxe

11.01.2022 PRAXIS Australia | Virtual Workshop Series | Quality Management Systems: An Introduction Facilitated by Jaspreet Sidhu, Senior Project Manager, Clinical Trials and Melanie Gentgall, CEO PRAXIS Australia This webinar will introduce the essential elements of a Quality Management System (QMS), and provide you with the foundational skills to help you to develop a QMS locally.... Clinical Trials are conducted to collect the data necessary to provide information about the safety and efficacy of new treatments and interventions, that ensure that we as a society receive access to high quality, safe and efficacious treatments. Applying and adhering to Standards such as GCP and other local and international guidance provides a framework for compliance but what about the Quality element that is now an essential component of clinical trial conduct? As our sector is impacted by possible downturns in business related to Covid-19, now is a good time to review your internal processes and systems to ensure they are robust when we return to full operational capacity. This webinar will introduce the essential elements of a Quality Management System (QMS), and provide you with the foundational skills to help you to develop a QMS locally. 14th October, 10:00am - 12:00 midday AEST Enrol Now: https://praxisaustralia.com.au//quality-management-system/

10.01.2022 PRAXIS Webinar Series: Quality Management Systems: An Introduction. Date: Friday, 24th July, 2020. Time: 11:00-12:00pm. ... LAST CHANCE TO ENROL! There are two more days left to enrol in this session. This webinar will introduce the essential elements of a Quality Management System (QMS), and provide you with the foundational skills to help you to develop a QMS locally. Facilitated by Melanie Gentgall (CEO, PRAXIS) and Jaspreet Sidhu (Senior Project Manager, Clinical Trials). Link to immediate registration: https://us02web.zoom.us//register/WN_bPpDldJ9QnCjIy6RuIpe6Q

10.01.2022 CT:IQ Launches Series of eConsent Use Cases CT:IQ has launched a series of use cases illustrating successful implementation of eConsent in Australia, aimed to be used as a guide for researchers and HRECs seeking to develop and implement eConsent. Our review of use cases revealed that use of digital platforms clearly and unequivocally enhance the informed consent process and are equally if not more acceptable than traditional methods, says Professor Nik Zeps from Chrysalis ...Advisory. Visit CT:IQ's Website: https://ctiq.com.au/ CT:IQ

10.01.2022 Early Phase Trials in Australia: Lessons from the clinic Quality. Speed. Cost. Reliability. Experience. All factors that make Australia a sought after and highly regarded destination for early phase trials. But as the rest of the world navigates the continuing impacts of the Covid-19 pandemic on their clinical trials enterprise, Australia is even better positioned to capitalise on our strengths and capabilities. In this webinar we will hear from our Australian early phase t...rial sector experts working across healthy and patient cohorts and discuss how they have responded to the call for rapid vaccine research design, reviews, approvals, and implementation. Session Panellists Yvonne Lungershausen, Chief Executive Officer @ Avance Clinical Leanne Weekes, Programme Director @ Clinical Trials: Impact and Quality (CT:IQ) Jerneen Williams, Early Phase Clinical Trial Manager @ Bellberry Limited Dr Paul Griffin, Principal Investigator and Medical Director @ Nucleus Network Zoe Harrison, Chief Business Development Officer @ CMAX Clinical Research Zelda Herbst, Director of Cancer Trials @ Linear Clinical Research Date: Tuesday, 17th November, 2020 Time: 11:00 am 12:30 pm AEDST Learn More: t.ly/b13O Register Now: t.ly/Vuf2

08.01.2022 MTPConnect is holding its next Seminar Series event on Thursday, 27 August at 11-12:15pm AEST with a webinar How the R&D Tax Incentive Helps to Grow Your Business. With panellists from government and industry, its sure to be an interesting session. Register here: https://mtpconnect.zoom.us//regi/WN_uf0Au_ubSLGyvc3anoC9-g

06.01.2022 MTPConnect is holding its next Seminar Series event on Thursday, 30 July at 11-12pm AEST with a webinar Frontiers of Biomechanics and Human Movement. With panellists at the research level and in industry joining in the conversation, it's sure to be an interesting session. The link to register is here: https://mtpconnect.zoom.us//regi/WN_AlDeyLOhTLaOjB_-v4d6Ug

05.01.2022 We are back! Join us online for our next Australian #WhyWeDoResearch Tweetchat. Our theme: What is the new research normal? When: Thurs 13 Aug, 7-8pm AEST Where: Twitter - search for the #WhyWeDoResearch hashtag We love these chats and hope you'll join in the conversation.

05.01.2022 PRAXIS Australia | Virtual Workshop Series Project Management Fundamentals for Research and Clinical Trials New Date Added! ... 20th November, 2020 10:00am - 12:00 midday AEDT Spaces fill quickly! Enrol Here: http://ow.ly/x59s50ByAb8 $150pp plus GST

04.01.2022 PRAXIS WEBINAR SERIES: NEW RECORDING AVAILABLE Incase you missed out or just want to review what you learned, a session recording is now available for our most recent webinar: COVID-19, Clinical Trials and the Life Sciences understanding cyber and liability risks of the virtual and digital world. You can access the recording here on our website: https://praxisaustralia.com.au/praxis-australia-webinar-se/... A big thank-you again to our sponsors Lockton Companies and Newline for their support. It is much appreciated.

04.01.2022 More to do than you have time for?... PRAXIS Australia | Virtual Workshop Series | Productivity and Time Management: Reducing the Overwhelm Facilitated by Dr Tim Dyke, Leading Well and Melanie Gentgall, CEO PRAXIS Australia... Many of us feel that we have more things to do than we have time for, and frequently get overwhelmed with the growing list of emerging priorities and tasks. This is especially true for those working in research and clinical trials roles, which can be complex and always shifting. Join us as we explore what is causing our overwhelm and what leads us to procrastination. Well explore proven productivity and time management tactics and strategies to really make a dramatic improvement in reducing that sense of overwhelm. 7th October, 10:00am - 12:00 midday AEST Enrol Now: https://praxisaustralia.com.au//productivity-and-time-man/

04.01.2022 Lessons learned from the UK RECOVERY Trial about enhanced #clinicaltrial efficiency-without sacrificing safety. Link to Nature editorial : https://lnkd.in/d7D5pmy

04.01.2022 Welcome to The Power of One campaign! The White Coats Foundation is raising awareness about the important role clinical trials play in advancing medical science and healthcare. If you would like to contribute to The White Coats' campaign and help raise awareness visit: https://whitecoatsfoundation.org/powerofone/... Let’s see what the Power of One can achieve. #clinicaltrialsawareness #powerofone #medicalscienceadvancement White Coats Foundation

04.01.2022 PRAXIS Australia: Consent to Research Online Training Course CONSENT TO RESEARCH ONLINE TRAINING: This module will give you an understanding of the legal and ethical foundations of consent, about why consent is important in research and about different approaches to obtaining consent in different types of research and with different populations. View Offering on Our Website: https://praxisaustralia.com.au/services/research-essentials/

02.01.2022 PRAXIS Virtual Workshop Series Writing Clinical Trials SOPs Essential Skills Standard operating procedures (SOPs) are written formal documents that describe how an individual will perform a task, and how to document the performance of that task. ... They provide a set of how to instructions : what to do, how to do it, when to do it and how to document the completion of the activity. There are already many templates available publicly that sites can use to develop their basic menu of SOPs and there is never any point recreating the wheel. However, each study may require its own new SOPs or Operating Guidelines created to support best practice. In this workshop well provide you with guidance on getting started or improving your current SOP repository or format, with a focus on aligning to emerging requirements around Quality Management standards and principles as articulated in ICH GCP and other guidance including ISO 14155:2020 GCP for Medical Devices. What youll learn: 1. The role and purpose of SOPs and Operating Guidelines 2. How SOPs, operational guidelines and other internal guidance documents relate to each other. 2. How much detail should be included in each document; and 3. How each document is going to be implemented and appropriate oversight and review processes managed 4. Including Why incorporating quality and risk management principles into your SOPs What youll leave with: Renewed confidence in reviewing and improving your current systems and processes A better understanding of how to embed quality into your SOP repository A toolkit of helpful resources Facilitated by Melanie Gentgall, CEO PRAXIS and Dr Sophie Mepham, Executive Manager Research, ICON. $150pp* | Session 1: 9th October | Session 2: 11th December | 10:00 am - 12:00 midday AEST Enrol Now: https://praxisaustralia.com.au/enrol-now/

01.01.2022 Correct procedure for recording study drug administration in a #clinicaltrial is critically important. Its not just a signature and date on a log. Are you doing it right? Do your SOPs and work instructions for each study reflect correct and relevant information? The EMA #GCP forum has some useful advice.... Link: https://lnkd.in/gCm65z2 #GCP #clinicaltrials #investigationaldrugmanagement #praxisaus #fromcompliancetoexcellence

01.01.2022 Good Clinical Practice Train The Trainer: Creating a culture of GCP across and within organisations. Working in partnership, Sophie Mepham GCP (SMGCP) and PRAXIS Australia Ltd provide a unique model of TransCelerate BioPharma Inc. endorsed #GoodClinicalPractice (GCP) training tailored for all those involved in clinical research. This one of a kind Australian program supports institutions and their research staff to build the skills they need to plan and conduct their own #G...CP training programs, and is delivered in Australia under exclusive license from the NIHR. The program is supported by a mentorship program, regulatory updates and access to real time support. With the roll out of the Australian Commission on Safety and Quality in Health Care Governance Standard for #ClinicalTrials, never has there been a more important time to invest in an organisational wide approach to #GCP training. More info here, noting virtual training (at reduced cost) is used in areas where travel remains restricted: https://lnkd.in/gh3MPAH #gcp #clinicaltrials #regulatoryrequirements #education #praxisaus #fromcompliancetoexcellence