Happy Canada Day from WCG! Our Canadian Board provides comprehensive IRB review services for clinical studies conducted in Canada. In compliance with Canadian regulations, a majority of IRB members on our Canadian board are Canadian citizens or permanent residents. Their reviews are conducted in accordance with Division 5 regulations of Health Canada, the Tri-Council Policy Statement, International Conference on Harmonization (ICH) Guidance for Industry – E6 Good Clinical Practice: Consolidated Guideline, and U.S. CFR Title 21 Parts 50 and 56 and CFR Title 45 Part 46. WCG is committed to advancing Canadian #clinicaltrials. #CanadaDay #WCG #IRB #IRBreview
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The European Access Academy (EAA) is a crowd funded, self-organised initiative aiming to facilitate and further support the development of a joint European Value Framework.
Last chance to register for the EAA Fall Convention! Don't miss out on your opportunity to discuss the role of medical and learned societies, of clinical guidelines, the MCBS and the concept of best-available evidence in the context of EU HTA. Join our panel of esteemed experts and register now at euaac.org. #euhta #eunethta #healthpolicy #europeancommission
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Revised CTIS Transparency Rules are now effective with the launch of v 2.0.0 of the CTIS public portal - https://lnkd.in/exuGiBgA Fantastic to see information on over 4000 clinical trials in the EU! In addition, updates to ACT EU guidance have also been released today to align with the revised CTIS transparency rules coming into effect: Guidance on the protection of personal data and CCI in CTIS, version 2 18 June 2024 - https://lnkd.in/egdqJpn2 Annex I to the above guidance - https://lnkd.in/eVzYfYNf EMA quick guide on the Revised CTIS transparency rules and Historical trials -https://lnkd.in/erpcFTsS #IQVIA #CTRM #ACTEU #Transparency #clinicaltrials Ann Markillie Christopher Bamford
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With less than a year to go until the launch of the Joint Clinical Assessment (JCA) in January 2025, its successful implementation relies on the readiness of each EU market and their willingness to incorporate the JCA into current HTA processes. In this article, written by Katherine Yang and Kate Gilbert, PhD, they look at how the SUSTAIN-HTA project aiming to bridge the gap between individual markets, the JCA and wider EU HTA updates, as well as the implications for manufacturers. Read the full article at our website: https://lnkd.in/ecwPE9SA #windrose #hta #jca #eu
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Author of the #1 best selling book on Medicare. :Dying to be Seen:The Race to Save Medicare in Canada. Member of the Writers’ Federation of Nova Scotia.
When informed consent is not informed consent.
Nova Scotia Mi’kmaq chief launches lawsuit alleging secret medical research CanadaHealthwatch.ca — Canada's hub for healthcare news 🍁 🔒 https://lnkd.in/gbtfWQgf .
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What did the latest text of the #EU #JCA implementing acts change? A little. But a little in helpful directions for making the JCA a more collaborative undertaking. See AESARA Europe's crisp summary below - and contact us for help with cross-functional training/awareness, process & governance design, or product-level PICO prediction, submission strategy and submission execution.
5x key #EU #JCA changes, in the revised text of the Implementing Acts voted on by member states on 30th April 2024: 1️⃣ 🤒 Patient expert selection could be via national HTA agencies if insufficient groups available at the EU-level; multi-country groups preferred 2️⃣ 🗓 Assessment scope will be issued just 10 days after D120 LoQ 3️⃣ 🙋♀️ HTD can now request a meeting to discuss scope, to take place within 20 days of scope publication 4️⃣ 📬 Dossier submission now 100 days after scoping (a whole extra 10 days!!) 5️⃣ 🔏 A review/appeal process for agreeing commercially confidential redaction in the final JCA is now allowed for - but no timeline is specified. Contact our Europe #HTA experts to discuss what these changes mean for you: Catherine Chamoux, Sameera Tak, Gavin Outteridge Ref: See Articles 6, 10, 11 , 12 and 20 of the 30th April text.
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To All ACRP Canada 🍁 Members: This is just a gentle reminder of next Tuesday's (12-Dec 12p ET) Canada Chapter event, the last of 2023; titled: Open Forum on ICF Challenges in Gaining Patient Consent. I've attached the flyer which contains the EvBr registration link in the top right. Hope you can join us. Please share with all your peers and network that I have missed. ACRP - Association of Clinical Research Professionals ACRP Canada Sassan Azad, M.Sc., ACRP-CP, PMP #clinicalresearch #clinicaltrials #clinicalstudy #humanresearch #Canada
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The 2022-2023 Medical Council of Canada Annual Report is now available, and this year’s central theme is "Inspiring confidence with transformative solutions.” Read the report to learn more about our organization and the new and ongoing projects we are leading to develop transformative solutions that will help achieve the highest level of medical care in Canada. ➡️ https://ow.ly/HmWS50Pt0iv #MedEd #annualreport
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Software, technology and IT are becoming more important within the medicines sector every year. Last week, the FAMHP organised an IT Directors Group meeting, bringing together the IT directors of the national medicines agencies. Through this meeting, technology cooperation between the different agencies can be further improved. Among other things, during the meeting it was discussed how the IT Directors Group can better support the activities of the national competent authorities by helping and guiding them through the changes coming within the IT field in the coming years. Thanks to this meeting, we will be able to continuously pursue new technological solutions for public health within the European Union. #EU2024BE
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A number of uncertainties remain as the roll-out of the EU HTA Regulation progresses. But, there are lots of things we do know. So far, seven of eight planned HTA methodology guidelines have been published, as well as all stakeholder interaction guidance and the joint clinical assessment submission and report templates. For a summary of the knowns and unknowns in this halfway point in the Regulation’s roll-out, download our latest whitepaper: #LumanityPerspectives #HEOR #HTA #EUHTARegulation
Half-time in the EU HTA Regulation roll out
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5x key #EU #JCA changes, in the revised text of the Implementing Acts voted on by member states on 30th April 2024: 1️⃣ 🤒 Patient expert selection could be via national HTA agencies if insufficient groups available at the EU-level; multi-country groups preferred 2️⃣ 🗓 Assessment scope will be issued just 10 days after D120 LoQ 3️⃣ 🙋♀️ HTD can now request a meeting to discuss scope, to take place within 20 days of scope publication 4️⃣ 📬 Dossier submission now 100 days after scoping (a whole extra 10 days!!) 5️⃣ 🔏 A review/appeal process for agreeing commercially confidential redaction in the final JCA is now allowed for - but no timeline is specified. Contact our Europe #HTA experts to discuss what these changes mean for you: Catherine Chamoux, Sameera Tak, Gavin Outteridge Ref: See Articles 6, 10, 11 , 12 and 20 of the 30th April text.
