Anna Graham’s Post

Fórum do Medicamento, which was supported by AstraZeneca Portugal, was once again the venue of choice for discussing key issues for the health sector. Not only were the data from the intermediate report of the National Index of Access to Medicines presented, confirming the challenges that the National Health Service continues to face, such as the shortage of human resources, an excessive administrative burden or the reorganisation of management models, which jeopardise access to medicines, but it was also debated the importance of the European Health Technology Assessment Regulation, with its numerous advantages and challenges. A moment of constructive debate that demonstrates the vitality of the health sector in Portugal and the commitment of its professionals to finding solutions to current challenges. #AstraZenecaPortugal #FórumdoMedicamento #AcessoaoMedicamento

Pharmacokinetics doesn't have to be an insurmountable challenge 🤯 I admit that during my college years, the Pharmacokinetics course didn't resonate with me—truthfully, it even traumatized me. That's why I was surprised to find myself captivated by a recent presentation on pharmacovigilance and pharmacokinetics 🤓 In a dynamic and straightforward presentation, Betânia Abreu Faria illustrated how her dual expertise—as a hospital pharmacist specializing in pharmacokinetics and as a pharmacovigilance professional—intersects and complements each other to ensure patient safety 🙌 Pharmacovigilance is not merely a reactive science; it is, and should be, proactive, aiming to minimize adverse drug reactions and their impact. In this mission, pharmacokinetics is an invaluable ally 💜

National Competent Authorities, including INFARMED, I.P. have endorsed a consensus statement on the status of the EU regulatory framework for medical devices. This statement outlines common priorities for future actions to implement and current challenges to overcome, and has been shared with the European Commission. #medicaldevices #invitrodiagnostic #MDR #IVDR #regulatory #regulatorycompliance

"CIOMS Cumulative Glossary with a Focus on Pharmacovigilance" The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, and non-profit organization established by the WHO and UNESCO in 1949. Its mission is to advance public health through guidance on health research and policy, including ethics, medical product development, and safety. 💻 Visit CIOMS website: https://cioms.ch/ 🤓 Follow Invitare Pesquisa Clínica 📌 Follow 'Recanto da Pesquisa Clínica' page for daily updates: https://lnkd.in/dEhjm_Tx #ClinicalResearch #ClinicalResearchSavesLives

Finding #solutions #together is essential in case of ending the commercialisation of #medicines. We share the concerns of some & believe that #dialogue is key to find timely, appropriate solutions for the manufacturer, healthcare providers and especially for #patients. Read our position: NL: https://lnkd.in/e4YQd9qW FR: https://lnkd.in/eYcgzb69 #geneesmiddelen #médicaments #santé #gezondheid #pharmastatus #België #Belgique #patiënten #patients FAMHP - Federal Agency for Medicines and Health Products APB-Association of Pharmacists Belgium-Association Pharmaceutique Belge-AlgemenePharmaceutische Bond Belga News Agency

Very good revision about #legibility #test. Clear point of view in the #regulatory journey of #drugs and #medicines Azierta | QbD Group Spain and Grupo QBD takes a step forward by sharing knowledge and content

What is wrong with importance? 👉 the Policy Rules Inducements Medicines Act 2018 🤷♂️ Because on April 8, 2024 the Dutch Minister of Medical Care published a letter to Dutch Parliament to better regulate transparency of financial relations and inducements. Back to 2018 Policy Rules Inducements Medicines Act 2018 (https://lnkd.in/ecqePyhm) was published to regulate financial relations with Healthcare Professionals. The requirements are more or less the same as in the CGR code of Conduct, and some references to the CGR Code are made as well. An important pillar for trustworthy financial relations is transparency, so in the Policy Rules it states that it is "[…] of importance that certain information from this written service agreement, referred to in Article 94, paragraph a, of the Medicines Act, is disclosed in the Transparency Register Healthcare."   Of importance “Of importance” in the context in which it is used in the Policy Rules is not a statutory obligation. The CGR Code requires reporting, but is mandatory for its members only. Meaning, if you are not a member of the CGR, then there is no obligation to report financial relations, not from the Policy Rules nor the CGR Code. Of importance but not obligatory 🤷♂️ (Note: the other party in the financial relation may have an obligation, which then should be addressed of course) New regulation on Financial Relations and Inducements (https://lnkd.in/eKUBagMU) The proposed regulations contain: - a statutory transparency register (addressing some concerns with the current register such as the “importance 🧐) (will this implement the proposed Wet Transparantieregister Zorg? https://lnkd.in/enqJps-T) -an increased role for the boards of healthcare providers -a better legal framework for sponsorship. Timeline ⏰ It will be some time until the proposed regulations take effect (late 2024 or 2025) so until then: -the current transparency register will be improved -IGJ will intensify enforcement of current rules 👮♀️

Clear & strong messages by the @Vereniging Innovatieve Geneesmiddelen in their latest publication “Medicines myths – and its consequences for the Dutch patient”. 👉 Medicine 💊 expenditure per capita has not increased for the past 18 years (adjusting for inflation) 👉 In the Netherlands, the share of medicines in total health care spending has declined in recent years. 👉 Value of innovative treatments is strong, providing health benefits rather than displacing care. #Innovative treatment options can lead to better health outcomes for patients. This has been truly seen in some diseases as #HIV – transformed from a deadly disease to a chronic condition thanks to innovative HIV treatment options. While de-mystifying myths is one step, it is time to work together to determine possible solutions. Through constructive dialogue we can create a sustainable environment that provides access to innovative treatment options. My colleagues & I at Gilead are ready to have a thorough discussion with all involved parties about how to improve access to innovative medicines in the future healthcare system

#Transparency in dealings between the industry and stakeholders is crucial. Last year, the betransparent.be search engine was considerably improved. This year, concrete measures have been taken to simplify #information for #patient associations. We have also adapted pharma.be's code of #ethics in line with the wishes of #patientassociations. Read about the newest stats here: NL: https://lnkd.in/eMdxn5tA FR: https://lnkd.in/edP6_dX9 #transparantie #transparence #pharma #farma #patiënten #patients #samenwerking #collaboration #vooruitgang #progrès #dokters #médecins #hôpitaux #ziekenhuizen #onderzoek #recherche #geldstromen #argent Guillaume Derclaye Xavier Counasse

PL6007/2023 can be a true game changer in the clinical research landscape for Brazil and Latin America. Brazil is a true reality in high quality enrollment for clinical research for a long time already - meaning a great volume of reliable data generated here, quality scientific professionals involved, regulatory authority, etc. With the law we expect more predictability and a streamlined assessment process for new trials while keeping an ethical and responsible approach to research. Activation times are to be reduced. All involved parties win. More to come. Want to learn more on the process, drop us a message and we will support! We are just a few steps before an important change. All stakeholders need to take part with responsibility. ABRACRO