ARCS Australia’s Post

🔔 New Implementing Act on Information Exchange with EMA - Now Published! 🔔 📢 The European Commission has released the second implementing act, establishing key rules for cooperation with the European Medicines Agency (EMA) under the Health Technology Assessment (HTA) Regulation. 📍 Key highlights: This important step forward in the implementation of the HTA Regulation establishes the framework for sharing essential information. It covers areas such as planning and forecasting Joint Clinical Assessments (JCA) and Joint Scientific Consultations (JSC), as well as identifying the patients, clinical experts, and other stakeholders to participate in joint procedures. In addition, it provides direction on ensuring that any confidential information shared between the EMA, the HTA Secretariat, and the Member State Coordination Group is handled securely and protected at all times. 📅 Stay tuned for more updates on the evolving HTA landscape and how it may impact your regulatory strategy! With our expertise and extensive experience, we are well-equipped to support our clients. #HealthTechnology #JCA #JSC #EMA #Pharmaceuticals #Innovation #HTA #RegulatoryAffairs #ImplementingAct

On Tuesday, the 26th, the first session of the new Scientific and Economic Committee for Medicines (CSE) of the Italian Medicines Agency (AIFA) took place. The CSE is a unified body that has replaced both the Technical and Scientific Committee (CTS) and the Pricing and Reimbursement Committee (CPR), which previously operated in AIFA. The agenda for the inaugural meeting included: ✴ Presentation of the proposal for the Organization and Functioning Regulations of the CSE to the AIFA Board of Directors. ✴ Discussion on the implementation of Article 1, paragraph 224, Law 213/2023, (update of the PHT handbook (reclassification from drug class A/PHT to A) . This first session marks a significant milestone in the culmination of work initiated when the plan for the AIFA restructuring was announced by the Minister of Health on Nov 8, 2022. However, it remains to be seen whether the launch of CSE will indeed bring about the promised improvements in AIFA’s organisational efficiency 📈 Are you up-to-date with the latest in the #marketaccess and #pricing space? Check out our resources page for more insights ➡ https://lnkd.in/ee7u5_gQ #healthcare #pharma #aifa #medicines #patientaccess

Today, our RA Pharma Network focused on pediatric regulatory requirements and the key differences between the US and EU frameworks. Thank you to Jonas Henningsen for leading this session. Learn more about our professional networks through the link in the comments below. #network #mediconvillage

We are pleased to share some exciting news from Synergen Bio. We are thrilled to announce that we have successfully undergone a highly challenging EMA inspection from April 16th to April 20th, 2024,conducted by two regulatory authorities simultaneously: The Federal Institute for Drugs and Medical Devices (BfArM) and the Danish Medicines Agency (DKMA). It was a comprehensive inspection comprising multiple studies and involving 4 inspectors. The scope encompassed full studies, and scrutiny extended to the inspection of CRO systems as well. This endeavour presented a significant challenge, rigorously testing both our team and our systems. This achievement serves as a testament to the unwavering dedication and seamless teamwork demonstrated within our organization. Our commitment to conducting studies with the utmost ethical standards and strict adherence to compliance for all major regulatory requirements remains steadfast. We express our sincere gratitude to our sponsors for their unwavering trust and collaboration. It's their confidence in our capabilities that drives our relentless pursuit of excellence. Learn more about us at www.synergenbio.com #QualityAssurance #BABE #Audit #DataIntegrity #ClinicalResearch

Developing complex generics is no easy task—regulatory pathways are often convoluted, and different health authorities like the FDA and #EMA have their own frameworks. This lack of alignment can delay access to these crucial medicines. However, a step in the right direction was taken with the launch of the FDA-EMA parallel scientific advice (#PSA) pilot program in 2021, designed to harmonize the approval process. But why have pharma companies not taken advantage of this program so far? Read the Op-Ed by Michael Banks to learn more about the challenges and potential solutions for complex generics. #ComplexGenerics #DrugDevelopment #HealthPolicy #RegulatoryAffairs

The programme of the 23rd #Regulatory Affairs Conference is online! Check it out ➡️ https://lnkd.in/d3RewRmG The conference will bring together key stakeholders, including leading regulators, industry experts, and European institution officials, to engage in discussions & debates on the regulatory challenges and opportunities that lie ahead. Register now and join us in Amsterdam on 27-28 February 2025! ➡️ https://lnkd.in/dqptZ2RF #RAC25 #Regulatoryaffairs #Genericmedicines #pharmaceuticallegislation #EUpharmaceuticallegislation #digitalisation #VariationsRegulation Medicines for Europe, Adrian van den Hoven, Beata Stepniewska, Trudy Beks, Cristina Romagnoli, Erika Zavan, Kate O'Regan, Beatriz S., Liana Petrosova, Loreleï L., Indiana Castro Alonso, Raluca Radu

🌟 Greath News! 🌟 The European Union is currently planning a revision of pharmaceutical legislation. In this process, the concept of the electronic format for patient information leaflets is introduced in the original proposal of the European Commission. In April 2024, the European Parliament voted on its position on this legislation. This position emphasizes that Member States can decide whether the package leaflet should be made available in both paper and electronic form, or only electronically.   We're thrilled to share an insightful article from #AESGP about the transition from paper to digital leaflets, making patient information more inclusive! 📱📄 This transformation is a significant step forward in providing accessible, up-to-date, and comprehensive information to patients, and we at Leaphy are proud to be at the forefront of this digital revolution. 🚀   At Leaphy, we are dedicated to ensuring that everyone has easy access to the latest Patient Information Leaflets (PIL) and other essential health services through our app. With this shift towards digital, we can offer more dynamic and engaging content that meets the diverse needs of patients today. 🌐💊   Join us in embracing this digital leap and learn more about how we're working to improve patient access to vital health information. Together, we're making healthcare more inclusive and accessible for all! 🙌❤️   #HealthcareInnovation #DigitalHealth #PatientAccess #Leaphy #InclusiveHealthcare #DigitalTransformation From paper to digital leaflets: making patient information more inclusive | AESGP https://lnkd.in/ewTKQWVA

Why are global drug developers choosing Australia to expedite clinical trials? (The answer goes beyond regulations.) Australia is known for its efficient trial environment, but navigating its unique landscape requires expertise. In this article, we explore the processes, partnerships, and precision that allow us to get trials up and running faster than ever. Read up on down under: https://hubs.ly/Q02Z1NTC0 #australia #clinicaltrials #clinicalresearch

#Didyouknow ✈✈ 𝑨𝒏𝒚 𝒄𝒍𝒊𝒏𝒊𝒄𝒂𝒍 𝒕𝒓𝒊𝒂𝒍 𝒆𝒙𝒑𝒆𝒄𝒕𝒆𝒅 𝒕𝒐 𝒃𝒆 𝒓𝒖𝒏𝒏𝒊𝒏𝒈 𝒃𝒆𝒚𝒐𝒏𝒅 30 𝑱𝒂𝒏𝒖𝒂𝒓𝒚 2025 𝒎𝒖𝒔𝒕 𝒃𝒆 𝒕𝒓𝒂𝒏𝒔𝒊𝒕𝒊𝒐𝒏𝒆𝒅 𝒕𝒐 𝒕𝒉𝒆 𝑪𝒍𝒊𝒏𝒊𝒄𝒂𝒍 𝑻𝒓𝒊𝒂𝒍 𝑰𝒏𝒇𝒐𝒓𝒎𝒂𝒕𝒊𝒐𝒏 𝑺𝒚𝒔𝒕𝒆𝒎 #CTIS 𝒕𝒐 𝒇𝒐𝒍𝒍𝒐𝒘 𝒕𝒉𝒆 𝒏𝒆𝒘 𝒓𝒆𝒈𝒖𝒍𝒂𝒕𝒊𝒐𝒏. The European Medicines Agency has published version 4 of the CTIS Sponsor Handbook, with updates on multifactor authentication and transition of #ClinicalTrials to the #CTR. ⚠️Remember 📍Sponsor organisations must determine whether a trial needs to be transitioned. 📍Sponsors must transition a trial from #EudraCT to CTIS if at least one of the following conditions is fulfilled: ✔the trial authorised under the CT directive is going to be submitted to an additional EU/EEA member state(s). ✔the EudraCT trial completion date is expected to be after 30 January 2025. 📍Only trials that meet the following criteria can be transitioned: ✔Interventional clinical trials in humans. ✔ Involve at least one site in the EU/EEA where the trial is still ongoing. ✔ No notification has been submitted regarding whether the trial has ended in the EU/EEA #clinicalresearch #goodclinicalpractice #drugdevelpment #pharma #pharmaindustry

Our session on “Optimal Strategies to Protect Commercially Confidential Information (CCI) in Clinical Documents and Reporting Trial Results Under Revised EU-CTIS Transparency Rules” is occurring in one week, and we want to make sure that you can attend! Register now if you want to learn: ✔️ Revised EU-CTIS transparency rules and how they impact redaction and disclosure activities in clinical documents. ✔️ Best practices for devising strategies to protect commercially confidential information (CCI) across clinical submission documents, including anonymization and redaction techniques. ✔️ How to effectively manage and communicate transparency expectations with internal and external stakeholders throughout the study lifecycle. ✔️ Practical usage of the CTIS portal to navigate and comply with evolving transparency requirements. Share this post with your network and register here: https://hubs.li/Q02TzPbl0 #OneMMS #DrugDevelopment #Transparency #CTIS #CCI #Pharma #EMA