Cavernoma Ireland’s Post

PN Update: Human medicines European public assessment report (EPAR): Exviera, dasabuvir, Date of authorisation: 14/01/2015, Revision: 26, Status: Withdrawn (authorisation)

Did you know that Pharmacovigilance (PV) plays a crucial role in building a pharmaceutical company's reputation and trust? By demonstrating a commitment to patient safety through continuous monitoring and risk management, companies not only comply with regulations but also earn the confidence of healthcare professionals, patients, and regulatory bodies. A strong PV system shows that safety comes first, enhancing credibility in an increasingly competitive industry. Pharmacovigilance is more than compliance—it’s a commitment to trust. #Pharmacovigilance #PatientSafety #PharmaIndustry #Trust #Healthcare

Do not miss out this opportunity to explore an array of reliance tools in this webinar on "Regulatory Reliance Tools Unveiled: A Practical Guide by EMA" and how they can enhance efficiency and collaboration across regulatory authorities.  #EuropeanMedicinesAgency #EMA #RegulatoryReliance #WHO #GlobalHealthcare Secure your spot by register here: https://lnkd.in/dsZxamt4 

Patients are at the center of all we do at Teva because #WeAreAllInForBetterHealth. And every year, we shine a light on the importance of patient safety by recognizing the World Health Organization’s World Patient Safety Day on September 17. We have a global Pharmacovigilance team that continuously monitors the safety of every Teva product worldwide. They collect and review drug safety events, and also address special situations related to the safe use of medicines. ✅ Before taking any medicine, it’s important to read the patient information leaflet that comes with it. This informs patients how to use the medicine in a safe and appropriate manner and includes the dosage, how often it should be given, and more. Discover more about patient safety at Teva: https://ow.ly/NAv750TlJy8 #SafeUseofMedicines #PatientSafetyFirst, #WorldPatientSafetyDay #Tevapharm

We have issued 5 infringement notices in the amount of $82,500 to the New South Wales based company Caruso’s Natural Health Pty Ltd, for an alleged failure to hold information or evidence to support 5 therapeutic uses in relation to 3 medicines. The therapeutic goods regulatory framework allows sponsors to supply certain low risk listed medicines to consumers without pre-market assessment of efficacy, quality and safety by the TGA. This is dependent on meeting certain regulatory requirements specified in the Therapeutic Goods Act 1989. Under the Act, sponsors of those listed medicines must, at all times, hold information or evidence that supports each therapeutic use for their medicine. Failure to hold information or evidence that supports the therapeutic uses for a listed medicine undermines the regulatory framework, potentially exposing consumers to avoidable risk. Sponsors must understand their legal obligations prior to including listed medicines in the Australian Register of Therapeutic Goods (ARTG) and must ensure that their listed medicines comply with the applicable legislative requirements at all times. Read more: https://lnkd.in/giitjjVs

Every day counts when it comes to access to life-saving medicines. In the EU, an EFPIA - European Federation of Pharmaceutical Industries and Associations  report reveals that reducing the time from CHMP recommendation to EMA approval by just 12 days could save 3,300 years of potential life. Behind that number lie untold stories of health restored, connections strengthened, and lives transformed. The cost of delays in medicine approval isn’t just about numbers—it’s about the priceless moments patients and their families lose each day they wait. These delays mean: • Lost moments of independence, well-being, and time with loved ones • Worsening health and emotional strain, impacting entire families • Greater pressure on healthcare systems and higher costs, felt by all • Lost potential for patients to engage in their communities, workplaces, and lives. Let’s work together to reduce these delays and ensure that patients don’t lose precious time—time that could be spent living with dignity, independence, and hope. #HealthcareAccess #PatientAdvocacy #InnovationInHealthcare #healthequity #teameveryone

#EMA released a new guidance on #RWE in April 2024! 🌟 Discover how Real-World Evidence is transforming regulatory decision-making in human medicines. 📊💊

Regulatory update 🔔: Medicines and Healthcare products Regulatory Agency (MHRA) pre-submission advice and support guidance ➡️ https://ow.ly/KTUo50Thbli The MHRA offers a pre-submission service before applying for medicines Marketing Authorisations. The service provides stakeholders with the means to understand how the process of compiling and submitting applications and supporting evidence applies for their product/s. Find out more information on the process and how to access the to relevant forms in our August Regulatory Round-up ☝️ #CellTherapy #GeneTherapy #AdvancedTherapies

Medicines and medical devices play a crucial role in maintaining and restoring public health and well-being. Quality-assured products ensure their effectiveness, whereas poor-quality medicines and devices can fail to treat diseases, cause harm, and, in extreme cases, lead to death. Additionally, substandard medicines may contribute to drug resistance. National Medicines Regulatory Agencies (NMRAs) are tasked with the registration and authorization of safe, effective, and quality-assured products. To ensure that the quality of these medical products is upheld until they reach the patient, NMRAs implement post-marketing surveillance (PMS) programs. What are the biggest challenges faced by regulatory agencies in ensuring the effectiveness of post-market surveillance programs? #MedicalDevices #Healthcare #PatientSafety #PostMarketSurveillance #Innovation

📢 The European Shortages Monitoring Platform (#ESMP) is live! The platform is now available to marketing authorisation holders, who will be able to submit data on shortages of centrally authorised human medicines in the ESMP. ESMP is an important regulatory tool that will: 🔸 gather comprehensive information on the availability, supply and demand of human medicines 🔸 help to detect, prevent and manage shortages in the EU and the EEA 🔸 facilitate communication between EMA, national competent authorities and industry to ensure medicines are available for those who need them.   Learn more about what’s next for ESMP from our news announcement (link in comments). #publichealth #shortages #medicines #healthunion