Kalpana Badgujar’s Post

🎬 A few months ago, we explored the topic of biosimilars, and your enthusiasm was evident! Today, we're excited to present a comprehensive summary of biosimilars, their development process, and their impact on healthcare. Biosimilars are near-replicas of original biologic drugs, offering the same therapeutic benefits at a lower cost. They undergo rigorous development and approval processes to ensure they match the safety, purity, and potency of their reference products. Risk Management Plans (RMPs) play a vital role in maintaining biosimilar safety, with ongoing pharmacovigilance post-approval. Economically, biosimilars drive down healthcare costs and expand access to life-saving treatments, benefiting patients and healthcare systems alike. For more info check : bioxpllore.org #Biosimilars #HealthcareInnovation #CostEffectiveCare #Pharma #Biologics #PatientAccess #Pharmaceuticals #Biotechnology #MedicalAdvances #BioXplore #MarketAccess #HealthcareSavings #ClinicalTrials #RMP #Pharmacovigilance #HealthEconomics #MedicalResearch #LifeSavingTreatments

🖐 𝐅𝐢𝐯𝐞 𝐂𝐨𝐦𝐦𝐨𝐧 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐍𝐢𝐠𝐡𝐭𝐦𝐚𝐫𝐞𝐬?  🔔 👇 Check out what all can go wrong during pharmacovigilance 💡 Do you think any of these risks are avoidable? Let us know why and how in the comments below. ⬇️ 🔜 Interested in learning how to implement an effective Pharmacovigilance and Post-Market Surveillance strategy? 🌐 Join us for our upcoming free webinar: "𝐄𝐬𝐬𝐞𝐧𝐭𝐢𝐚𝐥 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐞𝐬 𝐟𝐨𝐫 𝐒𝐮𝐜𝐜𝐞𝐬𝐬𝐟𝐮𝐥 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐨𝐯𝐢𝐠𝐢𝐥𝐚𝐧𝐜𝐞 𝐚𝐧𝐝 𝐏𝐨𝐬𝐭-𝐌𝐚𝐫𝐤𝐞𝐭 𝐒𝐮𝐫𝐯𝐞𝐢𝐥𝐥𝐚𝐧𝐜𝐞" 🗓 Date: November 21, 2024 🕒 Time: 4:00 PM – 5:30 PM CET | 10:00 AM – 11:30 AM ET 👩🏫 Speaker: Dr. Manolo Ernesto Beelke 🎗️🇺🇳, Chief Medical Officer 𝐖𝐡𝐚𝐭 𝐘𝐨𝐮 𝐖𝐢𝐥𝐥 𝐆𝐚𝐢𝐧: ✅ Develop a comprehensive pharmacovigilance program. ✅ Recognize crucial signals and triggers for your post-market strategy. ✅ Safeguard your organization against expensive recalls and penalties. 🎓 All attendees will receive a complimentary certificate of attendance! Follow the link in the comments to register now! 👇 Seize this opportunity to equip your organization with the knowledge needed to thrive in pharmacovigilance. Register today! 🤝 About the Event Partner: Qualio is a premier eQMS software provider that empowers life science companies to achieve their market potential more efficiently. #GMP #Pharma #Pharmaceutical #Pharmaceuticals #Quality #Pharmaceuticalmanufacturing #QualioWebinar21112024

🖐 𝐅𝐢𝐯𝐞 𝐂𝐨𝐦𝐦𝐨𝐧 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐍𝐢𝐠𝐡𝐭𝐦𝐚𝐫𝐞𝐬?  🔔 👇 Check out what all can go wrong during pharmacovigilance 💡 Do you think any of these risks are avoidable? Let us know why and how in the comments below. ⬇️ 🔜 Interested in learning how to implement an effective Pharmacovigilance and Post-Market Surveillance strategy? 🌐 Join us for our upcoming free webinar: "𝐄𝐬𝐬𝐞𝐧𝐭𝐢𝐚𝐥 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐞𝐬 𝐟𝐨𝐫 𝐒𝐮𝐜𝐜𝐞𝐬𝐬𝐟𝐮𝐥 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐨𝐯𝐢𝐠𝐢𝐥𝐚𝐧𝐜𝐞 𝐚𝐧𝐝 𝐏𝐨𝐬𝐭-𝐌𝐚𝐫𝐤𝐞𝐭 𝐒𝐮𝐫𝐯𝐞𝐢𝐥𝐥𝐚𝐧𝐜𝐞" 🗓 Date: November 21, 2024 🕒 Time: 4:00 PM – 5:30 PM CET | 10:00 AM – 11:30 AM ET 👩🏫 Speaker: Dr. Manolo Ernesto Beelke 🎗️🇺🇳, Chief Medical Officer 𝐖𝐡𝐚𝐭 𝐘𝐨𝐮 𝐖𝐢𝐥𝐥 𝐆𝐚𝐢𝐧: ✅ Develop a comprehensive pharmacovigilance program. ✅ Recognize crucial signals and triggers for your post-market strategy. ✅ Safeguard your organization against expensive recalls and penalties. 🎓 All attendees will receive a complimentary certificate of attendance! Follow the link in the comments to register now! 👇 Seize this opportunity to equip your organization with the knowledge needed to thrive in pharmacovigilance. Register today! 🤝 About the Event Partner: Qualio is a premier eQMS software provider that empowers life science companies to achieve their market potential more efficiently. #GMP #Pharma #Pharmaceutical #Pharmaceuticals #Quality #Pharmaceuticalmanufacturing #QualioWebinar21112024

A MEDASSESSMENT CASE STUDY: Early Development Safety Profile Rescue 🌟 MedAssessment completed a case study on rescuing the early development safety profile of a small pharma company. In the pharmaceutical industry, small companies can sometimes face challenges when working with CROs, who may prioritize their larger clients. 💡 This case study highlights how MedAssessment was able to step in and resolve the issues that arose from the small pharma's involvement with a large CRO. Our team was able to provide personalized attention and tailor our approach to meet the specific needs of the client, resulting in a successful outcome. 🔬 By collaborating closely with the small pharma company, we were able to establish a more effective and efficient safety profile for their early development stage. This experience showcases the importance of choosing the right partner who understands and values your unique needs in the pharmaceutical industry. Visit our website for full case study details: medassessment.com #Pharmaceuticals #CRO #DrugDevelopment #SafetyProfile #casestudy #drugdevelopment #datascience #clinicaltrials #clinicalresearch #pharmaceuticalindustry #pharmacovigilance #medassessment

A MEDASSESSMENT CASE STUDY: In-Sourcing a Drug Safety Function Small, pre-market pharma is constantly challenged to stretch funding and investment across early drug development to approval. Find out how MedAssessment can help manage headcount stresses while providing the highest quality drug safety services. Visit our website for full case study details: medassessment.com #casestudy #drugdevelopment #datascience #clinicaltrials #clinicalresearch #pharmaceuticalindustry #pharmacovigilance #medassessment

𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐨𝐯𝐢𝐠𝐢𝐥𝐚𝐧𝐜𝐞 (𝐏𝐯) 𝐌𝐚𝐫𝐤𝐞𝐭 - 𝐀 𝐂𝐨𝐦𝐩𝐥𝐞𝐭𝐞 𝐆𝐮𝐢𝐝𝐞 𝐟𝐨𝐫 𝐭𝐡𝐞 𝐅𝐨𝐫𝐞𝐬𝐞𝐞𝐚𝐛𝐥𝐞 𝐅𝐮𝐭𝐮𝐫𝐞 𝘿𝙤𝙬𝙣𝙡𝙤𝙖𝙙 𝙎𝙖𝙢𝙥𝙡𝙚 𝘾𝙤𝙥𝙮 (𝙘𝙤𝙧𝙥𝙤𝙧𝙖𝙩𝙚 𝙢𝙖𝙞𝙡 𝙄𝘿 𝙥𝙧𝙚𝙛𝙚𝙧𝙧𝙚𝙙 𝙛𝙤𝙧 𝙩𝙤𝙥 𝙥𝙧𝙞𝙤𝙧𝙞𝙩𝙮)-https://lnkd.in/gTXM5vYm The Pharmacovigilance Market involves services and systems for monitoring, detecting, assessing, and preventing adverse drug reactions, ensuring drug safety throughout the lifecycle, from clinical trials to post-market surveillance. The Pharmacovigilance (PV) Market size was USD 7.1 Billion in 2023, and it is anticipated to grow to over USD 20.1 Billion by 2033, at a CAGR of over 10.9% during the forecast period. The Pharmacovigilance (PV) Market is rapidly gaining importance as the global healthcare sector intensifies its focus on drug safety and patient well-being. With the increasing complexity of pharmaceuticals and the rise in adverse drug reactions (ADRs), PV has become a critical component in ensuring that new and existing therapies remain safe and effective throughout their lifecycle. 𝐊𝐞𝐲 𝐓𝐫𝐞𝐧𝐝𝐬 𝐒𝐡𝐚𝐩𝐢𝐧𝐠 𝐭𝐡𝐞 𝐌𝐚𝐫𝐤𝐞𝐭: Regulatory Mandates: Stricter global regulations from authorities like the FDA, EMA, and WHO require ongoing monitoring of drugs post-approval, pushing companies to adopt robust pharmacovigilance practices. Technology Integration: The use of AI, machine learning, and big data analytics is revolutionizing adverse event reporting, making signal detection more accurate and proactive. Outsourcing: Many pharma companies are opting for outsourced pharmacovigilance services to manage growing workloads efficiently, ensuring compliance and reducing costs. Rising Biopharmaceuticals: With the increasing development of biologics and biosimilars, PV has become crucial in tracking long-term effects and ensuring patient safety. 𝐊𝐞𝐲 𝐏𝐥𝐚𝐲𝐞𝐫𝐬 Pfizer Roche Novartis Johnson & Johnson Merck Group Sanofi GSK AstraZeneca #Pharmacovigilance #DrugSafety #HealthcareCompliance #AdverseEventReporting #PatientSafety #ClinicalResearch #PharmaInnovation #Biopharmaceuticals #BigDataInHealthcare #AIInHealthcare #OutsourcingSolutions #MedicalRegulations #GlobalHealthcare

Hello Connections ✨ I am excited to share that I have been attended a very informative webinar on the Topic - "Importance of the Patient safety in Global Drug Development". Which is held on the 19th October 2024 by Indian pharmaceutical association Students Forum (IPA-SF) and the Clinosol Research Pvt. Ltd From the webinar the various things come to know us related to patient safety. As a pharmaceutical industries continues to evolve, in the Global Drug development Patients safety is always a top priority. Ensure the safety and efficacy of Medications is to protecting public health. Why patient safety matter - 1) Prevent adverse reactions 2) Prevent medication error 3) Build a trust between Patients Healthcare providers and industry , 4) Enhance drug development efficiency and effectiveness, etc. Let's prioritize the patient safety in Global Drug development and work together to ensure the safest and most effective treatments for patients world wide #Pharmacy #Patientsafety #Globaldrugdevelopment #IPASF #ClinosolResearch #Pharmaceuticalindustry #Healthcare #Clinicaltrials #Pharmacovigilance #Patientcentered #Patientcare

💡 **Understanding Type A Adverse Reactions **💡 In pharmacovigilance, **Type A (Augmented) Adverse Reactions** are often predictable and related to the drug’s known pharmacological effects. Here’s a closer look at how they manifest: 1️⃣ **Excessive Pharmacological Activity**: Sometimes, a drug may produce an exaggerated response due to **higher doses**, **drug accumulation**, or **individual sensitivity**. For example, beta-blockers given at high doses may cause bradycardia (slow heart rate). 2️⃣ **Secondary Pharmacological Activity**: These reactions arise when the drug’s mechanism affects systems beyond the target. For instance, opioids not only relieve pain but also suppress respiratory functions as a secondary effect. 3️⃣ **Rebound Effect After Discontinuation**: Abrupt cessation of certain drugs can lead to a **rebound effect**, where the symptoms the drug was treating return, often more severely. An example is the rebound hypertension seen after stopping antihypertensives. Being aware of these aspects helps improve therapeutic outcomes and enhances patient safety. 📊💊 #Pharmacovigilance #Pharmacy #AdverseEffects #Pharmaceuticals #Pharmacology #PatientSafety #PharmacyEducation #PharmaExcellence

The draft report of the CIOMS Working Group on Severe Cutaneous Adverse Reactions (SCAR) is now available for comments. The deadline for comments is Friday, June 7th, 2024. Working Group objectives: To establish a balanced, efficient, global perspective on SCAR detection, susceptibility factors, severity, outcome and probability through causality assessment tools, monitoring and management during the drug development and post-marketing phases. https://lnkd.in/d4ZVqp8u #SCAR #CIOMS #DrugDevelopment #PublicHealth #MedicalResearch #DrugSafety #Healthcare #clinicaltrials #clinicalresearch #pharmaceuticalindustry #pharmacovigilance #medassessment