i-Pharm Consulting’s Post

Rare but real... 🌍   Despite their rarity, the need for effective treatments is crucial.   Let's embrace everyone who is part of this process since today is World #RareDiseaseAwareness Day.   What makes orphan drugs so vital? 🧬   They treat rare conditions that often lack other effective treatments. This can offer hope to the patients and their families.   Orphan drugs often pioneer new treatment approaches. They are pushing the boundaries of medical science and research.   Many countries offer incentives for orphan drug development. That helps bring treatments to market for a limited patient population.   As healthcare professionals and industry colleagues, our role is to support the development and accessibility of orphan drugs.   Let's continue to push the boundaries. We can advocate for the needed support. And ensure that no patient is left behind.   Just because their condition is rare.   But real.   Do you have any experience with orphan drugs?   👣 Take your PV to the #NextLevel with us! 🚀   #NextPVUniversity   #HealthcareInnovation #OrphanMedicines #Orphan #RareDisease #OrphanDrugs #RareDiseases #Pharmacovigilance #PatientCare

Primum Non Nocere isn't just a slogan, it's the heartbeat of patient safety in pharma. As a physician, I've always lived by the ancient Greek principle of "Primum Non Nocere" - First, Do No Harm. It's not just a fancy Latin phrase; it's the very foundation of medical ethics that has guided healers for millennia. In clinical practice, this principle is deeply personal. We carry the weight of every patient outcome, good or bad. But in the pharmaceutical world? The stakes are exponentially higher. Imagine the ripple effect of a single mistake in pharma - it could impact thousands, even millions of lives. That's why I'm in awe of the robust pharmacovigilance systems in place at pharmaceutical companies. It's not just a department; it's a mission-critical operation that spans the entire lifecycle of a drug. From the earliest stages of R&D to long after a drug hits the market, an army of experts - pharmacists, chemists, statisticians, biologists, and yes, physicians like me - work tirelessly to ensure patient safety. We're not just ticking boxes; we're the guardians of public health. As physicians in pharma, our clinical background is our superpower. We bring real-world insights to risk-benefit analyses, helping to decode complex safety signals and ensure regulatory compliance. We're the translators between lab data and human impact. Every day, I'm reminded that "Primum Non Nocere" isn't a constraint - it's a call to action. It pushes us to innovate responsibly, to question relentlessly, and to never lose sight of the faces behind the data. In the high-stakes world of pharmaceutical development, this ancient principle isn't just alive; it's the very heartbeat of everything we do. It's not just our job to develop drugs; it's our duty to develop them safely. So the next time you take a medication, remember: behind that pill is an entire ecosystem of professionals, all united by a single, powerful idea - First, Do No Harm. In pharma, it's not just a principle; it's our way of life. #PatientSafety #Pharmacovigilance #HealthcareInnovation #MedicalEthics #TevaNexter

Have you checked out our blog post on developing careers and medical jobs in the rare disease sector yet? 💉 In the blog post, we discuss hands-on experience and the ways that employers can offer this to new minds in the industry to give them the exposure they need Why is hands-on experience so crucial to the development of careers in medical jobs in the rare disease sector? _____________________ Check out the doc below to see what we think and read the full article here: 🔗https://lnkd.in/eNHWJV9q #raredisease #medicaljobs #iPharm

Patient Centricity and Access Programs - It’s all about the patients! Patient centricity is fundamental when we run an access program at BAP Pharma and is essential for delivering an effective, compassionate, and ethical program. To ensure the focus is on the patients: · We tailor the program to meet the specific needs of the patient. · We offer full support and transparency throughout the ordering experience. · We ensure timely access to treatment for patients by streamlining the enrolment and approval process to avoid any unnecessary delays. · We collect Real World Data (RWD) to help companies better understand the impact of their medicine. · We involve patient advocacy groups where possible to better understand patient insights and needs. Our experts in Early and Managed Access Programs (EAP/MAP) can assist and support your efforts to bring critical treatments to patients in need, ensuring they get the medicines they need, when they need them, anywhere in the world. To learn more about our Access Programs, contact us at BD@BAPPharma.com or visit our Medicines Access Web Page at https://lnkd.in/ewSSN2zH #patientengagement #patientadvocacy #healthcare #medicine #biotechnology #pharmaceuticals #expandedaccess #rarediseases #raredisease #drugdevelopment

Last week, we were taking a look at clinical trials and the importance of data quality in early-stage trials. 📈 We asked you what you think the biggest challenge in early-state clinical trials is and the results are in! With 37% of you voting that ensuring high-quality data is the biggest challenge, and 31% voting for consistency across trial sites, it is clear that opinions are divided and both these areas are of high importance during early stages. _____________ What do you think about these results? Leave your thoughts in the comments below! 💭 #iPharm #clinicaltrial #lifesciences

Interesting Clinical&Research Insight #2: 🌟 is Placebo is an empty drug?🤔 Placebos aren't always inert substances or empty pills! it can be the current standard of care or existing treatments. 🏥 For conditions like hypertension, where ethical guidelines prevent withholding treatment, placebos can be comparative treatments like a standard blood pressure medications. This allows researchers to assess new interventions against established practices, ensuring patient safety and ethical standards. 💡 Interestingly, placebo-controlled trials aren't just about comparing a new drug to nothing—it's about comparing its effectiveness against what's already considered effective in clinical practice. It's a delicate balance of science and ethics in healthcare research! 🌐⚕️ #Placebo #Clinical_Trials #Medical #Ethics #Healthcare #Research #Hypertension #Treatment #drug #pharmacovigilance

NITI Aayog’s Expert Group recommends CDSCO to be made an independent regulatory authority. Recommendations for Strengthening India's Pandemic Response: • Regulatory Reform: Make the CDSCO an independent regulatory authority with enhanced powers and a focus on accelerating approvals for innovative products. • Mission on Therapeutics and Drug Development: Launch a dedicated mission to drive research and development in this area. • Regulatory Harmonization: Develop a well-harmonized regulatory system with global regulators to facilitate mutual acceptance of regulatory data. • Clinical Trial Network: Establish a robust clinical trial network to expedite drug and device development. • Subject Expert Committees (SECs): Strengthen SECs with technical expertise and training. • Supply Chain Resilience: Build a resilient supply chain for essential components and indigenous manufacturing of medical supplies. • Community Engagement: Develop strategies for working with communities and the private health sector to manage public health emergencies. • Institutional Framework: Establish a Special Pandemic Preparedness and Emergency Response Fund, an Empowered Group of Secretaries (EGoS), and institutionalize the Epidemiological and INSACOG framework. • Research and Development: Invest in a High-Risk Innovation Research Fund, establish a Vaccine Science & Development Institute, and initiate Priority Pathogen research. • Capacity Building: Implement a well-established capacity-building training program at all levels. Innovate Research #fmcg #innovateresearch #Vaccines #Dengue #medicalwriting #datamanagement #regulatoryservices #projectmanagement #clinicaloperations #sitemanagement #biostatistics #biospecimen #studyfeasibility #research #cro #biospecimen #pharmaceuticals #drugsafety #drugdevelopment #clinicaltrials

🌟𝗛𝗼𝘄 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗟𝗶𝘁𝗲𝗿𝗮𝘁𝘂𝗿𝗲 𝗥𝗲𝘃𝗲𝗮𝗹𝘀 𝘁𝗵𝗲 𝗜𝗺𝗽𝗮𝗰𝘁 𝗼𝗳 𝗗𝗿𝘂𝗴 𝗔𝗱𝗺𝗶𝗻𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝗼𝗻 𝗦𝗽𝗲𝗲𝗱 Discovering unique cases in medical literature 📚shows that adverse reactions depend on the drug and how it's given. While many know about "red man syndrome" from fast vancomycin infusions💉, the 𝘿𝙧𝙪𝙜𝘾𝙖𝙧𝙙 𝙥𝙡𝙖𝙩𝙛𝙤𝙧𝙢 recently uncovered a rare yet serious side effect linked to rapid midazolam administration. 🔥For #pharmacovigilance experts and #healthcare professionals, these real-world insights from literature are invaluable for improving patient outcomes and enhancing drug safety protocols. #drugsafety #patientsafety

What factors influence the quality of adverse event reports submitted to #VigiBase? The completeness of adverse event reports is measured using the vigiGrade completeness score in VigiBase, the World Health Organization global database of adverse event reports for medicines and vaccines. In JMIR Publications Medical Informatics, UMC's Daniele Sartori and colleagues in Malaysia and Taiwan utilise machine learning and time-series analyses to determine the driving factors behind Malaysia's high vigiGrade completeness score. Open access article 🌐 doi.org/10.2196/49643 #MachineLearning #pharmacovigilance

Big Pharma has been increasingly aware of the need to conduct clinical trials in diverse populations, including those in low- and middle-income countries. This awareness stems from the desire to ensure that medications and treatments are effective and safe for all populations, not just those in high-income countries where most trials traditionally take place. However, there are challenges in conducting trials in these regions, including regulatory hurdles, logistical issues, and ethical considerations. Big Pharma companies often face these challenges when trying to implement clinical trials in resource-poor countries. VitaCore Solutions can be a trusted partner for Big Pharma companies looking to conduct clinical trials in poor countries. We can together contribute to improving healthcare access and outcomes in these regions. #GlobalHealth #VitaCoreSolutions #Collaborations #MedicalAffairs