DIA’s Post

🚨 Last chance! The early bird rate for the DIA India Annual Meeting 2024 ends tomorrow. Don't miss out on reduced rates for a conference packed with insights into the fields of pharmacovigilance, regulatory sciences, clinical innovation, medical devices, and more. Join the conversation with key stakeholders and explore how Artificial Intelligence (AI) and technology are transforming healthcare. Secure your spot now: https://bit.ly/4bR5YM0. #DIAIndia #Pharmacovigilance #Clinical #RegulatoryAffairs #MedicalDevices

The DIA India Annual Meeting 2024 is set to provide unparalleled insights into the fields of Pharmacovigilance, Clinical Innovation, Regulatory Sciences, and Medical Devices. This year, you can look forward to in-depth discussions on critical topics such as the latest developments and regulatory challenges in medical devices, risk mitigation strategies for chemotherapeutic agents, and the transformative role of AI and technology in healthcare. Engage with leading experts and decision-makers to explore the latest challenges and opportunities in these fields. The early bird registration deadline is approaching quickly. Secure your place today to benefit from reduced rates: https://bit.ly/4bR5YM0. For more insights, watch our Programme Committee Chair, Prof. Moin Don, as he highlights the key benefits of attending this conference. #DIAIndia #Pharmacovigilance #Clinical #RegulatoryAffairs #MedicalDevices

Real-world evidence (RWE) is a technique for acquiring information from medical records and other sources regarding how a treatment works in practice. RWE can help researchers comprehend practical results beyond what they see in studies, allowing them to make better decisions about which therapies to offer. In reality, the FDA uses RWE to help make choices on drug approval and label amendments. Real-World Evidence Solutions in India is helpful for clinicians and patients to make educated treatment decisions. It is important to remember that RWE does not replace clinical trials, but rather commonly supplements and complements them in order to increase therapeutic knowledge. RWD comprises a large and diverse set of raw source data relating to patient health status or healthcare delivery in real-world contexts. RWD and RWE have applications throughout the clinical development life cycle, from the NDA stage to post-market safety monitoring. For more info visit:https://bit.ly/3XBdAxL #realworldevidence #realworldevidence #realworldevidencesolutions #rwdcompaniesindia #RWEsolutions #RWDcompaniesindia

The DIA India Annual Meeting is back and it's bigger and better than ever before! This year's event features a diverse array of tracks including Pharmacovigilance (PV), Clinical Innovations, Regulatory Sciences, and Medical Devices, each offering new and interesting topics. Whether you're looking to deepen your expertise, stay up to date with the latest industry trends, or network with professionals, there's something for everyone. Don’t miss this opportunity to enhance your knowledge and connect with industry leaders! #DIA #Pharmacovigilance #MedicalDevices #Clinical #RegulatoryAffairs #MedicoLegal #GenerativeAI #PatientSafety

Why Real World Data (RWD) collection? Data collected in controlled randomised studies provide rigorous evidence of efficacy and safety of a drug. Due to their strict criteria, patient populations and treatment routines are often not perceived as reflecting standard clinical practice. That makes it vital to obtain Real World Data relating to patient health status and delivery of health care. RWD sources, such as... electronic health records (EHRs) health monitoring devices product and disease registries etc. Challenges of implementation of RWD in pharmaceutical development? 💡 Availability and access to high quality, reliable and relevant data 💡 Respecting patients' rights to privacy 💡 Trust and transparency #rwe #pharma #evidencebasedpractice #digitalhealth #realworldevidence

A strategic initiative has been proposed to streamline drug approval processes in India, aligning with global standards. This approach aims to reduce delays in introducing new medical treatments, enhancing patient access to innovative therapies and reinforcing India's role in global clinical trials. Swipe to know more. #indianpharma #drugapproval #medicaltreatment #patientaccess #globalindustry #pharmaceuticalindustry #clinicaltrials #healthcare #EMR #EMRhealthcare #claight #expertmarketresearch

Tool improved for exploring #Medicines #RegulatoryScience: added document-level combinations of queries into text units of European Public Assessment Reports (EPARs) - many thanks to Marcia Rückbeil for the question. See 'Assessment analysis' at

🌟 Exciting News! 🌟 I'm thrilled to share that I've successfully completed the 𝐈𝐧𝐭𝐫𝐨𝐝𝐮𝐜𝐭𝐢𝐨𝐧 𝐭𝐨 𝐆𝐨𝐨𝐝 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐏𝐫𝐚𝐜𝐭𝐢𝐜𝐞 course offered by 𝗡𝗼𝘃𝗮𝗿𝘁𝗶𝘀! 🎓🔬 🔍 𝗪𝗵𝗮𝘁'𝘀 𝗜𝘁 𝗔𝗹𝗹 𝗔𝗯𝗼𝘂𝘁? This 𝟑-𝐰𝐞𝐞𝐤 𝐜𝐨𝐮𝐫𝐬𝐞 delves into the fundamental principles and practices of 𝐆𝐨𝐨𝐝 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐏𝐫𝐚𝐜𝐭𝐢𝐜𝐞 (𝐆𝐂𝐏). As we know, GCP is 𝐞𝐬𝐬𝐞𝐧𝐭𝐢𝐚𝐥 for conducting clinical trials and ensuring the safety and well-being of human subjects. 📚 𝗖𝗼𝘂𝗿𝘀𝗲 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀: - 𝐊𝐞𝐲 𝐂𝐨𝐧𝐜𝐞𝐩𝐭𝐬: Explore the clinical trial process, the basics of good clinical practice, and the history of regulatory frameworks for medical treatment and testing. - 𝐃𝐫𝐮𝐠 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭: Understand the journey from drug development to clinical trials. - 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐅𝐫𝐚𝐦𝐞𝐰𝐨𝐫𝐤𝐬: Dive into the guidelines and requirements outlined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). 🚀 𝗪𝗵𝘆 𝗚𝗖𝗣 𝗠𝗮𝘁𝘁𝗲𝗿𝘀: Good Clinical Practice ensures the integrity and reliability of clinical trial data. As researchers, we play a crucial role in advancing medical knowledge and improving patient outcomes. Let's continue learning and contributing to the field! 💪🌍 #ClinicalResearch #ProfessionalDevelopment #LifelongLearning #GCP #NOVARTIS

Join a timely discussion on the value of clinical outcome assessment (COA) data in the context of patient-focused drug development and the many uses of COA data that can be leveraged beyond a typical COA strategy that will be held during next week’s short course “Leveraging Clinical Outcome Assessment (COA) Data to Maximize the Value of New Treatments Beyond Labeling.” Hear from experts on how COA data have the potential to influence overall licensing and HTA decisions, as well as policy decisions, clinician prescribing, and patient treatment choices. https://ow.ly/y62H50SiUC8 #clinicaloutcomeassessment #patientfocused #drugdevelopment

There has been significant concern and reaction against the Indian government regarding the approval of certain medicines deemed unsafe. Critics argue that regulatory processes may prioritize speed over safety, potentially compromising patient health. Activists, healthcare professionals, and the public have raised voices through protests, social media campaigns, and calls for stricter regulations. They advocate for transparency in drug approvals and more rigorous testing to ensure that medications are both effective and safe for use. The debate highlights the broader issues of public health, accountability, and the need for reform in the pharmaceutical regulatory framework in India.