Akshar Global Clinical Research (AGCR)’s Post

This Sunday, March 24, is 𝗡𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗔𝗱𝘃𝗲𝗿𝘀𝗲 𝗗𝗿𝘂𝗴 𝗘𝘃𝗲𝗻𝘁 𝗔𝘄𝗮𝗿𝗲𝗻𝗲𝘀𝘀 𝗗𝗮𝘆, and the World Drug Safety Congress Americas team is proud to show our commitment and support in raising awareness about adverse drug events (A.D.E.). ❤️🩹 We recognize the importance of this holiday initiated by our Partner, the American Society of Pharmacovigilance, and learning more about the complicated topic of #adversedrugeffects to better understand their effects on humans and society. With this, we can best find solutions while lowering the possible cases of A.D.E. According to the Agency for Healthcare Research and Quality (A.H.R.Q.), A.D.E. is the “number one most costly and number one most preventable hospital-acquired condition.” Join the collective endeavor to raise awareness for #NationalAdverseDrugEvent and meet the faces of the American Society of Pharmacovigilance taking the #WorldDrugSafety stage this October in Boston: ⭐️ Benjamin Brown, Executive Director, American Society of Pharmacovigilance ⭐️ Sara Rogers, President, American Society of Pharmacovigilance 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 𝘁𝗼 𝗷𝗼𝗶𝗻 𝘁𝗵𝗲 𝗯𝗶𝗴𝗴𝗲𝘀𝘁 𝗻𝗮𝗺𝗲𝘀 𝗶𝗻 𝗱𝗿𝘂𝗴 𝘀𝗮𝗳𝗲𝘁𝘆 𝘁𝗵𝗶𝘀 𝗳𝗮𝗹𝗹: https://lnkd.in/gFzSXQf9 𝗣𝗵𝗮𝗿𝗺𝗮 𝗮𝗻𝗱 𝗯𝗶𝗼𝘁𝗲𝗰𝗵𝘀 𝗮𝗽𝗽𝗹𝘆 𝗳𝗼𝗿 𝘆𝗼𝘂𝗿 𝗰𝗼𝗺𝗽𝗹𝗶𝗺𝗲𝗻𝘁𝗮𝗿𝘆 𝗽𝗮𝘀𝘀 𝗵𝗲𝗿𝗲: https://lnkd.in/gFzSXQf9

🗣️ A packed room for "𝐒𝐢𝐠𝐧𝐚𝐥 𝐫𝐞𝐟𝐢𝐧𝐞𝐦𝐞𝐧𝐭 𝐮𝐬𝐢𝐧𝐠 𝐑𝐖𝐃" – a day 1 presentation from #WorldDrugSafety's 𝘈𝘐 & 𝘔𝘢𝘤𝘩𝘪𝘯𝘦 𝘓𝘦𝘢𝘳𝘯𝘪𝘯𝘨 track with Jeffrey Brown, Chief Scientific Officer, TriNetX! Real-world data (RWD) is essential in pharmacovigilance (PV), providing a rich source of insights into drug safety and patient outcomes beyond clinical trials. This talk explored how RWD can be effectively harnessed in PV processes, improving signal detection and safety monitoring. Jeff notes that as we enter an era of AI-driven innovation, it’s crucial to recognize that AI’s success depends heavily on the quality, quantity, and diversity of the data it processes. ✅💡🙌 Get your ticket to be a part of the world's #1 drug safety event here: https://lnkd.in/gqpN6izz

A day trip to Amsterdam to take part in the European Medicines Agency's (EMA) insightful workshop on leveraging Real-World Evidence (RWE) for Regulatory decision-making. A truly collaborative event that brought together experts across Regulatory, Patient Representatives, Industry, and Academia to discuss EMA’s recent white paper on Non-Interventional Studies and explore the latest advancements and challenges in harnessing real-world data. The workshop underscored the shared commitment across stakeholders to enhance confidence in RWE as a new source of evidence to support patient access to safe, effective medicines and drive regulatory excellence to improve outcomes. Another step in the right direction…

Are you interested in improving patient engagement in your clinical trials. I realise that this is a big question. Specifically I am referring to Phase IIII post observational studies which are designed to capture RWD, RWE which informs and improves the safety profile and pharmacovigilance monitoring of certain drug combinations. Nye Health are doing some really progressive work in this field which can help to transform the perception and the value of personalized patient support programs. Working with the regulator to drive innovation and improve patient outcomes. #makingadifference #changinglives #gains

Excited to Share My E-Poster Contribution for National Pharmacovigilance Week! As part of the 3rd National Pharmacovigilance Week 2023, organized by the Indian Pharmacopoeia Commission , I submitted an e-poster titled "Fighting Adverse Drug Reaction - A Collective Effort." The e-poster depicts the story of "Satish," an IT engineer who experienced an adverse drug reaction (ADR). His journey emphasizes the importance of reporting ADRs through the #PvPIapp, ultimately contributing to scientific advancements and drug safety. Pharmacovigilance plays a vital role in safeguarding public health, and I am proud to have participated in raising awareness on this crucial issue through this platform. A big thank you to my mentors and collaborators for their support: - Dr. Debjyoti Halder (Design & Implementation) - Dr. Subhajit Karmakar (Concept & Story) - Prof. Dr. R.N. Maiti (HOD) - Dr. Balaram Ghosh (Coordinator) - Dr. Indrani Dalal (Deputy Coordinator) #Pharmacovigilance #NPW2023 #IndianPharmacopoeiaCommission #DrugSafety #EPPoster #PvPI #AdverseDrugReaction #HealthcareAwareness #ScientificContribution

Transitioning from a #GCP-focused clinical development stage to a #GVP-driven #PostMarket stage is a challenge that hinges on strategic decisions around the operating model for pharmacovigilance activities. Thanks Stefan Brüning for this great visualisation. Find out what the differences are 👇 #Pharmacovigilance #DrugSafety #Clinical #Pharma

WORKING SMARTER NOT HARDER Just because something has been done a certain way for 50+ years does not mean it is the best; accurate; most efficient; or cost effective. Sometimes, it requires someone to take a step back, look at the process and see the flaws and problems that exist and determine - 'there has to be a better and smarter way'. This is what PharSafer has done with our innovative, automated safety case processing IT tool which fits any safety database - RAPTAR. We at PharSafer looked at all of the pain points that confront routine safety case processing - warts and all' and then looked for the solutions. Once found it was up to the clever IT folks to code it and here it is RAPTAR. Think it too good to be true - then come and have a look. Prove it for yourself. What have you got to lose? You can always go back to the old method of manual case processing with compliance issues, errors, lack of follow up, translation problems, Regulatory findings, additional trainings, recruitment issues, costs etc..... 😄 Time to work smarter, not harder. #PharSafer: https://lnkd.in/eimySG2 #RAPTAR: https://lnkd.in/exZFGiw #TEAParty#BostonInnovation#DrugSafetyCongress#Pharmacovigilance #ExcellenceInSafety#Automation#CaseWorkflow#HealthcareInnovation#Compliance#caseprocessing#ICSR#SUSAR#QMS#validation#GDPR#

MedDRA, which standardizes terms used to code licensed drugs and medical events, allows health authorities and companies to exchange and analyse safety reports related to licensed products and more readily classify adverse event data from clinical trials. WHODrug Global, maintained by the World Health Organization’s Uppsala Monitoring Centre, creates standard codes for drugs and active ingredients used in clinical trials and post-marketing surveillance.   The systems allow faster, more straightforward communication among regulatory agencies and regulated entities. https://lnkd.in/eKFxtxnS #WorldStandards #Communication #Innovation #LATAM

I am very privileged to have been asked to join this panel of experts to discuss Global Harmonisation of PV today at the World Drug Safety Congress in Amsterdam. I am looking forward to participating in some interesting discussions. #worlddrugsafetycongress #pharmacovigilance