biologit’s Post

#3daystogo 🔬 Free Webinar: Principles of Good Laboratory Practice (GLP) 🧪 Join us on Monday, September 23, 2024, from 1:00 PM – 2:00 PM ET for an insightful 1-hour session on the Principles of #GLP hosted by BIOBOSTON CONSULTING and led by Michelle Tseng, a laboratory and CMC professional with 25 years of experience in drug development. This comprehensive webinar will help you understand how #GLP ensures the quality and integrity of non-clinical laboratory studies. 💡 What You’ll Learn: ·  Definition and Scope of Good Laboratory Practice (GLP) ·  Core principles and objectives of GLP ·  Key regulatory requirements and how to stay compliant ·  Important elements of a GLP system ·  Real-world case studies and practical examples 📅 Date: Monday, Sep 23, 2024 ⏰ Time: 1:00 PM – 2:00 PM ET 🔷 Speaker - Michelle Tseng 👉 Register now: https://lnkd.in/gJYr3BWD Whether you are new to GLP or looking to refresh your knowledge, this training program will provide essential insights to ensure your lab operations are compliant and of the highest standard! #GLPWebinar #GoodLaboratoryPractice #RegulatoryCompliance #LifeSciences #Biotech #LabQuality #BiobostonConsulting #NonClinicalStudies #webinar #lifesciencetraining #pharmacompliance #pharmaceuticals #biotechnology #FDA

Pharmacovigilance is super important because it focuses on monitoring and evaluating the safety of medicines. It helps to detect, assess, understand, and prevent any adverse effects or any other drug-related problems. By keeping an eye on the safety of medications, pharmacovigilance plays a vital role in ensuring that people can use medicines safely and effectively. It helps in improving patient care and public health by identifying and preventing any potential risks associated with medications. So, it's crucial to have robust pharmacovigilance systems in place to safeguard the well-being of individuals using various medications. #duhs #IBBPS #DOW_IBBPS Dow Institute of Biological, Biochemical & Pharmaceutical Sciences (IBBPS-DUHS)

🌟 Speaker Announcement!🌟  We are excited to welcome Heather Murphy, RN, MBA, CQA, Founder and CEO of HMGlobal Pharmacovigilance Consulting, LLC, as a #Speaker at Pharmacovigilance Europe 2025! 🎤 Heather will be presenting on the critical topic: "PV Audits in the USA: Challenges, Opportunities, and Audits Unique to the USA (e.g. REMS)". With her vast experience in #pharmacovigilanceaudits and #regulatorycompliance, Heather's session promises to offer valuable insights into the unique aspects of PV audits in the U.S. landscape. 📅 Don’t miss her presentation at the conference in London on 21May 2025! #Pharmacovigilance2025 #HeatherMurphy #KeySpeaker #PVAudits #REMS #DrugSafety #Pharma #Biotech #LondonConference #PVEurope #PharmaLeaders #worlddrugsafety #ClinicalSafety #patientsafety #RiskManagement #clinicaltrials #clinicalresearch #pv #pharma #healthcare #lifesciences #RegulatoryAffairs #RegulatoryWriting #MedicalWriting #scientificwriting #regulatory #medicinesaffairs #pharmaceuticals #biosimilars #biotech #patientcentric #vigilance #pharmaceuticalindustry

💡 Upcoming Event: Managing Regulatory Intelligence Virtual Roundtable! We're thrilled to announce our next PV Network roundtable event. We will be discussing Regulatory Intelligence in small pharma and biotech. Regulatory Intelligence is a vital component of Pharmacovigilance, as it increases efficiency and improves decision-making. However, recent results from Regulatory inspectors suggest that proactive planning and quality assurance within this area still require further improvements. Discuss with your peers how Regulatory Intelligence for PV works today and how we can strengthen this core component further to ensure regulatory compliance worldwide. Topics will include: - Current Regulatory Intelligence process - Future planning for geographic expansion - Recommendations for remaining current with evolving regulatory needs 📅 Date: Thursday 8 August 2024 🕚 Time: 10:30 - 12:00 EDT / 16:30 - 18:00 CET 📍 Reserve your seat now: https://lnkd.in/d6vBmYcj We look forward to welcoming you soon! For more information, visit https://lnkd.in/d5f-kYHV #PVInsightsNetwork #DrugSafetyLeaders #SmallPharma #Biotech #PharmaEvent #Pharmacovigilance #PV #RegulatoryIntelligence

How to select your pharmacovigilance partner? Pharmacovigilance is crucial for companies seeking market approval in drug and device development. To enhance efficiency, many companies outsource tasks related to their Pharmacovigilance Systems. When choosing a partner, consider your in-house expertise and identify potential long-term fits 👀 Reads our article for tips to follow in selecting your pharmacovigilance partner 👉 https://zurl.co/VgDD #pharmacovigiliance #pharma #pharmacovigilancepartner #lifescience #drugdevelopment #lifesciencepartners #article

Why late-stage pharma R&D processes need a rethink Across pharma regulatory affairs, quality and pharmacovigilance/drug safety functions, process rigour is wedded tightly to SOPs. But these snapshot definitions of processes do not, of themselves, foster efficiency. In many cases, there has been a loss of sight of the deliverables. Here, Tobias Hitziger, Management Consultant at MAIN5 considers what is inhibiting fuller process transformation, and what is being sacrificed as a result. https://lnkd.in/edaFiZiQ #Pharma #Biotech #Regulatory

How to select your pharmacovigilance partner? Pharmacovigilance is crucial for companies seeking market approval in drug and device development. To enhance efficiency, many companies outsource tasks related to their Pharmacovigilance Systems. When choosing a partner, consider your in-house expertise and identify potential long-term fits 👀 Reads our article for tips to follow in selecting your pharmacovigilance partner 👉 https://zurl.co/l0kK #pharmacovigiliance #pharma #pharmacovigilancepartner #lifescience #drugdevelopment #lifesciencepartners #article

Dr.Abhijit Surwade, Manager Global Pharmacovigilance, Colgate-Palmolive will be participating as a panellist at Virtue Insight's #Pharmacovigilance India 2024 https://lnkd.in/gXgnQ2fC For our upcoming conferences visit : https://lnkd.in/gjQY86dn #VIphv #ClinicalSafety #patientsafety #RiskManagement #clinicaltrials #mumbai #clinicalresearch #pv #Qualitycontrol #pharma #healthcare #lifesciences #RegulatoryAffairs #RegulatoryWriting #MedicalWriting #scientificwriting #regulatory #medicinesaffairs #pharmaceuticals #biosimilars #biotech #patientcentric #vigilance #pharmaceuticalindustry

Excited to share that I have successfully completed the "Stability Studies in Drug Development Process" course at PharmaState Academy! This comprehensive program, completed on May 14, has deepened my understanding of the critical role stability studies play in ensuring the safety and efficacy of pharmaceuticals over time. Key topics covered include: - 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗥𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀: (FDA, EMA, ICH guidelines) - 𝗧𝘆𝗽𝗲𝘀 𝗼𝗳 𝗦𝘁𝗮𝗯𝗶𝗹𝗶𝘁𝘆 𝗦𝘁𝘂𝗱𝗶𝗲𝘀: Long-term, accelerated, and stress testing - 𝗗𝗲𝘀𝗶𝗴𝗻𝗶𝗻𝗴 𝗦𝘁𝗮𝗯𝗶𝗹𝗶𝘁𝘆 𝗦𝘁𝘂𝗱𝗶𝗲𝘀: Batch selection, storage conditions, and testing intervals - 𝗔𝗻𝗮𝗹𝘆𝘁𝗶𝗰𝗮𝗹 𝗠𝗲𝘁𝗵𝗼𝗱𝘀: Physical, chemical, and microbiological testing - 𝗗𝗮𝘁𝗮 𝗔𝗻𝗮𝗹𝘆𝘀𝗶𝘀 𝗮𝗻𝗱 𝗜𝗻𝘁𝗲𝗿𝗽𝗿𝗲𝘁𝗮𝘁𝗶𝗼𝗻: Statistical methods and shelf-life estimation - 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗥𝗲𝗽𝗼𝗿𝘁𝗶𝗻𝗴: Stability protocols and regulatory submissions A huge thank you to PharmaState.Academy for providing such valuable insights and practical knowledge. I'm eager to apply what I've learned to contribute to the development of safe and effective drugs. #ProfessionalDevelopment #Pharmaceuticals #DrugDevelopment #StabilityStudies #ContinuousLearning #PharmaIndustry

How to select your pharmacovigilance partner? Pharmacovigilance is crucial for companies seeking market approval in drug and device development. To enhance efficiency, many companies outsource tasks related to their Pharmacovigilance Systems. When choosing a partner, consider your in-house expertise and identify potential long-term fits 👀 Reads our article for tips to follow in selecting your pharmacovigilance partner 👉 https://lnkd.in/eeA2kk_b #pharmacovigiliance #pharma #pharmacovigilancepartner #lifescience #drugdevelopment #lifesciencepartners #article