biologit’s Post

👋 Good Morning Network - Happy Thursday! As promised - please see below this weeks Pharmacovigilance and Drug Safety Industry Insights ✅ 🚨Topic of the week: Upcoming Regulatory Changes in Drug Safety: What You Need to Know 🚨 💡 Interested to hear your thoughts and feedback, and if you find this valuable, please leave a *LIKE and COMMENT*

In the EU, transitioning a medicinal product from clinical trials to full market release brings a new level of responsibility for the Marketing Authorization (MA) Holder, who must ensure an extensive Pharmacovigilance (PV) system is in place to protect patient safety. To let you know more details regarding the Comprehensive Pharmacovigilance System for EU Marketed Medicinal Products click the below link and follow Maven Scientific Laboratories Pvt Ltd for more interesting updates. https://lnkd.in/gSzCW7Ab #Pharmacovigilance #PatientSafety #DrugSafety #QPPV #RiskManagement #EUCompliance #EudraVigilance #MedSafety #PharmaCompliance #Outsourcing

Dear Valued Client, We would like to bring to your kind notice that the Pharmacovigilance new guidance document, version 2.0, will be effective from February 2025, as introduced by CDSCO with their circular dated: 11 Nov 2024 (CDSCO circular attached with this mail). The Pharmacovigilance new guidance document, version 2.0 sets stricter standards, mirroring EU regulations. Ensuring timely compliance is critical to avoid regulatory hurdles. To align your current pharmacovigilance practices with the updated Regulatory guidance, our seasoned pharmacovigilance experts, with 15+ years of experience, can navigate you through this transition. We offer: Comprehensive gap analysis of your current PV processes Expert guidance on implementing updated regulatory requirements Personalized training for enhanced PV practices Thorough revision of existing PV documents Our extensive expertise spans: Global regulatory requirements  PV operations across multiple countries Proven track record of successful implementations Partnering with us ensures: Seamless compliance with CDSCO's new guidance Enhanced PV processes and documentation Mitigated regulatory risks Optimized resource utilization Stay ahead of regulatory shifts with our expert guidance. Elevate your pharmacovigilance practices to mitigate risks and optimize operations. Reach out to us today to explore customized solutions that ensure regulatory adherence, risk mitigation, and sustainable growth. Best regards,  Sofiya Khan #Pharmacovgilance #Drug Safety #Indian Pharmaceutical's #Pharma manufacturer #Marketing Authorization holder #ADRs #Clinical Research #Drug discovery #Regulatory

Register for this webinar on April 8 to hear how Oracle Life Sciences’ AI-powered solutions are driving innovation in clinical trials, pharmacovigilance, and drug safety. https://lnkd.in/eC3MARfM

Calling all pharmacovigilance professionals! Don't miss out on our upcoming webinar discussing the role of the QPPV office in drug safety. Register now to secure your spot! #PharmaWebinar #DrugSafety #QPPV

Register for this webinar on April 8 to hear how Oracle Life Sciences’ AI-powered solutions are driving innovation in clinical trials, pharmacovigilance, and drug safety. https://lnkd.in/eEeZiVe7

Calling all pharmacovigilance professionals! Register now for our upcoming webinar on QPPV Office best practices. Stay ahead of the curve and enhance your expertise in drug safety. #PharmaEducation #WebinarAlert

OFF-X for PV applications, learn more.. Leverage class safety intelligence to anticipate adverse drug reactions and mitigate safety liabilities for drugs across all phases of R&D and post-marketing. Benchmark daily updated drug safety profiles of investigational, launched and discontinued products grouped by target classes to enable pro-active pharmacovigilance. Understand how Clarivate for Life Sciences & Healthcare's OFF-X can help you with Pharmacovigilance workflows. Talk to our specialist here: https://lnkd.in/exxDvDpF #OFF-X #pharmacovigilance

Regulatory framework in the European Union - Drug Regulatory Affairs Regulatory framework in the European Union - Drug Regulatory Affairs - This video focuses on the Regulatory framework in the European Union and the different registration routes followed by the European Medicines Agency (EMA). https://lnkd.in/dajfbMum #DRA #RA #pharmaceuticalindustry #RegulatoryAffairs #EMA #DrugRegulatoryAffairs #PharmaRegulations #PharmaceuticalIndustry #RegulatoryCompliance #ClinicalTrials #PharmaRegulatory #DrugApproval #HealthcareCompliance #RegulatoryUpdates #PharmaExperts #PharmacologicalRegulation #GlobalRegulatoryAffairs #DrugDevelopment #PharmaCompliance #HealthcareRegulations #RegulatoryScience#RegulatoryStrategy #PharmaProfessionals #MedicalDeviceRegulations #USRegulations #EURegulations

Regulatory framework in the European Union - Drug Regulatory Affairs Regulatory framework in the European Union - Drug Regulatory Affairs - This video focuses on the Regulatory framework in the European Union and the different registration routes followed by the European Medicines Agency (EMA). https://lnkd.in/dajfbMum #DRA #RA #pharmaceuticalindustry #RegulatoryAffairs #EMA #DrugRegulatoryAffairs #PharmaRegulations #PharmaceuticalIndustry #RegulatoryCompliance #ClinicalTrials #PharmaRegulatory #DrugApproval #HealthcareCompliance #RegulatoryUpdates #PharmaExperts #PharmacologicalRegulation #GlobalRegulatoryAffairs #DrugDevelopment #PharmaCompliance #HealthcareRegulations #RegulatoryScience#RegulatoryStrategy #PharmaProfessionals #MedicalDeviceRegulations #USRegulations #EURegulations