Muhammad Usman Aslam’s Post

Notice: New SFDA Products Classification Guidance - Version 8.0 The Saudi Food and Drug Authority (SFDA) has issued the latest version of the Products Classification Guidance, Version 8.0,effective from 20 November 2024. This revision enhances clarity and optimizes the classification process, ensuring adherence to regulatory standards and quality benchmarks. #Healthcare #MedicalDevices #Pharmaceuticals #Biotechnology #LifeSciences #DrugSafety #QualityAssurance #ClinicalResearch #Pharmacovigilance #RegulatoryAffairs #Compliance #HealthcareInnovation #MedicalRegulations #SaudiArabia #GCC #MiddleEast #HealthTech #PharmaIndustry #SFDA #ProductClassification #RegulatoryCompliance #HealthcareExcellence #MedicalTechnology #GlobalHealth #HealthcareStandards #InnovationInHealthcare #HealthcareCompliance #MedicalDeviceRegistration #DrugRegistration #AuthorizedRepresentative #UDI #TechnicalFileDevelopment #ISO13485 #QualityManagement #MedicalDeviceManufacturers #HealthcareSolutions #SFDACompliance #HealthcareIndustry #MedicalInnovation #GlobalCompliance #HealthcareRegulations #MedicalDeviceQuality #HealthcarePartnership #RegulatoryCompliance

Notice: New SFDA Products Classification Guidance - Version 8.0 The Saudi Food and Drug Authority (SFDA) has issued the latest version of the Products Classification Guidance, Version 8.0, effective from 20 November 2024. This revision enhances clarity and optimizes the classification process, ensuring adherence to regulatory standards and quality benchmarks. #Healthcare #MedicalDevices #Pharmaceuticals #Biotechnology #LifeSciences #DrugSafety #QualityAssurance #ClinicalResearch #Pharmacovigilance #RegulatoryAffairs #Compliance #HealthcareInnovation #MedicalRegulations #SaudiArabia #GCC #MiddleEast #HealthTech #PharmaIndustry #SFDA #ProductClassification #RegulatoryCompliance #HealthcareExcellence #MedicalTechnology #GlobalHealth #HealthcareStandards #InnovationInHealthcare #HealthcareCompliance #MedicalDeviceRegistration #DrugRegistration #AuthorizedRepresentative #UDI #TechnicalFileDevelopment #ISO13485 #QualityManagement #MedicalDeviceManufacturers #HealthcareSolutions #SFDACompliance #HealthcareIndustry #MedicalInnovation #GlobalCompliance #HealthcareRegulations #MedicalDeviceQuality #HealthcarePartnership #RegulatoryCompliance

FDA's New Guidance Update : The Food and Drug Administration (FDA or the Agency) is announcing the availability of the guidance for industry entitled "Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions." This guidance describes the electronic submission of certain data and information in standardized formats. This information is used by the Center for Drug Evaluation and Research (CDER) in the planning of, and by FDA’s Office of Inspections and Investigations (OII) in the conduct of, BIMO inspections. To Know more write to us at bd@pharmazones.com or visit our website at www.pharmazones.com #FDA #Guidance #CDER #BIMO #Pharmazone #ComplianceMatters #GCP #GMP #GMPAudit #compliance #vendorqualification #regulatoryaffair #Pharmacovigilance #ICSR

CDRH Portal Overview and Features #WHO #ICH #regulatoryaffairs #regulatory #guidelines #GMP #GCP #GLP #PharmaceuticalRegulation #DrugRegulation #MedicalDeviceRegulation #FoodAndDrugRegulation #RegulatoryAffairs #QualityControl #QualityAssurance #ResearchAndDevelopment #Pharmaceuticals #Biotechnology #LifeSciences #MedicalDevices #ClinicalResearch #RegulatoryCompliance #GMP #FDARegulations #HealthcareQuality #DrugDevelopment #ComplianceManagement #RegulatoryScience #RnD #BioPharma #ProductDevelopment #RegulatoryUpdates #PharmaRegulation #HealthAuthority #DrugRegulation #PharmaCompliance #RegulatoryAffairs #FDA #EMA #MHRA #TGA #HealthCanada #PMDA #SFDA #drap #NMPA #ANVISA #CDSCO #Drap #nafdac #efda #gfda #who #pics #swissmedic #ages #FAGG #bda #Halmed #sukl #fimea #DKMA #EOF #IMA #aifa #meb #MPA #ANM #HPRA #MOH #INVIMA #MHLW #MFDS #NPARA #NMRA #HSA #PPB #MCAZ #clinicaltrial #ctd #ectd #digitalization

"Navigating Regulatory Changes: Key Updates in India’s Pharmacovigilance Guidance for MAHs" The comparison table highlights key updates in the 2024 Pharmacovigilance Guidance for Marketing Authorization Holders (MAHs) compared to the 2018 version. Source: https://lnkd.in/dUCCAW_M #Pharmacovigilance #DrugSafety #SignalDetection #Healthcare #IndianPharmacopeia #NCCPvPI #CDSCO #PatientSafetyWeek #ContinuousLearning #PVGuidance #ICSR #MAHs #Pharmaindustries #Regulatory #PvPI

📌Therapeutic Goods Administration (𝗧𝗚𝗔) 𝗔𝗱𝗼𝗽𝘁 𝟭𝟭𝟮 𝗜𝗻𝘁𝗲𝗿𝗻𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗚𝘂𝗶𝗱𝗲𝗹𝗶𝗻𝗲𝘀, enhancing the regulatory framework for therapeutic goods in Australia by leveraging the work done by international regulatory counterparts. 𝙃𝙚𝙧𝙚 𝙖𝙧𝙚 𝙩𝙝𝙚 𝙠𝙚𝙮 𝙩𝙖𝙠𝙚𝙖𝙬𝙖𝙮𝙨: 🔸 𝗜𝗻𝘁𝗲𝗿𝗻𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗔𝗹𝗶𝗴𝗻𝗺𝗲𝗻𝘁: The TGA aligns with international regulatory counterparts, such as the European Union (EU) Guidelines, International Conference on Harmonisation (ICH), and the Food and Drug Administration (USA). 🔸𝗚𝘂𝗶𝗱𝗲𝗹𝗶𝗻𝗲 𝗔𝗱𝗼𝗽𝘁𝗶𝗼𝗻: Before adopting any guideline, the TGA undertakes extensive internal and external consultations to ensure consistency with Australian requirements. 🔸𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝘁𝗼 𝗠𝗲𝗱𝗶𝗰𝗶𝗻𝗲𝘀: The guidelines apply not only to prescription medicines but also to over-the-counter (OTC), complementary, and some listed medicines. 🔸𝗗𝗲𝘃𝗶𝗮𝘁𝗶𝗼𝗻 𝗝𝘂𝘀𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻: While the guidelines are not mandated by legislation, any deviation from them in an application must be justified. This reflects a move towards a harmonized approach to regulatory guidance globally. 𝙃𝙚𝙧𝙚'𝙨 𝙩𝙝𝙚 𝙇𝙞𝙣𝙠🔗: https://lnkd.in/eAaj3nK6 𝗧𝗵𝗮𝗻𝗸 𝘆𝗼𝘂 🙏 for 𝘆𝗼𝘂𝗿 time and please 𝗟𝗶𝗸𝗲 👍, 𝗦𝗵𝗮𝗿𝗲, and/or 𝗖𝗼𝗺𝗺𝗲𝗻𝘁 #medicaldevices #invitrodiagnostics #combinationproducts #mlv #qualityassurance #regulatoryaffairs #pharmaceuticals

🎗️EMA - Release Alert🎗️ EMA just released guidance on the electronic submission of information on investigational medicinal products for human use in the Extended EudraVigilance medicinal product dictionary (XEVMPD). The purpose of this document is to provide consolidated business guidance to users from the sponsor organizations registered with the European Medicines Agency (#EMA) for the submission of medicinal product information in the Extended EudraVigilance medicinal product dictionary (#XEVMPD). WKM Consulting Services LLC provides top-notch Quality and Compliance consulting services that include: ➡️GxP vendor audits ➡️ Internal mock inspections ➡️ Inspection readiness training ➡️ Comprehensive gap assessment, FMEA, and Risk Assessment of your systems, processes, and procedures. Additionally, We offer the following consulting services: ➡️ Quality Control (QC) ➡️ Quality Assurance (QA) ➡️ Vendor Management (VM) ➡️ System Validation (SV) ➡️ Project Management (PM) ➡️ Toxicology 📲Follow our page “WKM Consulting Services LLC” on LinkedIn to be notified when new regulatory updates are released. 📩Get your free consultation: ➡️ E-mail: drwafick@gmail.com ➡️Phone: 510-509-4195 Thank you 🙏 #SOP #StandardOperatingProcedure #Policies #QMS #Forms #WKM #WKMConsultingServices #RequestaService #Audits #WKM #Consulting #Services #fda #medicaldevices #pccp #ai #ml #Regulations #FDA #warrningletter #inspection #violation #EMA The link to full guidance is below ⤵️:

Regulatory Affairs Training Cohort 3 Enrollment ❗ Reliable access to safe, effective and quality healthcare products including pharmaceuticals is an imperative for quality healthcare outcomes for patients. According to World Health Organization (WHO), approx. 2 million people lack access to essential health products. About 10.5% of all health products in circulation globally are falsified or counterfeit. Fake medicines kill 500,000 people annually as per United Nations reports. Regulatory affairs as a field of practice provides the basis for timely access to medicines and assurance of #Quality of medical products which increase consumers' interest by ensuring efficacy, quality, and safety. Safeguarding public health from #Substandard & #Falsified medical products requires a robust regulatory system with competent and #Skilled regulatory professionals. As such, African Pharmaceutical Network (APN) is committed to nurturing pharmaceutical professionals to contribute towards robust & effective regulatory and pharmaceutical systems through our training and capacity building programs such as the Regulatory Affairs course. Join us on the path to becoming a skilled #RegulatoryAffairsProfessional and contribute to a strong pharmaceutical landscape. Register here: https://lnkd.in/db2Bfe22 Course Fee: 300USD (Installments are allowed) Training will commence on August 14, 2024 #RegulatoryAffairsTraining #PharmaceuticalWorkforceDevelopment

Difference Between Non-conformance and Non-compliance In the pharmaceutical industry we hear two terms frequently, non-compliance and non-conformance, but do you know the difference between the two, what is non-conformance and what is non-compliance? Let's try to understand, before understanding non-conformance and non-compliance we must know about conformance and compliance. Conformance: This refers to the degree to which a product, process, or service meets specified requirements or standards. It ensures that the product or process is in accordance with predefined criteria, regulations, or guidelines. In simple words we can say conformance is what an organization commit itself to. Compliance: Compliance involves adhering to laws, regulations, standards, or guidelines set forth by regulatory authorities such as the FDA (Food and Drug Administration) or EMA (European Medicines Agency). It encompasses meeting legal and regulatory obligations in terms of quality, safety, and efficacy. In simple words compliance is what is required from an organization based on local state and federal laws. Non-conformance: Non-conformance occurs when a product, process, or service does not meet specified requirements, standards, or expectations. It indicates a deviation from the prescribed criteria or norms, which may result in quality issues or regulatory concerns. Non-compliance: Non-compliance refers to the failure to adhere to laws, regulations, standards, or guidelines established by regulatory authorities. It signifies a breach of legal or regulatory obligations, which can lead to penalties, sanctions, or other enforcement actions. #GMP #cGMP #QualityAssurance #NonConformance #NonCompliance

Super Early Bird Price for 37th #Pharmacovigilance UK & EU 2025 closes this Friday! Register for the conference and save more than 35% off the Standard price! https://lnkd.in/g7uJhP9t Cencora | Pharma solutions HM Global Pharmacovigilance Consulting Fabio De Gregorio Zina Sadeq Rohan Mane Valentina Mancini Abidali Fazal Erika Barbarosie Michael Bean Dr Tanuja H. Tea Babić Ea Holst Leonardo R Pereira Yvonne Nanciu STEPHANIE MILLICAN Dr. Sabine Poltermann John Solomon MD Begüm Benli Peker Minhaj Obeidullah LEA GALOVIC Mircea Ciuca Pav Rishiraj Dr Sumit Munjal MBBS FRSPH MSc DLSHTM FFPM Raj Bhogal Ilaria Grisoni Mark Daniels Richard Jelley Claire Beggs Raj Hanvesakul, MD PhD Teresa Saragoça Suzanne Foncin Phillip Eichorn Yuung Yuung Yap Heather Murphy RN, MBA, CQA Rudi Scheerlinck Margherita D'Antuono Petar Gjorgiev Philip Jones Marianne Mounir Sanjeev Srivastav MD, MBA, PMP® Alexander Roussanov Sandy Eisen #VIphv #ClinicalSafety #patientsafety #RiskManagement #clinicaltrials #mumbai #clinicalresearch #pv #Qualitycontrol #pharma #healthcare #lifesciences #RegulatoryAffairs #RegulatoryWriting #MedicalWriting #scientificwriting #regulatory #medicinesaffairs #pharmaceuticals #biosimilars #biotech #patientcentric #vigilance #pharmaceuticalindustry