Storage Instructions and Handling of Your Medication

#Pharmacy #DrugRegulation #ClinicalResearch #Pharmacovigilance #FDA #EMA #MHRA #CDSCO #WHO #PharmaWorld #RegulatoryAffairs #BasavrajBirajdar

Common side effects

#AsiaRisk #Regulation #India To view or add a comment, sign in Drug regulator tightens safety norms after cough syrup deaths Following the death of 23 children in Madhya Pradesh due to consumption of Coldrif cough syrup contaminated with diethylene glycol (DEG), the Drugs Controller General of India (DCGI) mandated mandatory testing for both DEG and ethylene glycol (EG) in all raw materials and finished pharmaceutical products. To view or add a comment, sign in Understanding the Key Differences and Recent Updates in DSUR, PBRER, and PSUR for Drug Safety Reporting As pharmacovigilance and drug safety professionals, it’s crucial to grasp the distinct roles and evolving regulatory expectations of the three main periodic safety reports: 1️⃣ Development Safety Update Report (DSUR): - Focused on investigational drugs in clinical trials - Includes cumulative safety summaries, clinical and nonclinical trial data, and risk-benefit assessments - Recent regulatory updates (e.g., UK Clinical Trial Regulation) aim to reduce administrative burden by removing detailed SAE/SAR listings and potentially exempting DSUR submissions to Research Ethics Committees - DSUR concentrates on evolving safety data to protect trial participants and inform development decisions 2️⃣ Periodic Benefit-Risk Evaluation Report (PBRER): - Applied to marketed drugs and ongoing studies - Advances beyond PSUR by integrating comprehensive benefit-risk analysis alongside cumulative safety and efficacy information - Covers extensive sections on safety signals, risk minimization, benefit evaluations, and integrated benefit-risk conclusions - Helps optimize therapeutic profiles with focus on maximizing benefits and minimizing risks in real-world use 3️⃣ Periodic Safety Update Report (PSUR): - Traditionally for marketed drugs, centered mainly on safety updates and regulatory status - Includes patient exposure, adverse event summaries, clinical and nonclinical data, and overall safety evaluations - Increasingly replaced by the PBRER format in many global regulatory jurisdictions to incorporate benefit evaluation. Navigating these reports skillfully is vital for robust pharmacovigilance, regulatory compliance, and ultimately ensuring patient safety throughout the drug lifecycle. #Pharmacovigilance #DrugSafety #MedicalWriting #DSUR #PBRER #PSUR #BenefitRisk #ClinicalTrials #RegulatoryAffairs To view or add a comment, sign in Understanding the Key Differences and Recent Updates in DSUR, PBRER, and PSUR for Drug Safety Reporting As pharmacovigilance and drug safety professionals, it’s crucial to grasp the distinct roles and evolving regulatory expectations of the three main periodic safety reports: 1️⃣ Development Safety Update Report (DSUR): - Focused on investigational drugs in clinical trials - Includes cumulative safety summaries, clinical and nonclinical trial data, and risk-benefit assessments - Recent regulatory updates (e.g., UK Clinical Trial Regulation) aim to reduce administrative burden by removing detailed SAE/SAR listings and potentially exempting DSUR submissions to Research Ethics Committees - DSUR concentrates on evolving safety data to protect trial participants and inform development decisions 2️⃣ Periodic Benefit-Risk Evaluation Report (PBRER): - Applied to marketed drugs and ongoing studies - Advances beyond PSUR by integrating comprehensive benefit-risk analysis alongside cumulative safety and efficacy information - Covers extensive sections on safety signals, risk minimization, benefit evaluations, and integrated benefit-risk conclusions - Helps optimize therapeutic profiles with focus on maximizing benefits and minimizing risks in real-world use 3️⃣ Periodic Safety Update Report (PSUR): - Traditionally for marketed drugs, centered mainly on safety updates and regulatory status - Includes patient exposure, adverse event summaries, clinical and nonclinical data, and overall safety evaluations - Increasingly replaced by the PBRER format in many global regulatory jurisdictions to incorporate benefit evaluation. #Pharmacovigilance #DrugSafety #MedicalWriting #DSUR #PBRER #PSUR #BenefitRisk #ClinicalTrials #RegulatoryAffairs To view or add a comment, sign in IPC update on pharmacopoeial and regulatory resources for identifying ethylene glycol (EG) and diethylene glycol (DEG) in drugs: IPC has issued an update on resources for identifying EG and DEG in drugs to ensure quality and safety. To view or add a comment, sign in "Balancing the Pill Bottle:

Safety Advice for Levitra DA 500mg Tablet

Key takeaways from the session: 🚨PV activity spans the entire drug lifecycle: from pre-marketing and all phases of Clinical Trials (I/II/III/IV) to the post-marketing stage. 🚨The system operates with strict deadlines: 7 days for Fatal/Life-threatening events and 15 days for other Serious cases. 🚨 It protects the public from unsafe medicines, improves treatment quality, and builds trust in healthcare systems. If you're interested in the medical, pharmaceutical, or public health space, understanding PV is non-negotiable. Thank you for providing such a wonderful session! Unveiling the Pros and Cons of Deregulating Non-Essential Drug Prices in Pakistan"Pharma Point Advisors (DRAP consultancy firm) 2y Top 5 tips for maintaining regulatory compliance

How is Levitra used?

3️⃣ MHRA (Medicines and Healthcare products Regulatory Agency – UK) 🔹 Ensures safety, quality, and performance of medicines and devices. 4️⃣ CDSCO (Central Drugs Standard Control Organization – India) 🔹 Regulates approval, manufacturing, and clinical trials of drugs in India. 5️⃣ WHO (World Health Organization – Global) 🔹 Provides international guidelines, prequalification, and global health safety standards. 💬 These agencies together form the backbone of pharmaceutical governance, protecting millions worldwide through robust regulation and vigilance. #Pharmacy #DrugRegulation #ClinicalResearch #Pharmacovigilance #FDA #EMA #MHRA #CDSCO #WHO #PharmaWorld #RegulatoryAffairs #BasavrajBirajdar To view or add a comment, sign in 🧠 Top Global Regulatory Authorities in Pharmaceuticals 🌍💊 Every medicine you see on the market goes through rigorous evaluation by trusted regulatory bodies across the world. in the pharmaceutical sectorPharma Point Advisors (DRAP consultancy firm) 2y The impact of a shortage of Medicine in Pakistan: Causes and solutionsPharma Point Advisors (DRAP consultancy firm) 2y The Food and Drug Administration (FDA) has posted

Retail Pharmacies

DEG is a toxic chemical linked to fatalities in contaminated cough syrups for children in India. CDSCO has mandated testing of raw materials and excipients before drug manufacturing and release. IPC's free toolkit compiles key chapters and monographs to address contamination in oral medicines, especially allergy and cough syrups. General Chapters in the IP offer standardized methods for detecting impurities and ensuring quality. Users can access IPRS materials for ensuring analytical accuracy through IPC's online store. a discontinuation notice regarding Levitra (vardenafil HCl; Bayer and GlaxoSmithKline) 2.5mg strength tablets.

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Micro Therapeutic Research Labs Private Limited #Pharmacovigilance #DrugSafety #ClinicalResearch #Healthcare #LifeSciences #Pharmaceuticals #PV To view or add a comment, sign in ✨️ 24.10.2025 🚨🚨🚨 Protecting Patients: A Deep Dive into Pharmacovigilance (PV): I recently attended a fantastic webinar on Pharmacovigilance (PV) by MICRO THERAPEUTIC RESEARCH LABS, and it was a powerful reminder of this field's vital role in public health by Ms.Sangeetha (Business process lead - MTR Groups). Micro Therapeutic Research Labs Private Limited #Pharmacovigilance #DrugSafety #ClinicalResearch #Healthcare #LifeSciences #Pharmaceuticals #PV To view or add a comment, sign in 🧠 Top Global Regulatory Authorities in Pharmaceuticals 🌍💊 Every medicine you see on the market goes through rigorous evaluation by trusted regulatory bodies across the world. These organizations ensure safety, efficacy, and quality before a drug reaches patients. Here’s a quick visual snapshot of the major players in global drug regulation 👇 1️⃣ FDA (Food and Drug Administration – USA) 🔹 Sets global standards for drug approval, quality, and monitoring. 2️⃣ EMA (European Medicines Agency – Europe) 🔹 Oversees evaluation and supervision of medicines across the European Union. The discontinuation is not due to safety or efficacy reasons, according to the Company.

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#Pharma #Regulations #DrugSafety #Healthcare #CDSCO #Coldrif #PharmaIndustry #SterileManufacturing #LeadershipInPharma #TeamLeadership #OperationalExcellence #PharmaManufacturing #cGMP #RegulatoryCompliance #QualityCulture #ContinuousImprovement #India #IPC #IPRS To view or add a comment, sign in IPC update on pharmacopoeial and regulatory resources for identifying ethylene glycol (EG) and diethylene glycol (DEG) in drugs: IPC has issued an update on resources for identifying EG and DEG in drugs to ensure quality and safety. #Pharma #Regulations #DrugSafety #Healthcare #CDSCO #Coldrif #PharmaIndustry #SterileManufacturing #LeadershipInPharma #TeamLeadership #OperationalExcellence #PharmaManufacturing #cGMP #RegulatoryCompliance #QualityCulture #ContinuousImprovement #India #IPC #IPRS To view or add a comment, sign in ✨️ 24.10.2025 🚨🚨🚨 Protecting Patients: A Deep Dive into Pharmacovigilance (PV): I recently attended a fantastic webinar on Pharmacovigilance (PV) by MICRO THERAPEUTIC RESEARCH LABS, and it was a powerful reminder of this field's vital role in public health by Ms.Sangeetha (Business process lead - MTR Groups). PV is essentially the science of keeping a vigilant watch over medicines-from the Greek Pharmakon (Medicinal Substances) and Latin Vigilia (To keep Watch). It's more than just reporting; it's about the continuous collection, detection, assessment, monitoring, and prevention of adverse effects of pharmaceutical products. To ensure medicines are safe and effective while increasing their benefits for patients.