Northern Balance’s Post

Ensuring drug safety is critical across markets. Both the US FDA and EU EMA have rigorous GVP systems, from FAERS and REMS to EudraVigilance and RMPs, safeguarding patients. Discover how Freyr can help navigate these Regulatory frameworks with cutting-edge solutions. https://lnkd.in/gjtPYEAB   #Pharmacovigilance #DrugSafety #GVP #FreyrSolutions

Ensuring drug safety is critical across markets. Both the US FDA and EU EMA have rigorous GVP systems, from FAERS and REMS to EudraVigilance and RMPs, safeguarding patients. Discover how Freyr can help navigate these Regulatory frameworks with cutting-edge solutions. https://lnkd.in/gjtPYEAB #Pharmacovigilance #DrugSafety #GVP #FreyrSolutions

The U.S. Food and Drug Administration (FDA) has released a draft guidance for the industry regarding the use of data monitoring committees (DMCs) in clinical trials. The guidance, titled "Use of Data Monitoring Committees in Clinical Trials," aims to offer recommendations to clinical trial sponsors on when to utilize a DMC and how to guide their operations effectively. It replaces the previous guidance issued in March 2006 and provides updated procedures and practices for monitoring clinical trials. FDA CRC Pharma #fda #guidance #dmc #clinicaltrials

Update from the EMA: Improving processes for assessment and approval of new medicines in the EU. EMA and the European medicines regulatory network are taking measures to make processes for assessment and approval in the EU more efficient. The initiative strives to accomplish: ·      better use of expert resources ·      streamlining of assessment processes Furthermore, the initiative aims to encourage better and more comprehensive application dossiers from applicants at initial submission. Accelerating the availability of safe and effective treatments for patients is the overall objective of the initiative. Read the full news post via link in the first comment. Do you need support with regulatory affairs? Let’s connect! contact@arexadvisor.com #arexadvisor #EMA #clinicaltrials #regulatoryaffairs #drugdevelopment #cmc #CTIS #qualityassurance #GMP #pharmaceuticals

Medicines and Healthcare products Regulatory Agency (MHRA) released Drug Safety Update (DSU) - November 2024 #MHRA - The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency responsible for ensuring that medicines and medical devices work and are acceptably safe. #DrugSafetyUpdate #MedSafetyWeek The monthly newsletter from the Medicines and Healthcare products Regulatory Agency and its independent advisor the Commission on Human Medicines: The theme for this campaign is ‘preventing side effects’, focusing on the importance of using healthcare products in the right way to prevent harm and reporting suspected adverse drug reactions to medicines and suspected adverse incidents with medical devices. #pharmacovigilance #patientsafety Source: https://lnkd.in/djvEw27a

FDA official clarifies cGMP expectations for investigational drugs The US Food and Drug Administration (FDA) does not expect sponsors to have their commercial manufacturing processes finalized and fully compliant with current good manufacturing practice (cGMP) until a product is in Phase II studies. Question: Are the regulatory strategies for your drug development programs adequate to support an IND acceptance and first cycle approvals by the FDA and other health authorities? Have you addressed all possible regulatory gaps with compelling mitigation strategies?   Aexelar Inc. can help develop and/or validate your regulatory strategies, IND and NDA submissions to enable first cycle approvals, contact www.Aexelar.com

🛫 Are you ready for your product launch? Meticulous planning is key for success. Here are key considerations for Europe/UK/CH: 📑 Regulatory Compliance: Ensure compliance with all NCA requirements, like BfArM, ANSM, AIFA, AEMPS, MHRA. E.g. Is your IB according to § 74, in DE, available? 🏭 Supply Chain & Manufacturing: Establish a reliable supply chain, have QP/RP in place, and secure a Manufacturing Importation (MIA) License. 📲 Local contact point for HCPs and Patients established with a Medical Information team. 🕶 PV system ready with EU/UK QPPV, GPOs/LPPV. These areas are cruicial for your launch readiness for better patient outcomes and commercial success. 🚀 Need help preparing? Contact me if you're unsure or need assistance ProPharma #PharmaLaunch #Pharmaceuticals #ProductLaunch #Healthcare #PharmaMarketing #MarketStrategy #RegulatoryCompliance #Pharmacovigilance #GDP #GVP #MIA #WDA

I found this in-person conference very helpful in understanding the pharmacovigilance aspect of clinical trials. All the CDER Small Business and Industry Assistance (SBIA) staff where incredibly friendly and I am blessed to have meet wonderful people who are dedicated to simplifying and streamlining the clinical trial processes so that it is not just "Big Pharma" that gets to do drug research and FDA approvals. #SmallPharma #NewGeneration #ClinicalTrials #BotanicalDrugs #PlantExtracts #NaturesRemedies

Having a master validation plan is crucial for FDA inspections, aiding in the identification of validated and verified activities, according to FDA officials at the 2024 MedCon conference. Such a plan not only assists inspectors but also helps companies retain historical knowledge and ensure process transparency. Quality managers should regularly review all manufacturing processes to avoid overlooked validation needs. Click the link below to know more. https://lnkd.in/gceHSGF7 #validationplan #qualitymanagement #processvalidation #fda #pharmaregulation #regulatoryassessments #regulatoryupdate #dataintegrity #globalcompliance #regulationupdates #patientexperiencedata #pharmaceuticals #riskassessment #riskandcompliance #dataintegrity #qualitymanagement #qualitycontrol #validation #qualityassurance #csv #regulatoryaffairs #regulatoryintelligence #FDARegulations 

One of the most important issues in drug development involves dealing with ethical considerations and maintaining compliance with Good Regulatory Practices (GRP). Meeting strict regulatory requirements and guaranteeing patient safety depends on efficiently addressing issues. https://lnkd.in/ebS9QXw3