Semen Sen Kurt’s Post

The objectives of US-Post-marketing Adverse Drug Experience (PADE) Compliance Program are to monitor industry compliance with post-marketing safety laws and regulations for human drugs and therapeutic biologics and to ensure that accurate, reliable, and timely safety data are submitted correctly to the FDA, thus making it critical for #Drug #Safety. Join us on Aug 14 for the first webinar on Post-marketing Adverse Drug Experience (PADE) Inspection Series. Register with us as our expert panel guides you on how to Manage PADE Inspections, with a focus on USFDA requirements. Save your spot for the webinar and register now: https://lnkd.in/gkNFJpQ4 #drugtrials #clinicaltrials #Webinar #Soterius #SignalDetection #drugsafety #clinicalsafety #clinicalresearch #LifeSciences #pharmacovigilance #pv #pharmaceuticals #pharmacy #soterius #adverseevent #liverinjury

Clinical trials are becoming more complex, with sites spread further across multiple regions, placing a higher burden on Sponsors for pharmacovigilance regulatory compliance. If you are an early-stage drug development Sponsor or work with one, please attend today's webinar or request a copy of the recording to explore what constitutes a compliant pharmacovigilance program, learn of considerations as the new therapy progresses through key milestones, and understand the proper requirements to make informed decisions. It starts at 11AM EST! Last minute registration is still available here: https://hubs.li/Q02G9frG0 #OneMMS #DrugDevelopment #PV #Pharmacovigilance #DrugSafety #Pharmaceuticals

FDA finalizes guidance allowing generic drug manufacturers to electronically submit expedited individual case safety reports for serious adverse events from bioavailability studies exempt from investigational new drug requirements. This streamlines reporting to the FDA's Adverse Event Reporting System, offering more efficient pathways for pharmacovigilance monitoring. Click the link below to know more. https://lnkd.in/grm8UxJb #fda #pharmaregulation #drugsafety #bioavailability #drugstudies #pharmacovigilance #genericdrugs #adverseevents #safetyreporting #clinicaltrials #healthcarecompliance #regulatoryupdate #dataintegrity #globalcompliance #regulationupdates #patientexperiencedata #pharmaceuticals #riskassessment #riskandcompliance #dataintegrity #qualitymanagement #qualitycontrol #validation #qualityassurance #csv #regulatoryaffairs #regulatoryintelligence #pharmaceuticals

📢 FDA Advances Electronic Submission Standards for Adverse Event Reports As of April 1, 2024, the FDA now accepts electronic submissions of premarketing individual case safety reports (ICSRs) in electronic format using ICH E2B(R3) standard. This milestones mark a transformative shift towards enhanced efficiency and standardisation in safety reporting procedures. Takeaways: 🔺 Adopting E2B(R3) Standard: Industry players have until April 1, 2026, to transition to the E2B(R3) standard for electronic transmission of ICSRs. During this transition, submissions using E2B(R2) data standards will be accepted for two years. 🔺 Compliance Deadline: Submitters must comply with electronic submission requirements for postmarketing safety reports by April 1, 2026, as per FDA regulations. For more details and resources on FAERS submissions and electronic reporting standards, the link is below. #pharma #pharmaceutical #pharmacovigilance PharmOut https://lnkd.in/gGW7b6Sb

Regulatory Intelligence 101: Navigating the Labyrinth of Drug Regulations in the USA   For anyone involved in the pharmaceutical industry in the United States, Regulatory Intelligence serves as the compass through the intricate landscape of drug regulations. From FDA guidelines to compliance standards, staying informed is the key to navigating the regulatory labyrinth successfully.   Join us at booth 101 to gain insights into latest regulatory updates – a fundamental aspect of drug development and commercialization. Discover how a comprehensive understanding of regulatory requirements can not only ensure compliance but also streamline the pathway to bringing safe and effective medications to the public.   GRIP is one-of-a-kind subscription service consisting of a comprehensive collection, 160 countries and counting, of global requirements, that have been collected and analyzed by our pharmacovigilance experts. When GRIP is used within Insife’s PROHALO system, the intelligence gathered is linked automatically to other modules and the new rules, once verified and accepted by each GRIP member organization, can automate the submission process.   #thedrugsafetyexperts #DIA #conference #PV #riskstrategy #pharmacovigilance #pharma #clinicalsafety #regulatoryintelligence  

Are your PV searches aligned with the latest GVP guidelines? Ensuring comprehensive and accurate literature coverage is crucial for effective drug safety monitoring. Dialog consolidates all EMA-recommended databases, including Embase, Medline, International Pharmaceutical Abstracts and Allied and Comprehensive Medicine into one powerful tool. Our expertise helps you stay on top of regulatory requirements, even if you're pressed for time. From creating and maintaining your search strategies to setting up alerts, our experienced team supports pharmaceutical companies in achieving precise and compliant literature monitoring. Need to align your searches with GVP guidelines? Reach out through the contact form to learn how we can help you: https://lnkd.in/ekr7z5iM #DrugSafety #Pharmacovigilance #RegulatoryAffairs #PharmaceuticalResearch #MedicalLiterature

Drug safety analysis plays an important role when it comes to pharmaceutical development- and its starts from early clinical stages to ensure that patients are protected as more innovative drugs are developed and brought to the market. That said, the safety analysis with respect to how safety signals during post-market stages are evaluated, while incorporating statistical methodologies for signal detection, is a key factor that pharmaceutical organizations and global regulatory agencies should consider. Read our blog on leveraging statistical approaches in drug safety analysis https://lnkd.in/gbfaC9SS Discuss your clinical and post-market safety requirements with us at DIA Global. Schedule a meeting with us here: https://lnkd.in/grrwWGU6 #pharma #drug #safety #clinical #pharmacovigilance #statistics #analysis #data

On January 16, 2024, FDA implemented the E2B(R3) standard for electronic transmission of ICSRs and submitters have two (2) years to implement E2B(R3) standard for electronic transmission. #pharmacovigilance #pharma #drugsafety #safetystandards #adverseevents #pharmaceutical

𝙁𝘿𝘼 𝙁𝙞𝙣𝙖𝙡𝙞𝙯𝙚𝙨 𝙍𝙪𝙡𝙚 𝙤𝙣 𝘽𝙞𝙤𝙡𝙤𝙜𝙞𝙘𝙨 𝙇𝙞𝙘𝙚𝙣𝙨𝙚 𝘼𝙥𝙥𝙡𝙞𝙘𝙖𝙩𝙞𝙤𝙣𝙨 𝙖𝙣𝙙 𝙈𝙖𝙨𝙩𝙚𝙧 𝙁𝙞𝙡𝙚𝙨 Today, FDA issued a final rule to amend its regulations concerning the use of master files for biological products. A master file is a submission to FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Information contained in a master file can be used to support a submission to FDA by an applicant or sponsor. Drug master files (DMFs) are master files that contain certain information, such as drug substance, drug substance intermediate, or drug product (DS/DSI/DP) information, that is relevant to applications for drug products regulated under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The rule codifies FDA’s existing practice that applications for a biological product under the Public Health Service Act (PHS Act) may rely on a master file for information other than DS/DSI/DP information. The rule also codifies FDA’s existing practice of permitting investigational new drug applications to incorporate information from a master file, including DS/DSI/DP information. Under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), certain drug applications for biological products approved under section 505 of the FD&C Act were deemed to be biological licenses under section 351 of the PHS Act on March 23, 2020. This rule also codifies that such deemed biological license applications (BLAs) that originally referenced DMFs) for DS/DSI/DP information in an approved new drug application can continue to do so after March 23, 2020. #usfda #regulatoryaffairs #regulatory #biologics #masterfile #fda #DMF #regulatorycompliance #regulations #CMC #dossier #guidelines #regulatoryreporting #regulatoryupdates #regulatorysubmissions #biotech #regulatorystrategy #pharma #regulatoryrequirements