Carl Bufe’s Post

FDA Clinical Investigator Training Course (CITC) 2024: Preparing Investigators for High-Quality, Ethical Research Published by CDER Small Business & Industry Assistance (SBIA) in #UnitedStates The FDA’s Clinical Investigator Training Course (CITC) 2024 will be held virtually from December 10-12, 2024, offering a comprehensive curriculum for clinical investigators and stakeholders in biomedical research. This course provides the foundation needed to conduct clinical trials that meet ethical and regulatory standards. Key highlights of the course include: 🔺 FDA's approach to clinical trial design 🔺 Biostatistics and data analysis for clinical trials 🔺 Safety and ethical considerations in drug development 🔺 Regulatory compliance and investigator responsibilities 🔺 Innovations in trial design This event is an opportunity for clinical investigators, healthcare professionals, and those involved in drug development to enhance their understanding of critical regulatory standards and practices. For more information: https://lnkd.in/gwyqY3GU #FDATraining #DrugDevelopment #ClinicalEthics #HealthcareCompliance #pharma #clinicalresearch #clinicaltrials #pharmout PharmOut

Harmonised Global Approach for Adverse Event Data Exchange in Medical Devices Published by: International Medical Device Regulators Forum (IMDRF) in October 2024 Key Points: 🔺 The IMDRF has released a Common Data Set (CDS) for harmonizing the exchange of adverse event data among global medical device regulators. 🔺 This CDS aims to enhance signal detection and public health safety through better data sharing, similar to pharmacovigilance standards like ICH E2B. 🔺 It includes guidelines on data formats, confidentiality, and inter-jurisdictional data exchange processes to ensure secure, standardized communication. 🔺 The initiative builds on previous frameworks, including GHTF N54 (2006), and incorporates global terminologies for event reporting. 🔺 Data exchanged will focus on post-market adverse events, excluding premarket or non-industry reports. For more information: https://lnkd.in/gsrqHVRu #MedicalDevices #DataSharing #AdverseEvents #PatientSafety PharmOut #pharmout

Updated Post-Marketing Vigilance Requirements for Therapeutic Products and CTGTP Published by: Health Sciences Authority (HSA) in #Singapore, October 2024. Top four updates from the Post-Marketing Vigilance Guidelines (Version 5) for therapeutic products and Cell, Tissue, and Gene Therapy Products (CTGTP) include: 1️⃣ Updated Safety Reporting Processes: Submission methods for new safety information, reference Risk Management Plans (RMP), and supporting documents have been streamlined. 2️⃣ New 5-Year Schedule for PBRER: Companies are now required to provide a 5-year submission schedule for Periodic Benefit-Risk Evaluation Reports (PBRER). 3️⃣ Educational Materials: Finalized HSA-approved educational materials must adhere to updated text requirements, ensuring clarity for healthcare providers and patients. 4️⃣ Submission of Post-Registration RMP Obligations: New submission methods introduced to streamline post-market RMP compliance. More information: https://lnkd.in/gX_hXSAA #pharmacovigilance #riskmanagement #CTGTP #Singapore #vigilance #patientsafety #pharmout PharmOut

Updated Guidelines on Therapeutic Product Information in New Zealand (Edition 7.2) Published by: Medsafe in #NewZealand, October 2024. Key Updates to the Guidelines on the Regulation of Therapeutic Products (GRTPNZ) concerning prescribers and consumers: 🔺 New Template for Data Sheets: Standardized format for easier navigation and uniformity across product sheets for prescribers. 🔺 Data Sheet Requirements: Mandatory for prescription and restricted medicines, with specific guidelines on bioavailability and brand switching. 🔺 Consumer Medicine Information (CMI): While not required by law, pharmaceutical companies are encouraged to provide CMI to help consumers understand medication use, side effects, and interactions. 🔺 Self-Assessable Changes: Streamlined for minor data sheet modifications, with responsibilities resting on sponsors to ensure compliance. 🔺 Safety and Compliance: Medsafe continues monitoring published data sheets for accuracy, maintaining a proactive role in New Zealand’s pharmacovigilance. For more information: https://lnkd.in/gzjnjzDJ #medicinesafety #therapeuticproducts #Medsafe #pharmout PharmOut

Enhanced Product Standards for Therapeutic Vapes in 2025 Published by the Therapeutic Goods Administration (TGA) in #Australia on 1 October 2024 The TGA is set to implement strengthened standards for therapeutic vapes, aiming to enhance the safety and quality of vaping devices and substances used for smoking cessation and nicotine dependence. These updates are part of Australia's broader vaping reforms and will be phased in throughout 2025. Key points: >March 1, 2025: Only vapes meeting the new standards can be imported or manufactured. >July 1, 2025: Only compliant vapes can be lawfully supplied. >Key changes to TGO 110 include restrictions on nicotine content (max 50 mg/mL) and new packaging requirements (plain design, product leaflets, and traceability). >MDSO updates include enhanced technical requirements for vaping devices and accessories, alongside new labelling guidelines. >No therapeutic vapes are currently approved by the TGA and listed in the Australian Register of Therapeutic Goods (ARTG). > Suppliers will need to submit new compliance declarations and obtain updated permits before the 2025 deadlines. For more information: https://lnkd.in/gCHUpmA5 #vapingregulations #nicotinecontrol #tga #smokingcessation #pharmout PharmOut

Unveiling Key Insights from the Latest ADR News Bulletin 2024 The newest issue of the ADR News Bulletin (Volume 26 Number 2) brings vital updates on adverse event reports in paediatrics from 2019 to 2023, along with a summary of adulterated products reported to the HSA between November 2022 and December 2023. Three key takeaways: 🔺 Enhanced Patient Safety: Understanding trends in paediatric adverse events can lead to better prevention strategies. 🔺 Risk Awareness: Being informed about adulterated products helps us safeguard patients from potential harms. 🔺Improved Treatment Guidance: The new patient factsheet on the safe use of allopurinol is a valuable resource for optimizing patient care. Download the full bulletin here: ADR_News_Sep2024_Vol26_No2 #DrugSafety #HealthcareInnovation #PatientCare #ProfessionalDevelopment #pharmacovigilance #pharma #pharmout PharmOut