USAID - Bureau for Humanitarian Assistance’s Post

⏰ 𝗨𝗻𝗿𝗮𝘃𝗲𝗹𝗶𝗻𝗴 𝘁𝗵𝗲 𝗘𝘃𝗼𝗹𝘂𝘁𝗶𝗼𝗻 𝗼𝗳 '𝗗𝗮𝘆 𝟬' 𝗶𝗻 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗟𝗶𝘁𝗲𝗿𝗮𝘁𝘂𝗿𝗲 𝗦𝗰𝗿𝗲𝗲𝗻𝗶𝗻𝗴 Dive into our latest blog post as we unravel the fascinating journey of "Day 0" in medical literature 📚 screening. Historically, navigating this pivotal moment, especially concerning hard-copy journals, presented formidable challenges. However, the European Medicines Agency (#EMA) ushered in clarity in January 2023, aligning "Day 0" for Individual Case Safety Reports (#ICSR) from physical local journals 🗞️with the moment of journal receipt, mirroring the protocol for electronic database searches. But the story doesn't end there. In March 2024, EMA revisited its stance on "Day 0", refining it to tether with identifying sufficient information for ICSR reporting. Moreover, a strict 7-day 🗓️ processing deadline upon receipt was instituted, underscoring EMA's commitment to enhancing efficiency in pharmacovigilance practices. 🔔 This narrative is not just about regulatory updates; it's a testament to the evolving landscape of #pharmacovigilance. Learn more about this intriguing journey in our blog: https://lnkd.in/dcfSc_Tj

🔔𝗘𝗠𝗔 𝗨𝗽𝗱𝗮𝘁𝗲 🔔 The European Medicines Agency (EMA) has introduced an important update to its ongoing proof-of-concept (PoC) pilot, focused on enhancing regulatory assessments by requiring the submission of clinical study data in a standardized, electronic format. This change aims to improve the consistency and transparency of data used in evaluating the safety and efficacy of medicinal products.   🔑 𝗞𝗲𝘆 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀:   👉📊 𝗦𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝗶𝘇𝗲𝗱 𝗜𝗻𝗱𝗶𝘃𝗶𝗱𝘂𝗮𝗹 𝗣𝗮𝘁𝗶𝗲𝗻𝘁 𝗗𝗮𝘁𝗮: Applicants must now provide clinical study data in a structured format compliant with #CDISC standards (such as ADaM and SDTM). This approach facilitates in-depth analysis and contributes to more informed regulatory decisions. 👉📈 𝗘𝗳𝗳𝗶𝗰𝗶𝗲𝗻𝗰𝘆 𝗶𝗻 𝗗𝗲𝗰𝗶𝘀𝗶𝗼𝗻-𝗠𝗮𝗸𝗶𝗻𝗴: By enabling direct access to detailed patient data, the EMA aims to accelerate access to innovative therapies while maintaining high safety standards. 👉📃 𝗦𝗶𝗺𝗽𝗹𝗶𝗳𝗶𝗲𝗱 𝗣𝗿𝗼𝗰𝗲𝘀𝘀𝗲𝘀 𝗳𝗼𝗿 𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝗻𝘁𝘀: Streamlined data requirements can reduce the complexity of regulatory queries, potentially shortening approval timelines.   At FGK Clinical Research GmbH, we are equipped to assist in preparing and submitting #clinicaldata in compliance with these standards. Our expertise ensures that your submissions align seamlessly with regulatory expectations. If you’d like to discuss how these changes could impact your applications, feel free to connect with us!   #RegulatoryAffairs #ClinicalResearch

Training course for licensing and renewing the license of scientific offices in light of the regulatory guide issued in January 2024 The #EgyptianDrugAuthority announces the opening of registration for a #TrainingCourse for licensing and renewing the license of scientific offices in light of the regulatory guide issued in January 2024. The training course aims to introduce the types of scientific offices, clarify the differences between them, and provide a detailed explanation of the procedures necessary to license a new scientific office, clarify the technical requirements for scientific offices and sample Stores, in addition to explaining all cases of making amendments to the scientific office license, while educating company representatives about common mistakes when submitting a license file and how to avoid them, violations, and cancellation cases, in light of the regulatory guide issued in January 2024. The training course is scheduled to be held on Monday and Tuesday, November 18,19, 2024, at EDA premises Mansouria. The training course is targeting companies aiming to license (or renew the license) of a scientific office, whether they are: local companies, factories, foreign companies, agents or commissioners. The training course will start at 9:30 AM and end at 2:30 PM. The last date to register is Thursday, November 14, 2024. Attendees will receive a certificate of attendance accredited by the Egyptian Drug Authority's Center for Continuing Professional Development. To register, please click on the following link: https://lnkd.in/dYXynai9 #EgyptianDrugAuthorityMediaCenter #CenterforContinuingProfessionalDevelopment #EgyptianPharmaceuticals

WHAT DOES MY FUTURE HOLD? Most of the Pharmacy graduates I know have pursued Msc. in pharmaceutical analysis and Quality assurance, or Msc. in Health Supply chain Management and recently I can honestly see the appeal, but again what other option is there? I don't want to be influenced by other people's decisions; but I don't want to be dismissive as well... For a while now, I have taken up a role of content development for some Rwanda Pharmaceutical Students Association (RPSA/AEPHAR) conferences including The #RPSA13thIPS, #RPSASciCon on Drug safety and Vaccine safety and the soon-happening RPSA #HealthcareSummit... Not to boast or anything but If I collected a coin for every time I included supply chain management into the program of the day, I'd probably have thousands of them 😂. ...that and probably way too many google searches, "LinkedIn stalk" of professionals in the field and the most recent International Pharmaceutical Federation (FIP) digital event about “Pharmaceutical supply chain resilience in humanitarian crises... have deepened my understanding of the crucial frameworks of any if not all, supply chain systems... but still I got a lot of questions... so if we "happen" to meet (I will have probably stalked you to that moment... not in a weird way though😏) and I ask you a series of questions... just know they are coming from a curious and "eager to know" place I'm actively looking forward to a chance of witnessing all theories in a practical manner.

✨ Achievement Unlocked! ✨ I am thrilled to share that I have successfully completed the NPTEL certification course on "Current Regulatory Requirements for Conducting Clinical Trials in India for Investigational New Drugs/New Drug"! 📜 This 8-week journey provided me with in-depth knowledge of the regulatory landscape, compliance protocols, and ethical considerations surrounding clinical trials in India. Understanding these crucial aspects not only strengthens my professional skill set but also helps me contribute meaningfully to innovation in healthcare. 💡 Looking forward to applying this knowledge in my future endeavors and staying committed to fostering responsible and impactful clinical research. #NPTEL #ClinicalTrials #RegulatoryAffairs #HealthcareInnovation #ContinuousLearning #PharmacyProfessionals #ClinicalResearch

𝗦𝘁𝘂𝗱𝘆 𝗦𝘁𝗮𝗿𝘁-𝗨𝗽 𝗖𝗶𝗿𝗰𝗹𝗲 (𝗦𝗦𝗨𝗖) – 𝗟𝗮𝘂𝗻𝗰𝗵𝗶𝗻𝗴 𝗶𝗻 𝟭 𝗪𝗲𝗲𝗸! I'm thrilled to announce that in just 1 week, we're launching the Study Start-Up Circle (SSUC)! SSUC is a community for professionals in Study Start-Up and Clinical Regulatory Affairs to connect, share, and collaborate across industry borders — pharma companies, CROs, authorities, ECs, and hospitals. I warmly invite you to be part of this exciting journey. If you know someone who might be interested, please share this post with them. Stay tuned for more updates! #StudyStartUp #ClinicalTrials #RegulatoryAffairs #CTIS #ProfessionalDevelopment #SSUC #StudyStartUpCircle

ℹ Let’s take a look at what some of our attendees have said about the previous Orphan Drugs Clinical Trials online training course. This training course presents a unique blend of Orphan Drugs regulatory guidance and clinical trial strategies. Delegates will explore the legal basis for approvals, learn how to design a study and which methodology to use. Evidence-based medicine data analysis, conclusions, and reporting will be thoroughly discussed. The next live online training course will be on 3 - 4 June 2024 🗓 #orphandrugs #clinicaltrials #onlinecourses #SymmetricTraining

The European Medicines Agency (#EMA) is transitioning from the eXtended EudraVigilance Medicinal Product Dictionary (#XEVMPD) to the International Organization for Standardization (#ISO) identification of medicinal products (#IDMP) #standards to better standardise the #global exchange of #medicinalproduct information. This article from Ratnam Tammineedi, Navaneetha G, Prabu Selvaraj, Anil Kumar M, Anamika Goel, Manju Joon, Kirti Yadav, Jacci Squire, Dr. Vivek Tomar and Allison Gillespie in the #April 2024 issue of #RegulatoryRapporteur discusses the current #XEVMPD #standards and the benefits offered by the transition to #IDMP #standards. Read it online now 👉 https://lnkd.in/eucbeRK8 #RegulatoryRapporteur is our peer-reviewed journal, published online 11 times a year and available free to #TOPRA members. This edition focuses on #data and explores how #industry is increasingly harnessing its capabilities across the #medicinesdevelopment #lifecycle to keep pace with #innovation and #digitisation.

Updated on 29 February: 'Compliance with QRD template v10.4' section The QRD template v10.4 was revised to delete 'United Kingdom (Northern Ireland)' from the list of local representatives in the package leaflet to comply with the Windsor Framework for labelling and packaging of medicines. In addition, EMA has implemented the following minor changes: replacing hyperlinks from EMA's previous website correcting details in the list of local representatives for Denmark, in all available language versions, for both QRD and ATMP templates making linguistic amendments to the Norwegian version of the ATMP template  replacing the hyperlinks for the mutual recognition procedure, decentralised procedure and referral templates, in all available language versions For the implementation of the QRD template v10.4, please refer to the guidance below which includes questions and answers to stakeholders on the implications of Regulation (EU) 2023/1182 for centrally authorised medicinal products for human use (questions 5 and 9). #medicinalproducts #produktylecznicze #ffp https://lnkd.in/dT5E-twJ

I am pleased to announce that I have recently obtained certification in GCP Nida guidelines. This comprehensive course is founded upon the principles outlined in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines, as well as the Code of Federal Regulations (CFR) about clinical research trials. This certification underscores my commitment to upholding the highest standards of ethical conduct and regulatory compliance in clinical research endeavours. #clinicalresearch #GCP