African Union Development Agency-NEPAD’s Post

Privileged to have been part of a team of Information Technology (IT) and Monitoring & Evaluation (M&E) focal persons from National Medicines Regulatory Agencies (NRAs) of COMESA member states that attended a training workshop on Regulatory Information Systems Portal (RISP) from the 2nd- 4th December, 2024 in Chongwe, Zambia. Hosted by COMESA in collaboration with AUDA-NEPAD, under the African Medicines Regulatory Harmonization (AMRH) Programme, the training was part of the ongoing efforts by AUDA-NEPAD to support Regional Economic Communities (RECs) to harmonise and strengthen national regulatory systems for medical products. The goal is to train NRAs on IT and use of web tools to increase communication and transparency. Specific objectives were: (a) to train IT and M&E experts on the use and administration of RISP and Electronic Document Management Systems (EDMS) before systems go live; and (b) to collect information from NRAs to update RISP. Accordingly, my role as M&E focal point for the Pharmacy and Medicines Regulatory Authority, is to ensure that quality data is generated, organised and shared on the RISP using the applicable templates in line with the World Health Organisation (WHO) Global Benchmarking Tool (GBT).

Interesting information from the ECA Team today! EMA: Update of the Q&A Documents for "Centralised Procedures" In October 2024, the "Questions & Answers (Q&A)" documents relating to centralised marketing authorisation procedures were again updated and published on the website of the European Medicines Agency (EMA). "4.15. When do I have to submit revised product information? In all languages?" Full article at: EMA: Update of the Q&A Documents for "Centralised Procedures" - ECA Academy (gmp-compliance.org) hashtag#GMP hashtag#EMA hashtag#FDA hashtag#MRA hashtag#MutualRecognitionAggreement hashtag#regulatorystrategy hashtag#drugdevelopment hashtag#EUregulations hashtag#regulatorysubmissions

ESMP – monitoring medicine shortages in the EU and EEA. To gather information about medicine supply and demand, the European Medicines Agency (EMA) is setting up the European Shortages Monitoring Platform (ESMP). The ESMP is meant to enable EMA to monitor supply, demand and availability of critical medicines for needs in crises and emergencies. Data is collected from the national competent authorities (NCAs) and marketing authorisation holders (MAH) with the aim of preventing, detecting, and managing human medicine shortages in the European Union (EU) and European Economic Area (EEA). A list of the medicines monitored will be published by EMA.  The first version of ESMP will be live in February 2025. Do you need help with Quality Assurance or Regulatory Affairs? Let’s connect! Contact@arexadvisor.com #ESMP #drugshortage #medicineshortage #GMP #GDP #qualityassurance #regulatoryaffairs #EMA

💡𝐓𝐢𝐩𝐬 𝐟𝐨𝐫 𝐠𝐫𝐚𝐝𝐮𝐚𝐭𝐞𝐬 𝐥𝐨𝐨𝐤𝐢𝐧𝐠 𝐭𝐨 𝐝𝐢𝐯𝐞 𝐢𝐧𝐭𝐨 𝐭𝐡𝐞 𝐆𝐂𝐏 𝐫𝐞𝐚𝐥𝐦💡 𝐔𝐧𝐝𝐞𝐫𝐬𝐭𝐚𝐧𝐝 𝐑𝐞𝐠𝐢𝐨𝐧𝐚𝐥 𝐃𝐢𝐟𝐟𝐞𝐫𝐞𝐧𝐜𝐞𝐬: Did you know that the European Medicines Agency (EMA) and the FDA have slightly different requirements for clinical trials? Knowledge is power! 📚 𝐑𝐞𝐠𝐮𝐥𝐚𝐫 𝐓𝐫𝐚𝐢𝐧𝐢𝐧𝐠: Continuous learning ensures compliance and enhances quality. Invest in regular training sessions. 🎓 𝐂𝐨𝐥𝐥𝐚𝐛𝐨𝐫𝐚𝐭𝐢𝐯𝐞 𝐍𝐞𝐭𝐰𝐨𝐫𝐤𝐬: Join international QA forums and groups. Sharing experiences can provide insights that you might not find in a textbook! 🤝 #GCPCompliance #GCP #LifeSciences #QualityAssurance

Bringing years of experience managing clinical trials in Pakistan, we understand the nuances of Pakistan's regulatory requirements and leverage this expertise to design and implement regulatory strategies that align with study objectives and meet local and international regulations. Connect with us to explore how Metrics Research can provide end-to-end support to conduct clinical trials in Pakistan, from regulatory approvals to successful execution and achieving outcomes.   To learn more, visit https://lnkd.in/d-u2Y8ME #ClinicalTrialsInPakistan #ClinicalResearchPakistan #ResearchSolutions #RegulatoryApprovals #ClinicalTrialApplication #ClinicalTrialManagement #ResearchSolutions #FullServiceCRO #CROPakistan #MetricsResearch #ResearchInnovationExcellence

I’m happy to share that I’ve completed the Good Clinical Practice course with the NIDA Clinical Trials Network! This comprehensive training provided valuable insights into critical areas such as: • The Research Protocol • Participant Safety & Adverse Events • Quality Assurance • Documentation & Record-Keeping • Investigational New Drugs This certification enhances my knowledge in clinical research and regulatory affairs, ensuring that I can contribute to safe, ethical, and compliant clinical trials. I’m excited to apply these principles to future projects and continue growing in this field! #GoodClinicalPractice #GCP #ClinicalResearch #RegulatoryAffairs #ContinuouseLearning

Webinar Reminder: The Ukrainian eCTD in a Nutshell With the Ukrainian Ministry of Health implementing eCTD, staying compliant is crucial for all companies submitting in Ukraine. As the test period is already running, you need to prepare now to stay compliant and receive market authorization. Let our regulatory expert Michael Faust - Business Consultant for Regulatory Affairs guide you through everything you need to know about the upcoming eCTD requirements in Ukraine. Date: 13 June 2024 Time: 04:00 PM CEST Your Speaker: Michael Faust is an expert on Ukrainian eCTD with extensive experience in international regulations. As an eCTD trainer, he delivers crucial information concisely and concretely. Who Should Attend? Regulatory affairs professionals, submission specialists, and anyone involved in preparing and submitting eCTD dossiers in Ukraine. Gain the insights you need to ensure successful regulatory submissions in Ukraine and register now to secure your spot: https://lnkd.in/dm7fB3cU Can't attend live? No worries! Register anyway to receive the recording. #eCTD #Ukraine #Compliance #Pharma #RegulatorySubmissions #EXTEDO

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

Regulatory affairs professionals play a crucial role in harmonizing standards in the African region by ¹: - Encouraging dialogue with national regulatory authorities, regional regulatory bodies, and global regulatory networks. - Addressing key regulatory hurdles and identifying solutions to facilitate patients’ timely access to innovative therapies. - Collaborating with regulatory bodies to protect public health globally. - Advocating for aligned standards for medical products and supporting resource-constrained countries. - Providing industry-wide feedback on guidance documents to develop coherent, converging, and efficient science-based regulatory policies. - Contributing to the work of global regulatory networks, such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the World Health Organization (WHO). - Supporting regional mechanisms intended to harmonize regulations across national boundaries in Africa. - Encouraging the development of regulatory systems aligned with global standards through initiatives like the African Medicines Regulatory Harmonization (AMRH).