ClinChoice’s Post

Stay current with ever-changing regulations through routine Regulatory Intelligence updates from ClinChoice! Let's ensure unexpected changes in regulations don't impact your study. For regulatory updates, visit: https://hubs.la/Q02H8dY_0 #RegulatoryIntelligence #FDA #HPRA #CDSCO #EMA #MDA #TGA #MedSafe #NPRA #ClinChoice #ClinChoiceCanHelp

🚩 Navigating the Complex Regulatory Landscape: ✨️Why an Experienced, Multilingual CRO is Essential 🟢 The clinical research industry operates in a dynamic environment marked by constant regulatory evolution. Staying ahead of these changes is crucial for the success of your study. ✳️ That's where a seasoned, multilingual CRO like ClinChoice becomes an invaluable partner. ✅️ Our experienced team provides: 🔴 Deep Regulatory Expertise: We possess the knowledge and understanding to navigate complex regulatory requirements, ensuring your study remains compliant. Multilingual Support: Our diverse team can effectively communicate and collaborate with stakeholders across different regions, overcoming language barriers. 🔴 Proactive Regulatory Intelligence: Through our routine updates, you'll stay informed about the latest regulatory changes, allowing you to adapt your study accordingly. ✍️ Don't let unexpected regulatory shifts derail your clinical trial. 🔆 Partner with ClinChoice to mitigate risks and achieve your research goals. 📧 Contact us today to learn more about how our expertise can benefit your study.

Stay current with ever-changing regulations through routine Regulatory Intelligence updates from ClinChoice! Let's ensure unexpected changes in regulations don't impact your study. For regulatory updates, visit: https://hubs.la/Q02qg5Rl0 #RegulatoryIntelligence #FDA #HPRA #CDSCO #EMA #MDA #TGA #MedSafe #NPRA #ClinChoice #ClinChoiceCanHelp

Stay current with ever-changing regulations through routine Regulatory Intelligence updates from ClinChoice! Let's ensure unexpected changes in regulations don't impact your study. For regulatory updates, visit: https://hubs.la/Q02PlT5t0 #RegulatoryIntelligence #FDA #HPRA #CDSCO #EMA #MDA #TGA #MedSafe #NPRA #ClinChoice #ClinChoiceCanHelp

South African Health Products Regulatory Authority (SAHPRA) Launches eCTD 3.0 Submissions Portal https://lnkd.in/gRzNaCDQ The eCTD is the preferred format for submitting applications, variations to SAHPRA for evaluation, approval and registration. Please follow these guidelines when using this portal: All applications being submitted to the SAHPRA must be submitted via the new SAHPRA eCTD Portal. All applicants will need to apply for a login ID and password to gain access to the portal where they can register their applications, submissions, and each sequence they wish to upload and submit. Information on how to apply for access and how to upload content can be found in the SAHPRA eCTD Portal Process Guide. #europeancommission #mhra #sahpra #cdsco #usfda #mdcg #sushvin #AI #medtecheurope #ukresponsibleperson #newsletter #qa #ra #ukmdr #medicaldevicenewsletter #compliance  #qara #consultancy #audits #notifiedbody #healthcanada #swissmedic #eumdr #euivdr #comment

Final day at the symposium. The past two days have been interesting and interactive, so with today's topics focused on Bioequivalence and PV Compliance I'm looking forward to further discussion with regulators and variety of industry stakeholders - a great opportunity to both catch up and meet new experts! #ClinicalTrials #RegulatoryIntelligence #ICH_E6R3 #FDA #HealthCanada #MHRA

📣 The South African Health Products Regulatory Authority (SAHPRA) is hosting the 2nd session of their 𝐢𝐧𝐝𝐮𝐬𝐭𝐫𝐲 𝐰𝐞𝐛𝐢𝐧𝐚𝐫 𝐟𝐨𝐜𝐮𝐬𝐞𝐝 𝐨𝐧 𝐭𝐡𝐞 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐈𝐧𝐟𝐨𝐫𝐦𝐚𝐭𝐢𝐨𝐧 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐒𝐲𝐬𝐭𝐞𝐦 (𝐑𝐈𝐌𝐒) 💻 𝐫𝐨𝐥𝐥-𝐨𝐮𝐭 𝐮𝐩𝐝𝐚𝐭𝐞𝐬. ✅  The 𝐨𝐛𝐣𝐞𝐜𝐭𝐢𝐯𝐞 𝐨𝐟 𝐭𝐡𝐢𝐬 𝐰𝐞𝐛𝐢𝐧𝐚𝐫 is to provide a run-through on 𝐡𝐨𝐰 𝐭𝐨 𝐩𝐫𝐞𝐩𝐚𝐫𝐞 𝐭𝐡𝐞 𝐗𝐌𝐋 𝐭𝐫𝐢𝐠𝐠𝐞𝐫 𝐟𝐢𝐥𝐞 𝐚𝐧𝐝 𝐬𝐮𝐛𝐦𝐢𝐭 𝐗𝐌𝐋 𝐚𝐧𝐝 𝐞𝐂𝐓𝐃 𝐟𝐢𝐥𝐞𝐬 𝐨𝐧 𝐒𝐀𝐇𝐏𝐑𝐀 𝐬𝐅𝐓𝐏 𝐩𝐨𝐫𝐭𝐚𝐥. ✅  Kindly note that this webinar will be recorded and published on the SAHPRA website after the webinar. ✅  SAHPRA is planning a similar Update session once the eSubmission specifications and guidelines are ready – which tentatively will be held in July 2024. ✅  Use the below mentioned 👇 link to find more information and to register this SAHPRA RIMS webinar. https://lnkd.in/dv3dW6MC #rims #regulatoryaffairs #submissions #ectd #dossier #southafrica South African Health Products Regulatory Authority RegOrbit #pharmaceuticalindustry

Regional Economic Communities (RECs) in Africa continue to facilitate harmonization and capacity building of National Medicines Regulatory Authorities (NMRAs) regarding the use of the World Health Organization (WHO) Global Benchmarking Tool (GBT) assessment for regulatory systems strengthening. The global benchmarking tool is one of the global capacity maturity tools tailored for use by national regulatory authorities and regional initiatives, as well as aid agencies to assess the performance and functionalities of the NRAs in the areas of medicines regulation using the model of the five regulatory processes. Cognizant of the changing regulatory landscape of Africa due to key factors, such as; globalization, increased local manufacturing of medicines, increased reliance on regulatory processes, improved harmonization between regulatory agencies and regulatory convergence; these changes have brought about an important emphasis on the need for strengthening the capacity of NMRAs worldwide, given the importance of their role in regulating access to safe quality and effective pharmaceutical products. During the Regulatory Affairs Networking dinner hosted on August 9, 2024, Dr. Evans Sagwa, shared valuable insights on; Opportunities, Challenges and the way forward for NRAs to effectively use the WHO GBT assessment to enhance their regulatory capacity. Watch, Share and Subscribe: https://lnkd.in/driawVXi

Stay informed on the latest Regulatory developments in the Life Sciences industry with Freyr Regulatory Roundup!   Discover last week's updates from global Health Authorities such as MHRA, USFDA, ANVISA, DMA, Swissmedic, MDA, HSE, and more. https://lnkd.in/gKwkYVdX   #RegulatoryUpdates #FreyrRegulatoryRoundup #LifeSciences #HealthAuthorities #FreyrSolutions