SACRA South Africa

📜🎉🥂 Join Us for the SACRA Gala Dinner: RSVP Now! We are excited to announce that the SACRA Gala Dinner is officially open for RSVPs! This event presents an excellent opportunity to engage with fellow industry professionals and celebrate achievements within the healthcare community. Event Details: 📅: Thursday, 14 November 2024 🕕: 17:30 - 18:00 🚩: Bondev Venue, Royal Elephant Hotel, Centurion, GAUTENG #Attendance #Fees: SACRA Members: R250 per person Non-Members: R1000 per person The Gala Dinner is budgeted for 150 attendees (maybe more), creating a perfect setting for networking and sharing insights. #Sponsorship #Opportunity: We invite your organization to secure a table as a sponsor! For more details, please email your inquiry to admin@sacraza.com. As a sponsor, you have the opportunity to invite stakeholders and partners you wish to network with, facilitating collaboration and meaningful dialogue. #Booking #Confirmation: Please note that your booking will only be confirmed once payment is received. ⏳#RSVP #Deadline: Please confirm your attendance or sponsorship by 30 October 2024. With tables already being booked, don’t miss the chance to secure your seat and be part of this remarkable evening. 📢Reserve Your Spot Today! https://lnkd.in/dz38Kni3 For for more information, please contact us at on admin@sacraza.com. We look forward to celebrating with you and paving the way for a healthier future together! #SACRAGalaDinner #HealthcareNetworking #GalaDinner2024 #SACRAmembers #HealthcareCommunity #CelebrateSuccess #SponsorshipOpportunities #NetworkingEvent #FutureOfHealthcare #JoinUs #RSVPNow Sorika van Niekerk Leonard Neil L. Adriaan Kruger Robin Edward V. Charlotte Botha James Reinard Mc Pherson, MBChB, CPI Farhaad Shaik Azwidihwi Takalani Sonnika van Vuuren Ida Ndlovu Benjamin du Toit - Enslin

🌟 REMINDER - Webinar Alert! 🌟 Don’t miss our SACRA-hosted webinar featuring nuvoteQ.io, showcasing how this innovative South African tech firm is transforming clinical research in Africa through digitization. 🗓 Date: 03 October 🕒 Time: 4 - 5 pm (SAST/CAT) ⏳ Duration: 1 Hour 🔗 https://lnkd.in/ddRyHVjH Attendance: Free for SACRA members - RSVPs will receive meeting invite this week R150 for non-members - RSVP to register and receive an invoice, please send proof of payment to admin@sacraza.com to get meeting access. 💡 Join us and stay ahead in clinical research technologies innovation! Adriaan Kruger Sorika van Niekerk Leonard Neil L. Robin Edward V. Charlotte Botha James Reinard Mc Pherson, MBChB, CPI Azwidihwi Takalani Farhaad Shaik Sonnika van Vuuren Ida Ndlovu Benjamin du Toit - Enslin Tevan Naidoo #ClinicalResearch #TechInnovation #Digitization #SACRAWebinar #ResearchTechnology #nuvoteQ #ClinicalTrials #WebinarAlert #HealthTech #ResearchInnovation #ClinicalResearchAfrica

Dear SACRA Members, We have received feedback and request for support from both SACRA and IPASA members regarding the detainment of laboratory kits at Port Health. They have been requesting a copy of the SAHPRA authorization letter, which does not typically list the laboratory kits since they are not the primary item under research—rather, it is the pharmaceutical product. When the letter is provided, it is often rejected due to a request for additional information, including a Section 22c license or MD022. To this effect we had a call with SAHPRA Medical Device department to gain an understanding on the requirements when laboratory kits are imported. From the discussion and emails received from industry members it is clear that there is a lack of clear understanding with regards to the classification of Medical Devices (MD) . Since the classification has a direct impact with regards to process to follow for importation, we agreed with SAHPRA that we will circulate the latest guideline document in this regard and ask for feedback. To address these issues and ensure compliance, we would greatly appreciate your input/comments/questions on the classification of Medical Devices guidelines. Your feedback is crucial for further refining these guidelines and overcoming the current challenges. SACRA Members can access the document on this link: https://lnkd.in/d4UuX--k for review and comments (track changes to be used). Special focus on Section 4. 🔓SACRA Members:  Should you have any difficulty accessing the document via the link - please email me at admin@sacraza.com to grant/give access #SACRAUpdate #SAHPRA #MedicalDevices #LabKitDetainment #ImportGuidelines #MDClassification #HealthcareCompliance #RegulatoryFeedback #IndustryGuidelines #SAHPRAStandards #LabKitIssues #MedicalDeviceRegulation #SACRAFeedback #GuidelineReview Sorika van Niekerk Leonard Neil L. Adriaan Kruger Rob van den Bergh Charlotte Botha James Reinard Mc Pherson, MBChB, CPI Farhaad Shaik Azwidihwi Takalani Sonnika van Vuuren Ida Ndlovu Benjamin du Toit - Enslin Tevan Naidoo Itumeleng Siweya Tirhani Maluleke, PhD

🚀🎉 We’ve Reached 5,000+ Followers on LinkedIn! 🎉🚀 We are elated to announce that our LinkedIn community has grown to over 5,000 followers! A huge thank you to each and every one of you for your support and engagement. Your enthusiasm and feedback have been instrumental in helping us share valuable insights, industry updates, and innovative ideas. We’re excited to continue this journey with you and bring even more valuable content to your feed. Stay tuned for upcoming updates, exclusive content, and opportunities to connect. Together, let’s keep the momentum going and achieve even greater milestones! Thank you for being a part of our community. Here’s to reaching new heights together! Sorika van Niekerk Leonard Neil L. Adriaan Kruger Rob van den Bergh Charlotte Botha James Reinard Mc Pherson, MBChB, CPI Azwidihwi Takalani Farhaad Shaik Sonnika van Vuuren Ida Ndlovu Tevan Naidoo Benjamin du Toit - Enslin #Milestone #ThankYou #LinkedInCommunity #Growth #TogetherWeGrow #Networking #SouthAfricaClinicalResearchIndustry #StrongerTogether #LetsKeepGoing

🌟 Exciting Webinar Alert! 🌟 Join us for an exciting SACRA-hosted webinar featuring nuvoteQ.io, where we'll explore how this innovative South African tech firm is transforming the African clinical research landscape through digitization. 🗓 Date: 03 October 🕒 Time: 4-m - 5pm (SAST/CAT) ⏳ Duration: 1 Hour 🔗https://lnkd.in/ddRyHVjH Attendance: - Free for SACRA members - R150 for non-members To register, simply RSVP, and you'll receive an invoice. Non-members are kindly requested to send proof of payment to admin@sacraza.com to secure access to the webinar. 💡Learn from industry leaders and stay ahead in clinical research innovation! Adriaan Kruger Sorika van Niekerk Rob van den Bergh Leonard Neil L. Charlotte Botha James Reinard Mc Pherson, MBChB, CPI Azwidihwi Takalani Farhaad Shaik Sonnika van Vuuren Ida Ndlovu Benjamin du Toit - Enslin Tevan Naidoo #SACRA #Webinar #ClinicalResearch #Digitization #AfricanTech #BuiltLocally #TrustedGlobally

DEAR SACRA MEMBERS, 👉 We Need Your Input! 👈 We’ve observed a recent increase in both planned and unannounced inspections by SAHPRA at clinical trial sites. Along with this, there have been some variations in how inspection findings are categorized—sometimes a finding is labeled as "Major" and at other times as "Minor," even when similar issues are observed. To get a clearer picture of how widespread these variations might be, we’re conducting a survey. Your insights will help us understand whether this is a broader industry trend or specific to a few cases. Share your experiences and observations to help us address potential inconsistencies in inspection findings. Your feedback will be invaluable in fostering clearer guidelines and practices. #SURVEY #LINK: 🔗📝 https://lnkd.in/d4UuX--k 🎯Closing date for responses: 13 September 2024 Your participation will contribute to a better understanding of current practices and help drive positive improvements. Thank you for your time! Sorika van Niekerk Leonard Neil L. Adriaan Kruger Charlotte Botha James Reinard Mc Pherson, MBChB, CPI Farhaad Shaik Azwidihwi Takalani Sonnika van Vuuren Tevan Naidoo Ida Ndlovu Benjamin du Toit - Enslin Tirhani Maluleke, PhD Itumeleng Siweya #ClinicalTrials #SAHPRA #ResearchCompliance #Survey #IndustryFeedback

Investigator & Site Staff Certification Course (CLIC): 📅 9 - 13 Sep 2024 💡CLIC Event Organizers #LISTENING to #YOUR Investigator Site #NEEDS - ❗️❗️Opening Up for DAILY attendance❗️❗️ 📢 Don't miss out! For more information regarding the programme updates & daily event topics, presenters and fees visit our website: https://lnkd.in/d9RhquT9 #ClinicalTrial #InvestigatorSites #OptimizeQuality #PatientsFirst #ClinicalTrials #ClinicalResearch #InvestigatorTraining #SiteStaffTraining #ClinicalTrialExcellence #ResearchCompliance #ClinicalTrialManagement #ClinicalTrialOptimization #HealthcareInnovation #ResearchSkills #ClinicalResearchTraining #PharmaTraining #ClinicalResearchCompliance #TrialEfficiency

DEAR SACRA MEMBERS: 🚀 Help Streamline CTF2 & CTF3 Approval Timelines! 🚀 We’re reaching out to our SACRA network to gather valuable insights into the approval timelines for CTF2 and CTF3 submissions. Recent feedback suggests that these timelines might exceed 6 weeks, and we’re committed to improving this process. We’d appreciate your input! If you’ve made any CTF2 submissions from January to August 2024, please share the details with us. We’re looking for information on: 🔹 Major PA 🔹 Minor PA 🔹 Increase in patient numbers 🔹 IP Doses 🔹 Change of Address/Sponsor Your input will be instrumental in our analysis and will help us prepare for an upcoming stakeholder meeting. 🔗📝Survey link is accessible to SACRA Members only: https://lnkd.in/d4UuX--k survey deadline for input - Friday, September 6, 2024. #ApprovalTimelines #CTF2 #CTF3 #Healthcare #Pharma #StakeholderEngagement #DataDriven Sorika van Niekerk Leonard Neil L. Adriaan Kruger Charlotte Botha James Reinard Mc Pherson, MBChB, CPI Farhaad Shaik Azwidihwi Takalani Sonnika van Vuuren Tevan Naidoo Ida Ndlovu Benjamin du Toit - Enslin Tirhani Maluleke, PhD Itumeleng Siweya

📅UPCOMING INVESTIGATOR & SITE STAFF COURSE: 9 - 13 Sep 2024 To thrive in the competitive world of clinical trials, investigator sites must operate at the highest standards of excellence. By adhering to rigorous protocols, maintaining impeccable data integrity, and fostering strong relationships with sponsors, your site can distinguish itself as a top contender. Striving for excellence not only enhances the quality of your research but also ultimately ensures patient safety and successful outcomes, contributing to better healthcare for all. Elevate your operations to attract prestigious opportunities and make a meaningful impact on the future of medicine. 👉 Don't miss out, registrations closing soon! For more information regarding the programme, topics, presenters and fees visit our website: https://lnkd.in/d9RhquT9 #ClinicalTrial #InvestigatorSites #OptimizeQuality #PatientsFirst #ClinicalTrials #ClinicalResearch #InvestigatorTraining #SiteStaffTraining #ClinicalTrialExcellence #ResearchCompliance #ClinicalTrialManagement #ClinicalTrialOptimization #HealthcareInnovation #ResearchSkills #ClinicalResearchTraining #PharmaTraining #ClinicalResearchCompliance #TrialEfficiency

🧑⚕️👩⚕️The Clinical Research Education Programme (CREP) - Gauteng Wits Health Consortium 📆Classroom Training dates: 12 September - 07 November 2024 🎯The Clinical Research Education Programme (CREP) provides new Principal or Sub-Investigators or other Senior Research team members with the knowledge and skills to develop competency in clinical trial conduct. #ResearchTraining #ClinicalTrials #ResearchExcellence #ResearchProtocols #EthicsInResearch #InvestigationalProducts #ClinicalTrialManagement #StudyManagement #DataIntegrity #ResearchCompliance #GautengEvents #ClinicalInvestigators #InvestigatorSiteStaff #ProfessionalDevelopment #ResearchLeadership