RFQ/OBP319/2025/26
See details below or the tender documentation
Tender Closed on: 2026-01-25 15:00
Onderstepoort Biological Products Limited
Consulting Services, Education, Training, Mentorship and Coaching, Professional Services
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Tender Description: Training Provider & Facilitator Accreditation: Look for courses accredited by HPCSA, SAHPRA or SAMAREC (South African Medical Association Research Ethics Committee). Compliance: Courses must cover the latest ICH GCP E6 (currently R3) and South African guidelines. Validity: A South African GCP certificate is valid for 3 years. Training Format: Interactive sessions with a live accredited facilitator (in person classroom set-up) At least 10 yearsâ?? experience in offering GCP training Course duration: To be provided by service provider Course content shall include: â?¢ Proportionality and Risk-Based Quality Management: The guideline promotes a "fit for purpose" approach, requiring that the level of quality management and risk assessment be proportionate to the specific objectives and nature of each clinical trial. - Flexibility for Modern Trials: E6(R3) supports diverse and modern trial designs, including decentralized models and the use of electronic data capture, promoting innovation and technological advancements. - Clear Roles and Responsibilities: The guidance provides more explicit details on the roles and responsibilities of the sponsor and the investigator, emphasizing clear delegation and overall accountability. - Focus on Data Integrity: Sponsors are required to implement robust data management systems to ensure the reliability and integrity of data throughout the entire trial lifecycle. - Integration of Digital Technologies: The guideline encourages the seamless incorporation of new technologies, such as electronic informed consent and remote monitoring, to streamline trial processes and enhance participant engagement. Implementation and Impact â?¢ Global Adoption: Major regulatory bodies, including the FDA in the US and the EMA in Europe, have aligned with the new guidelines and are proceeding with their implementation. - Impact on Stakeholders: Sponsors and investigators must update their strategies and protocols to align with the new expectations, ensuring compliance and the successful integration of new technologies and processes. â?¢ GCP auditing.
Information:
Contact:Quotations should be submitted online
For futher enquiries please contact: 012 522 1500
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Tender URL: https://eprocurement.obpvaccines.co.za/Opportunities/Details?Id=2ec11945-2cfd-4ef6-bf7d-39326b75ab16
Application URL: https://eprocurement.obpvaccines.co.za/Suppliers/Bids/Add?id=2ec11945-2cfd-4ef6-bf7d-39326b75ab16
The primary objective of this tender is to procure Good Clinical Practices (GCP) implementation and auditing training services. The training aims to ensure participants are knowledgeable about the latest GCP guidelines, including ICH GCP E6 (R3) and South African regulations, to promote compliance, data integrity, and quality in clinical trials.
The scope includes:
The technical requirements specify that:
The skills and experience required from the training provider include:
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