Kona Medical Consulting’s Post

GSAR Case 2022-G514, Standardizing Federal Supply Schedule Clause and Provision Prescriptions, was published as a final rule today (1/12/2024) and goes into effect 30 days after publication (2/12/2024). This final rule to amends the GSAR to clarify when GSAR provisions and clauses apply to Federal Supply Schedule (FSS) (also known as Multiple Award Schedule (MAS) or "Schedules")) contracts when those contacts are established by a delegated agency. One example of a delegated agency is the Department of Veterans Affairs (VA) which manages a set of Schedules to procure medical supplies and services. A delegated agency has autonomy over the Schedules contracts it awards. The rule explains that these contracts are "...published on the FSS website, and often looks like every other available FSS contract apart from the naming convention. Contracts administered solely by GSA have a “GS” naming convention. This change will streamline the prescription language. Prescription language is the language that instructs when a clause is to be applied, when establishing a Schedule contract." The resulting clarifications issued for provision and clause prescriptions will help contracting officers use them correctly, assist with the understanding of how delegation from GSA to other agencies works, and documentation of the file as well as the process for deviations. There are no changes to the provisions or clauses themselves as a result of this rule. Permalink: https://lnkd.in/gMRYvF-h

Quality by Design (QbD) principles should be adopted by sponsors to smooth the transition to E6(R3). Customer identification is fundamental to quality by design. Read more in the article: https://lnkd.in/e9SFqufG While on the subject you may take a look at our free Good Clinical Practice Training: https://lnkd.in/eYcR-ix #pharmalessons #gcp #goodclinicalpractice #tmf #training #courses

Quality by Design (QbD) principles should be adopted by sponsors to smooth the transition to E6(R3). Customer identification is fundamental to quality by design. Read more in the article: https://lnkd.in/e9SFqufG While on the subject you may take a look at our free Good Clinical Practice Training: https://lnkd.in/eYcR-ix #pharmalessons #gcp #goodclinicalpractice #tmf #training #courses

Quality by Design (QbD) principles should be adopted by sponsors to smooth the transition to E6(R3). Customer identification is fundamental to quality by design. Read more in the article: https://lnkd.in/e9SFqufG While on the subject you may take a look at our free Good Clinical Practice Training: https://lnkd.in/eYcR-ix #pharmalessons #gcp #goodclinicalpractice #tmf #training #courses

Quality by Design (QbD) principles should be adopted by sponsors to smooth the transition to E6(R3). Customer identification is fundamental to quality by design. Read more in the article: https://lnkd.in/e9SFqufG While on the subject you may take a look at our free Good Clinical Practice Training: https://lnkd.in/eYcR-ix #pharmalessons #gcp #goodclinicalpractice #tmf #training #courses

Quality by Design (QbD) principles should be adopted by sponsors to smooth the transition to E6(R3). Customer identification is fundamental to quality by design. Read more in the article: https://lnkd.in/e9SFqufG While on the subject you may take a look at our free Good Clinical Practice Training: https://lnkd.in/eYcR-ix #pharmalessons #gcp #goodclinicalpractice #tmf #training #courses

HEALTH CANADA: Medical device establishment license application form (FRM-0292). If you sell or import any class of medical devices in Canada, you must apply for and maintain a Medical Device Establishment License (MDEL), unless you meet exemption(s) in section 44 of the Medical Devices Regulations. You must use this form to apply for an MDEL. To complete this form properly, follow these 7 steps: Step 1: Learn about MDEL's Step 2: Determine if your product is a medical device Step 3: Determine if your activities require an MDEL Step 4: Register as a small business (if applicable) Step 5: Complete the application form Step 6: MDEL fees Step 7: Submit your application form #healthcanada #Medicaldevice #licence #application #form #application #checklist Sources: https://lnkd.in/drZzKTE2 & https://lnkd.in/dcX-YGVS

Quality by Design (QbD) principles should be adopted by sponsors to smooth the transition to E6(R3). Customer identification is fundamental to quality by design. Read more in the article: https://lnkd.in/e9SFqufG While on the subject you may take a look at our free Good Clinical Practice Training: https://lnkd.in/eYcR-ix #pharmalessons #gcp #goodclinicalpractice #tmf #training #courses

It’s costly. It needs resources. Does it make sense? Sponsors and CROs that delegate tasks in clinical trials should ALWAYS qualify a solid number of vendors early on. Just to avoid the "Oops" moment, which happens when your vendor fails the audit.    And now you're in a tight spot, looking for alternatives at the last minute. No time to qualify before the study starts. Yes, it does make sense: Keep your options open from the start, as qualifying early means fewer headaches down the road. I am convinced that it is better to have more options than none at all. 

👀 Looking for an #CDMS / #EDC vendor who can support your study from early phase to post-marketing? Medrio CDMS/EDC scales with you as you grow. No matter the study size or phase, our technology safeguards your most important asset: your data. Read more: https://bit.ly/3KIyIeE #ClinicalTrials #ClinicalData #ClinicalDataManagement