Q: How does a sponsor make a Project Orbis request and what are the criteria?Ī: Sponsors can inquire from the respective Office of Oncologic Diseases review divisions whether their proposed application submission would be suitable for Project Orbis. Sponsors can request Project Orbis for their applications. Q: How does an application get nominated for Project Orbis?Ī: The FDA review team can recommend an application for Project Orbis based on a combination of the following: breakthrough designation, impressive results, and unmet need. Q: Will other therapeutic areas be involved in future Project Orbis reviews?Ī: Other therapeutic areas are not within the Oncology Center of Excellence’s purview. FDA is exploring other options to collaboratively work with regulators interested in this collaborative review program. Q: Will other countries be involved in future Project Orbis reviews?Ī: At this time, we are unable to increase the number of countries participating in Project Orbis. Does Canada and Australia have similar expedited approval programs?Ī: Yes, Health Canada approved the 1st Project Orbis application under conditional approval with conditions and TGA used its provisional approval with conditions of registration. In Canada, the approved indication was slightly different than the approved indication in the United States and Australia. The regulators exchanged drug labels to learn about any potential differences. Each country has its own format for the drug label. Q: Did the three countries issue the same drug labels for the two products involved?Ī: No. The aim of this collaborative review was to identify any regulatory divergence across the review teams. Q: For the first Project Orbis review, what was the role of each country in the review process?Ī: The three regulatory agencies collaboratively reviewed this application, allowing for simultaneous decisions in all three countries. Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA) and Health Canada (HC) took part in this application review. In the past twenty years, we have seen that work placement systems are on the rise and being implemented faster.Q: Which countries were involved in the first Project Orbis collaborative review ?Ī: The U.S. Symplicity did exactly this, with the bonus of getting the most trusted experiential learning solution for post-secondary institutions in Canada.Īs mentioned above, today more than ever, students need to develop job market skills in addition to their fundamental training to be ready for their careers. ![]() ![]() With little to no white space in this product category in Canada, acquiring competitors is the only way to increase market shares. Symplicity comes in second place with 10%. Orbis dominates the Canadian market in the work placement category, with over 85% of all market shares. Our database shows that almost all Orbis clients are Canadian. Improving work skills outside of the classroom is essential to students’ success in the job market. In these unprecedented times, tighter integration of higher education with career services will play a critical role. With Orbis’ solutions, connections were forged between more than 350,000 employers and one million students. Orbis can call 100 institutions its clients. While the acquirer is well-known for its student employability systems, the acquiree is Canada’s most trusted experiential learning solution.Īccording to the press release, Symplicity wanted to expand its footprint in Canada. In early December 2021, we learned that Symplicity Corporation acquired Orbis Communications.
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