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Mexico aims to conduct late stage trials for coronavirus vaccines designed by US and Chinese companies. This is in hope that these countries may base their vaccine production in Mexico. Ebrard said he hoped that trials would start between next month and January if they get approval from Mexico’s food and drug agency.
There will also be a number of noteworthy conferences taking place this month pertaining to the vaccine and medical technology industries. Many of these webinars and trainings sessions are geared towards medical devices and in vitro diagnostics (IVDs). s Medicines and Healthcare products Regulatory Agency (MHRA).
Upcoming Webinar Hosted by Xtalks Webinar/Seminar ( OPEN) Xtalks 11/6/2023 11/6/2023 What is the evidence for high-risk medical devices in the field of cardiovascular disease and diabetes?
There are also some product-specific bioequivalence guidelines open for comment, along with concept papers proposing the development of materials on the topics of biosimilar development and non-inferiority comparisons in clinical trials.
While the work on the pharma package will likely take quite some time, another deadline is coming up fast: the full transition of all clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation.
Device regulators have dropped important guidance recently , publishing guidance on alternative trial designs for orphan devices and updating how to carry out benefit-risk assessments on the use of toxic phthalates in medical devices. elections over, AgencyIQ is also anticipating the new European Parliament to start work again soon.
As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. Prior to the passage of FDORA, the AA confirmatory trial requirements were listed in the approval letter with three deadlines: final protocol submission, trial completion, and final report submission.
A January 2022 Seminars in Arthritis and Rheumatism publication noted that a “generic [drug] may only cost $1 million to $4 million and take two years to develop vs $100 million to $250 million and seven to eight years for a biosimilar.”
Start Date End Date Event Event Type Organization 12/01/2023 12/01/2023 BIVDA Environmental Working Party Webinar/Seminar ( CLOSED ) British In Vitro Diagnostics Association (BIVDA) 12/04/2023 12/04/2023 HMA/EMA Big Data Stakeholder Forum 2023 Webinar/Seminar ( OPEN ) European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) 12/04/2023 12/04/2023 (..)
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