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Collaboration Makes The (Real) World Go Round: Global Efforts Strive To Anchor RWE With Real-World Data Standards And Practices
Can the decentralized global healthcare ecosystem to turn real-world evidence from a buzzword to a useful approach to fit-for-purpose evidence generation?
The latest initiative under the UK’s Life Sciences Vision is intended to fund the development of innovative treatments while saving the National Health Service “millions of pounds.”
Revised labeling requirements for unauthorized investigational and auxiliary medicinal products under the EU Clinical Trial Regulation have been published in the Official Journal.
New, more flexible regulatory approaches will be needed to deal with the integrated therapies coming through company pipelines, and the European Medicines Agency should play a “key orchestrating role” in smoothing the way, says Sabine Atzor, Roche’s head of EU regulatory policies.
The European Medicines Agency has partnered with eight institutions having access to real-world healthcare data to enable its DARWIN EU project to deliver real-world evidence to the EU medicines regulatory network when needed.
Faced with the rise in its workload, the UK’s health technology assessment body NICE is exploring ways of tailoring its approach to appraisals according to the type of product under consideration.
Improvements have been made to the second phase of an EU pilot that allows drug sponsors to obtain simultaneous scientific advice from two member states.
If successful, a new Swedish model for reimbursing antibiotics that involves guaranteed minimum annual revenues for companies, could be tested on other kinds of products.
New EMA Innovation Group To Provide Point Of Entry For Developers & Contribute To Regulatory Assessments
The European Medicines Agency’s newly established Quality Innovation Expert Group will focus on innovative pharmaceutical manufacturing approaches, starting with continuous manufacturing for biologicals and end-to-end processes, and decentralized manufacturing.
The European Medicines Agency and the international association of pharmaceutical inspectorates, PIC/S, say they need to make extensive changes to their guide on using computerized systems when manufacturing medicines.
The European Medicines Agency believes that a scientific guideline on clinical trials incorporating a platform design is needed because such studies are expected to play an increasingly important role in future marketing authorization applications.
The European Medicines Agency is seeking feedback on its position on assessing whether biological substances and advanced therapy medicinal products qualify for NAS status.
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