Europe
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
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?
UK To Use Vaccine Taskforce Model For ‘Cutting-Edge’ R&D Funding Program
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.”
EU Finalizes Option To Omit Expiry Date On Inner Labeling Of Investigational Drugs
Revised labeling requirements for unauthorized investigational and auxiliary medicinal products under the EU Clinical Trial Regulation have been published in the Official Journal.
Roche Wants EU Pharma Legislative Revision To ‘Dare Something New’
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.
EMA Launches First RWE Studies Under Big Data Project
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.
UK HTA Body To Conduct More Appraisals, And Faster, Through Proportionate Approach
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.
EU Refines Simultaneous Scientific Advice Pilot With Focus On Clinical Trials
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.
Results Imminent From Sweden’s Pilot Of Novel Antibiotic Reimbursement Model
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.
EMA, PIC/S To Update 11-Year-Old GMP Guide On Computerized Systems
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.
EMA Consults On Need For New Guide To Enable Confirmatory Platform Trials
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.
EMA Tackles How To Substantiate New Active Substance Claims For Biologics & ATMPS
The European Medicines Agency is seeking feedback on its position on assessing whether biological substances and advanced therapy medicinal products qualify for NAS status.
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
Email Article
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.