The European Medicines Agency’s updated guideline on risk minimization and the measures drug sponsors should take to ensure their products are used safely places greater emphasis throughout on the need to involve health care professionals and patient representatives in designing, testing, disseminating and evaluating the effectiveness of such measures.
EMA Explains How To Make Risk Minimization Measures Robust & Effective
Pharmacovigilance experts speaking at an event organized by the European Medicines Agency discussed the rationale behind revised requirements relating to how drug sponsors must develop and evaluate risk minimization measures and thereby improve the safety of their medicines.
More from Europe
• By
The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
• By
Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
• By
The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.
• By
A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.
More from Agency Leadership
• By
The General Services Administration’s updated list of “assets identified for accelerated disposition” does not include any buildings at the agency’s headquarters in White Oak, MD after its original list of “non-core” government properties for disposal had more than half the buildings on campus.
• By
FDA staffing cuts are making negotiation preparations more difficult, but also could mean the result is a smaller user fee renewal package.
• By
Stakeholders are pleading for newly confirmed FDA Commissioner Martin Makary to stand up for the agency's high scientific standards and staff as he begins his term.