The EMA's guidance on data integrity expectations focuses on good manufacturing practice requirements and offers advice on minimizing risks at all stages of the data lifecycle in pharmaceutical quality systems.
The European Medicines Agency has issued new guidance to help ensure the integrity of data generated while testing, manufacturing, packaging, distributing and monitoring medicines.
As data integrity is a "significant topic" for industry and the regulators alike, it's helpful to have further clarification on...
The report gave examples of missed opportunities for innovation and patient access, as well as regulatory and operational problems that undermine the conduct of timely clinical trials in Europe.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
Japan looks set to press ahead with a reimbursement price cut for Eisai's Alzheimer's drug Leqembi following a cost-effectiveness review, despite differences with the company over methodology.
