OPINION The upcoming 15th Industry Standing Group meeting presents a pivotal opportunity for stakeholders in the pharmaceutical sector to engage in meaningful dialogue with regulatory authorities. Such gatherings are essential…
OPINION The upcoming meeting organized by the European Medicines Agency (EMA) highlights a crucial intersection of patient advocacy and regulatory oversight. Engaging both patients and healthcare professionals is not merely…
OPINION The upcoming EMA/HMA annual data forum represents a pivotal moment for the intersection of regulatory oversight and data management in the pharmaceutical sector. As the landscape of medicine becomes…
OPINION The upcoming Quarterly System Demo hosted by the European Medicines Agency (EMA) serves as a crucial platform for stakeholders in the pharmaceutical and healthcare sectors. In an era where…
OPINION The upcoming EMA workshop on non-clinical data for regulatory decision-making highlights a crucial, yet often overlooked, aspect of medical countermeasures. In an age where clinical trials tend to dominate…
OPINION The Committee for Medicinal Products for Human Use (CHMP) is set to convene in December 2025, a pivotal moment for the European Medicines Agency and the future of drug…
OPINION The upcoming 15th industry stakeholder platform on research and development support at the European Medicines Agency marks a pivotal moment for the pharmaceutical industry. In an era where collaboration…
OPINION The convening of the Medicine Shortages Single Point of Contact (SPOC) Working Party highlights a crucial shift in how the healthcare industry is addressing the pervasive issue of medicine…
OPINION The mandatory adoption of ISO/ICH E2B(R3) in individual case safety reporting represents a pivotal shift in the pharmacovigilance landscape within the EU. This new standard not only seeks to…
OPINION The introduction of mandatory ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU marks a significant shift in pharmacovigilance practices. This evolution is critical as it aims to enhance…