6. Direct healthcare professional communication. Communicating medicines safety information directly to healthcare professionals: an introduction to DHPC
Patient involvement in EMA regulatory committees - EUPATI Toolbox
Change management for the EudraVigilance system | European Medicines Agency
An Industry Perspective on the 2017 EMA Guideline on Firstâ•'inâ•'Human and Early Clinical Trials
European Medicines Agency guidelines relevant to product-specific... | Download Table
A Comparison of FDA and EMA Drug Approval: Implications for Drug Development and Cost of Care
Differences in Evidentiary Requirements Between European Medicines Agency and European Health Technology Assessment of Oncology Drugs—Can Alignment Be Enhanced? - Value in Health
Consultations on adoption of European Union guidelines in Australia
Pharmaceutics | Free Full-Text | The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA
Quality Review of Documents veterinary product-information annotated template (English) version 8 - clean
GE Healthcare : BioProcessing Asia Conference In Review
Certifying Pharmaceutical Exports A Roadmap To EMA's Certificate Of Medicinal Product
EMA Guidelines Series: British Journal of Clinical Pharmacology
Guideline on registry-based studies (EMA/426390/2021)
Kühler et al 2019 – To what degree are review outcomes aligned for new active substances between the EMA and the US FDA? – CIRS
ARTICLE OF THE YEAR: The linguistic review process in the centralized procedure in the EU | RAPS
Impact of the European Union on access to medicines in low- and middle-income countries: A scoping review - The Lancet Regional Health – Europe
Guidelines for Emergency Managers working with Culturally and Linguistically Diverse Communities - World | ReliefWeb
User guide on how to generate PDF versions of the product information - human
Medicines for Europe Press release – EMA states no scientific evidence to deter use of ibuprofen in COVID19 patients | Medicines for Europe
Regulatory Perspectives on Biosimilars in Europe
Frontiers | Contribution of patient registries to regulatory decision making on rare diseases medicinal products in Europe
The EU is ready for non-biological complex medicinal products - GaBI Journal
