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DIA Global Inspire Award winning paper!

Read more: Implementation of Quality by Design Principles in Regulatory Dossiers of Medicinal Products in the European Union (EU) Between 2014 and 2019 

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CTIS transition – time is running out! Click here for the full article

EMA Policy 0070 – Clinical Data Publication – Relaunch. Click here for the full article

2023

• Navigating types of clinical study reports for optimal reporting of trial results Read more
• Clinical development times for anti-cancer drugs shortened via accelerated regulatory pathways Read more
• Clinical Trials Information System for clinical trial applications in Europe Read more
• Promotional and informational Materials for Prescription Medication within the EU Read more
• Upcoming changes to the CEP procedure and documentation Read more
• Oligonucleotide therapy: Regulatory & Development challenges Read more

2022

• Analysis of approval times of anticancer drugs between 2010-2017 Read more
• Geriatric Regulation: can we do without? Read more
• Old medicines, new indications Read more
• Orphan drug designation in the EU and the US – a critical review Read more
• A detailed analysis of expedited regulatory review time of MA applications for new anti-cancer drug in the US and EU Read more
• Post-Authorisation Studies Read more
• Preclinical requirements for anticancer Drugs in the EU Read more
• A Decade of Marketing Authorization Applications of Anticancer Drugs in the European Union Read more
• ATMP challenges in the EU – lessons for future applications Read more
• Drug Registration in Emerging Countries Read more
• Implementation of Quality by Design Principles in Regulatory Dossiers of Medicinal Products in the European Union (EU) Between 2014 and 2019 Read more