Regulatory Rapporteur April 2020
FOCUS: Real-world data - gathering data beyond clinical trials to obtain real-world evidence. PLUS: • Veterinary clinical trials: Overview and comparison between the EU and US • Health apps: International initiatives to define requirements • Mergers and acquisitions: Examining the benefits and challenges
Regulatory Rapporteur April 2020 (Full issue)MEMBERS
International initiative to define requirements for health appsMEMBERS
Steep learning curve awaits new FDA CommissionerMEMBERS
Mergers and acquisitions in pharma – a growing trendMEMBERS
The expanding role of real-world evidence in the regulatory environmentMEMBERS
Interview with EMA's Hans-Georg Eichler: Harnessing real-world data to generate real-world evidenceMEMBERS
Veterinary clinical trials: new EU law and global approachesMEMBERS
Interview with Danish Medicines Agency's Nikolai Brun: The power of big data PUBLIC
Real-world data: harnessing the real opportunity PUBLIC
EMA stakeholder workshop: advancing animal health through multi-stakeholder dialogue PUBLIC