How To Avoid Regulatory Mistakes: Experts Put To The Test
Target product profiles, database locks, infarct size as a surrogate endpoint, and changes in the manufacturing process featured in a session of this year’s TOPRA Symposium on dealing with tricky regulatory questions.
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Delegates and experts were faced with some difficult choices during a session at this year's TOPRA annual symposium.
Coronavirus Notebook: Australia OKs Paxlovid, Lagevrio & Nuvaxovid, New Sputnik Data Show ‘Strong Protection’ Against Omicron
International regulators have broadened their discussions on the possible use of bivalent and multivalent vaccines, and the French presidency of the Council of the EU has called for “international solidarity” on vaccine provision.
The World Health Organization’s BioHub project is gathering momentum, with the spotlight on the equitable and timely sharing of viruses and other biological materials to develop medical products for use in future health emergencies such as a pandemic. But while its objectives are lauded by many, concerns have been raised about the intellectual property implications of the project.