Vaccine Development; Considerations when Meeting with Regulators; Impact of CTR/CTIS

As the Covid-19 pandemic demonstrated, pandemic preparation is key to addressing global threats. That’s why collaborative efforts are so important for vaccine development, and a recent European Commission roundtable is a case in point. Preparation is equally important for meetings with regulators, since they are integral to knowing what is expected by the health authorities. Meanwhile, conducting clinical trials in Europe will soon require all clinical trial applications to be submitted through the CTIS, but very few have transitioned to the Clinical Trials Regulation.

Roundtable focuses on vaccine development for epidemics and pandemics?

The European Commission’s Health Emergency Preparedness and Response Authority (HERA) and the Coalition for Epidemic Preparedness Innovations (CEPI) held a roundtable with global partners to discuss R&D measures to address pandemic threats. A key goal is to identify ways to collaborate in order to drive scientific and technological breakthroughs, including in vaccine development. As a recent article explored , one way novel vaccine innovation will be enabled in future is through the use of artificial intelligence, which can dramatically accelerate R&D and potentially address future viral threats.

Top 10 Considerations when Meeting with Regulators?

Regulatory authorities should be regarded as allies in the effort to bring new drugs to patients in need. Therefore, companies should ensure they are prepared for meetings with the regulators and see these discussions as opportunities for sharing critical information and gaining alignment. Such meetings can help organizations build stronger relationships with the health authorities and better understand what regulators expect. Learn about the top 10 takeaways when preparing to meet with the regulators.

Exploring the impact of the CTR and CTIS at the DIA RSIDM ?

Complying with the Clinical Trial Regulation, including mandatory use of the Clinical Trial Information System (CTIS), will have an impact on sponsor business processes, system use and data. During the DIA RSIDM in Bethesda from 12 to 14 February, PharmaLex’s Cary Smithson will chair a session that explores sponsor approaches to comply with the CTR and preparing for the CTIS.