Rasi signs off as EMA chief, Cooke to take the reins amid pandemic

Regulatory NewsRegulatory News | 13 November 2020 |  By 

Incoming Executive Director Emer Cooke

Guido Rasi, the European Medicines Agency’s (EMA) long-serving executive director, ended his second five-year term on Friday, handing the reins to Emer Cooke, who is returning to the agency after a stint at the World Health Organization (WHO).
Cooke, who will be the first woman to lead the agency in its 25-year history after being nominated for the role in June, will begin her tenure at the height of the COVID-19 pandemic where her role as the EU’s top regulator will put her in the critical position of overseeing the medicines and vaccines being developed for the disease. (RELATED: EMA nominates executive director to replace Rasi, Regulatory Focus 25 June 2020).
“I hand over my responsibilities at this critical time to the capable hands of Emer Cooke, whom I have had the pleasure of working with over the years,” Rasi said. “I know Emer to be a strong leader who is committed to steering EMA during this very challenging period and ensuring that the Agency’s work on COVID-19-related activities continues uninterrupted. She will have the support of EMA’s talented and resilient staff, as well as the broader community of colleagues across the European medicines regulatory network.”
Cooke comes to EMA after serving as the director of the Regulation and Prequalification Department at WHO, where she has led the international agency’s work on health technology regulation, standards, prequalification and regulatory systems strengthening. Prior to joining WHO, Cooke spent more than a decade at EMA, serving as head of inspections and head of international affairs, among other positions.
Rasi first took the helm at EMA in 2011 after heading up the Italian Medicines Agency and serving on the EMA’s management board from 2008-2011. After being forced to step down from his post in 2014 when the European Union Civil Service Tribunal annulled his appointment, Rasi returned to the agency for a second term in 2015. During his tenure, Rasi led the agency through the implementation of the EU pharmacovigilance legislation and clinical trial regulation and oversaw its move from London to Amsterdam in 2019.
Under his watch, EMA also took strides to improve transparency by mandating the proactive publication of clinical data, expanded its collaboration with international regulators and launched its priority medicines (PRIME) scheme to speed the development of innovative new medicines.


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