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Rolling Review mechanisms and CMAs (Conditional Marketing Authorisations) have made it possible to speed up the approval of treatments against Covid-19

GENESIS BIOMED recently interviewed Xavier Luria, former Head of Safety and Efficacy of Medicines at the European Medicines Agency (EMA), and now Veristat’s Vice President of Regulatory Affairs, Europe.

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Rolling Review mechanisms and CMAs  have made it possible to speed up the approval of treatments against Covid-19 

 An interview with Xavier Luria, MD

In the interview, Dr. Luria discusses two key mechanisms put in place by the EMA to expedite the approval of medicines by express route: Rolling Reviews, instituted during the COVID-19 pandemic to increase regulatory agility. Rolling reviews served as the impetus for COVID-19 vaccines to be approved in an accelerated fashion. The second mechanism, Conditional Marketing Authorizations (CMAs), have been in place for more than 15 years and were also designed to serve as a way to improve access to new treatments for unmet or serious needs by allowing study sponsors to market a product based on incomplete clinical data until such time the sponsor can submit comprehensive data. 

Read the article to gain Dr. Luria’s perspective on the value of these mechanisms in the context of micro, small and medium-sized enterprises (SMEs) when authorizing a new medicine, the PRIME option, the challenges involved when manufacturing ATMPs, and more. 

Download The Article

Xavier Luria, MD

Xavier Luria, MD, is Vice President, Regulatory Affairs Europe for Veristat, responsible for providing strategic and implementation counsel across the spectrum of global regulatory and pharmacovigilance services for drugs, IVDs, and medical devices. Levering his deep expertise, Dr. Luria drives productive communication with health authorities and associated meetings and submissions, along with overseeing the development of impeccable project regulatory documentation and safety reporting.

Prior to joining Veristat in 2021, Dr. Luria was CEO and Founder of Drug Development and Regulation (DDR), a European-headquartered consultancyorganization focused on providing scientific and regulatory expertise for the global development and registration of drugs and medical devices. Dr. Luria built and oversaw a team of professionals who served as trusted partners to a number of small and midsized companies largely involved in rare diseases and cancers among others, helping them achieve commercial success, transforming their businesses, and supporting positive patient outcomes.

Prior to DDR, from 2005-2012, Dr. Luria was Head of Safety and Efficacy of Medicines at the European Medicines Agency (EMA), where he coordinated regulatory teams from the 28 European Member States in order to evaluate medicinal products for the entire European Union. Dr. Luria participated and led several cross-agency projects.

 

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Rolling Review mechanisms and CMAs (Conditional Marketing Authorisations) have made it possible to speed up the approval of treatments against Covid-19

GENESIS BIOMED recently interviewed Xavier Luria, former Head of Safety and Efficacy of Medicines at the European Medicines Agency (EMA), and now...

Read More