KCR’s Regulatory Expert, Anna Kubik, discusses the current status of ethical assessment in the European Union vs planned changes mandated by Clinical Trial Regulation 536/2014.
Berlin – 29 March 2017 – Since the publication of the EU Clinical Trial Regulation (CTR) 536/2014 in the Official Journal a new scheme of Clinical Trial Application (CTA) has been developed. Although certain rules for timelines, coordinated assessment and IT infrastructure are detailed, it remains up to each Member State how to organize ethical assessment and the cooperation of the Ethics Committee(s) (ECs) with National Competent Authorities (NCAs). KCR’s Anna Kubik, Director Regulatory Affairs, who is a speaker at the DIA EuroMeeting this year, presents an overview of the current status focusing on the development of local requirements in terms of ethical assessment as well as proposed schemes respectively.
“As soon as the EU regulation becomes applicable, which is planned for October 2018, national laws in EU need to be ready to ensure a smooth CTA assessment process functioning,” said Anna Kubik. “This means for the Member States that the organization of ECs, their number and settlement (national vs local), communication with NCAs and scheme of assessment need to be established to make the assessment of each Clinical Trial Application feasible as per CTR rules.”
Before the regulation is fully in force and the EU portal functional, national governments need to discuss and implement the scheme of ethical assessment. As soon as it seems easier for countries like Bulgaria, Hungary, Latvia, in which a Central Ethics Committee is established to provide its opinion, it may become more challenging for those countries which have multiple ECs to be selected as central or even both, central and local ethical assessments, ongoing under current legislation.
“One of the most interesting cases is Spain, where certain responsibilities have been assigned to Competent Authority, ECs and supervising bodies. Additionally, thanks to accreditation criteria one of multiple ECs may provide an assessment of clinical trial within legal timeframes,” added Anna Kubik. “It shows the example of possible multiple ECs functioning for other Member States which have had multiple EC systems currently in place.”
Mrs. Kubik presentation entitled “Ethical Assessment of Clinical Trials Following EU CTR Implementation – Are We Ready for Changes?” is set for Thursday, 30th March, session S0302, 11.00 am – 12.30 pm, at the DIA EuroMeeting 2017 in Glasgow, UK. If you would like to speak to Mrs. Kubik directly or receive the presentation after the event, please contact us at firstname.lastname@example.org.
KCR is a Contract Research Organization (CRO) providing clinical development solutions for the pharmaceutical, biotechnology and medical device industries. More than 300 professionals support clients with full-service capabilities across our three main service areas: Trial Execution (TE), Functional Service Provision (FS) and Late Phase (LP). Focusing on knowledge, quality and innovation, KCR offers reliable, customized and fast solutions to fulfill the clients' needs. The company’s geographical set up suits perfectly to deliver optimized trial execution strategies. Headquartered in Berlin, Germany, KCR operates across 20 countries in Europe, Asia as well as the U.S. This year the company celebrates its 20th anniversary.
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