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Regulatory authorities in Italy enforce new legislation that hardens the requirements for education and certification of staff at CROs.
A new law that imposes very stringent requirements on the educational background and continuous medical education levels of staff at CROs, as well as the need for quality accreditation, is causing confusion and raising concerns in Italy.
Requirements for Operating in Italy Under New Law
"This demanding law, which also affects foreign CROs that want to operate in Italy, will put really strong pressures on companies," said Mario Corrado, quality assurance manager of CROss Alliance (Arzo, Switzerland).
To provide information about the law and to discuss its implications, the Italian Association of Pharmaceutical Medicine (SSFA) organized three special one-day events in March and April.
At the first meeting, Daniela Marcozzi from Sigma Tau underlined that in the future sponsors should be very careful when selecting CROs because Article 9 of the new law may prevent the use of some clinical data in an NDA if the data are generated by CROs that do not meet the specified criteria.
Marcozzi also said that some clarifications are needed to answer pending questions: What is to be done with current activities? Who will certify CROs from abroad? How do we produce a self-certificate and should these be part of the NDA package? She also raised an ethical dilemma related to Article 9: What should sponsors do when they realize a CRO does not meet the requirements of the new law? Are sponsors running any risk?
Marco Romano, MD, European medical director of Chiltern, said that although the quality of professional training is very important, these principles should be applied with a dose of common sense, without jeopardizing the activities of CROs in Italy. In addition, and for a principle of equity, the same rules should be applied to all parties involved in the clinical development of drugs, i.e., clinical research associates and project managers from pharmaceutical companies, as well as investigators.
Roberto Braguti, a lawyer at the Studio Legale Braguti Raccagni Law Offices, said the law does make reference to the past training activities of CRAs and project managers; in fact, the law refers to activities over the past 30 months. In legal terms, this is unusual because, by definition, a law can only regulate the future. Further doubts also exist because in Italy health care laws are delegated to regions, and not to the central authorities. Finally, some doubts also surround freelance certifications, which are not clearly defined.
"Any new law creates doubts and requires clarifications," said Domenico Criscuolo, MD, FPPM, chief executive officer of Genovax, Colleretto Giacosa, Italy. "The SSFA will collect details about all controversial issues related to this law, and will offer them to the Italian drug agency (AIFA) in order to open a constructive forum that will help to improve quality and the professional training of CROs operating in Italy."
An English translation of the law is available online at:http://oss-sper-clin.agenziafarmaco.it/normativa/DM_CRO_English.pdf.
Editors' note: We would like to thank Dr. Criscuolo for providing some of the information in this article. Dr. Criscuolo is also a member of the Applied Clinical Trials Editorial Advisory Board (EAB).