regulatory sciences

Access to the drug: a two-speed Europe?

Access to the drug and reimbursement: a two-speed Europe? We talked about it to Dr. Enrico Bosone, president of SIAR (Italian Society for Regulatory Activities), a non-profit organization whose membership comprises about 200 professionals in Italy involved in regulatory activities related to the regulation of those products, including drugs, which require a production and/or marketing authorisation provided by Health Authority. The association’s objectives are to study and understand the regulation in the field of drugs, medical devices, food and food supplements, as well as the constant updating about laws and documents issued by the Italian, European and non European authorities, and the promotion of cooperation with the competent authorities and public and private institutions involved in the regulatory activities. To achieve these objectives, SIAR has established several working groups: the first deals with the R & D and has published a practical manual on clinical trials in Italy; the second deals with medical and scientific information, and organizes seminars to disseminate the results of the scientific activities; the third deals with access to the drug by patients. What is meant by "access to the drug?". "In the European Union, access means reimbursement" - explains Dr. Bosone, "This is because the medicines, especially the most innovative ones, are often expensive and, in principle, are reimbursed by the National Health Service in each country, which supplies them to patients free of charge or by a modest ticket payment (as in Italy). It happens, however, that normally a delay is generated between the marketing authorization and the reimbursement, or the availability of the drug to the patients, which in Europe varies from country to country. In fact there are two types of marketing authorization", clarifies Dr. Bosone,"the first [...]

2017-01-03T11:18:01+00:00 01/03/2016|Categories: News|Tags: , , , |

“Clinical Trials in Paediatrics — Regulatory and Methodological Aspects” chapter is now online!

On June, 2015,  the chapter entitled "Clinical Trials in Paediatrics — Regulatory and Methodological Aspects" and included in the book Drug Discovery and Development - From Molecules to Medicine, ISBN 978-953-51-2128-2, edited by Omboon Vallisuta and Suleiman Olimat has been released online. This chapter has been written with the contribution of Adriana Ceci, Viviana Giannuzzi, , Donato Bonifazi, Mariagrazia Felisi Fedele Bonifazi and Lucia Ruggieri on behalf of TEDDY-CVBF (Consorzio per Valutazioni Biologiche e Farmacologiche). The aim of this chapter is to describe the requirements for implementing paediatric clinical trials in compliance with the principles of Good Clinical Practice (GCP), in order to be part of an approved PIP (Paediatric Investigational Plan-EMA) or PSP (Paediatric Study Plan-FDA).  The chapter addressed the main three topics of a paediatric clinical trial: the regulatory aspects, the paediatric plans and paediatric trials methodology and the incentives provided by the existing legislation and the main results  achieved by today. The chapter also explores the distribution and the other characteristics of recently conducted paediatric trials in Europe and in the United States,  also providing a comparison between the two areas. At this link you can get access to the full article.

2017-01-03T11:18:08+00:00 07/08/2015|Categories: News|Tags: , , |

International Master In Regulatory Sciences (IMRS) facing the Mediterranean area, an article on Corriere Del Mezzogiorno

On 5th April, 2015, “Corriere del Mezzogiorno”, the special insert of the national newspaper Corriere della Sera, have published an article focused on the launch of the first edition of International Master in Regulatory Sciences (IMRS) facing the Mediterranean countries, sponsored by Fondazione per la Ricerca Farmacologica Gianni Benzi  Onlus. The Master, organized in collaboration with the Turkish Ondokuz Mayis University (OMU) and the Community of Mediterranean Universities (CMU), foresees a one year course dedicated to graduates (specialist and master) coming from different disciplines who wish to acquire skills and specific tools in the field of the regulatory activities, by offering a complete and updated training at both European and extra-European. The Master intends to meet the challenge resulting from the increasing complexity of the regulatory sector, characterized by a highly sophisticated and complex legislative and regulatory system. The aim of the course is to train experts able to act in the whole Mediterranean area and create a common operational background, thus promoting more job opportunities for youngsters. The International Master in Regulatory Sciences represents an instrument of innovative training from both a methodological and conceptual point of view, because all the theoretical training is delivered online through a virtual learning platform. The educational activities will feature lectures and e-learning, seminars and webinars, workshops, self-learning and internships. At the end of the course students will obtain a Diploma of International Master. For more information, please visit the Fondazione Gianni Benzi Onlus website. Here you can read the full article.

European Medicines Agency policy on publication of clinical data

In October 2014, the European Medicines Agency (EMA) Board adopted the wording of the Agency’s new policy intended to further increase the availability of clinical trials data for medicinal products authorised in the EU: European Medicines Agency policy on publication of clinical data for medicinal products for human use Q&A on the European Medicines Agency policy on publication of clinical data for medicinal products for human use This new policy aims to ensure that all clinical study reports supporting an application for a centralised marketing authorisation are systematically made public once the regulatory procedure for authorisation is concluded. By enabling the general public to access this data, it is hoped that these measures will contribute to increasing citizens' understanding and confidence in the EU authorisation system for medicines. This is the result of an extensive consultation phase launched in June 2013 when the Agency released the draft policy for a three-month public consultation. For more information, please visit the EMA website.

2015-11-26T15:42:19+00:00 30/12/2014|Categories: News|Tags: , , |

“G. Benzi” Biennial Master’s Program in Regulatory Sciences

The University of Pavia has launched the eleventh edition of the “G. Benzi” Biennial II level Master’s Program in Regulatory Science. The deadline for the submission of applications is January 15th, 2015. Please see the following references (ITA) for more information: Call for applications to the University of Pavia master’s programs Regulatory Sciences Master’s Program call for applications Master’s Program’s website Master’s Program’s brochure […]

2015-11-26T17:00:57+00:00 05/12/2014|Categories: News|Tags: , , , |