V FTC – Science, Regulation and Business in pharmacotherapies: how to solve conflicts and exploit synergies for the benefit of Patients
On 29 and 30 September the Gianni Benzi Foundation, with the support Warsaw Children’s Memorial Health Institute, organises the V Foresight Training Course “Science, Regulation and Business in pharmacotherapies: how to solve conflicts and exploit synergies for the benefit of Patients” to be held in Warsaw (Poland) at the Hyatt Regency Warsaw Hotel.
The Foresight Training Courses have an educational mission: to offer an update on the mechanisms and procedures of the current and future regulatory and scientific world, but they are also a Forum where professionals from different areas analyse the present situation, compare their different points of view and offer possible solutions.
On this occasion, the Course wants to focus on the current controversies in the field of pharmacological therapies and discuss possible different solutions.The economic crisis and the austerity, which most of the Countries are facing, make the identification of priorities more and more difficult. The allocations of limited resources in health care has become and will be in our future a mandatory part of our activities. Therefore, the allocations of available resources for the increasing demands of patients is a matter of dialogue. This will be the subject of the first Session of the Course.Research of new treatments is the heart of Science and we should collectively challenge our approach to new product development to advance the speed of access to medicines for patients.
The Course will encourage an open debate on the consequences of a rigid or more relaxed application of the rules for clinical studies (non profit / profit). This may pave the way to find the right balance between the freedom of scientists and regulations.
The third session of the Course will be devoted to paediatric, rare and neglected diseases. The paediatric issue and the needs of orphan drugs for rare diseases are far away to be satisfied. On the basis of the experience of the European Regulations already enforced for paediatric and orphan drugs, can we expect to enlarge the incentives and commitments for the neglected diseases which affect 400 millions children out of 1 billion people? Which actions can we implement to face these gaps?When a new treatment for an unmet medical need is announced, a conflict triggers between patients who immediately require the treatment and Regulatory Authorities, which prefer a better definition of the benefit/risk ratio of the new therapy. Which are the pros and cons of a more proactive attitude, as applied by the FDA, which in some cases releases a MA on the basis of phase II studies, and the more conservative position of EMA? How will the new European pharmacovigilance system work in this scenario?
The 2012 Foresight Training Course wants to be more provocative, bringing to light some of the most relevant current controversies between science, regulation and business, proposing theses and antitheses with the aim to find possible syntheses, with the interest of Patients as final objective. As for previous editions, the Course brings together Representatives of all the interested stakeholders (Regulators, Researchers, Physicians, Health Professionals, private and public Companies, Patient Associations), thus making it a stimulating and interesting confrontation experience.