Drug's Approval in Europe and in Italy

MessageThis Webinar is over
Date Feb 3, 2015
Time 01:00 PM EDT
Cost $139.00
Overview: Despite the common drugs approval by EMA in Europe, differences may arise between the European Countries. In fact, the final approval and the pharmaceutical reimbursement systems in health care are different from Country to Country. Therefore it is important to have knowledge of decision-makers and decision-making processes for coverage and payment of new and emerging pharmaceuticals in the single Country. 

The webinar will explain why some drugs approved by EMA cannot be available in Italy (and/or in other European Countries) at the end. 

Why should you attend: In Italy, the national regulatory authority establishes the general conditions of the reimbursement system at a national level and then implementation may arise at a regional level by governmental bodies. The National Healthcare System provides healthcare coverage to the Italian population, nevertheless there are limitations in the possibility to prescribe expensive drugs.

In particular, the introduction of new expensive drugs in the Oncology field has involved in heavy expenditures that have caused several limitations that may also differ on a Regional and/or on a Hospital basis.

During the webinar a description of Health Care System in Europe and in particular in Italy will be provided, with a special focus on the possibilities and on the limitations in the prescription of new agents. 

Areas Covered in the Session:
  • We will begin by describing the Health Care System in Italy which is completely different from other European Countries
  • We will look over the approval process in Europe (EMA)
  • Then we will focus on the approval process in Italy (AIFA)
  • We will also review the reimbursement and pricing negotiation process in Italy
  • Finally, an analysis of the possibilities and of the limitations in prescribing new anti-cancer drugs by the Oncologists will be provided

Who Will Benefit:
  • Companies and Professionals involved in the development of New Anti-cancer Drugs
  • Production Managers
  • Investors
  • CROs
  • Clinical Research Associates (CRAs) and Coordinators (CRCs)
  • Medical Oncologists
  • Principal Investigators/Sub-investigators

Rossana Berardi, MD is a Consultant Medical Oncologist and Lecturer at University Hospital. She is also the Responsible of the Trial Unit at Dept of Oncology – Università Politecnicadelle Marche – Italy. Dr Berardi usually deals with about 35 GCP trials/year with new drugs, with a special focus on early phase trials. 

Roger Steven
contact no: 8003851607
fax no: 302-288-6884
Event Link: http://www.mentorhealth.com/control/w_product/~product_id=800445LIVE/


Create your own event
Turn your passion into a business.
Join our mailing list