Symposium: Research Ethics Committees
Adaptation to the new European regulation of Clinical Trials
Monday, June 29th, Auditorium, 17:30-19:00
César Hernández (AEMPS, Spain)
Magí Farré (Chair of Research Ethics Committee IIS Germans Trias i Pujol, Barcelona, Spain)
Jozef Glasa (Institute of Medical Ethics and Bioethics, Bratislava, Slovak Republic)
Joerg Hasford (President of the Permanent Working Party of Research Ethics Committees, Germany)
Catherine Blewett (Health Research Authority, UK)
Francisco Abad (Research Ethics Committee IIS la Princesa, Madrid, Spain)
Round table where speakers from Research Ethics Committees and National Authorities, with the participation of attendees, will address different topics, focusing mainly on the distribution of tasks and responsibilities between RECs and Medicines Agencies and on the changes needed to adapt to new regulations. Some of the identified aspects to be discussed are:
- How to simplify procedures and reduce bureaucracy.
- Assessment of benefits and risks by the REC and the NCA
- Low intervention trial. Uncertainties around classification
- Responsibilities of the REC in the revision of the protocol
- Responsibilities of the REC in the safety follow-up after approval
- Composition of the REC.
- Independence of RECs
- Insurance coverage
- Assessment of the suitability of Investigators/facilities
- REC fees and multiple payments
This session will be webcasted with free access to members of Research Ethics Committees
Supported by Fundación
Meet the Expert Session by Ferrer
The "polypill", a new therapeutic strategy to improve the use of medicines in the secondary prevention of cardiovascular diseases
Monday, June 29th, Room Castilla, 17:30-19:00
Juan Cosin Chair
by Cristina Avendaño (Madrid, Spain)
Chair (Dr. Cristina Avendaño): Brief introduction (10 - 15 min.) with background information on the rationale of a fixed dose combination ("polypill") for cardiovascular prevention. General overview of the regulatory requirements as compared with the clinical need of a "polypill" in CVD prevention (efficacy, experience of use, and Clinical Practice Guidelines recommendations based on the single components) and how this can be reflected in the SmPC.
Expert (Dr. Juan Cosin): Under his presentation "Why do I need a polypill like this to treat my patients?", the expert will review (20 min.) the available clinical data for Trinomia® (Ferrer's approved aspirin, atorvastatin and ramipril fixed dose combination) and then he will share different clinical case studies of real life patients that are candidates to treated with a cardiovascular "polypill" (60 min. approx.). The expert will challenge the audience with questions related to the clinical need of a "polypill" in individual patients who can benefit from different therapeutic strategies in the secondary prevention of cardiovascular diseases.