Date(s) And Time(s):
Nov 3 2011 9:00AM - Nov 4 2011 5:00PM
Avenida Diagonal 589-591
Advances in cardiovascular (CV) safety and better understanding of the potential for cardiotoxicity of new drugs in development have recently gained a regulatory and public focus. Concerns involving the CV safety of new anti-diabetes agents have prompted the US FDA to issue a specific guideline calling for sponsors to present a retrospective meta-analysis, or perform a prospective, dedicated, large-scale CV outcome trial prior to, or post-approval. Likewise, the EMA recently released an updated diabetes guideline restating its requirements for demonstrating CV safety of new anti-diabetes drugs.
Similar CV safety issues have also been widely reported for marketed anti-obesity drugs, prompting a high profile worldwide withdrawal of one drug and a FDA non-approval of three other anti-obesity drugs. The later developments highlight the need for better directions for the development of anti-obesity drugs.
Oncology agents have also been implicated with a number of CV safety issues, ranging from QT prolongation and arrhythmia to myocardial tissue toxicity leading to heart failure and possibly premature death, therefore triggering specific regulatory actions. While no formal guidelines have been issued for CV safety of oncology drugs in development, a de-facto compliance with current CV safety standards are expected.
The above topics will be discussed in detail by clinical, regulatory and industry experts at the 5th European DIA Cardiovascular Safety Conference.
Who Will Attend
• Drug development and clinical research managers and associates
• Pharmacovigilance, drug safety and drug surveillance personnel
• Pharmaceutical physicians and medical directors
• Safety pharmacology and nonclinical scientists
• Clinical pharmacology scientists
• Regulatory affairs officers
• Data managers
• Outsourcing and marketing managers
ELISABETHENANLAGE 25, POSTFACH
4002 BASEL, SWITZERLAND
PHONE: +41 61 225 51 51
FAX: +41 61 225 51 52