2nd Cardiac Safety Conference

Posted:
20
November 2007

2nd Cardiac Safety ConferenceBrief Description: ICH E14 QT Guidance were finalised (step 4) in May 2005. However, implementation of the new guidance (step 5) seems to have taken a different pace in different ICH regions, with US FDA leading the trend and Japan PMDA still developing their own version. The controversy regarding the predictive value of different non-clinical and clinical QT assays (including the TQT study itself) continue to underline the regional regulatory variations. As global experience is building up, Thorough QT (TQT) study designs are improving, sample size dropping and the use of positive control(s) becoming more sophisticated. The potential benefits of capturing and viewing multidimensional aspects of continuous QT and morphology data are gathering momentum with innovative technologies and methodologies coming up. Analysing and reporting QT data is also evolving while various TQT outcome scenarios are emerging. Concentration-effect modelling, promoted by US FDA, is increasingly taking a central role in the analysis and reporting of QT data. At the same time certain therapeutic classes, such as oncology and biological products, are still cast with uncertainty and face inconsistent regulatory requirements in the various regions.At the other end of the drug development spectrum, ongoing issues involving post marketing pharmacovigilance continue to make headlines. Cardiac Adverse Reactions, whether repolarisation-based, thrombosis-related or other are reported increasingly, involving a variety of drug classes. While legal and financial liabilities are still strong driving forces for cardiac safety pharmacovigilance, new public and regulatory initiatives are endorsing more proactive risk management and risk minimisation plans. These topics and others will be interactively discussed during the conference.Date: December 3 - 4, 2007Location: Dorint Praha Don Giovanni Hotel, Prague, Czech RepublicStand Number: 4

Latest news

Upcoming Event

ACCP 2020, Translating Clinical Pharmacology Research into Patient-centered Care

21 - 23 September 2020
Dr. Jorg Taubel will be presenting posters that explore the subjects of cardiac health and diabetes.
View event

Richmond Pharmacology is delighted to confirm partnership with Intellia Therapeutics

October 20, 2020
Phase I study of Intellia Therapeutic’s NTLA-2001 for the treatment of hereditary transthyretin amyloidosis with polyneuropathy (hATTR-PN)
Read more

Richmond Pharmacology supports ReViral with the development of Sisunatovir

September 9, 2020
ReViral has confirmed the FDA has granted Fast Track designation to Sisunatovir.
Read more

Richmond Pharmacology helps UK patients gain early access to ultra-rare disease drug Lumasiran

August 17, 2020
Richmond Pharmacology early phase drug development update.
Read more