Day 1&2: October 8th & 9th – Late Phase Leaders Forum
Late-phase clinical trials, observational studies and the use of patient registries are some of the fastest growing areas of pharmaceutical and medical device research. Such post-marketing studies are becoming increasingly important as regulatory agencies demand more long-term data which proves efficacy, safety and quality. Furthermore, a key driver for these types of studies are the demands of health technology assessors and payers and their need for evidence-based health economic data, again over the long-term. As phase IV and observational studies tend to be more commercial in nature, successfully planning and implementing them can be a major challenge, especially in terms of motivating investigators and recruiting patients who may already have access to the latest medications. Observational data whilst demonstrating actual patient and prescriber behaviour also presents the additional challenge of the issue of bias and regulatory acceptance. This event will be a 2 day forum, structured to provide the latest and most value-adding, real-life experiences in post-marketing studies, including their benefits and challenges. The event will be focused on the strategic use of late phase studies and it will be an ideal opportunity for benchmarking and networking with the experts and will bring the post-marketing community together to discuss solutions to the challenges in this vital area of research.
Day 3: October 10th - Comparative Effectiveness Leaders Day Overview
Data resulting from comparative effectiveness studies has more recently become an important decision-making tool in the hands of drug budget-holders at payer organisations to enable smarter reimbursement decisions. As drug costs are increasing year on year, often well above the inflation rate such studies answer a crucial question in health technology assessment -”is this drug better than what we already have?” The pharma industry recognises comparative effectiveness research is crucial for product value and superiority demonstration and therefore is reacting by conducting more comparative effectiveness studies to support reimbursement arguments.
Who Will Benefit:
Pharmaceutical, Biotech and Medical Device Companies:
Vice Presidents, Directors & Managers of: Medical Affairs, Epidemiology, Clinical Development & Operations, Drug Safety, Pharmacovigilance, Data Management, Regulatory Affairs, Clinical Outsourcing.
CROs, EDC & Data Management, Clinical Software, Market Access & Health Outcomes Consultancies.
Academics & Doctors:
Epidemiology, Principle Investigators, Government: Ministries of Health, Regulatory & Health Technology Assessment Agencies