2-Day In-Person Workshop (February 11-12, 2016)
Adaptive Clinical Trials Adaptive designs today are gaining more acceptance of drug developers for its flexibility and effectiveness. These allow for significant reduction in cost and time to market the products under development, and can also increase the probability of success of the development program. It is based on the principle that various factors such as sample size, eligibility criteria, dosing, or treatment settings can be adjusted during the process of trial itself, by using accruing data. The ultimate objective is to effectively and quickly bring the fruits of research and development to the patient. To successfully complete a trial, the people in-charge should have excellent knowledge of adaptive and complex designs that can be achieved through both operational and statistical expertise. Use of accrued data for adaptive designs has proven suitable for Phase I & II therapeutic trials, but for advanced stage clinical trials this method has serious concerns and its implementation has to pass through stringent reviews and series of discussions with FDA & EMA. This workshop will give you an in-depth understanding of the important aspects of adaptive design clinical trial and successful regulatory approval. Why should you attend?
This workshop will cover pretty much everything you need to know about adaptive trials; right from the FDA’s and EMA’s current guidance documents and practical solutions in adaptive design trials to statistical considerations and regulatory approval of adaptive trials. You will learn how to reduce cost and time of your trials without compromising on the quality from the experts who have successfully completed trials. Speakers from FDA will be participating in the workshop and will be a great learning experience for all the participants. |
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Who Will Benefit:
For additional information on the workshop agenda and logistics, please call +1 877-566-4981 or +1 410-501-5777 or email: info@fdamap.com
- Orphan drug developers
- Manufacturers of FDA regulated products: Drug, Medical Device and Biotech Companies
- Clinical trial Professionals such as project managers, CRAs, medical writers
- Senior management for companies developing new products for US market
- Regulatory affairs professionals
- People investing in FDA-regulated products intended for the US market
For additional information on the workshop agenda and logistics, please call +1 877-566-4981 or +1 410-501-5777 or email: info@fdamap.com