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TORONTO, ON--(Marketwired - December 14, 2017) - In this webinar speakers from Simbec Research will discuss the use of integrated protocols (umbrella protocols) to maximise programme efficiency.
Attendees will learn how to combine multiple standard trials in one protocol, including SAD, MAD, food effect, age and gender, and efficacy in patients.
In addition, key aspects of the revised EMA First-in-Human guidance will be considered in order to design suitably-flexible protocols to avoid unnecessary regulatory delays. Pros and cons of conducting early phase research in the EU will also be discussed, along with the acceptability of clinical trial data from trials run in the EU by the FDA.
Join the live session on Tuesday, January 16, 2018 at 10am EST (3pm GMT) with Dr. Annelize Koch, Medical Director and Dr. Simon Hutchings, Director of Scientific Affairs.
For more information or to register for this complimentary event visit: Effective Implementation of the Revised EMA First-into-Human (FIH) Guidance to Accelerate Your Early Clinical Development.
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
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Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is ingested by an organism ...
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...