This three-part webinar series reviews the key considerations for design and conduct of a development plan for a monoclonal antibody (mAb) product.
Read Press ReleaseBringing a drug from discovery to market is an expensive and time-consuming business. Every drug that fails comes with a cost which could be both reputational and financial. Keeping your development program on track is therefore critical to success.
Read Press ReleaseJoin this webinar for a discussion of the most common medical communications business challenges and potential solutions. This event will also feature a live demonstration of how patient-centric medical communications technology can be leveraged to streamline and optimize medical inquiry fulfillment, adverse event reporting and product complaint management.
Read Press ReleasePharmaceutical development is inherently risky. To develop a molecule that has a desired, efficacious, but safe, effect in humans is a remarkable achievement considering the statistics.
Read Press ReleaseCNS drug developers have to focus on physical safety and efficacy first, especially when developing products for rare disorders or diagnoses that are often unresponsive to other therapies. Although these products rarely have notable CNS mediated side effects, they fall under the FDA's requirement for an abuse potential assessment because they cross the blood-brain barrier.
Read Press ReleasePresenters will focus on the role of an abuse potential assessment (also referred to as the Controlled Substances Act 8-factor analysis) in the development of cannabinoid products and how it relates to the U.S. scheduling process, and related interactions with the FDA and DEA
Read Press ReleaseThe 6th Annual Pharmacovigilance & Risk Management Strategies 2016 brings together Pharmacovigilance and Drug Safety Officers, EU and National Regulatory, Clinical Risk-Benefit Groups, Regulatory Affairs Officers, Consultancies, Local Medicines Authorities, CROs and others.
Read Press ReleaseStottler Henke Associates, Inc. today announced the immediate availability of an enhanced version of its DataMontage™ software for rapid visual analysis of complex, time-oriented data. DataMontage 4.0 introduces dozens of new features that enable analysts to visualize data more flexibly and interactively.
Read Press ReleaseLeading provider of Oracle's clinical trial, data, and dug safety software will discuss why and how Empirica Topics should be implemented and used to strengthen an organization's pharmacovigilance systems and processes.
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