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Combining APIs: MPT Development & Regulatory Considerations

This third webinar in the “Let’s Talk MPTs” discussion series will provide MPT product developers and other stakeholders an overview of clinical development and regulatory considerations when developing products that combine one or more active ingredients into an MPT product. Speakers Dr. Virna Schuck, PhD is Senior Director of Clinical Pharmacology at Certara and has over 16 years … Continued

Purity is a Virtue: A Practical Guide to the Reporting of Impurities

Many pharmaceutical companies struggle with characterizing drug substance (DS) and drug product (DP) impurities and how to include them in their regulatory applications. This webinar is designed to increase the understanding of the regulatory guidances (e.g., ICH, FDA, and EMA) available on impurities, including key take away messages. We will start by defining the various … Continued

Chemistry World: Treating our brains better

Major pharmaceutical companies have long been downsizing their central nervous system (CNS) research and development programmes. Between 2009 and 2014, there was a 52% drop in CNS drug discovery and development programmes pursued by large pharma, with almost all companies showing a decline. That situation has continued, despite great unmet needs remaining in mental health and other … Continued

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