In the pharmaceutical industry, regulations govern every aspect of drug development, from preclinical testing and toxicology studies through human clinical trials, drug approval, commercialization and pharmaceutical marketing. No matter the stage of development you’re involved in, our collection of pharmaceutical regulation webinars will help you stay up-to-date on the latest regulatory changes with the FDA, EMA and other global regulatory agencies.
In recent years, the rise of electronic data collection (EDC) methods, such as eConsent, have prompted clinical researchers to explore how they can maintain regulatory compliance while making use of new technologies. The shift towards decentralized and virtual clinical trials has also presented challenges that are addressed in these pharmaceutical regulatory webinars. And as relationships with institutional review boards (IRB) grow in complexity with changing regulations, it’s important to stay on top of the best ways to streamline IRB submissions to keep trials on track.
In terms of regulations, the development and manufacture of biologic drugs – like vaccines, monoclonal antibodies and immunotherapies – can often be more complex and stringent compared with traditional pharmaceutical drugs since these products are made in living systems. Our pharmaceutical regulation webinars cover FDA guidance on Good Manufacturing Practices (GMP) for biologics and how the agency classifies biosimilars.
Webinars on combination products, which include both a drug and a device, also fall under this category as they have their own associated regulations. Information on pharmaceutical regulation of rare and orphan drug products is also covered in these events.
Scroll down to discover what’s new in the industry with our wide selection of pharmaceutical regulatory webinars.