CDER and CDRH invite you to interact with and learn directly from FDA’s regulatory experts. This course is designed to provide participants with a strong, basic foundation in understanding the FDA’s drug and medical device regulatory requirements. Attendees will leave with a set of tools to assist in preparing regulatory filings and interacting with the [...]
Presented by the Society for Biological Engineering (SBE), this conference will bring together leaders and trainees from cutting edge fields of bioengineering and nanotechnology. Topics to be presented include: biomolecular engineering, translational medicine, cell engineering, immunoengineering, and mechanobiology. The global objective of the conference is to bring to the forefront truly transformational development in bionanotechnology. For [...]
Building Safety Month is an international campaign that takes place in May to raise awareness about building safety. This campaign reinforces the need for the adoption of modern, regularly-updated building codes, and helps individuals, families and businesses understand what it takes to create safe and sustainable structures. The International Code Council, its 64,000 members, and [...]
For more than 50 years, the President of the United States has issued a proclamation announcing National Small Business Week, which recognizes the critical contributions of America’s entrepreneurs and small business owners. More than half of Americans either own or work for a small business, and they create about two out of every three new [...]
Biobased production of industrial chemicals, fuels, and specialties (industrial biotech) has had many triumphant moments in the last few decades. Along with these successes, however, industrial biotech has also faced and had to overcome challenges, disappointments, and delays. We seem now to be at a turning point where regulatory and environmental factors, customer and consumer [...]
The FDA released code and technical documentation for the FDA MyStudies Platform on November 20, 2018. External organizations can now use these materials to configure and create branded apps for their own use in traditional clinical trials as well as real world evidence studies and registries. This event will demonstrate the capabilities of the system [...]
This annual conference brings together leading authorities from FDA, industry and academia to address the latest statistical trends and issues facing medtech organizations. This conference allows attendees to take a deeper dive into either therapeutic device or diagnostics topics. The two day conference will include topic table discussions and a poster session. Keynote Speaker Confirmed: [...]
This two-day comprehensive Course on Latin America Regulatory compliance requirements will cover topics ranging from pre-clinical and clinical requirements through product registration, amendments and renewals across Pharmaceuticals, Biologics, Medical Devices and Combination Products. The Course will address the structure of the regulatory agencies in Latin America and discuss local cultural nuances to help you be [...]
This 2.5-day course provides attendees with practical tools and techniques for process validation requirements for FDA’s Quality System regulation and recognized Process Validation Guidance from the Global Harmonization Task Force. The program includes industry best practices and real-life process validation examples. Demonstrate Return on Investment (ROI) to employers by completing and passing the Process Validation [...]
For registration info: https://www.aami.org/events/eventdetail.aspx?ItemNumber=7186