Monthly Archives: November 2018

//November

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements – December 3-7, 2018 in Manchester, UK

The regulatory world for quality management systems (QMS) is changing fast. To succeed in today's global market, the manufacturers of medical devices must understand those requirements. This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System [...]

2018-11-28T16:26:40+00:00November 28th, 2018|

Webinar – Final Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations – December 6, 2018, 1:00 pm to 2:00 pm

The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), is pleased to announce this virtual event. Issuing the guidance for industry on the use of electronic health record (EHR) data in clinical investigations is part of the agency's commitment to furthering the advancement and usage [...]

2018-11-28T16:22:01+00:00November 28th, 2018|

6th International Conference on Stem Cell Engineering 2018 – December 5-7, 2018 in Los Angeles, CA

Presented by the Society for Biological Engineering (SBE), this conference will bring together leaders and trainees from cutting edge fields of stem cell engineering including basic and applied studies to discuss progress and needs to develop the next generation of stem cell technologies. For more info:  https://www.aiche.org/sbe/conferences/international-conference-on-stem-cell-engineering/2018  

2018-11-28T16:12:22+00:00November 28th, 2018|

FDA Study Data Technical Conformance Guide Webinar – November 27, 2018, 1:30 pm to 2:30 pm ET

The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), welcomes you to our webinar series. These events focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation.  The webinars support [...]

2018-11-16T19:28:02+00:00November 16th, 2018|

FDA Clinical Investigator Training Course – November 13-15, 2018 in Silver Spring, MD

Experts from FDA’s Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), the University of Maryland and the University of Pennsylvania will provide a deep dive into the scientific background and practical methodology needed when conducting clinical trials. In this intensive course, attendees [...]

2018-11-09T19:48:14+00:00November 9th, 2018|