SEED 2019 will focus on advances in science, technology, applications, and related investments in the field of synthetic biology. For more info: http://synbioconference.org/2019
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 Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. For [...]
Submissions to a regulatory agency involve more than just writing of applications. They also encompass strategy, editing, publishing and systematic tracking of key information. Through formal lectures, case studies, and hands-on exercises, new and experienced regulatory professionals will learn how to interpret regulations and guidance documents to produce submissions that comply with the requirements and [...]
FDA subject matter experts will introduce the Identification of Medicinal Products (IDMP) initiative, scope, and benefits. They will also discuss FDA’s approach and challenges with the adoption of the five International Organization for Standardization (ISO) standards. The goals, objectives and timeframe for the development and implementation of the Global Substance Registration System’s (G-SRS) will also [...]
The Shrimp Boil will feature great food, music, and top business and community leaders. Elected officials and others from across Tennessee have been invited to this extraordinary affair. Casual attire is encouraged! Location: Jackson Terminal, 213 W. Jackson Avenue, Knoxville Cost: $35 for members, $45 for non-members Purchase your tickets at eventbrite.com https://www.eventbrite.com/e/shrimp-boil-2019-tickets-53026144626
Learn about FDA economic assistance and economic incentives so you may maximize potential benefits. Economic assistance is available in the pre-approval period of drug development for the conduct of clinical trials. Economic incentives are granted post-approval to reward innovation in drug development. For more info: https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/regulatory-education-industry-redi-webinar-financial-incentives-cder-medical-products-june-10-2019