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2019 Synthetic Biology: Engineering, Evolution & Design (SEED) in New York City, June 23-27, 2019
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
The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements – June 24-28, 2019 in Arlington, VA
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 [...]
Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings – June 20-21, 2019 in Philadelphia, PA
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 [...]
Webinar: CDER/CBER – Identification of Medicinal Products Initiative – June 13, 2019 – 1:00 pm to 2:30 pm ET
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 [...]
Knoxville Chamber of Commerce – Shrimp Boil 2019 – June 13, 5 to 7 pm
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
Webinar: Financial Incentives for CDER Medical Products – June 10, 2019, 10 am to 3 pm ET
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
AAMI Exchange – June 7-10, 2019 in Cleveland, OH
AAMI has changed the name of its premier health technology event from the AAMI Annual Conference & Expo to the AAMI Exchange. The new name and brand promise reflect the Association's commitment to connect the full gamut of AAMI stakeholders—biomedical and clinical engineers, technicians, cybersecurity and sterilization experts, and hospital administrators and managers and the [...]
SBIA REdi Annual Conference 2019 – May 29-30, 2019 in Boston, MA
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 [...]
8th International Conference on Bioengineering and Nanotechnology – May 28-31, 2019 in Baltimore, MD
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 [...]