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 [...]
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) [...]
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, [...]
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 [...]