URGENT PANDEMIC INFORMATION
COVID CANCELLED: Project Management in Human Resources, Boston MA, Jan 6-8, 2021
COVID CANCELLED: InterDrone, The International Drone Conference, Cambridge MA, Jan 11-13, 2021
COVID CANCELLED: Supplier Management for Medical Device Manufacturers, Cambridge MA, Feb 2-4, 2021
COVID CANCELLED: US Immigration Compliance Strategies, Boston MA, Feb 15-18, 2021
COVID CANCELLED: Project Management Training, Boston MA, Mar 3-5, 2021
COVID CANCELLED: Internal Audit, Fraud Risk Assessment Workshop, Boston MA, Mar 22-25, 2021
COVID CANCELLED: Agile / Scrum Training, Boston MA, Apr 12-14, 2021
COVID CANCELLED: Validation, Verification and Transfer of Analytical Methods, Boston MA, Apr 19-21, 2021
COVID CANCELLED: Computer System Validation - Reduce Costs and Avoid 483s, Boston MA, May 10-12, 2021
COVID CANCELLED: SharePoint Technology Conference, Boston MA, May 26-28, 2021
COVID CANCELLED: Employment Laws Certificate Program, Boston MA, Jun 7-9, 2021
Following events are tentatively planned but may be rescheduled, based on CDC guidelines or attendee registration interest .
TENTATIVE: 21 CFR Part 11 Compliance, Boston MA, Sep 22-24, 2021
TENTATIVE: Quality Control Laboratory Compliance, Boston MA, Oct 6-8, 2021
TENTATIVE: Analytical Instrument Qualification and System Validation, Boston MA, Nov 15-17, 2021
TENTATIVE: FDA's New Import Program for 2021, Boston MA, Dec 7-9, 2021
Boston Professional Events List
3 Hrs Webinar on 505(b)(2) NDAs By Peggy J. Berry, (Ex FDA)
Link to Website
Ticket Price: $349 One Dial-in One Attendee, $859 Group, $379 Recorded, $479CD/DVD
NDAs submitted under FD & C 505(b)(2) are a submission for which it is
Not a generic nor is it a tratitional brand. However, as such a hybrid, it is a great sponsorship opportunity. Learn the requirements for studies, reference information and marketing requirements.
What is a 505(b)(2)
What products qualify for submission under 505(b)(2) and which do not.
Examples of data that may be referenced
Requirements for studies to be conducted
Submission content requirements
Limitations to and benefits of a 505(b)(2)
Who will Benefit
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