CMC Considerations for INDs and NDAs for 505(b)(2) Products
Instructor:
Peggy Berry
Product ID: 705928
Training Level: Intermediate
- Duration: 90 Min
Why Should You Attend:
NDAs submitted under FD & C 505(b)(2) are those for which the product is not a generic nor a traditional brand. Learn the requirements for studies, reference information, and marketing requirements to take advantage of this great sponsorship opportunity.
NDAs submitted under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (FD & C) allow sponsors to reference data that was not generated by them. This type of submission can shave years off of the development process and save millions of dollars.
Areas Covered in the Webinar:
- What is a 505(b)(2) NDA
- What products qualify for submission under 505(b)(2)
- Examples of data and information 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:
- Manufacturing
- Supply chain
- Technical operations
- Quality control
- Quality assurance
- Regulatory affairs
Peggy Berry
Founder, Synergy Consulting LLC
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting, she was Vice President of Regulatory Affairs at Insmed where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. She also worked as Vice President of Regulatory Affairs and Quality at Amarin and held a variety of senior level positions at Dyax, MGI Pharma, AstraZeneca and Dey Pharma. She has also held Regulatory Affairs roles within two clinical contract research organizations and has worked in review divisions at the FDA. In addition, Ms. Berry is active in the Regulatory Affairs Professionals Society. She is an editor-in-chief of Fundamentals of US Regulatory Affairs, 6th edition (RAPS, MD 2010). Editor of “Choosing the Right Regulatory Career” (RAPS, MD 2010) and author of “Communication & Negotiation” (RAPS, MD 2011).
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Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
