DUBLIN--(BUSINESS WIRE)--The "Preparation of FDA Submissions and Communicating with the FDA (INDs, NDAs, BLAs, ANDAs, PMAs, 510(k)s, IDEs, Post-Approval Supplements)" conference has been added to ResearchAndMarkets.com's offering.
Course "Preparation of FDA Submissions and Communicating with the FDA (INDs, NDAs, BLAs, ANDAs, PMAs, 510(k)s, IDEs, Post-Approval Supplements)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Why you should attend:
- What do the regulations say?
- Navigate the FDA drug and device approval system
- Prepare, construct and submit well-written IND, NDA, BLA, PMA, 510(k) and IDE submissions and regulatory filings
- Navigate the FDA review process
- Identify the required regulations and guidance documents for drug and biologic submissions
- Use regulations and guidance documents to outline and construct a variety of drug and biologic submissions
- Formulate a working knowledge of regulatory submissions, publishing, and style guides
- Create checklists that encompass timelines and sections needed from contributors
- Strategic and technical guidance for drug and medical product development and regulatory review
- Regulatory policy guidance
- Regulatory Strategy planning and communications
- FDA 510(k) submissions for obtaining FDA clearance
- FDA Investigational Device Exemption (IDE) submissions for US clinical studies
- FDA Requests for Classification and Requests for Determination
- FDA Pre-Submission (Pre-sub) meetings
- Attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion
- Challenges and possible solutions will be discussed, and examples will demonstrate how the requirements can be put into practice
- Where does the PMA fit into the medical device universe (e.g. how to decide whether to use the PMA or another pathway to market)?
- How can the PMA be your friend (e.g. when a PMA is actually preferred over a 510k)?
- What are the 'required contents' of a PMA submission?
- How to decide amongst the types of PMA submissions (e.g. traditional, modular, streamlined, etc. and what are the advantages and disadvantages of each)?
- What is the Summary of Safety and Effectiveness Data (SSED) and how is it used?
- What are the differences in clinical trials for devices compared to drugs and biologics?
- How can we design device clinical trials to maximize our success to market?
- When can we combine pathways via label expansion?
- Want to avoid the PMA? Consider the De Novo - using classification to your advantage!
- How to use the PMA beyond the device world? i.e., using combination products: PMA+NDA/PMA+BLA, etc.
- Define basic terms related to device research
- Locate applicable regulations
- Determine when an IDE is required
- Describe Sponsor & Investigator responsibilities
- Know contents and submission process for an IDE Application
- Conduct IDE, PMA and 510(k) submission management activities
- Regulatory strategy and regulatory planning for effective IND, NDA, ANDA and BLA submissions
- Preparing for and conducting effective and efficient FDA meetings and communications
Upon completion of this course, attendees will have an understanding of the framework for FDA submission regulations and an approach on how to construct a submission. An appropriate submission strategy is necessary to legally manufacture a product in the US market. The course focuses on how a company's product situation needs to be evaluated in order to determine the correct interpretation of the submission requirements. Emphasis will be placed not only on regulatory aspects, but on the overall medical device and drug product development strategy and environment. Creating an effective submission strategy will help your company avoid spending unnecessary time and money by avoiding an inappropriate path.
For more information about this conference visit https://www.researchandmarkets.com/research/22gfzw/preparation_of?w=4