Upcoming Events at Hilton Zurich Airport
Wed Jun 20, 9:00 AM - Thu Jun 21, 5:00 PM
Hilton Zurich Airport
Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +, Zurich, Zu 1211
Community: Upper West Side
Description
Navigate the FDA drug and device approval system
Event Details
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.
Overview:
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 d
Overview:
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 d
