Upcoming Program Topics

Below are several planned topics for the upcoming year – please note that dates and details are subject to change. Subscribe to our emails and event calendar for the most current program information and registration details.

June
  • Managing Global Regulatory Assessments and Submissions for Modified Medical Devices – Best Practice, Points to Consider, and Pitfalls to Avoid
  • 510(k) Submission: A Focus on Predicate Device and Intended Use Strategy
  • OCRA-DIA collaboration
July
  • From Concept to Commercialization (IP and Regulatory Law)
  • Combination Product Submission Best Practice and Common Mistakes to Avoid 
  • Food Importation & Labeling Requirements, Common Custom Clearance Issues, and Pitfalls to Avoid
August
  • Compiling a Successful BLA Submission
  • Global Cosmetic Labeling & Registration Strategy – with a Focus on US, EU, and China
  • De Novo Submission, from Strategy to Approval
September
  • Essentials of Packaging Validation for Medical Device Professionals
October
  • Managing Post-Approval Drug Changes and Submissions
  • LDTs and the FDA Proposed Ruling
  • Essential Skills for RA Professionals (student member only)
 
November
  • Clinical Pathway Strategy for Medical Device Registration in China
  • Essentials of Sterilization Validation for Medical Device Professionals
 
December
  • Optimize Your Process for Streamlined and Sustainable Risk Management Throughout Product Lifecycle