Webinar Lunch and Learn 

This webinar will focus on a high-level introduction of the different areas of regulation under the US FDA (Cosmetic vs. Drug vs. Device vs. Biologic). The most common types of regulatory filings will be covered including Monograph, NDA, IND, 510K, DeNovo, and PMA, and Combination products. David and Terri will also help unscramble some of the “acronym alphabet soup” of which organizations review which submission types (CBER, CDER, etc). Finally, they will provide their experience in understanding how to use expedited programs and other approvals and clearances for aid in development. Join ISPE-Delaware Valley Chapter for this 1-hour introduction to US Regulatory 101.


Speakers:

Terri Williams

Terri Williams

Johnson & Johnson Consumer Regulatory Affairs

Terri Williams joined the J&J Consumer Regulatory Affairs team a year and a half ago and has been part of J&J Regulatory Affairs for 20 years:  she has worked most of her career in the Pharma sector in the Oncology and CNS therapeutic areas. She has her PhD in molecular genetics from Rutgers University and did her undergraduate work at UNC-Chapel Hill, NC. Terri also has a strong passion for teaching and mentoring. 

David Morra

David Morra

Johnson & Johnson Consumer Regulatory Affairs

David Morra joined the J&J Consumer Regulatory Affairs team a year and a half ago to lead the organization with regard to US Medical Devices. He has worked in a variety of roles across R&D, Quality, Make, Project Management, and Regulatory throughout his career in large, mid-sized, and start-up medical companies. David obtained his bachelors in bioengineering from Lehigh University.


Registration Information:

 

COST

ISPE Members

$10

Non-Members

$10

Young Professional Member

$10

Student/Retired/Unemployed

$10

Group Registration (multiple people in one setting) $30

Register Now