Biotech Breakfast Recap

PRESENTATION:
Speaker, LT Renu Lal, Presentation: “Engaging with the FDA’s Center for Drug Evaluation and Research.”

SPEAKER: Lieutenant Renu Lal, United States Public Health Service Commissioned Corps, Food and Drug Administration
BIO: LT Renu Lal has been with the Food and Drug Administration, Center for Drug Evaluation and Research, in the Division of Drug Information (DDI) since 2002.  In DDI, she works with the Small Business Assistance (SBIA) team and responds to emails from the public regarding a wide range of topics, from drug safety to drug development. She also is active in maintaining and developing the SBIA Program, finding new ways to reach out to the pharmaceutical industry. Renu received her Doctor of Pharmacy from the Medical University of South Carolina, and her Bachelor’s degree in Pharmacy from the University of Connecticut. She is also an officer of the United States Public Health Service.

DOWNLOADS:
Presentations:

“Engaging with the FDA’s Center for Drug Evaluation and Research.”

Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry

Good Documentation Practices from QUIBIT


Thank you to our sponsors:
QUIBIT
Sanford Health
EDA Regional Innovation Strategies i6 Challenge Grant