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SBIA Chronicles

by | Nov 18, 2025 | News From Around The Web | 0 comments

Improving Data Quality with Centralized Statistical Monitoring – with Dr. Paul Schuette and Xiaofeng (Tina) Wang December 13, 2024

 Podcast

(12:30 min, 17.2MB, MP3)
Transcript

The Need for Artificial Intelligence in Pharmacovigilance with Dr. Robert Ball November 14, 2024

 Podcast

(11:00 min, 15.1MB, MP3)
Transcript

Considerations for Drug Products that Contain Nanomaterials May 17, 2024

 Podcast

(11:19 min, 16.2MB, MP3)
Transcript

Using Bayesian Statistical Approaches to Advance our Ability to Evaluate Drug Products August 17, 2023

 Podcast

(7:30 min, 10.3MB, MP3)
Transcript

Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products July 10, 2023

 Podcast

(7:58 min, 7.31MB, MP3)
Transcript

The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development April 10, 2023

 Podcast

(9:48 min, 13.5MB, MP3)
Transcript

FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds February 6, 2023

 Podcast

(11:28 min, 10.5MB, MP3)
Transcript

The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities September 29, 2022

 Podcast

(7:09 min, 6.54MB, MP3)
Transcript

An FDA Self-Audit of Continuous Manufacturing for Drug Products June 28, 2022

 Podcast

(11:12 min, 10MB, MP3)
Transcript

The Key Elements of Being “Recall-Ready” April 19, 2022

 Podcast

(7:51 min, 7.4MB, MP3)
Transcript

The ABCs of Product Specific Guidances September 2, 2021

 Podcast

(7:23 min, 6.8MB, MP3)
Transcript

Improving Regulatory Communication via the CDER NextGen Portal December 19, 2019

 Podcast

(6:01 min, 6.8MB, MP3)
Transcript

Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA? September 19, 2019

 Podcast

(7:48 min, 9.6MB, MP3)
Transcript

Research Investigational New Drug Applications – What You Need to Know June 25, 2019

 Podcast

(4:58 min, 6.8MB, MP3)
Transcript

Competitive Generic Therapies May 23, 2019

 Podcast

(6:49 min, 9.49MB, MP3)
Transcript

FDA Modernizes Clinical Trials with Master Protocols February 26, 2019

 Podcast

(5:34 min, 5.1MB, MP3)
Transcript

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Medically Reviewed By: Felicia Eddings, Pharm.D.

Clinical :: Oncology :: Nuclear :: Geriatric :: Regulatory :: Technology :: Consulting

"My passion is helping businesses, small and large, perform at their best." - Felicia Udoji-Eddings, Pharm.D.

Dr. Felicia Udoji-Eddings is the Founder and CEO of The Health Pals Company, a vertically integrated Healthcare System. As an experienced Clinical Pharmacy Leader, Pharmacy Consultant, Healthcare Executive, and Licensed Pharmacy Practitioner with deep backgrounds in Information Technology (IT), Scientific Research, and Business Management. Dr. Udoji-Eddings has a strong track record of exceptional performance in different business environments. A skilled Business Strategist, Dr. Udoji-Eddings has tackled complex problems and helped several organizations refocus their strategy in tough economic times. As a highly motivated and proactive individual, Felicia enjoys working with teams, in various capacities, to facilitate positive outcomes.

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