Conference Spotlight

Key takeaways, industry discussions, and insights from major regulatory conferences.

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Redica Systems
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Conference Spotlight

A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part Two

May 25, 2023
Jerry Chapman
Cell and Gene
FDA
GMP
Inspections
Pharma
Conference Spotlight

A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part One

April 27, 2023
Jerry Chapman
Cell and Gene
CGT
Quality
Conference Spotlight

Is Raw FDA Data Skewing Your Analyses?

March 23, 2023
Redica Systems
Drug recalls
GMP
Pharma
Quality
quality systems
Conference Spotlight

Should ICH Tackle Standard Development for CGT Products?

March 8, 2023
Jerry Chapman
483
GMP
ICH
ISPE Annual Meeting
Pharma
Conference Spotlight

FDA on the Evolution of Biologics Inspections: Part III

January 26, 2023
Jerry Chapman
Biologics
BLAs
FDA
FDA inspection
remote inspection
Conference Spotlight

FDA on the Evolution of Biologics Inspections: Part II

December 6, 2022
Jerry Chapman
Biologics
CDER
FDA
FDA Inspections
GMP by the Sea
Conference Spotlight

FDA on the Evolution of Biologics Inspections: Part I

November 28, 2022
Jerry Chapman
Biologics
CBER
ConOps
FDA
FDA Inspections
Conference Spotlight

The Evolving Clinical Trial Ecosystem

November 2, 2022
Jerry Chapman
clinical trials
Donald Ashley
GCP
Conference Spotlight

Persistent Non-Compliance Leads to a Consent Decree

October 27, 2022
Jerry Chapman
CDER
Compliance
consent decree
Contamination
FDA
Conference Spotlight

Japan’s PMDA Formalizing Post-Approval Change System Based on Recent Pilot

October 26, 2022
Jerry Chapman
No items found.
Conference Spotlight

Senior Management Failures Lead to Patient Deaths, Prison Sentence

October 25, 2022
Jerry Chapman
CDER
Compliance
FDA
patient deaths
PharmaTech
Conference Spotlight

Post-Approval Change Management Protocol Pilot Aims to Reduce Approval Time

October 19, 2022
Jerry Chapman
APAC
auditing
GMP
inspection preparation
Japan
Conference Spotlight

Navigating Drug Approvals and Post-Approval Changes in the Asia-Pacific Region

October 11, 2022
Jerry Chapman
101
APAC
Asia-Pacific
Drug Approval
Pharma
Conference Spotlight

How To Get Drug Products Approved In Asia-Pacific Markets

October 5, 2022
Jerry Chapman
101
APAC
Pharma
Conference Spotlight

Who Decides if my FDA Inspection is Classified OAI?

September 29, 2022
Jerry Chapman
483
CFR
Code of Federal Regulations
compliance officer
FDA
Conference Spotlight

Getting Drugs Approved in Mexico, Argentina, Colombia, And Peru

September 27, 2022
Jerry Chapman
101
ANMAT
Argentina
COFEPRIS
Colombia
Conference Spotlight

How to Get New Drugs Approved in Brazil

September 21, 2022
Jerry Chapman
ICH
Latin America
Pharma
Conference Spotlight

FDA on Compliance Issues in Pharma

September 16, 2022
Jerry Chapman
Donald Ashley
FDA
FDA inspection
Francis Godwin
GMP

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