Deep Dive into Biosimilars Continues

Stephan Krause, AstraZeneca, Emanuela Lacana, U.S. FDA, and Rebecca Stauffer, PDA

Our Data Integrity Journey Has Only Just Begun

Jackie Veivia-Panter, Legend Biotech

Thanks for the Warning Letter: Part II

Steven Lynn, Lynn Consulting, LLC

EMA's Amsterdam Move Reflects Larger Trend

Toni Manzano, bigfinite

Holistic Verification Requires a New Mindset

David Hubmayr, CSL Behring

Thanks for the Warning Letter: Part I

Steven Lynn, Lynn Consulting, LLC

Risk Management Shines Light on ICH Q12 Use for Biologics

Jose C. Menezes, PhD, 4Tune Engineering

Hot Read: GMP in Practice

Rebecca Stauffer, PDA

Drug Delivery Combination Products Go “Viral”

Lee Leichter, P/L Biomedical

Data Integrity in the Age of Metadata and Big Data

Toni Manzano, bigfinite

Quality/Compliance Management for Virtual Companies

David Chesney, DL Chesney Consulting

PDA Responds to Annex 1 Revision

Rebecca Stauffer, PDA

Container Closure Integrity Requires Adaptation

Dominick DeGrazio, PhD, Janssen R&D, LLC

ATMPs: What a Difference a Year Can Make

John Geigert, PhD, BioPharmaceutical Quality Solutions

Awareness Critical for Container Closure Components

High Regulatory Expectations for Biosimilars

Stephan Krause, PhD, AstreZeneca Biologics, Emanuela Lacana, PhD, U.S. FDA, Jens Schletter, PhD, Sandoz, and Rebecca Stauffer, PDA

Formalizing a Risk Assessment for Excipients

Frithjof Holtz, Merck KGaA, Darmstadt, Germany

Collaboration Through Mutual Reliance Brings FDA and EMA to the Table

Rebecca Stauffer, PDA

Flexibility Needed for PAC

Rebecca Stauffer, PDA

Regulators Tackle Tough Micro Questions on Panel

Rebecca Stauffer, PDA

A Risk Assessment is an Opportunity Assessment

David Hubmayr, CSL Behring

PDA and IFPMA Foster Discussion on PAC

Ursula Busse, PhD, Novartis

PQS: An Effective Lever for Managing PACs

Anders Vinther, Sanofi Pasteur, Emma Ramnarine, Genentech/Roche, Kevin O’Donnell, Irish Health Products Regulatory Authority

OPQ Establishes Manufacturing Science CoE

Kurt Brorson and Sau L. Lee, U.S. FDA

A Maturing Model of Quality

Jacqueline Kunzler, PhD, Baxter International Inc.

Industry Expert Weighs in on Quality Metrics

Rebecca Stauffer, PDA

U.S., UK Regulators Share Passion for Quality Culture

Rebecca Stauffer, PDA

PDA’s 4th Metrics Conference

Stephanie Gaulding, DPS Engineering

Creating a Global Incentive for Pharma

Anders Vinther, Sanofi Pasteur; Emma Ramnarine, Genentech; co-chairs PDA Post Approval Change: Innovation for Availability of Medicines (PAC iAM) Task Force

Hear From Industry, FDA Leaders on the Issues of the Day

Susan Schniepp, Regulatory Compliance Associates, and Steven Mendivil, Amgen