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

Regulators, USP Taking a Close Look at Visual Inspection

John Shabushnig, PhD, Insight Pharma Consulting, and Markus Lankers, PhD, rap.ID Particle Systems GmbH

A QUICK Guide To Selecting a CMO

Brittany Cloud, Eurofins Lancaster Laboratories, Inc.

Quality Metrics to Impact Different Pharma Sectors

Rebecca Stauffer, PDA

Storm Surrounds Clinical Trial Data in China

Yingying Liu, ECURAC, and Siegfried Schmitt, PAREXEL

Annex 1 Showcases the Need for Clear Guidance

Geert Vandenbossche, Novartis; Marc Besson, Sanofi; Gabriele Gori, GSK Vaccines; Jette Christensen, Novo Nordisk; Gerry Morris, Eli Lilly and Company

Four Steps to Conducting a Successful Data Integrity Audit

Crystal Mersh, Quality Executive Partners

Data Integrity and the Preapproval Inspection

John Godshalk, Biologics Consulting

Drug Shortage is a "Wicked Problem"

Anders Vinther, PhD, Sanofi Pasteur