PDA Letters (Cards)

IG Meetings to Address Complexity of New Products

Lee Leichter, P/L Biomedical

4 April, 2017

How to Get Your ATMP From the Lab to the Market

Andy Fry, Team Consulting

4 April, 2017

Viral Safety Approaches for Advanced Therapy Medicinal Products

Thomas R. Kreil, PhD, Global Pathogen Safety, Shire

4 April, 2017

WHO Should Align with ICH on PACs

Rebecca Stauffer, PDA

4 April, 2017

Quality Metrics to Impact Different Pharma Sectors

Rebecca Stauffer, PDA

14 March, 2017

Leveraging Video to Improve Operations

Colleen Walson-Billin, Amgen

7 March, 2017

Storm Surrounds Clinical Trial Data in China

Yingying Liu, ECURAC, and Siegfried Schmitt, PAREXEL

7 February, 2017

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

10 January, 2017

GMP Oversight of Medicines Manufacturers in the European Union

Riccardo Luigetti, EMA, Emer Cooke, EMA, Brendan Cuddy, EMA, Sebastien Goux, European Commission, and Ian Rees, MHRA

14 November, 2016

When a Routine Trip Becomes a 1980s Comedy of Errors

Walter Morris, PDA

4 October, 2016

A Line of Sight Approach for Assessing Aseptic Processing Risk: Part III

Hal Baseman, Marsha Hardiman, Walter Henkels and Mike Long, ValSource

27 September, 2016

PDA Program to Address Post-Approval Hurdles

PDA Post Approval Change: Innovation for Availability of Medicines (PAC iAM) Task Force

24 August, 2016

When Data Integrity Takes Front and Center Stage

Doug Chambers, MilliporeSigma

9 August, 2016

Three Questions for MHRA’s David Churchward

Rebecca Stauffer, PDA

26 July, 2016

Four Steps to Conducting a Successful Data Integrity Audit

Crystal Mersh, Quality Executive Partners

19 July, 2016

A Line of Sight Approach for Assessing Aseptic Processing Risk: Part II

Hal Baseman, Marsha Hardiman, Walter Henkels and Mike Long, ValSource

7 July, 2016

Data Integrity and the Preapproval Inspection

John Godshalk, Biologics Consulting

22 June, 2016

A Line of Sight Approach for Assessing Aseptic Processing Risk: Part I

Hal Baseman, Marsha Hardiman, Walter Henkels and Mike Long, ValSource

31 May, 2016

Drug Shortage is a "Wicked Problem"

Anders Vinther, PhD, Sanofi Pasteur

4 May, 2016