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PPD In The News

Changing the face of the clinical trials industry

Chris Clendening and Brent Reed discuss the PPD® Laboratories Preclarus® investigator site portal and companion mobile application, which were acknowledged for industry leadership in the CenterWatch Monthly 25th anniversary special edition, which spotlights top innovators in clinical research.

CenterWatch  (January 2018)

Single-Use Bioreactors Pose E&L Challenges

Derek Wood comments on the challenges posed by single-use bioreactor bags in contributing to extractables and leachables in the biomanufacturing process.

BioPharm International  (December 2017)

Trending 2018: What does the future hold?

Susan Atkinson comments on risk-based monitoring in this feature in which industry experts identify the trends they think will impact life sciences in the coming year.

PharmaVOICE  (November 2017)

2017 year in preview: Trends revisited

Jai Balkissoon, M.D., and Elizabeth Madichie offer their thoughts one year later on the Cancer Moonshot and combination therapies, two of the key trends PharmaVOICE identified for 2017.

PharmaVOICE  (November 2017)

Marketing applications for biopharmaceuticals: Considerations for different jurisdictions – Part 2

In this two-part series, John Watkins and Clare Ryder highlight the similarities and differences in global submission requirements.

Regulatory Rapporteur  (November 2017)

The Virtual Opportunity in Rare Disease Trials

In this article written by Karen Kaucic, Horacio Plotkin and Christopher Komelasky, the authors discuss how rare disease research can be solved with virtual trials and their supporting technologies.

Applied Clinical Trials  (November 2017)

Analytical Testing – Extractables and Leachables Testing for Pharmaceutical Products

Xiaochun Yu and Derek Wood provide a detailed overview of extractables and leachables.

Pharmaceutical Outsourcing  (November 2017)

The Medical Device Coordination Group: A New Authority Under EU Device Regulations

This article by Robert Cumming and Nancy Mathewson discusses the organization and functions of the Medical Device Coordination Group established under the new EU Medical Device Regulation and In Vitro Diagnostic Medical Device Regulation.

Regulatory Focus  (November 2017)

CE Marking of In Vitro Diagnostic Medical Devices Under the New EU Regulation

Jonathan Bray, Michelle O’Connor and Robert Cumming authored this article to explain the revised classification rules, conformity assessment procedures and new requirements for clinical evidence to support the safety and performance of an in vitro diagnostic medical device.

Regulatory Focus  (November 2017)

A New Regulatory Paradigm for Medical Devices in India

Vibhu Yadav, Dushyant Kumar and Nancy Mathewson outlines medical device classification rules, manufacturer registration procedures, dossier filing procedures, and pre-clinical and marketing application approval processes.

Regulatory Focus  (November 2017)

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