International GCP Inspections: The EMA Perspective
by Nicky Dodsworth
from the December 2011 issue of CRfocus (www.crfocus.org)
based on a presentation by Ana Rodriguez, Head of Clinical & Non-Clinical Compliance part of the Patient Health Protection Unit at the EMA at a session chaired by Nicky Dodsworth during the 2011 ICR Annual Conference

Resource for Multisite Studies and Emerging Markets – Poland
by Tomasz Kowalczyk
from the December 2011 issue of Journal for Clinical Studies

The European Guide to Pediatric Assent
by Dr. Daniela Kösling and Dr. Karen Menke
from the December 2011 issue of Scrip Clinical Research

New Frontiers in Transcatheter Heart Valve Technologies
by Sarah Zanon
from the December 2011 issue of Clinica

Fraud and Misconduct in Clinical Research
by Nicky Dodsworth
from the October 2011 issue of Quasar, the official journal for the British Association of Research Quality Assurance (BARQA)

Setting your Sites
by Erin Anderson and Daryl Fallon
from the October 2011 issue of European Biopharmaceutical Review

Devices: Select the Right Approach
by Erdmann J. Zippel and Robert Bäckmann
from the September 2011 issue of Pharmaceutical Market Europe

Mark of Approval
by Erdmann J. Zippel
from the September 2011 issue of EPC

Common Technical Document Development
by Mary Jane Lunsford and Thomas Kalfas
from the August 2011 issue (Volume 20, Issue 8) of Applied Clinical Trials

The New ISO 14155: A Practical Approach to your Quality Assurance System
by Caroline Ricklin and Nicky Dodsworth
from the July/August 2011 issue of Regulatory Affairs Medtech

Quality First – Implementing Quality in Times of Change
by Nicky Dodsworth and Sherri Hubby
from the June 2011 issue (Volume 3, Issue 3) of Global Forum (www.diahome.org)

The Cost of Quality
by Nicky Dodsworth and Sherri Hubby
from the May 2011 issue of International Clinical Trials

Paediatric Regulations: Similar but Different
by Susan Bhatti, Ph.D. and Charlene Sanders, M.D., F.A.A.P.
from the Spring 2011 issue of EPC

Joint EMA-FDA GCP Inspections: A Comparison between the FDA and European Inspection Process
by Nicky Dodsworth and Sherri Hubby
from the February 2011 issue (Volume 3, Issue 1) of Global Forum (www.diahome.org)

Improving Quality of Data through Metrics
by Sherri Hubby and Nicky Dodsworth
from the January 2011 issue of Quasar, the official journal for the British Association of Research Quality Assurance (BARQA)

Best Process, Best Outcome
by Dr. Thomas Ng and Patrick Melvin
from the Autumn 2010 issue of EPC

Differences in Standards for IECs
by Nicky Dodworth, Mary O'Flaherty, and Colin Wilsher
from Volume 19, Issue 6 June 2010 of Applied Clinical Trials

Are IRBs Really in Compliance?
by Sherri Hubby
from the June 2010 issue (Volume 2, Issue 3) of Global Forum (www.diahome.org)

Choosing the Right Medical Device CRO
by Efraim Roe and Patrick Young
from Life Science Leader's Annual Guide to Outsourcing Partners, 2010 Edition

GCP Discussion: Pregnancy of Research Subject's Partner
by Nicky Dodsworth
from the Volume 20 Number 12 December 2009 of CRfocus (www.crfocus.org)

PAEDIATRIC LUNG DISEASE
School age outcome of hospitalisation with respiratory syncytial virus infection of prematurely born infants
A Greenough¹, J Alexander², P Boit², J Boorman³, S Burgess⁴, A Burke⁵, P A Chetcuti⁴, I Cliff², W Lenney², T Lytle³, C Morgan⁵, C Raiman¹, N J Shaw⁵, K P Sylvester¹ and J Turner⁶
from the June 2009 volume of Thorax (64(6):490-5)
1 King’s College London
2 University Hospital of North Staffordshire
3 Abbott Laboratories
4 Leeds General Infirmary
5 Liverpool Women’s Hospital
6 Premier Research Group

Lost in Translations: Challenges in Preparing Participant Information for Multilingual Studies
by Nicky Dodsworth and Efraim Roe
from the Volume 20 Number 5 May 2009 of CRfocus (www.crfocus.org)

Contribution to the Treatment of Rare Diseases: Orphan Drugs
by Christiane Breithaupt
from Vol. 18, No. 1, 2009 issue of The Write Stuff (EMWA’s quarterly publication)

The Regulatory Medical Writer: More than a Writer, an Expert
by Mary Jane Lunsford
from Vol. 18, No. 1, 2009 issue of The Write Stuff (EMWA’s quarterly publication)

Monitored Progress
from the Winter 2007 issue of International Clinical Trials

Q&A: The Role of Regulatory Affairs
by James Ottinger
from the Q4 2007 issue of Next Generation Pharmaceutical

Outreach to Global Markets
by Chris Nowell and Mark Wade from Lionbridge Technologies, Inc.
from the Q4 2007 issue of Future Pharmaceuticals

New Kids on the Bloc
by Ralle Paleveev
from the Autumn 2007 issue of European Pharmaceutical Contractor

Monitoring Adaptive Clinical Trials: Knowing When to Challenge the Planning Estimates
from the Summer 2007 issue of PharmaTechnology