Blog

Improving Informed Consent in Clinical Trials

October 20, 2020

Does more information mean better knowledge? Authors: Ruth Cohen PhD, Regulatory Affairs Associate, CATO SMS Recruitment and retainment of patients...

Blog

New FDA Guidances for September 2020 and Upcoming Advisory Committee Meetings

October 12, 2020

 Special Interest Guidances/Information Date Posted The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development,...

Blog

Towards Quality Harmonization via Computer Systems Validation in Clinical Research

October 2, 2020

Authors: Kevin Dickie MScAuthor affiliations: CATO SMS, Walaardt Sacréstraat 401-403, 1117 BM Schiphol, The Netherlands  In recent years, there has...

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New FDA Gudiances for August 2020 and Upcoming Advisory Committee Meetings

September 3, 2020

By Dieanira Erudaitius, PhD, RAC, Regulatory Scientist, Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Principles for...

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New FDA Gudiances for July 2020 and Upcoming Advisory Committee Meetings

August 5, 2020

  By Joshua Taylor, PhD, RAC, Director – Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Pediatric...

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Immuno-oncology updates in the virtual era – ASCO 2020

July 27, 2020

This year’s ASCO Annual Scientific Meeting took place between May 29-31, with the Education Program planned for August 8-10. Unlike previous...

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New FDA Gudiances for June 2020 and Upcoming Advisory Committee Meetings

July 5, 2020

By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Development...

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Are you ready for the new European clinical trial regulation?

June 29, 2020

The new European Clinical Trial Regulation (ECTR) will replace the 2001/20/EC Directive, the directive that currently describes how clinical trials should be conducted in...

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Clinical Research Regulation in the Netherlands

June 15, 2020

Before the first human subject receives an investigational medicinal product, the clinical trial has to be approved according to applicable...

Blog

What’s New Health Canada?

May 7, 2020

By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate What’s New in: Therapeutic Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html Biologics and Genetic Therapies Directorate:...