Search Results for Features

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Regulatory Career Paths and Progression, Resources and Training, FDA Inspections, Cleaning Validation and a Preview of August By Gloria Hall - Published 01 August 2017

Feature articles over the past several weeks highlighted regulatory affairs as a profession, including careers in regulatory advertising and promotion, possible pathways and career progression and resources and training for regulatory professionals. Other articles covered various types of inspections conducted by FDA and processes for cleaning validation in the pharmaceutical industry.

Categories: Features, Career Development

Tags: Features, Regulatory Focus

Biosimilars, 21st Century Cures Act, Clinical Trial Regulations, PDUFA, Global Regulatory Strategy and a Preview of May By Gloria Hall - Published 02 May 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in May.

Categories: Asia, Europe, US, EMA, FDA, ISO, Biologics and biotechnology, Combination products, Drugs, Medical Devices, Submission and registration

Tags: Features, Regulatory Focus

Regulatory Business and Strategy, Medical Device Regulations, Adverse Event Reporting Requirements and a Preview of April By Gloria Hall - Published 05 April 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in April.

Categories: Features, Asia, Europe, Oceania, US, EC, FDA, Business Skills, Human cell and tissue, Medical Devices

Tags: Features, Regulatory Focus

Regulatory Focus Features Recap: July 2016 By Gloria Hall - Published 29 July 2016

Feature articles for July focused on managing regulatory information and systems and eCTD submissions.

Categories: Features, Submission and registration

Tags: Features Recap, Regulatory Focus, eCTD, Electronic Common Technical Document