Medical Writing Generics and biosimilars Document management systems for medical writing
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Volume 28, Issue 2 - Generics and biosimilars

Document management systems for medical writing

Author: Brendan Thorne

Abstract

Clinical trial data are rightfully protected by robust regulations; given these requirements and increasing demands from clients, a validated and compliant electronic document management system is now a necessity for established medical writing organisations and contract research organisations. Even without this impetus, the improvements in admin istrative function, audit readiness, and team collaboration can justify the investment required.

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References

  1. FDA, CFR - Code of Federal Regulations Title 21, Volume 1. Revised: 01 April 2018 [cited 2019 April 26]. Available from: Available from: https://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfcfr/CFRSearch.cfm? CFRPart=11.
  2. Article 47 of European Commission Directive 2001/83/EC. Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. Annex 11: Computerised Systems. [cited 2019 April 26]. Available from: Available from: https://ec.europa.eu/health/sites/health/ files/files/eudralex/vol-4/annex11_01– 2011_en.pdf.
  3. FDA Guidance for Industry Part 11, Electronic Records; Electronic Signatures – Scope and Application. [cited 2019 April 26]. Available from: Available from: https://www.fda.gov/downloads/Regulatory Information/Guidances/ucm125125.pdf.

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Articles

Introduction
James Visanji Tribute
President’s Message
EMWA News
Regulatory pathways for development and submission activities
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Statistical principles in biosimilar development
Writing biosimilar clinical study reports and submission documents – what to expect and what to consider
Medical writing for generics throughout the life cycle
Same but different: Basic tools for biosimilar and generic pharmacovigilance writing
Layperson materials in the sphere of biosimilars and generic medicines
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Biosimilars: Change, challenge, and accomplishments
ICMJE requirements for sharing individual participant data from interventional clinical trials
Medicinal products and medical devices in clinical trials conduct and disclosure
Publication of clinical trial protocols and statistical analysis plans on ClinicalTrials.gov
Collecting metrics in medical writing – the benefits to you and your business
Document management systems for medical writing
Winner of the Geoff Hall Scholarship Essay Competition
Regulatory Matters
News from the EMA
Getting Your Foot in the Door
Veterinary Medical Writing
Teaching Medical Writing
Medical Devices
My First Medical Writing
Journal Watch
Good Writing Practice
Regulatory Public Disclosure
Out on Our Own

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