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Regulatory Affairs White Papers

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1-15 of 31 results
Single-Use-Bioprocesses – Hype or Future Technology?
| By Rentschler
Single-use bioreactors offer many advantages for the manufacturing of biopharmaceuticals. They are used in approximately two thirds of all new bioprocesses in the biopharmaceutical market and have become indispensable in biopharmaceutical development and production processes.
Regulatory Affairs > White Papers
Specialised Project & Technology Transfer- Laboratory Equipment & Automated Systems
| By SHL Group
A US-based company dedicated to developing intelligent inspection solutions and equipment for the biotechnology, pharmaceutical, and medical device industries wanted to partner with an established manufacturer, possessing design and engineering capabilities as well as appropriate in-house quality systems. With lab equipment that finds defects in medical syringes, vials, cartridges, test tubes, and other medical containers, it was vital for the manufacturing partner to have ISO13485 and ISO9001 quality systems in place.
Regulatory Affairs > White Papers
Design-To-Build – Laboratory Handling Equipment
| By SHL Group
A leading high-end laboratory handling and diagnostics equipment manufacturing company devoted to helping scientists meet challenges regularly faced in the lab, approached SHL Technologies with a request to develop benchtop laboratory tube array handling equipment. This equipment had to be available in a modular set-up and capable of pick-and-place sorting, weight measurement, and barcode reading.
Regulatory Affairs > White Papers
Complex Module Manufacturing – IC testing Devices
| By SHL Group
An established manufacturer of Integrated Circuit (IC) testing equipment from Germany was following a global sourcing initiative and needed to search for a suitable supplier in Asia that had experience in manufacturing and offered strong production capabilities. Sustaining high quality manufacturing in an environment with established quality systems was vital to the manufacturer and became one of the key determining factors when choosing the right supplier.
Regulatory Affairs > White Papers
Specialised Project & Technology Transfer – Precision Neurosurgical Equipment
| By SHL Group
An established manufacturer of Integrated Circuit (IC) testing equipment from Germany was following a global sourcing initiative and needed to search for a suitable supplier in Asia that had experience in manufacturing and offered strong production capabilities. Sustaining high quality manufacturing in an environment with established quality systems was vital to the manufacturer and became one of the key determining factors when choosing the right supplier.
Regulatory Affairs > White Papers
Supply Chain Management – Surface Mount Technology & Solar Cell Manufacturing
| By SHL Group
A leading provider of screen printing equipment located in the UK with an established presence in China was looking for a manufacturing partner that was capable of taking over their supply chain management while maintaining international quality standards. With markets largely located in Asia, the company hoped to find a partner within the region that not only possessed the key manufacturing capabilities required, but one that could also offer western style management to ensure that the technology transfer would go smoothly.
Regulatory Affairs > White Papers
Best Practices for Streamlining Electronic Implementation of Established COAs; Copyright January 2015
| By ERT
This paper addresses the best practices for building an electronic Clinical Outcome Assessment (eCOA) solution in support of clinical research as it relates to the operational and licensing compliance aspects of administering COAs on electronic platforms.
Regulatory Affairs > White Papers
Symptoms and Impact of COPD Assessed by an Electronic Diary in Patients with Moderate-to-Severe COPD: Psychometric Results from the SHINE Study; International Journal of COPD; January 2015.
| By ERT
This paper presents the results of psychometric assessment data from a COPD eDiary developed by Novartis to provide a more detailed assessment of symptom frequency and severity and their impact on patients with COPD.
Regulatory Affairs > White Papers
The Use of Ambulatory Blood Pressure Monitoring in Drug Development; Copyright, January 2015
| By ERT
This white paper delves into the basics of blood pressure, along with the well-documented limitations of standard and digital office blood pressure measurements. It reviews ABPM device functionality, common drug classes where blood pressure monitoring comes into play and compares the advantages and disadvantages of different monitoring options in clinical studies.
Regulatory Affairs > White Papers
The Use of Continuous ECG Recordings (Holters) in Drug Development; Copyright, December 2014
| By ERT
Continuous 12 lead ECG recorders, often referred to as Holter devices, offer specific advantages to be considered over the standard 12 lead ECGs often collected during clinical trials for cardiac safety. This white paper explores the history of Holters, how sponsors, sites, and patients use these devices, and the benefits of continuous ECG recordings.
Regulatory Affairs > White Papers
Predictive Value of Baseline electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) Assessments for Identifying Risk of Prospective Reports of Suicidal Behavior During Clinical Research; Innovations in Clinical Neuroscience; November 2014
| By ERT
This meta-analysis examined the ability of baseline eC-SSRS lifetime suicidal ideation and behavior categories to predict prospective reports of suicidal behavior in psychiatric and non-psychiatric research participants. The review of over 74,000 eC-SSRS assessments determined that increasingly more severe lifetime suicidal ideation at baseline was associated with a progressively greater likelihood of prospectively reported suicidal behavior during study participation.
Regulatory Affairs > White Papers
How the Vaisala Continuous Monitoring System Aids Compliance with Title 21 CFR Part 11 and EU GMP Annex 11
| By Vaisala pbr
This white paper outlines how Vaisala’s Continuous Monitoring System helps to meet the requirements of Title 21 CFR Part 11 and EU GMP Annex 11 as they apply to environmental monitoring and validation.
Regulatory Affairs > White Papers
GMP Warehouse Mapping - Step-by-Step Guidelines for Validating Life Science Storage Facilities
| By Vaisala pbr
This step-by-step paper describes how to map a warehouse to comply with internationally recognized GMPs and regulatory requirements.
Regulatory Affairs > White Papers
Monitoring Systems - Sorting Out Wireless
| By Vaisala pbr
This white paper describes the most common methods of connecting sensors to a monitoring system focusing on selecting wireless options.
Regulatory Affairs > White Papers
Nine Things you Need to Know About Continuous Monitoring Systems in FDA-Regulated Environments
| By Vaisala pbr
The white paper outlines nine crucial evaluation points that will allow you to select the monitoring system best suited to your monitored applications, controlled environments and GxP facilities.
Regulatory Affairs > White Papers
1-15 of 31 results