Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club | Medical Devices | Videos

Regulatory Affairs
Return to: PBR Home | Regulatory Affairs | White Papers
Search Refinements

Regulatory Affairs White Papers

View white papers from other Pharmaceutical sectors:
1-15 of 37 results
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
DIA EUROPE CONFERENCES AND WORKSHOPS 2013-2014
| By Drug Information Association
For more information and a complete listing of all DIA conferences, please visit: www.diahome.org > click on Meetings & Training
Call DIA Europe on +41 61 225 51 51 or email: diaeurope@diaeurope.org

Regulatory Affairs > White Papers
Combination Products Workshop, 17th October 2013, Basel, Switzerland
| By Drug Information Association
This one-day workshop will provide delegates with an understanding of the current regulatory framework for drug/device combinations and companion diagnostics, and of the anticipated impact of the revision of the European medical device and In-Vitro Diagnostics (IVD) legislation.
Regulatory Affairs > White Papers
14th DIA Conference on European Electronic Document Management (eDM) 20–22 November 2013 Dublin, Ireland
| By Drug Information Association
During the middle ages alchemists were looking for the Philosopher’s Stone. As it was believed, the mythical substance could not only turn lead into gold, but also prolong life and restore youth. Although the goal was never achieved, alchemy paved the way to scientific methods and so to the medical advances of today. This has transformed our lives in more than one way.
Regulatory Affairs > White Papers
7th DIA/EFGCP/EMA Medicines for Children Conference, 24th-25th September 2013, London, UK
| By Drug Information Association
This year’s DIA/EFGCP/EMA paediatric conference will take place in the seventh year of the EU Paediatric Regulation. Over 1’000 Paediatric Investigation Plans (PIPs) have been submitted so far and paediatric aspects are now an integrated part of drug development.
Regulatory Affairs > White Papers
Joint DIA/MHRA Statistics Workshop 2nd-4th October 2013, London, United Kingdom
| By Drug Information Association
Life-cycle management is a widely accepted concept for the development and marketing of medicines. At each step of this process, pre- and post-licensing, statisticians work to develop methods that can improve efficiency and can enhance decision-making through optimal study design, analysis and inference. The workshop aims to discuss the latest developments in statistical methodology and decision-making in exploratory development, confirmatory development, licensing decisions and management of benefits and risks post-licensing.
Regulatory Affairs > White Papers
7th Annual DIA Clinical Forum Dublin, Ireland on 8–9 October 2013.
| By Drug Information Association
The DIA Clinical Forum is known as a conference that brings together experts from different fields, including data management, clinical operations, drug safety, medical affairs, medical information and medical writing. Experts share their expertise and experience with people from other companies and disciplines. Making the presentations and workshops relevant to the day to day work of participants has always been the focus of previous programme committees – and I am glad to confirm that this won’t be any different this year.
Regulatory Affairs > White Papers
1-15 of 37 results