Regulatory Affairs

Regulatory Affairs White Papers

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31-45 of 52 results
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
10th Middle East Regulatory Conference (MERC) 2013. Collaboration, Partnership and Interaction: Authority and Industry
| By Drug Information Association
This is the 10th DIA Middle East Regulatory Conference in partnership with the Middle East Regulatory Network (MERN). The MERN is an ad hoc regional network of the EFPIA (European Federation of Pharmaceutical Industries and Associations). The MERN works in partnership with regulatory authorities and the pharmaceutical industry in the Middle East to develop legislation and regulatory practices that enable patients to have access to good quality medicines, including innovative medicines.
Regulatory Affairs > White Papers
26th Annual EuroMeeting Vienna 2014, 25th - 27th March 2014 ACV, Vienna, Austria
| By Drug Information Association
The Annual EuroMeeting is DIA’s largest conference in Europe, attracting more than 3,000 professionals from industry, government, academia, as well as patient groups and students. It is unique in the quality of its content and speakers, and in the opportunity to network with like minded professionals, regulators and thought leaders. Early-bird rate for DIA Members – register by Tuesday, 11 February 2014 and save €185! Register onsite at DIA 2013 to save an additional €100!
Regulatory Affairs > White Papers
Quality by Design: Manufacturing at a Comprehensive GMP-Level
| By 3R Pharma Consulting
This whitepaper is Dr. Manuel Zahn’s presentation, 'Quality by Design'. This was delivered at the ,VISION PHARMA 2013, trade fair in Karlsruhe, Germany. 3R Pharma were present for the duration of the trade fair.
Regulatory Affairs > White Papers
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