Search Results for Good Clinical Practice

Showing 1 – 8

Regulatory Challenges for Direct-to-Patient Clinical Trials By Andrea Zobel - Published 22 December 2017

On-site clinical trials may present a number of participation obstacles for individuals living at distances from clinical trial sites or for patients with mobility problems. Direct-to-patient clinical trials can be an alternative. This article reviews applicable regulations and analyzes current strategies for conducting direct-to-patient clinical trials using technologies, such as mobile 'apps' and wearables to report data, as well as the potential for sending trial drugs directly to participants. The author recommends ways to improve the regulatory landscape for direct-to-patient clinical trial participation and provides examples of best practices for working with regulatory agencies to ensure the efficacy and success of such trials.

Categories: Features, Europe, US, EC, EMA, FDA, ICH, Clinical, Drugs

Tags: Clinical Trials, Good Clinical Practice, Data Privacy, Direct-to-Patient Trials

ICH Offers Reflection Paper on Good Clinical Practice Revisions By Zachary Brennan - Published 12 January 2017

The International Council for Harmonisation (ICH) on Thursday opened for comment a new reflection paper on Good Clinical Practice (GCP), part of a plan to modernize ICH guidelines on clinical trial design, planning, management and conduct.

Categories: News, Asia, Canada, US, ICH, Clinical, Quality, Regulatory intelligence, Regulatory strategy

Tags: Good Clinical Practice, ICH guidance, ICH E6, ICH E8

ICH Looks to Revamp GCP Guidelines, Adds New Members By Michael Mezher - Published 17 November 2016

Members of the International Council for Harmonisation (ICH) agreed on several moves that would revamp the organization's good clinical practice (GCP) guidelines during a meeting in Osaka, Japan last week.

Categories: News, Anvisa, ICH, MFDS, Biologics and biotechnology, Clinical, Drugs, Regulatory strategy

Tags: ICH, International Council for Harmonisation, Good clinical practice, GCP, Real world evidence

EMA Recommends Suspending Alkem Drug Over Flawed Studies By Michael Mezher - Published 24 June 2016

The European Medicines Agency (EMA) on Friday recommended suspending the marketing authorization of a drug made by Indian generic manufacturer Alkem Laboratories over data integrity issues at the company's bioequivalence facility in Taloja, India.

Categories: News, India, Europe, EMA, MHRA, Clinical, Generic drugs, Submission and registration

Tags: Alkem, riluzone, Good Clinical Practice, GCP

EMA Takes a Firmer Stance on GCP Non-Compliance By Zachary Brennan - Published 01 December 2015

Drug and biotech companies cannot replace pivotal clinical trials that are non-compliant with good clinical practice (GCP) standards during the assessment of marketing authorization applications, according to a new position paper from the European Medicines Agency (EMA).

Categories: News, Asia, Europe, EC, EMA, Biologics and biotechnology, Clinical, Compliance, Crisis management, Drugs, Government affairs, Quality, Regulatory strategy

Tags: good clinical practice, clinical trials, EMA, CHMP, GCP non-compliance

EMA: Revised Rules for GCP and Veterinary Type IA Fees Take Effect By Michael Mezher - Published 30 July 2015

The European Medicines Agency (EMA) is reminding companies that beginning 1 August 2015, several changes to its implementing rules on fees payable to the agency will enter into force.

Categories: News, Europe, EMA, Clinical, Drugs, Regulatory strategy, Veterinary products

Tags: Fees, Good clinical practice, GCP

FDA Guidance Explains How Medical Device Companies Can Rely on Foreign Clinical Data By Alexander Gaffney, RAC - Published 21 April 2015

New draft guidance issued by the US Food and Drug Administration (FDA) seeks to make it easier for medical device companies to rely on data obtained from clinical studies outside the US, provided those studies are conducted to appropriate federal standards.

Categories: News, US, CDRH, Clinical, Ethics, Medical Devices

Tags: GCP, Good Clinical Practice, Guidance, Draft Guidance, FDASIA Section 1123, Clinical Data

Good Clinical Practice: Where Ethics and Quality Meet By Jim Moran, Erika Stevens and Julie Statzel - Published 09 May 2013

This article discusses the history and primary principles of Good Clinical Practice (GCP), explaining that is much more than just a single document outlining the standards for clinical research.

Categories: Features, Ethics

Tags: Good Clinical Practice, clinical trials, GCP