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The article discusses the benefits of the electronic patient reporting (ePRO) than the paper-based diaries for clinical research sponsors as accepted by Food and Drug Administration (FDA) and European Medicines Agency (EMA). The author says that the ePRO technology can cut costs through compliance rates and the function of the ePRO automates data management which includes reviewing, collating, and verifying. Moreover, he presents an overview regarding the research on paper vs. ePRO model.

The article offers suggestions for meeting regulatory concerns regarding Electronic Data Capture (EDC) data integrity and site control over the source of data in clinical trials. Topics include the consensus across the pharmaceutical industry regarding the maintenance of clinical data by writing results on papers; the guidelines of the U.S. Food and Drug Administration regarding use of electronic data in clinical trials; and guidelines of European Medicines Agency regarding electronic data.

The article reports on the emergence of a paper from the European Medicines Agency to address the challenges arising in clinical research in 2012. The paper intents to strengthen procedures to offer assurance to regulators that clinical trials meet the needed ethical standards. The paper puts forward plans for international cooperation in clinical trials' regulation and clarifies how the regulators of the European Union (EU) can assure that ethical standards are used in clinical trials.

The article offers information on the Reflection Paper on Risk-Based Quality Management in Clinical Trials by the European Medicines Agency (EMA) which demonstrates the need for systematic, prioritized, risk-based approach to quality management in clinical trials program. Topics discussed include need of developing central monitoring systems using statistical methodology to monitor clinical trials, analyzing individual patient data, and efficiency of contract research organization (CRO).

The article discusses the activities of European Union related to integrating biomarkers and personalized medicine techniques into studies. Topics include an annual gathering in October 2015 on how patients will be impacted by adaptive pathways and breakthrough designations, the European Medicines Agency's (EMA) pilot project on adaptive drug pathways, and a paper of their own on personalized medicine.

In this article, the author discusses aspects of conducting clinical trials beyond the European Union (EU). He cites the efforts of the European Medicines Agency (EMA) to address ethical and Good Clinical Practice (GCP) issues of clinical trials conducted in developing countries. He stresses the significance of routine inspections and regulations that can help maintain GCP standards in global clinical trials.

The article discusses the developments in risk-based monitoring, with particular consideration on the evolution of the role of clinical research associate (CRA) in clinical trials. Topics include CRAs and the application of informatics technology in lign with U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) and significant role of CRAS including increased use of specialist skills, focus on high-value compliance inspections, and quality by design.

The article reports on the future of pharmacovigilance in the field of applied clinical research in Europe. Topics discussed include risk management, signal detection, and periodic reporting. Also being discussed are the topics like the good pharmacovigilance practices (GPVs) of the European Medicines Agency (EMA).

The article offers information on European Medicines Agency updated its plan for existing guideline on first-in-human clinical trials. Topics discussed include use of integration of pharmacokinetic and pharmacodynamic data, aim of the guideline to increase first-in-human clinical trials, and need to introduce principle for starting dose in humans and dose escalation.

The article focuses on the issues regarding writing and constructing layperson summaries of clinical trial results in European Union (EU). Topics discussed include European Parliament released the Regulation 536/2014 on clinical trials on medicinal products for human use, European Medicines Agency (EMA) implemented a public European database in which to collect and retrieve all relevant information on clinical trials submitted to the agency and target audience for a layperson summary.

This 2018 survey findings showed that approximately two thirds of sponsor respondents and three quarters of CROs have adopted some type of RBM. Small pharma/biotech and small CROs were the main organizations that have not adopted RBM in the five years since the 2013 FDA and European Medicines Agency (EMA) releases of recommendations for adopting a risk-based approach to monitoring, m A wide variety of implementation approaches have been adopted, with varying ability to detect "errors that matter." A significant, unmet medical need exists to test and publish data to determine the effectiveness of the different RBM implementation approaches. This would help the industry make informed decisions about how to best protect study participants' safety and obtain scientifically valid data to support the delivery of new medicines for patients. [ABSTRACT FROM AUTHOR]

The article focuses on issues concerning the publication of the European Union's (EU) regulation and directive for the conduct of pharmacovigilance within the member states. It notes that sponsors or marketing authorization holders (MAH) raised concerns over how to implement a legislation with no clear guidance from the European Medicines Agency (EMA). The impact of adverse drug reactions (ADRs) on the EU is presented.

The article reports on the new agreement between Canada and the European Union which will allow their respective regulatory experts to share confidential information, such as safety and authorization issues regarding medicines on the market or in development. According to the report, the European Commission (EC) and the European Medicines Agency (EMEA) struck the deal with the Health Products and Food Branch of Health Canada at their bilateral meeting on December 7, 2007 in Brussels, Belgium.

The article offers information on the worldwide pediatric research about the health of the children. Different organizations all over the world collaborate such as the World Health Organization (WHO), U.S. Food and Drug Administration (FDA), and European Medicine Agency (EMA) to exchange information in pediatric development. The author notes that pediatric improvement will be attained through the risk assessment, contingency planning, and careful placement of the studies among varied nations.

The article discusses the clinical development plan on stem-cell medicines by the European Medicines Agency in Europe. The author explores the new draft guidance releases by the agency to have communication on the current status of discussions and comments for the stem-based medicinal product development. Moreover, he also states the exceptions to the general rules in pharmacovigilance, pharmacological, and immunological.

The article focuses on the implementation of a regulation on medicinal products for pediatric use by the European Union. According to the European Federation of Pharmaceutical Industries and Associations, more medicines will soon be available across Europe, which will change the region's research and development environment. The 2007 agenda of the European Medicines Agency (EMEA) is discussed. Key information on the agency tasks for EMEA are presented.

The article looks at the proposed revisions by the European Medicines Agency (EMA) to guidance on first-in-human clinical trials. Topics covered include the EMA being prompted to revisit the guidance following the death or hospitalization of volunteer subjects during a trial performed by French research organization Biotrial for drugmaker Bial, the suggestion by the EMA to explore a dozen of areas when dealing with protocols, and the need to expand the non-clinical aspects of the guideline.

The article reports on the launch of a survey by the European Medicines Agency (EMA) to understand the awareness of patients and healthcare professionals about the adverse drug reactions in Europe in 2017.

The article discusses the claim of the European Union (EU) about the success for the pharmacovigilance rules that came into effect in July 2012. The author talks about a report from the European Medicines Agency (EMA) which suggests that the legislation offers better promotion and protection of public health. Also tackled is the potential for new clinical trials rule.

The article focuses on a draft policy issued by European Medicines Agency (EMA) related to the publication and access to clinical trial data for maintaining transparency. It mentions that under this policy the clinical trial data will be released automatically unless there will be an irresistible case for withholding. It informs that European Union has adopted the plans for Horizon 2020 that is the multi-billion research project for seven years that is expected to begin from 2014.

The article offers information about the activities of the European Medicine Agency (EMA) in the year 2012. It states that EMA's executive director Guido Rasi has appointed liaison officer at the U.S. Food and Drug Association (FDA) for promoting EMA-FDA interaction on issues related to medicines, clinical trials and drug development. It highlights that EMA has received 42 good clinical practice (GCP) requests for clinical and non clinical compliance.

The article reports on the effort of the European Medicines Agency (EMEA) in boosting its professionalism in 2008 in Europe. The effort would ensure the availability of top-quality scientific expertise, strengthening the development of regulatory competence across the 27 member states, and extending peer review systems in the Agency's network. In addition, the effort is considered a constructive reaction to innovation in terms of medical development and related European Union (EU) legislation.