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International Clinical Trials

Harmonising Safety Reporting
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International Clinical Trials Spring 2011:56-63. *

Pharmaceutical safety is a continuum that begins with preclinical animal testing, continues throughout human clinical trials and up to market approval. However, rather than ending with its emergence on the market, performing ongoing surveillance and assessment of new safety information is critical to mitigating and managing a pharmaceutical's (drug or biologic) potential for adverse effects in patients, and overall public health. Thus, planning for how pharmacovigilance is to be performed upon approval, as well as constant reevaluation of a product’s benefit/risk profile throughout its life cycle, are of great necessity.

This article will examine current perspectives in two of the main ICH regions (US and EU) and approaches to pharmacovigilance planning and risk management throughout the medical product life cycle. US FDA and European Medicines Agency (EMA) regulatory requirements and standards, in combination with ICH guidelines, will be discussed along with examples of risk assessment and minimization methods, and the challenges industry faces in performing high-quality risk management in a global environment.

* With Permission from International Clinical Trials

Food and Drug Law Journal

U. S. Postmarketing Pharmacovigilance Compliance
in the Midst of Regulatory Uncertainty
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Food and Drug Law Journal 2007; 62:3: 513–528. *

In the U.S., ongoing analysis of the national program for drug safety led to changes intended to enhance FDA’s ability to protect public health via increased funding for new personnel, upgraded methods and available data, organizational and structural changes, and new regulatory authority provided by Congress under FDAAA.

However, the numerous investigations of FDA’s postmarketing drug safety program, scientific literature and associated media coverage were hardly comprehensive in scope or depth. In particular, the critical role of FDA’s inspectional programs for pharmaceutical adverse event reporting compliance, and the significant impact of delays in finalization and release of needed rules, regulations and guidances related to drug safety, received little if any emphasis or consideration.

This paper reviews the status of significant safety-related FDA documents, concomitant repercussions that have already been felt due to the regulatory lag, and postmarketing pharmacovigilance inspections in the U.S. and E.U.

* With Permission from the Food and Drug Law Institute

Drug Information Journal

Auditing Safety Related Processes and Procedures:
Lessons Learned for Global Compliance and Quality
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Drug Information Journal 2006; 40: 165–175.

Given the major public health importance of medical product safety, it has never been more critical for companies to ensure that their processes and procedures for performing pre--marketing clinical safety and post-marketing vigilance are in compliance with regulatory requirements and foster the ongoing accumulation of high-quality data. The evolving global environment for medical product safety necessitates that companies look beyond strictly local (ie national) regulatory requirements to meet the demands of the new international paradigm. Utilizing a proactive approach that entails ongoing auditing of safety-related processes and procedures for effectiveness and compliance with appropriate remediation, medical product safety departments can be better prepared for regulatory agency inspections while maximizing their contribution to company vigilance/ risk management efforts.
Examining results of safety-related audits executed internationally provides insight into deficiencies that are common across companies and medical product categories, while offering lessons learned of global applicability.

Drug Information Journal 

Adverse Event Reporting
and Standardized Medical Terminologies:
Strengths and Limitations
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Drug Information Journal 2002; 36: 439–444.

The International Conference on Harmonization (ICH) is a unique multinational effort involving globalization of the pharmaceutical industry. In response to a need perceived by both industry and regulatory authorities for a common medical terminology designed for regulatory purposes, the Medical Dictionary for Regulatory Activities (MedDRA) was developed under ICH auspices. As a dynamic terminology, MedDRA has undergone review and refinements by its associated Expert Working Group to facilitate analysis and presentation of data. The MedDRA Maintenance and Support Services Organization is responsible for maintaining and updating the terminology, utilizing user experience and feedback. While not the first coding terminology designed for adverse reaction reporting, Med-DRA reportedly offers advantages over previous terminologies. Further, a common terminology provides for greater ease of analysis and data transmission both within and between countries. However, no medical terminology is without limitations, particularly with respect to coding issues and specific clinical entities. These limitations must be recognized and considered in the performance of pharmacovigilance and pharmacoepidemiology, if the terminology’s utility as a safety tool is to be maximized.



The Clinical Impact of Adverse Event Reporting
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 The Food and Drug Administration (FDA)'s monitoring of the continued safety of marketed medical products depends greatly upon reporting of adverse events by health professionals. An understanding of how FDA uses this information, and of the limitations/strengths of the national postmarketing surveillance system, underscores the importance of this professional responsibility to the public health.
A MEDWATCH Continuing Education Article



Clinical Therapeutics
and the Recognition of Drug-Induced Disease
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 Physicians and other health professionals should be aware of the extent and spectrum of drug-induced disease. Monitoring for and reporting adverse events can save lives and spare others from illness.
A MEDWATCH Continuing Education Article