Drug Risk/Benefit Analysis; Sentrx Comments New E.U. Regulations

Online, July 31, 2012 (Newswire.com) - In order to continuously assess the safety of medicinal products for human use in a global environment, the European Union often issues amendments in regards to pharmacovigilance regulations.

In July 2012, the E.U. released such updates in the Official Journal of the European Union, which lays out a number of community procedures for the authorization and supervision of medicinal products for human use. One of the most significant July 2012 updates pertains to the Pharmacovigilance Risk Assessment Committee.

The job of this department is to "detect, assess, understand and prevent adverse reactions, and to identify and take actions to reduce the risks of and increase the benefits from, medicinal products for human use." 1) To do so, the Pharmacovigilance Risk Assessment Committee "may at any time ask the marketing authorization holder to forward data demonstrating the risk-benefit balance remains favorable." 2) This means that in addition to submitting the Periodic Safety Update Reports (PSURS), which contain cumulative data about the drug's safety throughout its lifecycle, drug safety departments will also need to produce organized risk-benefit evaluations.

How Will New E.U. Regulations Affect Pharmacovigilance?

At the 2012 Annual DIA Conference, EVP of Pharmacovigilance Client Services and the head of the Sentrx Adverse Management Unit, Doreen Lechner, PhD., was interviewed by PharmaVoice Magazine about the newest regulatory changes for their "Editor's Take Video Program Series". According to Lechner, "Facing new E.U. regulatory changes is always one of the key challenges for any Pharmacovigilance organization in the global regulatory environment. The newest regulations focus on the risks vs. benefits concern, which essentially means that instead of submitting individual case reports and just saying 'okay that report has already reached the agency', the agency has changed its prospective on the aggregate reports. Instead of looking at individual cases they're asking the sponsors of those products to assess what all of the possible risks and benefits of utilizing the product are."

How Sentrx Is Preparing For the Challenge

In order to ensure that Sentrx is prepared to support any forthcoming E.U. Regulations, Sentrx has built a regulatory support team that will continually review impending regulations and complete gap analyses across internal procedures and the services likely to be provided. In addition, Sentrx is expanding on its existing quality management system, to make certain that key resources are trained on new regulations and that all processes and procedures throughout the pharmacovigilance spectrum of a drug are well documented. For this new risk/benefit centered regulation, Sentrx will also ensure that training modules and technology support systems are in place to coincide with new requirements and that any additional reports are submitted in a timely manner. Lechner is an industry veteran with exceptional command of drug safety and all of its related issues including expertise in quality standards, pre-qualification audits, client audits, and regulatory audits. She is aware of the importance of audit readiness and will make certain that Sentrx is ready should any audits result from the new regulations.

With drug safety services outsourced to Sentrx a client can expect efficiency, consistency, flexibility, seamless integration of new regulatory processes and, above all, quality management for data integrity. All of these elements are important in launching and maintaining a drug's presence in the market.

For additional information on Sentrx - or the full range of available pharmacovigilance services - visit http://www.sentrx.com/.

Media Inquires:
Amanda M. Ignaut
Marketing Coordinator
Sentrx
E-mail: amanda.ignaut@sentrx dot com

1 (2010). Regulation (eu) no 1235/2010 of the european parliament and of the council. Official Journal of the European Union, (348), 4. Retrieved from http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0001:0016:EN:PDF
2 (2010). Regulation (eu) no 1235/2010 of the european parliament and of the council. Official Journal of the European Union, (348), 6. Retrieved from http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0001:0016:EN:PDF