Global vaccines regulation: Safety and quality

5^th International Conference and Exhibition on Pharmaceutical Regulatory Affairs

August 03-05, 2015 Orlando, USA

Anthia Zammit

Anthia Zammit Legal, Malta

Posters-Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

The World Health Organization views vaccines as an important solution to averting public health crisis. Under EU legislation, vaccines are defined as â�?�?medicinal productsâ�?, and are as such subject to regulatory requirements. As pharmaceutical products, vaccines carry benefits as well as risks. In response to complications and diseases that occur following vaccination, various countries have implemented vaccine-injury compensation programs. In the US, the Vaccines Act of 1986, and the Supreme Court judgment Russell Bruesewitz et al v. Wyeth et al. (decided February 22, 2011), substantially reduced the pharmaceutical manufacturerâ�?�?s civil liability, even for mandated drugs. What steps are being taken by the pharmaceutical industry to ensure a higher level of vaccines safety? The best age of tolerance to an antigen; the number of vaccines that have the best clinical outcomes; the spacing out of vaccines; the right dosage; and the lowering of mercury and aluminum levels would be revised and updated via legislation and policy. There should be a way for the regulators to step in and with their teams, define the nature of the vaccines, their quality free of potential toxic reagents, and how and when the vaccines should be delivered. This would however come at a substantial cost to stakeholders, particularly the pharmaceutical industry.

Biography :

Email: az@anthiazammit.com