’Global Regulatory Affairs Resources In A Small World’
Yes, the world is getting smaller and smaller. Pharmacovigilance, Genetically Modified Organisms, Consumer Alertness, HIV/AIDS, the Tsunami Disaster, Bioterrorism and Counterfeit Drugs are among a few of the topics demanding humankind to seek knowledge outside of his/her immediate borders.
There is an increasing need of Pharmaceutical Companies not only for International Marketing Rights but for conducting International Clinical Trials. In order for companies to have a fair share of the global market, it is critically important for them to be conversant with the Regulatory Affairs Climates of these countries.
International Regulatory Affairs Updates (IRAUP.COM) was founded in March 2004 by Solomon Sackitey to provide a free Virtual Regulatory Affairs Comprehensive Library for Regulatory Affairs Professionals, Regulatory Agencies and Consumers alike. This website also aims at sharing more knowledge about various aspects of the regulatory framework pertaining to Clinical Research Governance, Human Drugs, Animal Drugs, Biologics, Medical Devices, Combination Products, Traditional or Herbal Medicines and Biosafety issues, among other things. In partnership with Michael Moxley of The Storm Group, Solomon Sackitey has designed and continues to maintain the International Regulatory Affairs Updates (IRAUP.COM) website.
For a small company that needs to conduct either a foreign or multinational clinical trial or to register its products in the US or in a foreign country but cannot afford a Regulatory Affairs Department, IRAUP.COM is expected to serve as a useful resource. At the same time, the large company that needs to register a product or conduct international clinical trials but is not sure about the current regulatory requirements and cultural demands of that country, International Regulatory Affairs Updates is expected to be a valuable real-time Electronic Library.
Developing countries are rapidly growing into ’Emerging Markets’ for Veterinary and Human Medicinal Products and countries in the Industrialized World and the Developing World all have a lot to learn from one another. International Regulatory Affairs Updates hopes to bring both Worlds to the same learning experience.