PharmaLeaf, India and Cambreg, UK will organize a one-day international regulatory conference to provide the industry a first hand information on how to handle the regulatory processes in the West. The event titled ‘Your Passport to the World', will be organized on Friday, October 22, 2010 in Bangalore.
The event will be addressed by Dr Mike James, ex UK Regulator (MHRA) and technical director at CambReg and Shenaz Khaleeli, Founder & Technical, Director, PharmaLeaf . The event would highlight ways to overcome barriers in international regulated market for generics.
According to the organizers, “the global pharmaceutical market is expected to touch over US$ 1 trillion by 2014 with Northern America and Western Europe still leading in terms of sales. A rapid evolution would only speed up between 2010 and 2012, when many drug manufacturers lose patent protection on their largest or second-largest products. To survive, companies have started to adapt and change their strategies. On one hand, for Western Drug companies this means increasing the focus on emerging markets to sale off-patent medicines in high volumes under a multinational brand name. On another hand, drug manufacturers in emerging markets have now the opportunity to accessing the Western Market.”
In order to assist companies in the emerging markets especially India, the workshop is aimed at companies producing/selling medicines that are already successful in Asia and are now ready to reap the benefits of exporting to the west. Entry to the West is only possible for GMP compliant or inspection ready companies. However anyone interested to learn more about registering medicines in the EU and USA would find this workshop beneficial. The discussions are aimed at Business Development and Regulatory Affairs Managers apart from others in the pharma industry, according to the organizers. Therefore the workshop can be attended by chief scientific officers of GMP or GMP-inspection ready companies, Regulatory Affairs Professionals seeking to get an update on the Regulatory Environment, among others who intend to augment their knowledge on the Generics Drugs Market in Western Countries, added the organizers.
Dr James will focus on the topic “What to expect during the Regulatory processes in the West?” which will cover the application lifecycle: from pre application to grant of authorization and will include relevant case studies and timeframes.