SIRO Clinpharm, a global Clinical Research Organization (CRO) with its base in India, US, Europe and Israel, in association with leading regulatory experts from Europe, today announced a workshop on regulatory strategy for European market access. The workshop is aimed at addressing the needs of Indian pharma and biotech companies including those in the herbal business.

Many Indian companies find the lucrative European market as difficult to access due to varying regulatory and economic barriers to entry, including a requirement to register new generic drugs in each EU country. The workshop will have experts in European regulatory affairs discuss many key topics that are relevant to Indian companies. These include: The marketing application and clinical trial application process; How to reduce time to market significantly? How to enhance profits by having a longer unopposed sales period? How to avoid wasting money on unnecessary development work and trials? The most cost effective way to conduct clinical trials for regulatory submissions in Europe; and Focussed strategies for new chemical entities, biotech/biologics, generics/biosimilars and herbals.

Speaking about the need for the workshop, Karen James, the lead faculty and MD of CambReg regulatory, said: “The European market is constantly evolving and a number of recent regulatory changes and those proposed can have a significant impact on business”. Stressing the need for a focused regulatory strategy early on, she commented, “At whatever stage of development or product lifecycle a company is in, the right regulatory strategy is crucial for success and to costs and timelines.”

The workshop is relevant for personnel in regulatory services and international business development divisions of companies wishing to register human medicines of any kind including new small molecule or biotech entities, biologics and herbals as well as generics. The workshop would be held on November19, 2009 at Mumbai and November 20, 2009 at Hyderabad. Attendees will also have the opportunity to discuss their individual company challenges on a one to one basis with the experts.