Workshop on Regulatory strategy for European market access
Experts from Europe to shed light on the implications of recent developments and chart the most optimal way in terms of
speed and cost
Mumbai/London, November 9, 2009
- 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 pharmaceutical 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.
- 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.
- Focused strategies for New Chemical entities, Biotech/Biologics, Generics/Bio Similars and Herbals.
Speaking about the need for the workshop, Karen James, the lead faculty and the MD of CambReg regulatory said that
'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 19th November 2009 at Mumbai and 20th
November 2009 in Hyderabad. Attendees will also have the opportunity to discuss their individual company
challenges on a one to one basis with the experts.
To ensure a true Workshop environment, seats would be limited and registrations allotted on a first come first
serve basis. Further details can be obtained from regulatory.html
or by emailing