Clinical trials in emerging markets

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

S.V.Krishna Prasad

Keynote Forum: Pharmaceut Reg Affairs

Abstract :

As the world is becoming a larger platform for Clinical Trial arena, emerging markets are the focus areas. Oncology Clinical Trials are one of the very fast growing trial segments in Emerging Markets. Common misconceptions about Emerging Market segments such as Russia, Africa have made Asia the preferred location for economical and expedited trial completions. EM trials help development teams meet recruitment target relatively easier than other segments. Look at the potential that a continent such as Africa holds for various trials especially anti retroviral. Running trials in EM requires a strong nodal control/centralized communications. Understanding the Cultural challenges, Ethos and Law of the land are crucial for choosing a CRO partner in the planned segment. As is well known, in some countries, locally registered drugs require trial conduction on local population only is a factor which needs to be kept in mind e.g. Japan, Mexico, Russia. Last, but never the least, it is of primordial importance that due diligence is conducted on CROs in the emerging markets before making them the partners for trials. Local expertise is crucial to the trial. According to several interviewed clinical executives, such expertise or lack of it can either make or break it, so making sure that the highest quality and compliant CROs and vendors need to be pressed into service of conducting a trial; While Quality Assurance would set out the agenda and the policies, it is the Regulatory Affairs division that needs to update the operations and hence the top most importance to the Regulatory Affairs function in this spectrum.

Biography :

Mr. Krishna Prasad, CEO & Director, Cito Healthcare P Ltd has been associated in various positions with SOL Pharmaceuticals Ltd, Nicholas Piramal India Ltd (Now Piramal Healthcare), Aurobindo Pharma Ltd, QPS Bioserve India Pvt Ltd, RAChem Pharma Ltd (CRBio), ClinSync Clinical Research P Ltd, Development & Advisory Board member, Larasan Pharmaceutical Corporation, Florida, Orem Access Bio for medical/diagnostic kits in the fields of Commerical Management, Materials Management,Project Management, Human Resources, Administration, Business Development & Marketing, Non Medical Scientist on Suraksha Independent Ethics Committee, invited speaker at APITCO, SIPS,VIPER,Chitkara University, Member-Ex-SOL, Usha Alumni. ALCAA