The continued growth of clinical research in India can be attributed to a number of factors. The regulatory environment has improved in recent years, as has the infrastructure and the level of experience. These, when combined with the never-ending quest to reduce drug development costs and timelines, have fueled an increase in the number of clinical trials in India. With that expansion has come a growing diversity in both the size and types of trials sponsors are seeking to conduct in the Indian market. In response to this diversification, the regulatory requirements continue to evolve, both in an official context and also through the views and opinions of the agency and how they are evaluating the submissions.

Though the market for clinical trials in India has improved dramatically, a number of complexities still exist and like most markets today, specifics in the regulatory guidelines, combined with regional and cultural intricacies make having an strong grasp on these elements critical. This audio conference presentation is designed to provide attendees with specific details regarding the regulatory guidelines that exist today in India, and where these regulations might be headed in the future.

This audio conference covers:

• The structure, make-up, views and expectations of India's regulatory bodies
• Types of studies allowed in India
• Recent changes in the regulations and potential impact
• How to submit a study for regulatory review and approval (forms needed, approach taken, etc)
• Common mistakes and how to avoid lengthy delays
• Drug import and export licensing intricacies
• Case studies, including success stories and potential pitfalls

About the speakers:

Dr. Vijai Kumar, President and CMO of Excel Life Sciences (ELS) is responsible for starting the concept of site management organizations in Asia. He joined ELS from Neeman Medical International, Inc where he served as the first President and CEO. Prior to that, he worked as Medical Director at Sandoz and Regional Director, Asia for The Upjohn Company, where he was responsible for contributing to more than 20 NDA submissions.

He has experience as a clinician, investigator, pharmaceutical physician, consultant and service provider. He has over 35 years experience in global drug development, strategic relationship building, business development and various other aspects of clinical research and the pharmaceutical industry. Dr. Kumar has served as a member of the expert committee constituted by the Drugs Controller General (India) to develop GCP Guidelines in India and as a member of the Board of Governors for the Institute of Clinical Research, India. He holds an M.D. in Internal Medicine and an M.B.B.S. from Armed Forces Medical College, Pune.

Dr. Kumar was recently recognized as a most inspiring leader in the drug development and life sciences industry. His long time passion, dedication and contributions to clinical research were highlighted in a special profile within the PharmaVoice Magazine special issue - "100 of the Most Inspiring People".

Dan McDonald, Vice President of Business Development, Excel Life Sciences has over 12 years of industry experience working with biopharmaceutical companies assisting them with their patient recruitment, site selection and global clinical research strategies. Prior to joining ELS he served as Sr. Vice President of Strategic Development for D. Anderson & Company, a leading provider of global patient recruitment and retention services.

The majority of Dan’s career in the industry was spent at CenterWatch, where he worked for nearly 9 years, most recently as the General Manager. He also had organizational responsibility for NEIRB, an independent institutional review board. Dan has conducted over 50 presentations at industry conferences and meetings, and has conducted workshops and sessions on patient recruitment. He has been published numerous times in industry trade magazines and journals, he has been interviewed by NPR and has authored chapters in several books on patient recruitment and clinical trial registration.

Who should attend?

• VP Regulatory Affairs
• Directors of Regulatory Affairs
• Managers of Regulatory Affairs
• VP Clinical Operations
• Directors of Clinical Operations
• Managers of Clinical Operations