Clinical Research


DRAFT PROGRAM

08:00 – 09:30 Hrs

Registrations

09:30 – 10:30 Hrs

BioAsia 2015 Keynote Addresses

10:30 – 11:45 Hrs

Panel Discussion: Indian Regulatory Landscape

Panelists:
  • Mr. Solomon Yimam, Assistant Country Director, U.S. FDA India Office, India
  • Dr. Khalid Khan, Managing Director, Fermish Clinical Technologies Pvt. Ltd., India
  • Ms. Maggie Massam, Head of Business Development, Clinical Practices Resource Datalink (CPRD), MHRA, UK
  • Ms. Divya Chadha Manek, NIHR Clinical Research Network, UK

Details..

11:45 - 12:15 Hrs

Networking Break & Visit to the Exhibition

12:15 – 13:30 Hrs

Session: Indian Biosimilar Guidelines and the Global Alignment

Session would focus on the following:
  • Presentation on the need to have a view on the approach to the Biosimilars
  • Comparison and contrast between Indian Biosimilar guidelines and the global alignment
  • Roundtable discussion:
    • Is India prepared to participate in this area
    • Can India be considered as a preferred destination for the conduct of Biosimilar Clinical Trials?
Chairperson:

Dr. Maurice R. Cross, Group Medical Director, Veeda Clinical Research


Speaker:

Dr. Anand Eswaraiah, Head Clinical Development and Regulatory Affairs, Clinigene International Ltd., India

Details..

13:30 – 14:30 Hrs

Networking Lunch & Visit to the Exhibition

14:30 – 16:00 Hrs

Session: Bioequivalence Studies in India

Session would focus on the following:
  • Challenges and solutions for BA-BE studies in India
  • Volunteer safety and Compensation
  • Sharing of Volunteer database between CROs
  • Clinical End Point studies with placebo use
  • Import and export of biological samples
Chairperson:

Mr. Apurva Shah, Founder and Group Managing Director, Veeda Clinical Research Pvt. Ltd., India


Speakers:
  • Dr. Charu Gautam, Director, Global Clinical Operations, Cliantha Research Ltd., India
  • Dr. Mukesh Agarwal, Vice President, Clinical Research Division, Vimta Labs Ltd., India

Details..

16:00 - 17:00 Hrs

Session: Challenges and Solutions for Conducting Clinical Trial in India

Session would focus on the following:
  • Challenges and solutions for conducting clinical trials in India
  • Restriction of 3 studies per investigator
  • Certifications of Investigators / institutions
  • Video recording of the informed consent process
  • SAE reporting and recording at the CT sites
  • Protocol development and site management to comply with Indian regulators
Chairperson:

Dr. Kiran Marthak, Director, Lambda Therapeutic Research Limited, India


Speakers:
  • Dr. Jeroze Dalal, General Manager, Clinical Operations, GlaxoSmithKline Pharmaceuticals, India
  • Dr. Shariq Anwar, Head Operations, Max Neeman Medical International Limited, India

Details..

17:00 - 18:00 Hrs

Closing Reception
 

Global Leaders @BioAsia 2015

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For More Info Contact -

Ms. Paridhi Gupta
paridhi@bioasia.in

+91 - 40 - 6644 6477 / 6577

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