Clinical Research


08:00 – 09:30 Hrs


09:30 – 10:30 Hrs

BioAsia 2015 Keynote Addresses

10:30 – 11:45 Hrs

Panel Discussion: Indian Regulatory Landscape

  • 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


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?

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


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


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

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

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


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

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

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


17:00 - 18:00 Hrs

Closing Reception

Global Leaders @BioAsia 2015


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