Defogging the Regulatory Scenario for Biological Products in India

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In the past decade biopharmaceutical companies have focused on developing new biological products to treat medical conditions with high unmet needs. The commercial success of these drugs has also attracted several companies to make generic equivalents or 'biosimilars' of the aforementioned biological drugs.

Emerging markets like India have been using biological products and biosimilars for some time now. Additionally, several clinical trials for biologicals and biosimilars have been conducted here. However, there is widespread ambiguity about the regulations governing biologicals and biosimilars in India. In such a situation, acquiring unbiased and real time information becomes invaluable. As the industry's foremost experts we have developed this webinar to clear the air regarding this burning issue.

In this webinar, our expert discusses the current regulatory process for biological products, the timelines involved and its impact on the clinical research programs of global biopharmaceutical companies.

Key Learnings from the Session

  • Get an overview of regulatory functioning in India pertaining to biotechnology and biosimilar products
  • Regulatory bodies involved in reviewing and approving clinical trials for biotechnology products in India
  • Understand clinical trial administration and different categories of applications
  • Guidelines on biosimilars for Marketing Authorization in India

Who Should Attend?

  • Clinical Research Professionals
  • Regulatory professionals in clinical research
  • Outsourcing & procurement executives
  • Senior management of SMEs

Speaker Profile

Mr. Ganesh Rotte

Clinical Team Leader

Ganesh is involved in conducting clinical trials and monitoring within SIRO Clinpharm's clinical operations group. He has over 8 years of experience in clinical research and over 4 years in academics. He has been involved in conducting clinical trials for various therapeutic areas such as Oncology, Respiratory, Neurology, Cardiology, Nephrology, Diabetology and Infectious Disease of which 4 clinical trials were for biotechnology products. He is a graduate in Biotechnology, Microbiology, Chemistry and a post graduate in Clinical Research.