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The impact of regulatory changes on drug safety reporting in clinical trials


For webinar on demand, write to us at bd@siroclinpharm.com
Clinical research worldwide is a multi-billion dollar industry. India is an emerging destination for clinical research, but it is susceptible to the vagaries of regulatory winds.

Recent regulatory changes have greatly altered the methodology of drug safety reporting in clinical trials. To clear the air and bring some clarity to the stakeholders, we are organizing a webinar - The impact of regulatory changes on drug safety reporting in clinical trials.

Key Learnings from the Session

  • Understand the changes in safety reporting regulations vis-à-vis earlier regulations
  • Positives and negatives of these changes
  • Responsibilities of various stake holders
  • Differences as compared to other regulated markets

Who Should Attend?

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

Speaker Profile


Nandita Dingankar (MD)

Head - Medical Services

Medical doctor by training and an MD in Pharmacology from Mumbai University, Nandita has about 13 years of cumulative Pharma and CRO experience.

She is responsible for the creation of feasibility services department at SIRO Clinpharm. Nandita oversees medical monitoring and drug safety for global clinical trials, involving safety reporting in various geographies.