Clin Infotech

Teacher Name

35 Days

Advance Certification In

Regulatory Affairs

Regulatory affairs professionals are the primary communication link between the company and global regulatory agencies such as USFDA (United States Food and Drug Administration) and European Union of Drug Regulatory Affairs (EUDRA). The pharmaceutical, biotechnology and medical device research and development industries are among the most highly regulated industries globally. As pharmaceutical sector is growing rapidly, there is a need of regulatory affairs professionals to cater the current needs of industries for the global competition. Regulatory affairs professionals are the link between pharmaceutical industries and worldwide regulatory agencies. Pharmaceutical Industry, being one of the highly regulated industries, is in immense need of people than ever before who are capable of handling issues related to regulatory affairs in a comprehensive manner.


The focus of the lectures will be mainly on the following topics:


  • Introduction to Regulatory Affairs
  • Pre-clinical & Clinical Studies
  • USFDARegulations,
  • Pharma Regulations Practices and Procedure
  • DMFand ANDA Submissions
  • Global Pharmaceutical Industry Scenario
  • Indian Pharmaceutical Industry
  • Global Regulatory Environment
  • Regulations Governing Clinical Trials and New Drugs
  • Schedule Y
  • Regulatory Inspections in Clinical Research (FDA, EMEA, UK and Indian)
  • Future of Regulatory Compliance
  • Orphan Drugs
  • ICHGuidelines
  • Import and Export of Drugs
  • Good Manufacturing Practice
  • Quality Assurance and Regulations
  • Global Drug Policies
  • Regulation in Pharmaceutical Devices
  • Test
  • TRIPPs and Pharma Industry
  • Intellectual Property Right Management
  • Patents


Practical Training with live project will be provided in 


  • Compliant eCTD submissions
  • eCTD Submissions for ANDA, 505(b)(2), DMF and ASMF
  • Placement Assistance 

Why Clininfotech:

Our training programs are completely different from the traditional clinical research training institutes as our basic approach is focused on imparting rigorous practical training on databases/ software tools which are widely used in Pharmacovigilance and Clinical Data Management activities. Training would be imparted by professional from the industry who possesses rich experience in their respective domains. Our competitive edge along with new training techniques puts us at the forefront of Pharmacovigilance and Clinical Data Management training services.


Any study without a good job is equivalent to no study at all. Thus post successful completion of the training our placement team would provide 100% placement support to all students. We have already placed 90% of our previous students in Pharmaceuticals, CROs & IT Organizations globally.

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