Program Highlights

• A one-day workshop-based training program aimed at imparting skills on clinical research, drug development process and Good Clinical Practice guidelines
• Live Lectures on important topics such as:
  • New Drug Discovery Process and Clinical Research
    Drug discovery process, pre-clinical development, clinical research, clinical trial phases, stakeholders, critical success factors etc.
  • Foundation to Good Clinical Practices (GCP) Guidelines
    Principles of GCP, applicable GCP guidelines, evolution of GCP guidelines and responsibilities of various stakeholders (Sponsor, CRO, Investigator and Ethics Committee) etc.
  • Essential Clinical Trial Documents
    Protocol, Informed Consent Document (ICD), Investigator’s Brochure (IB), Case Record Form (CRF), Source Data/Document (SD) etc.
  • Overview of Informed Consent Process
    Purpose, process requirements, essential elements, format, procedure etc.
  • Serious Adverse Event (SAE) Reporting and Compensation
    Adverse event, valid case, regulatory definition of serious criteria, reporting timeframe and recommendations for determining compensation for study related injuries
  • Regulatory Landscape
    Types of applications, data requirements, New Drugs and Clinical Trials Rules (2019), National Ethical Guidelines for Biomedical and Health Research Involving Human Participant (2017) etc.
• Certificate of Participation awarded to the participants on successful completion

Target Audience

• Clinical Research and allied professionals employed in pharmaceutical companies, CROs, site management organizations, research/academic institutions.
• Students/individuals aspiring to pursue their career In clinical research
• Research scholars, lecturers, investigators and ethics committee members

For more information mail at info@catalystclinicalservices.com or contact Program Coordinator at +91 9818356273