GCP Training Workshop

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Workshop on Good Clinical Practice (GCP) and Clinical Research Methodology

All you need to know about GCP and Clinical Research

This training program is aimed at providing foundation to clinical research and Good Clinical Practice guidelines along with soft skills development in a workshop setting.

Clinical research companies 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

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

Catalyst Clinical Services Pvt. Ltd.
UG-11, Aggarwal Prestige Mall, Plot No. 02, Road No. 44, Pitampura, New Delhi – 110034
Ph: +91-9818356273, +91-8826806862; Email: info@catalystclinicalservices.com

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