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44 - MDC - Medical Sciences and Clinical Research

MDC 135 - Ethical and Regulatory Considerations in Clinical Research

Code Start Date Duration Venue
MDC 135 15 July 2024 5 Days Istanbul Registration Form Link
MDC 135 12 August 2024 5 Days Istanbul Registration Form Link
MDC 135 09 September 2024 5 Days Istanbul Registration Form Link
MDC 135 07 October 2024 5 Days Istanbul Registration Form Link
MDC 135 04 November 2024 5 Days Istanbul Registration Form Link
MDC 135 02 December 2024 5 Days Istanbul Registration Form Link
Please contact us for fees


Course Description

Clinical trials must be conducted with a high degree of regulation and legislation. This course is designed to familiarize candidates with the legal and ethical principles that form the basis for the modern organization. The course will cover comparative legislation by examining the current legal systems of different countries. The fundamental dimension of ethics will also be covered describing contextual significance of ethical issues in relation to clinical research.

Course Objectives

  • Learning the fundamentals of the Investigational New Drug (IND) and New Drug Application (NDA) Processes
  • Carrying out NDA preparation
  • Understanding prescription drug labeling
  • Understanding post-marketing requirements

Who Should Attend?

  • Regulatory affairs professionals
  • Clinical research and development professionals
  • Researchers
  • Quality and manufacturing professionals
  • Medical writers
  • Clinical Business Development professionals
  • Project Managers
  • Those who intend to expand their understanding of ethical and regulatory considerations within the scope of clinical research

Course Details/Schedule

Day 1

  • Introduction to regulatory affairs
  • Intellectual property  management
  • Know about the regulatory strategy into the drug development plan
  • Identify requirements for IND/NDA in the Common Technical Document (CTD) Format

Day 2

  • Plan and prepare an IND/NDA, and know the reporting requirements for IND/NDA amendments
  • Regulatory aspects in pharmacovigilance
  • Regulations governing clinical trials & new drugs
  • Define NDA post-approval responsibilities and requirements

Day 3

  • Identify regulatory mechanisms to facilitate development of new therapies
  • Report adverse events in accordance with current FDA or European  regulations  
  • Regulatory aspects in pharmacovigilance 


Day 4

  • Apply formal meeting principles and practices when interacting with the FDA and European regulations
  • Outline the regulatory requirements for prescription drug labeling
  • Global drug policy &  patent aplications
  • Orphan drugs

Day 5

  • Manufacturing requirements for investigational products
  • Clinical investigator inspections
  • International inspections
  • Electronic data