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FDA/DCGI clinical Trial Requirements Regulations, Compliance, and GCP Conference, Investigator, HiPPA

  • FDA/DCGI clinical Trial Requirements Regulations, Compliance
  • Discuss the Role of the FDA/DCGI District Offices, how they are Structured and their Responsibilities
  • Describe what FDA/DCGI Expects in a Pharmaceutical Clinical Trial
  • Discuss the Science, Regulation and Assessment of Adverse Events
  • Discuss how Studies with Investigational Devices differ from those with Drugs and Biologics
  • Describe the Regulations that Apply to the Informed Consent Process
  • Discuss how the Ethical Principle of Justice underlies Responsible Participant Selection
  • Describe the IRB Regulations and FDA/DCGI’s Mechanisms to Assure Compliance
  • Describe the Parameters included in Regulations Applying to Electronic Signatures
  • Describe how the FDA/DCGI Small Business Representatives assist the Research Community
  • Discuss the Responsibilities of the Clinical Investigator
  • Describe how Pre-IND Meetings and the FDA/DCGI Meeting Process assist the Research Goal
  • Describe the Sponsor/Investigator’s Legal Responsibilities, Additional Duties and Concerns
  • Describe how the FDA/DCGI’s Center for Biologics Regulates Research
  • Discuss the Array of Actions taken when Research Fails to Meet Standards Enforced by the FDA/DCGI
  • Describe how the FDA/DCGI’s Center for Food Safety and Applied Nutrition Regulates Research on Food Additives
  • Describe how the FDA/DCGI’s Office of Science and Health Coordination, Good Clinical Practice Program, Promotes Confidence in Clinical Research
  • Legal, Ethical and Practical Considerations in Protecting Human Research Participants
  • Discuss the fundamentals, history, ethics, and regulatory aspects of the informed consent process and the informed consent document
  • Describe the myriad of challenges associated with successful implementation of informed consent in research
  • Discuss the psychological and biological underpinnings of how subjects process information delivered or shared during the informed consent process and by the informed consent document
  • Discuss the operation of the legal system and its impact on research
  • Discuss specific pediatric regulatory and ethical considerations including recent national and international efforts that impact the conduct of research in children
  • Discuss the training and education of health care professionals related to the ethical conduct of human research.
  • Discuss the critical evaluation and decision-making roles played by the members of the DMC team
  • Discuss what constitutes a conflict of interest and how conflicts may be managed
  • Discuss FDA/DCGI inspection findings and case studies to highlight the impact of inspection failures on subject protection and the quality and integrity of data generated by a clinical trial
  • Discuss how the use of stored biological samples and data prompts ethical questions about privacy and confidentiality.
  • Discuss human research protection issues through case study examples.

Clinical Investigator

Clinical Investigator GCP & Trials Management Conference
for Clinical Investigators and Key Research Staff

  • Describe the Drug Development Process
  • Discuss Investigator and investigational site responsibilities related to regulations and ethics
  • Describe the Protocol Development Process
  • Describe the Research Grant Proposal Development Process
  • Discuss the Informed Consent Process
  • Explain Development of Informed Consent Forms: Rights, Rites, and Rewrites
  • Describe Investigator-Initiated Research Projects
  • Discuss Safety Reporting and Adverse Events / Serious Adverse Events
  • Explain Source Documentation and Research Record Management
  • Discuss the Financial Management of Study Funds
  • Discuss the Elements Related to Successful Successful Clinical Study Agreements
  • Describe the Basic Requirements of Monitoring Visits and Audits
  • Discuss the Development and Implementation of Standard Operating Procedures

 Please note that:

  • Only eligible ICON members (those who have paid their membership fees and those who actively participate in ICON activities such as enrollments in ICON protocols) can avail of benefits from ICON.
  • Registration for the workshop will be strictly on a first come first serve basis as there are limited enrollments.
  • The attached registration form should be sent to Dr G.S. Bhattacharyya latest by 31st December 2009.
  • This program will offer _______________ So CRA Continuing Education Credits