Fundamentals of Drug Development and the Conduct of Clinical Trials

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Course Description

This course provides an introduction to the scientific, ethical and regulatory aspects of clinical research. Topics include basic principles and current methodologies used in the drug development field and the conduct of clinical trials, including first-in-human studies (dose-finding, safety, proof of concept, and Phase I), Phase II, Phase III, and Phase IV studies. The recent ICH GCP E6 R2 addendum and its impact on conduct of clinical trials are discussed, and all aspects of the development of a study protocol are addressed, including criteria for the selection of participants, assignment of study treatments, endpoints, randomization procedures, adverse event reporting, and protocol compliance monitoring. The ethical issues that arise at each phase of new biomedical product development are also explored.

Learning Objectives

  • Discuss the role of regulatory bodies in drug development
  • Explain the logistics of the drug development process
  • Provide an overview of regulations and guidance documents for drugs and biologics submissions
  • Discuss content and requirements for the Investigational New Drug (IND) Application
  • Review fundamentals of clinical trial structure and design, including Phases I-IV clinical studies
  • Identify scientific and practical issues associated with the planning of a clinical research study

Who Should Attend

  • Clinical or Project Team Leaders who will be managing projects
  • New Clinical, Regulatory, and Department Staff who will design clinical trial programs
  • Clinical Research Associates, Data Managers or others interested in transitioning into clinical trial management
  • Grant Administrators
  • Medical Directors
  • Medical Writers
  • Regulatory Affairs Professionals
  • Research and Development Personnel


The course will be led by one of the following instructors:

Marina Malikova, Ph.D., MSci, M.A., C.C.R.A., RAC

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Course Outline

Day 1: 8:30 a.m. – 5:00 p.m.

  • Module 1: Drug Development Process, Requirements and GCP Compliance: The drug development process for FDA regulated studies; clinical trial regulatory requirements for drugs and biologics; overview of regulatory requirements to plan, initiate and execute a clinical trial; GCP compliance to ensure ethical and procedural conduct of clinical trials to produce high-quality data
  • Module 2: Clinical Trial Design and Study Population Considerations: Developing clinical trial/fundamental principles of prospective design; selecting a study population
  • Module 3: The Investigational New Drug Application: Transition from pre-clinical to clinical phase of drug development; review the Investigational New Drug (IND) content and application process for human testing of drugs and biologics
  • Module 5: Transition from Clinical Research to Practice:  

Day 1: 8:30 a.m. – 5:00 p.m.   

  • Module 4: Safety Monitoring, GCP Regulations, Ethics and Informed Consent:  Data Safety monitoring committees (DSMBs), integrated safety summaries; safety reporting and requirements; Institutional Review Boards (IRBs); ethical considerations and responsibilities of the parties involved in clinical research; research ethics and informed consent implementation and the responsible conduct of research; overview of required and optional elements of the Informed Consent Form (ICF) according to current FDA and GCP ICH regulations
  • Module 5: Transition from Clinical Research to Practice:: Requirements for a New Drug Application (NDA) and Biologic License Application (BLA) content and regulatory process; key aspects of transition from clinical research to clinical practice; Biologics License Application (BLA) and regulatory requirements for safety and efficacy assessments to be addressed in the study design for biologics
  • Module 6: Assurance of Compliance and Quality in Clinical Research: Review of Industry Gold Standards; Quality by Design (QbD) principles and Risk-Based Monitoring; applying a Quality Risk-Management (QRM) approach in development of relevant Key Performance and Quality Indicators (KP-QIs)

Interactive Activities

  • Review of Informed Consent: Identification of required and optional elements of the consent form according to current FDA and GCP ICH regulations
  • Review of Form FDA 1571 for an IND application: create checklists that encompass timelines and sections needed from different parties involved


Registration Fees

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.     

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Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-19-049-L01-P. Released: 8/19.


Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.