Pharmaceutical Research and Drug Development

Course Information
TitleΦαρμακευτική Έρευνα και Ανάπτυξη Φαρμάκων / Pharmaceutical Research and Drug Development
CodeΜΙΦΒ0009
FacultyHealth Sciences
SchoolMedicine
Cycle / Level2nd / Postgraduate
Teaching PeriodSpring
CoordinatorChrysanthi Sardeli
CommonNo
StatusInactive
Course ID600000114

Programme of Study: PPS Clinical and Industrial Pharmacology - Clinical Toxicology

Registered students: 0
OrientationAttendance TypeSemesterYearECTS

Class Information
Academic Year2017 – 2018
Class PeriodSpring
Faculty Instructors
Weekly Hours2
Class ID
600116766
Type of the Course
  • Background
  • General Knowledge
Course Category
General Foundation
Mode of Delivery
  • Face to face
  • Distance learning
Digital Course Content
Language of Instruction
  • Greek (Instruction, Examination)
Learning Outcomes
The aim of the course is to provide professionals working in or involved with the pharmaceutical and biopharmaceutical innovation industry a basic but broad overview of issues related to pharmaceutical research, new drug development and the regulatory framework. Specifically, after completion of this course the student should be able to: 1) Incorporate the basic principles of pharmacology, pharmacokinetics and biostatistics in the drug development process, intended to ensure the required levels of safety and efficacy. 2) Be able to plan, prepare and submit a comprehensive proposal to develop a new drug (original or generic), including IND and NDA license applications. 3) Be able to identify and solve practical, theoretical and technical problems associated with preclinical and clinical drug trials (including post-marketing surveillance and environmental risk assessment). 4) Be able to understand the function of and be able to communicate and interact with national and international authorities that control the conduct of drug trials and issuing or amending authorization of medicines (original and generic). 5) Know and be able to critically analyze all stages of new drug development (original or generic).
General Competences
  • Apply knowledge in practice
  • Retrieve, analyse and synthesise data and information, with the use of necessary technologies
  • Make decisions
  • Work autonomously
  • Work in teams
  • Work in an international context
  • Work in an interdisciplinary team
  • Generate new research ideas
  • Design and manage projects
  • Respect natural environment
  • Advance free, creative and causative thinking
Course Content (Syllabus)
Drug development Non clinical drug development Design of clinical drug development programs Dose response and concentration response analysis Animal scale up and Phase I studies Disease progression models and clinical trial simulation Physiological and laboratory markers of drug effect/Quality assessment of drug therapy Post-marketing Surveillance Studies GLP/GCP requirements in drug development Environmental risk assessment Drug development for special populations Development of biotechnology products and large molecules Development and applications of cell based therapies Role of the FDA/EMEA in guiding drug development
Keywords
Pharmaceutical Research, Drug Development, Preclinical trials, Clinical trials, Post-marketing surveillance, Environmental risk assessment, Biomarkers, GLP/GCP
Educational Material Types
  • Notes
  • Slide presentations
  • Video lectures
  • Book
Use of Information and Communication Technologies
Use of ICT
  • Use of ICT in Course Teaching
  • Use of ICT in Laboratory Teaching
  • Use of ICT in Communication with Students
  • Use of ICT in Student Assessment
Description
Lectures with powerpoint presentations Digital training material Email communication with the Professors
Course Organization
ActivitiesWorkloadECTSIndividualTeamworkErasmus
Lectures993.3
Written assigments511.7
Total1505
Student Assessment
Description
Written multiple choice type exam
Student Assessment methods
  • Written Exam with Multiple Choice Questions (Summative)
  • Written Assignment (Formative)
Bibliography
Course Bibliography (Eudoxus)
1) Designing Clinical Research, 2013, 4th Edition, Stephen B. Hulley, Steven Cummings, Warren S. Browner, Deborah G. Grady, Thomas B. Newman 2) Design & Analysis of Clinical Trials, 2013, 3rd Edition, Shein-Chung Chow, Jen-Pei Liu
Additional bibliography for study
http://www.ich.org/products/guidelines.html http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/landing/human_medicines_regulatory.jsp&mid= http://www.fda.gov/Drugs/default.htm
Last Update
21-01-2020