Clinical Development and Documentation

Course content

The first study element consists of the Medicademy module “Clinical Development and Documentation”. The key topics are:

-Global development plan
-General considerations for clinical trials
-Clinical Protocol
-Global Regulatory requirements and new trends
-Clinical study
-PK/PD interaction
-Exploratory clinical development
-Statistics and clinical trials
-Interaction with health authorities
-Documentation in relation to type and application.

The second study element is offered by the Faculty of Health and Medical Sciences in which a case is defined within the topic of clinical development and documentation. The project report will be supervised by maximum 7 hours. The final project report should contain 7-10 written pages (excl. title page, table of content, abstract, and literature list). The project report must include:

-Title Page
-Table of content
-Abstract
-Introduction including relevant law frame and literature to clinical development and documentation related to the case as well as presentation of case
-Discussion of relevant law frame an literature to clinical development and documentation related
to the case

-Conclusion and future perspectives
-Literature list.

Education

Master of Pharmaceutical Regulatory Affairs (MPRA)

Learning outcome

After completing the course the student is expected to be able to:

Knowledge

  • Explain and discuss the required clinical documentation for a Marketing Authorisation

  • Explain and identify the principles of clinical development from phase I to IV

  • Explain and discuss how clinical risk assessment can be handled during development

Skills

  • Create, analyse and evaluate a regulatory strategy plan for the clinical development of a new drug

  • Evaluate the possibilities and consequences of the clinical development plan on the desired label

  • Organize, discuss and communicate a scientific problem in the form of a written project report

Competencies

  • Make plans and take decisions with regard to clinical development and documentation

The course consists of the following 2 study elements:

The Medicademy module “Clinical Development and Documentation” which include a 4 days residential module and approximately 2000 pages of self study. The module is followed by a written exam. For further information please visit the Medicademy homepage

An individual project report undertaken with the guidance of supervisors at The Faculty of Health and Medical Sciences. As part of the study, participants must define a relevant case within the area of clinical development and documentation. The case should be described and discussed within the written project report.

In order to apply for the course the applicant must have a relevant educational background at Bachelor level e.g. a Bachelor degree in Chemistry, Biochemistry, Pharmaceutics, Health Science, Technical Science or equivalent. The applicant should have at least 2 years of experience within Drug Regulatory Affairs or equivalent qualifications. The applicant must be able to understand, speak and write English at an advanced level.

ECTS
See exam description
Type of assessment
Written examination, 4 hours under invigilation
See Medicademy homepage
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assessment

See Medicademy homepage

ECTS
See exam description
Type of assessment
Written assignment
The final project report should contain 7-10 written pages (excl. title page, table of content, abstract, and literature list).
Marking scale
7-point grading scale
Censorship form
No external censorship
Criteria for exam assessment

The grade awarded for the project report constitutes the grade awarded for the course in its totality.

Grade 12

The participant has written an original project report which demonstrates thorough and complete law frame and literature search of which the most important and relevant to the case is selected and properly referenced.

The participant demonstrates that he/she masters to analyze, recapitulate and critically evaluate the most important and relevant law frames and literature for the selected topic

The participant demonstrates correct application of terms and law frames within the field of clinical development and documentation

The participant demonstrates that he/she is mastering to combine central concepts and disciplines within clinical development and documentation in his/her analysis of the case

The participant has written a coherent project report in which the various subtopics of the selected case are excellently balanced and perform within the size limits and frame of the project report

Grade 7

The participant has written a original project report which demonstrates thorough law frame and literature search of which the most relevant to the selected case has been properly referenced

The participant demonstrates ability to analyze, recapitulate and partly evaluate relevant law frames and literature for the selected case

The participant demonstrates fairly correct application of terms and law frames within the field of clinical development and documentation

The participant demonstrates that he/she is mastering central concepts and disciplines within clinical development and documentation and has the ability to relate those to the selected case

The participant has written a coherent project report in which the various subtopics of the case is properly balanced and perform within the size limits and frame of the project report

Grade 2

The participant has written a project report in his/her own words which demonstrates a satisfactory law frame and literature search of which some of the most relevant to the selected case has been referenced.

The participant demonstrates ability to understand, report and occasionally evaluate relevant law frames and literature for the selected case

The participant demonstrates knowledge to apply terms and law frames within the field of clinical development and documentation

The participant demonstrates that he/she understands central concepts and disciplines within clinical development and documentation of relevance to the selected case.

The participant has written a project report in which important subtopics of the case is described within the size limits and frames of the project report

Part time Master and Diploma courses

  • Category
  • Hours
  • Preparation
  • 76
  • Project work
  • 55
  • Lectures
  • 30
  • Exam
  • 4
  • English
  • 165