SMPMA3201U Role and Responsibilities of a Regulatory Affairs Professional

Volume 2013/2014
Education
Master of Pharmaceutical Regulatory Affairs (MPRA)
Content

The first study element consists of the Medicademy module “Role and responsibilities of a regulatory Affairs Professionals”. The key topics are:
-Role and responsibilities in drug development and product life cycle management
-Role of a regulatory affairs organization
-How quality build into daily activities may result in faster submission and approvals
-Quality aspects influence on regulatory affairs
-Basic issues of Good Regulatory Practice (GRP) in polices, processes and standards
-Expectations to regulatory affairs professionals as specialists, coordinators and trouble-shooters
-Values of communication and cooperation skills as a tool to improve performance.

For further information please visit the Medicademy homepage

The second study element is offered by the Faculty of Health and Medical Sciences in which a case is defined within the topic of role and responsibilities of regulatory affairs professionals and the following project report will be supervised by maximal 7 hours. The final project report should contain 7-10 written pages. The project report must include:
-Title Page
-Table of content
-Abstract
-Introduction including relevant law frame and literature within role and responsibilities of a regulatory affairs professional releated to the case as well as presentation of the case
-Discussion of relevant law frame and literature to role and responsibilities of a regulatory affairs professional related to the case
-Conclusion and future perspectives
-Literature list.

Learning Outcome
The course provides comprehensive knowledge regarding role and responsibilities of regulatory affairs professionals in all aspects of a drug development process and product life cycle management. Furthermore, the course provides knowledge with regard to the role of a regulatory affairs organization, and how quality build into daily activities may improve performance and may result in faster submissions and approvals. Knowledge regarding quality aspects influence on regulatory affairs, the basic issues of Good Regulatory Practice (GRP), including polices processes standards and expectations to regulatory affairs professionals as specialists, coordinators, and trouble-shooters, are also included. Communication and cooperation skills of regulatory affairs professionals are discussed.

On completion of the entire course the participants will understand and be able to make plans and decisions with regard to Role and Responsibilities of a Regulatory Affairs Professional.
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 experience within Drug Regulatory Affairs or equivalent qualifications. The applicant must be able to understand, speak and write English at an advanced level.
The course consists of the following 2 elements:

The Medicademy module “Role and Responsibilities of a Regulatory Affairs Professional” which include a 3 days residential module and approximately 1500 pages of self study. The module is followed by written exam. For further information please visit the Medicademy homepage

An individual project report undertaken with the guidance of a supervisor from the Faculty of Health and Medical Sciences. As part of the study, participants must define a relevant case within the area of Role and Responsibilities of a Regulatory Affairs Professional. The case should be described and discussed within the written project report.

In order to initiate the individual project report participants must have passed the Medicademy course.
  • Category
  • Hours
  • Exam
  • 4
  • Lectures
  • 22
  • Preparation
  • 56
  • Project work
  • 55
  • Total
  • 137
Credit
3 ECTS
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 assesment
Credit
2 ECTS
Type of assessment
Written assignment
The final project report should contain 7-10 written pages.
Marking scale
7-point grading scale
Censorship form
No external censorship
Criteria for exam assesment

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 demonstrate 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 regulatory affairs professional

The participant demonstrates that he/she is mastering to combine central concepts and disciplines within regulatory affairs professional 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 demonstrate 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 regulatory affairs professional

The participant demonstrates that he/she is mastering central concepts and disciplines within role and responsabilities of regulatory affairs professional 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 role and responsabilities of regulatory affairs professional

The participant demonstrates that he/she understands central concepts and disciplines within role and responsabilities of regulatory affairs professional 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