SMRM18008U Labelling as driver for Regulatory Strategy

Volume 2024/2025
Education

This course is a compulsory course at  Master of Medicines Regulatory Affairs (MRA) at the University of Copenhagen

 

See homepage for course dates on the webpage for  Master of Medicines Regulatory Affairs



Course is open for master students and single course students.

Content

This course provides you with the necessary competences to prepare and optimize regulatory strategies.

Your role and responsibilities as a regulatory lead professional are emphasized in relation to development, approval and the entire life cycle of a pharmaceutical product.

A strong regulatory storyline of a product requires competences within chemical manufacturing control, non-clinical, clinical, safety, approval procedures, regulatory science, identification of product competitors and market access criteria. Faster approval of treatments may become reality with a strategic approach to the processes.

Product content and information as driver for strategy is a central part of the course. We focus on strategic considerations and challenges from early on in the development through the approval and life cycle processes.

The following topics will cover the rationale for a regulatory strategy:  

  • Intellectual property rights, including patent and patent extension, as well as regulatory data and market exclusivity
  • Applying regulatory intelligence and policy into a medicines development and life cycle for the benefit of the patients, the society and the company at the right time and in the right manner  
  • Target product profile, company core data sheet, product information, including considerations of when to include patients and health technology assessment aspects for the benefit of patients and society
  • Patient reported outcomes, health economics and market access factors with regulatory relevance
  • Patient engagement and perspectives in product information
  • Authority perspectives    
Learning Outcome

After completion of the course, the participants will be able to:

Knowledge

  • Explain and describe the roles and the responsibilities of a regulatory lead professional in the pharmaceutical industry
  • Identify what a regulatory strategy should contain, including general and context specific content
  • Explain and describe why product information is a key driver for approval and market access
  • Explain and describe when to use patient reported outcomes, patient and health technology assessment aspects in product information
  • Explain and describe various types of scientific advice in e.g. EU, USA, Japan and China during medicines development and throughout the entire life cycle    

 

Skills:

  • Analyze and discuss the roles and the responsibilities of a regulatory lead professional in the pharmaceutical industry
  • Analyze and discuss context related challenges in a regulatory strategy and what can be excluded    
  • Analyze and discuss why a regulatory lead professional should challenge the product information from early development and throughout the entire life cycle of a product
  • Analyze, evaluate and apply the relevance of using patient reported outcomes, patient and health technology assessment aspects in product information
  • Discuss when and apply regulatory intelligence and policy work during medicines development and throughout life cycle 
  • Analyze, evaluate and apply when to use various types of scientific advice in e.g. EU, USA, Japan and China during medicines development and throughout the entire life cycle   

 

Competence;

  • Independently and in the most efficient manner initiate, critical reflect and drive the development of a regulatory strategy ensuring a strong, reliable quality based story line for product approvals during the entire product life cycle in a collaborative manner
  • Independently challenge the related product information statement professional experts in the most efficient and collaborative manner, ensuring evidence based, supporting data
  • Independently, critical reflect and drive the development of a competitive, evidence based, approvable product information in the most efficient manner
  • Initiate and facilitate good, respectful and efficient relations to global health authorities, as appropriate
  • Enabling transparent, regulatory science as contributor to the market access process after regulatory approval

Relevante papers, guidelines and other material that will be supplied before the course

See admission requirements at the programme website: https:/​/​mra.ku.dk/​admission/​
Lectures, groupwork and self-study of course literature
  • Category
  • Hours
  • Lectures
  • 18
  • Preparation
  • 30
  • Theory exercises
  • 8
  • Exam
  • 25
  • Total
  • 81
Continuous feedback during the course of the semester
Credit
3 ECTS
Type of assessment
Written assignment
Type of assessment details
Individual written assignment based on a relevant set of questions provided by the course managers.
Aid
All aids allowed

The use AI chatbots, such as ChatGPT or any similar softwares, is not allowed during exams.

Marking scale
7-point grading scale
Censorship form
External censorship
Exam period

Announced on the MRA programme's webpage

Re-exam

The exam form for the reexam is the same as the ordinary exam. See dates in the exam schedule on the MRA programme's webpage

Criteria for exam assesment

Knowledge

  • Identify what a regulatory strategy should contain, including general and context specific content
  • Explain and describe why product information is a key driver for approval and market access
  • Explain and describe when to use patient reported outcomes, patient and health technology assessment aspects in product information
  • Explain and describe various types of scientific advice in e.g. EU, USA, Japan and China during medicines development and throughout the entire life cycle    

Skills

  • Analyze and discuss context related challenges in a regulatory strategy and what can be excluded    
  • Analyze, evaluate and apply the relevance of using patient reported outcomes, patient and health technology assessment aspects in product information
  • Discuss when regulatory intelligence and policy work during medicines development and throughout life cycle 
  • Analyze and evaluate when to use various types of scientific advice in e.g. EU, USA, Japan and China during medicines development and throughout the entire life cycle   

 

Competence

  • Independently challenge the related product information statement professional experts in the most efficient and collaborative manner, ensuring evidence based, supporting data
  • Independently, critical reflect and drive the development of a competitive, evidence based, approvable product information in the most efficient manner