Labelling as driver for Regulatory Strategy

Course 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
  • Basic biostatistics, including critical review of chemical manufacturing control, non-clinical and clinical conclusions and clinical relevance
  • Patient reported outcomes, health economics and market access factors with regulatory relevance
  • Patient involvement and perspectives in product information
  • Authority perspectives    
Education

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

 

See course calender for course dates



Course is open for master students and single course students.

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 EU, USA and Japan 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 basic biostatistics skills to impact of what is able to conclude from statistical outcomes 
  • 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 EU, USA and Japan 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

Lectures, groupwork and self-study of course literature

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

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English

Continuous feedback during the course of the semester
ECTS
3 ECTS
Type of assessment
Written assignment
Individual written project assignment
Marking scale
passed/not passed
Censorship form
External censorship
Criteria for exam assessment

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 EU, USA and Japan 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 basic biostatistics skills to impact of what is able to conclude from statistical outcomes 
  • 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 EU, USA and Japan 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

Part time Master and Diploma courses

  • Category
  • Hours
  • Preparation
  • 30
  • Lectures
  • 18
  • Theory exercises
  • 8
  • Project work
  • 25
  • English
  • 81