SMRM18008U Labelling as driver for Regulatory Strategy
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.
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
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
- Category
- Hours
- Lectures
- 18
- Preparation
- 30
- Theory exercises
- 8
- Exam
- 25
- Total
- 81
Application deadline is 8 weeks before the first day of instruction. If we have empty seats after the application deadline, it is possible to apply after deadline.
- 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
Course information
- Language
- English
- Course code
- SMRM18008U
- Credit
- 3 ECTS
- Level
- Part Time Master
- Duration
- 3 days
- Placement
- Spring And Autumn
- Schedule
- 3 days full time
- Course capacity
- 35
Study board
- Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
- Department of Pharmacy
Contracting faculty
- Faculty of Health and Medical Sciences
Course Coordinators
- Lene Jørgensen (lene.jorgensen@sund.ku.dk)
- Jesper Kihl (jesper.kihl@sund.ku.dk)