OD9213 ¨C Regulatory Affairs

Course content

Regulatory affairs play a key role in the development, approval, and marketing of biomaterials and medical devices, including tissue-engineered implantable devices. Regulatory bodies, such as the European Medicines Agency (EMA) in Europe and the Food and Drug Administration (FDA) in the United States, establish and enforce regulations to ensure the safety, efficacy, and quality of medical products. In the field of tissue engineering, regulatory compliance is essential to bring innovative implantable medical devices from concept to market

Students taking the course in regulatory affairs will be introduced to the framework of regulations and guidelines governing every stage of product development and commercialization and explore key regulatory processes applicable to biomaterials and implantable medical devices.

Through lectures, case studies, and interactive discussions, students will develop a deep understanding of the regulatory landscape and its impact on the global?biomaterials' market.

Learning outcome

Knowledge

After complting this course you will be able to

• Understand the regulatory framework governing the development, manufacturing, and commercialization of biomaterials and medical devices, including regulations set forth
• Understand the requirements for good manufacturing practices (GMP), quality management systems (QMS), and risk management from development and till products reach the market
• Understand the factors contributing to implant failure, including mechanical, biological, and material-related issues, and understand how regulatory requirements address safety and performance concerns

Skills

After compliting this course you will be able to

• Analyze the key components of a regulatory submission dossier for a product, including preclinical testing data, clinical trial protocols, and manufacturing processes
• Evaluate the ethical and safety considerations associated with the clinical investigation and use of tissue-engineered implantable medical devices, including informed consent, patient monitoring, and adverse event reporting
• Explore the role of regulatory affairs professionals in coordinating interactions with regulatory authorities, preparing regulatory submissions, and r requests for additional information
• Assess and evaluate real-world examples of regulatory challenges and successes in bringing tissue engineered implantable medical devices to market, considering factors such as product classification, intended use, and patient population.

General competence

By completing this course you will be

Introduced to the regulatory pathways for different classes of tissue-engineered implantable medical devices, including premarket notification and approval.

Introduced to post-market surveillance requirements for tissue-engineered implantable medical devices, including adverse event monitoring, field corrective actions, and device recalls, and their implications for regulatory compliance and patient safety.

Admission to the course

The course is open to all registered PhD students.

Special admission requirements

No special admission requirements.

Formal prerequisite knowledge

No mandatory prerequisites.

Recommended previous knowledge

The course assumes foundational understanding of biomaterials science (e.g., degradation, biocompatibility) and regulatory frameworks (e.g., FDA/EMA pathways, ISO 13485). Familiarity with ATMPs (cell/gene therapy products) and medical device classification (Class I-III) is advantageous. Basic knowledge of clinical trial design (phases I-III) and quality management systems (GMP/GDP) will enhance engagement. Prior exposure to technical documentation or risk management is helpful but not mandatory. Introductory materials will bridge gaps for interdisciplinary participants.

Teaching

10-week program begins with lectures in Weeks 1-2, followed by Workshop 1 in Week 3 where students finalize their essay topics. Week 4 features Lecture 3, while Week 5 combines Lecture 4 with submission of a 2,000-word first draft. Peer reviews of drafts by one peer are due in Week 6, followed by a peer review workshop in Week 7. After the holiday break, the course concludes in Week 10.

Examination

Peer review of the draft of one peer.

4,000-word essay

10-minute oral presentation.

Examination support material

To be announced.

Language of examination

All work submitted must adhere to formal academic English standards, including, discipline-appropriate terminology and flawless citation management of all sources.

Grading scale

A-F

Resit an examination

Late submissions follow standard penalty protocols.

More about examinations at UiO

• Use of sources and citations
• How to use AI as a student
• Special exam arrangements due to individual needs
• Withdrawal from an exam
• Illness at exams / postponed exams
• Explanation of grades and appeals
• Resitting an exam
• Cheating/attempted cheating

You will find further guides and resources at the web page on examinations at UiO.