Combination Products for Pharma – Device Perspective

On-site session with e-course

About the Course

This course is for those with regulatory knowledge in pharmaceuticals who wish to deepen their understanding of the medical device aspect of combination products. The course includes a mandatory e-learning module and an in-person session, equipping you with the knowledge needed to ensure compliance within the EU. The E-course is in English and the on-site session is held in Swedish.

Who Should Attend?

The course is designed for individuals with regulatory expertise in the pharmaceutical field who wish to enhance their understanding of the medical device aspect of combination products and the requirements under the MDR. It is also suited to those relatively new to medical devices who seek to gain knowledge of what is required to obtain approval for a combination product. You might work, for example, in regulatory affairs, quality assurance, or drug development involving administration via a medical device.

Learning Objectives

The goal of the course is to promote compliance with combination product regulations by understanding the interaction between regulatory requirements for pharmaceuticals and medical devices. After the course, participants are expected to:

• Understand the regulatory framework for combination products within the EU.
• Have an overview of the development process for the medical device component of combination products.
• Understand the criteria for determining whether a combination product is regulated as a pharmaceutical or a medical device.
• Be familiar with the roles/responsibilities of key authorities from a medical device perspective.
• Understand product documentation for the medical device aspect of different types of combination products.
• Comprehend the differences between development activities for the medical device component versus the pharmaceutical component, highlighting the importance of risk management, usability, biocompatibility, and clinical requirements.
• Gain insights into the principles of quality management systems (QMS) for medical devices and learn to manage QMS to ensure compliance with both pharmaceutical and medical device regulations.
• Acquire knowledge of EU vigilance requirements and the importance of proper product labeling for the medical device component of combination products.

Structure and Course Content

The course begins with an interactive e-learning module, providing a foundation for understanding combination products (approx. 2 ½ hours). This e-course is mandatory and forms the basis of your knowledge in the area.

After completing the e-course, you are ready for the next step: the in-person session. Here, we will further explore the content of the e-course and expand device knowledge. The goal is to provide an understanding of the medical device aspect of the product development process for pharmaceuticals that require the use of a medical device. You will gain access to the e-course approximately one month before the in-person session and will retain access for a total of 6 months.

Course Content:

• Introduction to Combination Products (drug-device)
• Development of Combination Products in the EU
• Product Documentation for the Medical Device Component of Combination Products
• Compliance Control including Vigilance for the Medical Device Component of Combination Products
• Quality Management for the Medical Device Component of Combination Products

Language: The e-learning module is in English, and the in-person session is in Swedish.