Course objective and outcome

The course is focused on the regulatory challenges for combination products (device + drug/bio) and will give a detailed description of the basic regulatory definitions within US, EU, UK, Canada, Switzerland and Australia and we will go through the approval process focusing on US and EU requirements.

The course will give the participants a solid understanding of submission pathway for pre-filled syringes, injection devices and other combination products and will go through the key content of the ISO 11608 standard and the ISO 11040 standard. The quality challenges within both the pharmaceutical and the medical device business will be a topic covered on the course together with the risk management process following the ISO 14971:2019 standard and the design validation process (usability) according to the IEC 62366 standard. Finally, the course will cover topics such as Design Control and the Good Engineering Practice.

Content

The learning goals of the course are to:

• Give a solid understanding of the basic regulatory definitions & requirements of combination products
• Specify the Submission pathway for prefilled syringes and injection devices in the key markets in the world
• Give a basic knowledge of post approval changes and license maintenance
• Drug vs. Device cGMP
• Give basic knowledge of the risk management process within combination products
• Exchange experience within the authority inspection area
• Introduce the design validation (usability) area with basic in IEC 62366 standard requirements
• Introduction to product design, engineering and manufacturing

The course comprises lectures and interactive workshops. The trainer will follow up on learning objectives throughout the course. This means that you will have to answer questions on the topics covered to ensure that the objectives are met.

Who should attend?

The course is targeted towards professionals who are involved in the following areas:

• Quality Assurance within the combination product area
• Regulatory Affairs working within the combination product area
• Development of combination products
• Development of medical devices intended for delivery of medicine
• Pharmaceuticals who need a better understanding of the medical device business

Recommended minimum pre-requisites for this course are any or all of the following:

• Some years of experience within either the pharmaceutical or medical device business
• Quality professionals who would like to join the regulatory area within combination products
• Development engineers

Trainer

Søren Lyngsø-Petersen, CEO, Phama4ever QA

"Good overview"

"Presentor was good at sharing examples/anecdotes and at presenting the topics in a pragmatic and understandable way"

"New knowledge that will prepare me for submissions especially outside EU. The trainer included great examples. Knowledge sharing between participants. Great atmosphere and room for questions. The trainer had great and relevant experience"

"Getting some perspective on what adheres to the device and what [adheres] to the API"