Combination Products: Challenges and Expectations (T47)
With the increasing regulatory scrutiny on combination products, this new highly interactive course provides six (6) different aspects of a combination product which are:
- Combination Product GMPs
- Criticality of Design Input and how to define the requirements
- Design Verification and Validation approaches
- What to expect and considerations for Clinical Trial for Combination Products
- Human Factors for Combination Products
- Post Market Considerations
An overview and the intricacies of the GMPs for combination products will be provided that specifically address the challenges and expectations from industry and global regulatory agencies. The development of the basis for the product, testing, and specifications including identifying design inputs, user requirements and design requirements as starting points to the development process will be reviewed in detail.
What You Will Learn
- How to test and how to determine the appropriate level of design validation for combination products, which has been a hot topic recently for regulatory bodies.
- Discussions and interactive sessions for the application of proper design of validation studies, which is critical to assuring that your customers are satisfied and can appropriately use your combination products, will be explored to provide insights into the development for designing validation studies.
- Designing and executing a clinical trial for combination products, which often presents unique challenges, will be explored
- Identifying common questions surrounding clinical trial design including sample size requirements, number and extent of clinical studies required, as well as claims that may be made based on the trials will be discussed
- Case studies for use of drug delivery systems will be provided for an in-depth review
Resources and Activities
- Pre-Course Work Materials
- Interactive Exercises
- Learning Assessments
- Combination Products Definition and Classification
- Jurisdiction, Regulatory Challenges, Regulations / Guidance
- Design Controls
- Design Verification and Validation
- Human Factor Studies
- Clinical Trials
- Post Market Surveillance
- Regulatory and Regulatory Challenges
- Regulation and Guidance Documents
- Case Studies designed as problem-based sessions to develop solutions
Who Should Attend
- Individuals working with Operations, Regulatory Affairs, Clinical Affairs, Manufacturing, Quality, Product and Process Development Engineering
- Project Management professionals
Additional Course Details
Additional content will address key questions regarding establishment of appropriate studies to assure that user requirements have been met.
Human Factors studies are an integral component of product development for most combination products today. This course will discuss the special considerations for designing formative and summative human factors studies for combination products, including unique user group requirements and how they are defined (elderly, visually impaired, pediatrics), sample size, and environmental use conditions. Course participants will review the US FDA’s perspective into common issues and challenges as well as how to address them, and how to best present the information.
Participants should be prepared to work in groups to prepare and organize human factors study data in preparation for a regulatory submission to facilitate a timely US FDA review.
The course will also consider the role of post-marketing safety surveillance and other design corrective and preventive action inputs in product design evolution and validation during the life-cycle of a device containing combination product.
- Clearly define and identify what constitutes a combination product.
- Identify the correct global regulatory agencies, specific regulations and guidance documents applicable to combination products.
- Review the current regulatory challenges for combination products and develop strategies.
- Demonstrate the ability to prepare and maintain design elements.
- Know how to design a verification/validation program for combination products.
- Understand Human Factor Study data and be able to organize it for a submission.
- Determine what specific components are needed for combination product clinical trials.
- Understand the frequency of post market surveillance and how to analyze the required data.
Community of Practice (COP)
This training course is of particular interest to existing and future members of the ISPE Process/Product Development Communities of Practice (COPs).