Regulation of Combination Products

Expert Lecturer: ד"ר Sara Horn

Categories: Clinical Trials, Medical Devices, Pharmaceutical R&D, Pre-clinical, R&D, Regulatory Affairs

SKU: 21432

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The field of combination products is dynamic and is constantly growing and developing in the world and within Israel as well. This field include products made of a combination of different components (such as device, biologics or and/or drugs). The regulatory requirements in this field are getting more and more complex and raise new standards and challenges, due to the...Continue reading

Being these combination products, the development pathways to be used may be different and the strategy chosen might lead to a different outcome in terms of product requirements and time to market. The regulatory strategy to be selected is therefore particularly critical for the success of the development of these types of product.

The course is aimed to provide an overview of the current regulatory guidelines in this field. The course provides information about the life cycle of these products and different regulatory approach for biological products, pharmaceuticals and medical devices and focuses on the possible approaches for these type of products.

Dates: Coming soon.
The course will be scheduled based on the level of interest

Interested? Click here

Course location: Virtual Course

Duration: 1-Day Course

Hours: 09:00 - 12:30

Credits: 2

Course Language: עברית

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Issues to be covered

Introduction
- The history behind the need for combination product regulations
- Definitions
- Differences between drugs/biologics and devices
The regulatory process
- Primary mode of action
- FDA OCP
- RFD content
- Jurisdiction process
- Meetings with RA bodies
Development of combination products
- Non clinical
- Manufacturing
- Clinical
- Meetings with RA bodies
- Development considerations
Products classification and RA strategies
- Combination product types and product classification
- Regulatory challenges and strategy
Downstream issues
- Quality systems and cGMP for combination products
- Post Approval modifications
- Post marketing safety reporting
Borderline products in EU
- Regulatory bodies/processes
- Products classification
Case studies

Who should attend

Quality assurance and regulatory affairs managers and experts
Project managers dealing with combination products
Managers in start-up companies dealing with combination products

Benefits to the Participants

Knowledge of the regulatory bodies that shape this emerging field. Understanding of the main differences in the regulatory requirements of different types of products (device/biologics/drugs). Evaluation of the possible different regulatory approaches and understanding of the processes for a successful product development for these product types. Understanding of the differences in the approaches in US and in EU.