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Key Quality and Regulatory Aspects for the Development of Combination Products


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Who should attend?

All development, regulatory and quality personnel involved in development of combination products (drug/device and device/drug products). Pharmacovigilance/vigilance personnel will find this seminar beneficial. Also device experts looking to expand their knowledge to medicines and vice-versa.

Details

Introduction

Drug/device and device/drug combination products are becoming increasingly important in the medical industry. The development of these products raises a number of complex issues regarding the development process and their manufacture. The quality and regulatory aspects to consider are also challenging. This seminar will clarify the EU and US approach to combination products. It will discuss the requirements for the Device Technical File/Design File. The Biological and Synthetic Drug Regulation will be explained as will the registration procedure for these products. The regulatory strategy to adopt for these products will be considered and the key aspects of GMP and quality processes applicable for these types of products will also be covered, including the data expectations for the Common Technical Document. Delegates will find this a comprehensive overview of the requirements for these combination products and will have an opportunity to discuss the complexities with an expert in this field.

 

Contact

Leigh White
info@management-forum.co.uk

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