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WorldConference

Combination Products


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Who should attend?

Regulatory Affairs Medical Officers Clinical Trial Managers

Details

This seminar provides Professionals working in this area with:

A thorough understanding of the complexities involved

Covers all the relevant regulations and guidelines

Gives real life examples of how to register and maintain various types of combination products

Interfaces: Change Management and LCM

Compliant safety reporting for combination products

Documentation requirements and interfacing

Why you should attend:

Combination products are especially challenging to register and maintain since they consist of two or more regulated components covered by different and usually independent sets of regulations in both the EU and US and various other regions.

Delegates working in this area must keep abreast of current and new legislation in this complex area to ensure a good regulatory strategy and compliance of their products.

Areas Covered in the Session:

Documentation requirements and interfacing

Documentation requirements for combination products EU

Documentation requirements for combination products US

Interfacing, development, quality, regulatory

Managing third parties and document control.

Who will benefit:

Regulatory Affairs

Medical Officers

Clinical Trial Managers

Prices

Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Register now and save $200. (Early Bird)

Contact

John Robinson
globalcompliancepanel@gmail.com

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