Audio Conference

EMEA vs. Notified Bodies: Best Options for Combination Products Phil Brown Senior Consultant Quintiles Consulting Purchase recording - US$199

Purchase recording of this audio conference 

Does your company manufacture combination products? Are you in the process of deciding whether to classify as a drug or device? Combination products, possessing both pharmaceutical and medical device components, have become attractive to an increasing number of manufacturers. However, as patient need for tissue repair, skeletal reconstruction or even drug delivery becomes more complex and demanding, manufacturers are being faced with the corresponding challenge of dealing with more than one regulatory regime. On one side is EMEA's centralized procedure for pharma products, and on the other stands the EU's Notified Body structure regulating devices. In this audio conference, Phil Brown describes how this complex picture can be mapped, providing practical solutions on how to negotiate products onto the marketplace.

This audio conference will address:

• What actually constitutes a combination product?
• Requirements of the two regulatory routes
• How to choose the most appropriate, efficient route for your combination product
• Key players and stakeholders: who to speak to...and when
• Threats and opportunities for business
  

About the speaker:

Phil Brown is a senior consultant with Quintiles Consulting. As part of the Biological Business Unit, Phil has over 17 years of regulatory affairs experience, 12 of them working directly with combination products as well as human and animal tissue products.

Phil started work with Smith & Nephew in the UK, and after 10 years, which included regulatory support for medical device woundcare programs, moved to the Netherlands to work for Genzyme Biosurgery. In this new capacity, he took direct responsibility for the Biosurgery product portfolio, which included orthopaedic, woundcare and neurological applications.

Throughout his career, Phil has been actively involved in European industry efforts to develop and define future European requirements for 'appropriate' regulations, both at Trade Association and European Commission levels. Phil holds a degree in Chemistry and frequently lectures and writes on European tissue regulatory issues.

Who should attend?

• Business development personnel
• Regulatory affairs staff
• Quality control
• Quality assurance
• International sales and marketing staff
• Senior management

This audio conference is classified as General Interest.

Purchase Options

• Purchase recording US$199