Finding the Optimal Regulatory Pathway for Your Combination Product

is being presented by Suzanne O'Shea, Of Counsel, with Baker & Daniels, LLP and airs on Thursday, September 15th, 2011. For more details, or to register please visit our site at www.fxconferences.com

Some view combination products as double the burden, but they also represent an opportunity for creativity and flexibility. And within the complexities of combination products, it is still possible to tailor a regulatory pathway that best meets your specific needs.

This audio conference presentation discusses marketing applications, how many are required and how many would best serve your needs. It also looks at whether the device component of a drug – device combination product can serve as a barrier to generic drug market entry. Our speaker also addresses the issue of cross labeling -- what is it? Is it still a possibility? The presentation explores the flurry of recent guidance documents on companion diagnostics, chemical action, and classifying products as drugs or devices. Do they help or hinder? The presentation provides attendees with a solid understanding of these topics, the possibilities arising from combination product innovations, and the current regulatory environment.

Implementing GMP for Combination Products: What Applies When?

For 10 years now FDA has been progressively developing its regulation of the complex product area known as combination products, with very few formal guidance documents for industry. Combination product manufacturers are faced with the challenge of deciding how to implement a quality system that is compliant with applicable Good Manufacturing Practices and Quality System Requirements.

In this audio conference, our speaker discusses the applicable guidance and current thinking on meeting FDA expectations for combination products, sharing specific examples of accepted practices and how FDA regulations and guidance are currently being applied. The presentation also examines the recent history of combination product approvals in the US, as well as important trends and issues for the future.

Implementing GMP for Combination Products: What Applies When? is presented Thursday, Sept. 18, 2008 by Linda Alexander, CEO & Founder, of Alquest. For more information, please visit our site www.fxconferences.com

Implementing GMP for Combination Products: What Applies When?

For 10 years now FDA has been progressively developing its regulation of the complex product area known as combination products, with very few formal guidance documents for industry. Combination product manufacturers are faced with the challenge of deciding how to implement a quality system that is compliant with applicable Good Manufacturing Practices and Quality System Requirements.

In this audio conference, our speaker will discuss the applicable guidance and current thinking on meeting FDA expectations for combination products, sharing specific examples of accepted practices and how FDA regulations and guidance are currently being applied. The presentation will also examine the recent history of combination product approvals in the US, as well as important trends and issues for the future.

Implementing GMP for Combination Products: What Applies When? is presented by Linda Alexander, CEO & Co-Founder, Alquest, Inc. For more details, please visit our site www.fxconferences.com