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Below is a listing of all sessions the speaker is scheduled to present.

Daniel Matlis

President

Axendia

Speaker Bio

Daniel R. Matlis is the Founder and President of Axendia a trusted advisor to Life-Science executives on business, technology, and regulatory issues.

Dan's 18-year experience in the life-sciences industry has included projects in research & development, manufacturing, regulatory compliance, business development and information technology.

Prior to founding Axendia, Dan was Vice President and General Manager at Stelex, Inc. a leading consultancy to life-science companies. He started his professional career at
Ethicon, Inc., a Johnson & Johnson Company.

He holds degrees from both Polytechnic University (BS in Electrical Engineering) and New Jersey Institute of Technology (MS in Management.

Dan is the chief contributor and editor of Life-Science Panorama a publication covering business, regulatory and technology issues facing industry executives.

Thursday, March 19, 2009

PharmaMedDevice Symposium

PMD14: The Future of FDA's interactions with Device Manufacturers
Room: 1E07 ~ 9:00AM - 10:00AM (Thursday, March 19, 2009)

Historically, Interactions with the FDA required Life-Scinece Manufacturers to create print and ship reams of paper documents to the agency.
Over the last few years, FDA and the industry have recognized the need to maintain a modern, well-integrated, reliable, efficient and affordable information infrastructure to support FDA administrative and regulatory business operations.
On February 21, 2006, the FDA’s Senior Management approved the formation of a Bioinformatics Board to oversee the planning and control of FDA's bioinformatics activities and to ensure that the activities related to its charge are communicated to all levels of the Agency.
To obtain a deeper understand of the breadth, scope and impact of FDA’s Bioinformatics Board initiatives Axendia conducted a research study focusing on electronic transactions between Medical Device Manufacturers and the FDA throughout the total product lifecycle.
During this session, we will present the findings of this research study and provide analysis on its impact on future interactions between FDA and the industry.
The session will cover:
1. FDA’s Bioinformatics Board charter, role and structure
2. Strategic framework for FDA business automation initiatives
3. Information Technology Initiatives currently underway
4. Regulatory policies and procedures supporting Bioinformatics Board initiatives
5. Data Standards enabling Bioinformatics Board initiatives

Speaker:

Daniel Matlis - President, Axendia

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